Document Document Compliance Manual

ISO 9001:2000
Document Development
Compliance Manual
A COMPLETE GUIDE and CD-ROM

Syed Imtiaz Haider, Ph.D.
St. Lucie Press

Boca Raton London New York Washington, D.C.
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Library of Congress Cataloging-in-Publication Data

Haider, Syed Imtiaz.
ISO 9001:2000 document development compliance manual : a complete guide and
CD-ROM / Syed Imtiaz Haider.
p. cm.
Includes bibliographical references.
ISBN 1-57444-308-9 (alk. paper)
1. ISO 9000 Series StandardsHandbooks, manuals, etc. I. Title.
TS156.6 .H32 2001
658.562dc21
2001019637
This book contains information obtained from authentic and highly regarded sources. Reprinted material
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Visit the CRC Press Web site at www.crcpress.com

2001 by CRC Press LLC
St. Lucie Press is an imprint of CRC Press LLC
No claim to original U.S. Government works
International Standard Book Number 1-57444-308-9
Library of Congress Card Number 2001019637
Printed in the United States of America 1 2 3 4 5 6 7 8 9 0
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PREFACE
The ISO 9001:2000 Document Development Compliance Manual: A Complete Guide and CD-ROM provides guidelines to those involved in the
development of quality system manuals and applicable standard operating
procedures (SOPs) to comply with the requirements of international standard ISO 9001:2000 and proceed with the registration/certification process.
The quality manuals (models) and SOPs provided in the CD-ROM are also
a valuable tool for the companies to transform their existing ISO 9001,
ISO 9002, and ISO 9003 quality manuals and SOPs to meet the requirements of revised standards.
The text provides explicit documentation packages to the end users
globally, to develop documentation without spending a lot of money and
resources. The information provided will serve as the first milestone to
lead companies to ISO 9000 registration/certification.
The CD-ROM is user-friendly and provides meaningful understanding
of documentation requirements, which can be adopted by any company
after minor changes suitable to their operations. The contents of the quality
manuals and SOPs are written in simple and precise language to be in
compliance with revised international standard ISO 9001:2000 and provide
readers and front-line management with all the information they need to
make a successfully documented quality system. The manual will ensure
the minimization of documents, to avoid the nightmare of management
representatives at the time of a registration/certification audit.
The text refers to the elements of the standards, however, specific
working formats are not included to ensure that the electronic package
can be used by a diversified range of industries and organizations.
iii
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ACKNOWLEDGMENTS
The author would like to thank his friends and colleagues for their help
and encouragement in this endeavor and for creating a professional
environment that demanded the development of this manual. He would
also like to thank the staff of CRC Press, particularly Drew Gierman, for
his patience and diligence in the production of this work.
Syed Imtiaz Haider
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THE AUTHOR
Syed Imtiaz Haider has a Ph.D. in chemistry
and is a quality assurance specialist with over
10 years of experience in aseptic and nonaseptic pharmaceutical processes and equipment validation, in-process control, and auditing. Dr. Haider is the author and co-author of
more than 20 research publications in international journals dealing with products of
pharmaceutical interest, their isolation, and
structure development. He is a professional
technical writer and author of more than 500
standard operating procedures based on FDA
regulations, ISO 9000, and ISO 14000 standard.
Dr. Haider is a certified auditor of IRCA and a registered provisional
environmental auditor of EARA.
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ABOUT THE MANUAL

This manual takes into account documentation of quality manuals and
applicable procedures based on quality elements described in international
standard ISO 9001:2000. No other manual in print deals exclusively with
the key elements of quality and provides hands-on templates to be tailored
to achieve ISO 9000 registration/certification.
ISO 9001:2000 quality manuals, together with 20 standard operating procedures, provide explicit instructions on how to achieve the standard for
anyone responsible for writing and executing quality manuals and applicable
procedures. Included herein is the ready-to-use template on a CD-ROM that
one can immediately use as his own without reinventing the wheel, thus
saving time and money without missing any critical quality elements.
This manual provides instant answers for quality professionals, quality
assurance managers, auditors, and protocol writers regarding what should
be made part of quality manual standards and ISO 9000 standard operating
procedures to enhance productivity.
INTRODUCTION

Objective
What is Quality?
Correspondence between ISO 9001:1994 and ISO 9001:2000
The Basic Changes
Documentation and Registration/Certification
QUALITY SYSTEMS MANUALS

Model-1: Quality Manual ISO 9001:2000
ix
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ISO 9001:2000 Document Development Compliance Manual

STANDARD OPERATING PROCEDURES

Management Responsibility
Quality Systems
Contract Review
Design Control
Document and Data Control
Purchasing
Customer-Supplied Product
Product Identification and Traceability
Process Control
Inspection and Testing
Inspection, Measuring, and Test Equipment
Inspection and Test Status
Control of Nonconforming Product
Corrective Action
Handling, Storage, Packaging, and Delivery
Quality Records
Internal Quality Audits
Training
Servicing
Statistical Techniques
APPENDICES
Recommended Readings
INDEX
The manual is designed especially for individuals involved in writing
and executing quality manuals and applicable procedures. This manual
provides a complete, single-source reference which details quality manuals
and over 20 explicit procedures based on quality elements described in
the ISO 9001:2000 international standard.
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CONTENTS
100.10
Objective
100.10.1
100.10.2
100.10.3
100.10.4
200.20
Quality Manuals
200.20.1
200.20.2
200.20.3
200.20.4
300.30
What is Quality? ................................................................... 8

Correspondence between ISO 9001:1994
and ISO 9001:2000............................................................. 12
The Basic Changes ............................................................ 22
Documentation and Registration/Certification................. 26
Model-1:
Model-2:
Model-3:
Model-4:
Quality
Quality
Quality
Quality
Manual
Manual
Manual
Manual
ISO
ISO
ISO
ISO
9001:2000 ......................... 32
9001:2000 ....................... 122
9001:2000 ....................... 186
9001:2000 ....................... 248
Standard Operating Procedures

300.30.1
300.30.2
300.30.3
300.30.4
300.30.5
300.30.6
300.30.7
300.30.8
300.30.9
300.30.10
300.30.11
300.30.12
300.30.13
300.30.14
300.30.15
300.30.16
300.30.17
300.30.18
Management Responsibility............................................. 308

Quality Systems................................................................ 314
Contract Review ............................................................... 324
Design Control ................................................................. 330
Document and Data Control .......................................... 340
Purchasing ........................................................................ 348
Control of Customer-Supplied Product.......................... 352
Product Identification and Traceability .......................... 356
Process Control ................................................................ 360
Inspection and Testing .................................................... 366
Inspection, Measuring, and Test Equipment ................. 372
Inspection and Test Status .............................................. 376
Control of Nonconforming Product ............................... 380
Corrective Action ............................................................. 384
Handling, Storage, Packaging, and Delivery ................. 388
Quality Records................................................................ 392
Internal Quality Audits .................................................... 396
Training............................................................................. 402
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xii
300.30.19
300.30.20
Servicing ........................................................................... 406

Statistical Techniques....................................................... 410
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INTRODUCTION
The ISO 9001:2000 Document Development Compliance Manual: A Complete Guide and CD-ROM is designed and written for the quality professionals, auditors, managers, supervisors, and management representatives
who are responsible for writing and maintaining quality management
systems for the successful operation of their companies. This document
provides a set of three model ISO 9001:2000 quality manuals and applicable standard operating procedures (SOPs) revised on the basis of
ISO 9001:2000 international standard. These can be used to manage and
document critical elements in an organization in order to build quality
into the products and services provided by the company.
The numbering of the sections and the related quality manuals and
SOPs begin with 100 and go through 300. In addition, the reader may
add SOPs that are unique to his products and services. The term management representative is used extensively throughout the SOPs. It refers
to the person who has been delegated the authority by organizational
management and deemed responsible for performing the duties associated
with management of the quality system.
The ISO 9001:2000 Document Development Compliance Manual: A
Complete Guide and CD-ROM is comprised of the following three sections.
Objective: This section describes the meaning of quality correspondence between ISO 9001:1994 and international standard
ISO 9001:2000 and basic changes in ISO 9001:2000 international
standard. It also provides a time line chart and documentation,
and describes the registration/certification process.
Quality Manuals: Four template quality manuals are provided as
models. Quality manual Model-1 can be directly adopted by a company planning for the first time for registration/certification to an
international standard ISO 9001:2000. Model-2 will be useful for a
xiii
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xiv
company in possession of ISO 9001 registration/certification that

intends to revise its quality manual and quality system. Organizations
already holding the ISO 9002 and ISO 9003 quality manuals may refer
to Model-3 and Model-4, respectively, to incorporate changes in the
existing ISO 9002 and ISO 9003 quality manuals in order to be in
compliance with the requirements of the ISO 9001:2000 standard.
Standard Operating Procedures: This provides 20 explicit template procedures that can be adopted after minor changes suitable
to each companys operations.
QUALITY MANUAL FORMAT

Your Company Name: At the top of each page of the quality
manual space is provided to enter your company name.
Quality System Manual: The quality manual is assigned a space
to indicate the standard used to document the quality management system.
Manual Serial Number: Each quality manual is assigned a unique
number that appears at the upper right hand corner of the page.
Revision Number: At the right hand corner of each page is the
revision number box, which is provided to document the revision
number.
Written by: The quality manual is assigned a space to provide the
author name, title, and the department with signatures and the date.
Checked by: The quality manual is assigned a space to provide
the name of the person responsible for the verification of the
contents of the manual, the title, and the department with signatures and the date.
Approved by: Each page of the quality manual has a space to
provide the name, title, and department of the person in the quality
assurance unit or the management representative approving the
manual with signatures and the date.
Date Supersedes: Each page of the quality manual is assigned a
space to indicate the issue date of the manual superseded.
Date Issued: Each page of the quality manual is provided with a
space to provide the manuals issue date.
Distributed to: Each top page of the quality manual is assigned a
space to indicate the recipients of the manual.
Controlled Copy Number: Each front page of the quality manual
is assigned a space to provide the copy number assigned to the
manual for distribution.
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Introduction
xv
Section, Clause: Each page of the quality manual has a box to

indicate the section and the applicable clause.
Reasons for Revision: On the top page of the quality manual,
space is provided to describe the reasons for revision of the procedure with the date.
Reference SOP Number: On the last page of each clause
described in the quality manual, space is provided to write the
applicable SOP number.
SOP FORMAT
All SOPs have been designed and formatted to have the same look, and
similar information is located in the same place on all SOPs. Information
common to all SOPs is described below.
Your Company Name: At the top of each page of an SOP, space
is provided to enter your company name.
Subject: The subject of each SOP appears at the upper left hand
corner of the SOP and describes the quality element described in
the SOP.
SOP Number: Each SOP is assigned a unique number that appears
at the upper right hand corner of the SOP, based on the reference
clause of the ISO 9000 series of standard.
Corresponding Clause: All SOPs are provided with a space in the
second line of the SOPs header to provide reference to the corresponding clause of an international standard ISO 9001:2000.
Distributed to: Each SOP is assigned a space to list the recipients
of the SOP.
Based on: Each SOP is assigned a space to list the applicable ISO
9000:1994 series of standard.
Revision Number: At the right hand corner of each page is the
revision number box. The box is provided to document the revision
number.
Written by: Each SOP is assigned a space to provide the author
name, title, and department with signatures and the date.
Checked by: Each SOP is assigned a space to provide the name
of the person responsible for the verification of the procedure, title,
and department with signatures and the date.
Approved by: Each page of the SOP has a space to provide the
name, title, and department of the person in the quality assurance
unit or the management representative approving the SOP with
signatures and the date.
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xvi
Date Supersedes: Each page of the SOP is assigned a space to

indicate the issue date of the SOP superseded.
Date Issued: Each page of the SOP is provided with a space to
provide the SOP issue date.
Page Number: Each SOP page is numbered.
Purpose: Each SOP is supported with reasons, describing the purpose of that SOP.
Responsibility: Each SOP is supported with responsibility, describing the department and the employee responsible for implementing
the procedure.
Definition: Where necessary, definitions are provided in the SOP
for better understanding.
Procedure: Following the responsibility statement are the individual
steps of the SOP. These are arranged in logical order and numbered
sequentially to make the SOP easy to perform, and they are based
on the ISO 9000:1994 series of standards.
Reasons for Revision: At the end of each SOP, space is provided
to describe the reasons for the revision of the procedure with the date.
CD-ROM: An electronic copy of the quality manuals and SOPs are
provided. See pg. 413 of this manual for the CD-ROM instructions.
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RECOMMENDED READINGS
1. ISO 9000-3:1997, Quality Management and Quality Assurance Standards
Part 3: Guidelines for the Application of ISO 9001:1994 to the Development,
Supply, Installation, and Maintenance of Computer Software.
2. ISO 9004: Quality Management Systems Guidelines for Performance
Improvements.
3. ISO 10005:1995, Quality Management Guidelines for Quality Plans.
4. ISO 10006:1997, Quality Management Guidelines to Quality in Project
Management.
5. ISO 10007:1995, Quality Management Guidelines for Configuration Management.
6. ISO 10011-1:1990, Guidelines for Auditing Quality Systems Part 1: Auditing.
7. ISO 10011-2:1991, Guidelines for Auditing Quality Systems Part 2: Qualification Criteria for Quality Systems Auditing.
8. ISO 10011-3:1991, Guidelines for Auditing Quality Systems Part 3: Management of Audit Programs.
9. ISO 10012-1:1992, Quality Assurance Requirements for Measuring Equipment
Part 1: Metrological Confirmation System for Measuring Equipment.
10. ISO 10012-2:1997, Quality Assurance for Measuring Equipment Part 2:
Guidelines for Control of Measurement Processes.
11. ISO 10013:1995, Guidelines for Developing Quality Manuals.
12. ISO/TR 10014:1998, Guidelines for Managing the Economics of Quality.
13. ISO 10015, Quality Management Guidelines for Training.
14. ISO/TR 10017:1999, Guidance on Statistical Techniques for ISO 9001:1994.
15. ISO/TC 178/SC 2/N 378, Quality Management Principles and Guidelines on
Their Application.
16. ISO 9001:2000, Quality Management Systems Requirements.
xvii
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SL3089_frame_100.10 Page 1 Monday, May 7, 2001 11:09 AM
100.10
100.10
OBJECTIVE
This manual is written in general terms so that it can be used as a
procedural guideline by the individual responsible for writing quality
manuals and applicable standard operating procedures and programs. The
format of this manual, these procedures, and the numbering system can
easily be used by small to large companies and are acceptable to ISO
certification bodies.
The CD-ROM consists of manuals and procedures that should be useful
to all companies. As the ISO 9000 series of quality standards becomes
more widely adopted by organizations, both in the United States and
elsewhere in the world, it is essential for compliant companies to create
quality systems manuals and applicable standard operating procedures
(SOPs) for their employees. These SOPs enable both new and experienced
staff to understand the requirements of the ISO 9000 series of standards,
along with the principles and practices of the company, and comply with
these regulations to build the elements of quality into their products and
services with a particular reference to customer satisfaction.
For companies already in compliance with the ISO 9000 series of
standards, and who are registered, certified, and have long since developed
and adopted the quality manual and SOPs, this manual will help them have
an easy transition to the new international standard ISO 9001:2000 requirements. This ISO 9001:2000 Document Development Compliance Manual: A
Complete Guide and CD-ROM will be of enormous value to recently emerged
companies with a big investment in the slogan of quality. While these
companies are few, if any, they will have the expertise to fully understand
the elements of quality and achieve registration/certification.
The ISO 9001:2000 Document Development Compliance Manual: A
Complete Guide and CD-ROM with an included CD-ROM provides an
administrative solution for management both in text and software. The
quality manuals and standard operating procedures on the CD-ROM are
valuable tools, especially for those companies in the process of applying
or planning to apply for registration in the future. The documentation
package is especially relevant to quality management representatives,
designers, internal auditors, and external auditors or to anyone interested
in developing a documented quality system.
The ISO 9000 series of standards (1994) was based on the process
approach. The management organizations that have adopted the 1994
edition of the standards had to describe their business processes and
develop quality manuals and procedures needed to support them. The
revised ISO 9001:2000 international standard model is very clear; it encourages the adoption of the process approach as a means of readily identifying
and managing opportunities for improvement. The present family of 21
standards in the ISO 9000 series is reduced to five.
100.10
The development, implementation, and maintenance of a quality manual and key SOPs are essential for compliance with the ISO 9000 series
of standards and are a requirement of the international standard
ISO 9001:2000. Writing SOPs can be time consuming for those new to the
system. Moreover, the standards do not specify how SOPs are to be written,
what format they should be in, or how many procedures are enough.
Those new to international standard ISO 9001:2000 compliance may
have difficulty knowing the best route to take. Generally, companies
new to applying for registration are allowed an adequate amount of
time for remedial action and demonstration of their commitment and
continuous improvement. Documentation management can, however,
minimize the number of adverse findings for incomplete or missing
SOPs and prevent repeated adverse findings by making the development of SOPs a top priority. The quality manuals and pr ocedures
provided in an electronic form can be easily adapted to any facilitys
needs and style.
The text and CD-ROM provide end users with resource data to develop
and improve their quality system without spending a lot of money on
consultants or reinventing the wheel. The SOPs are made available in
such a form that end users can input them into their computer and use
their own Microsoft Word program to edit and print these documents.
The contents of the quality manuals are written in simple, precise, and
global text in order to be in compliance with the elements of international
standard ISO 9001:2000, which r eplaces the second edition of
ISO 9001:1994 together with ISO 9002 (1994) and ISO 9003 (1994).
The quality manuals and procedures provide users and frontline managers with all the information they need to make a successful documented
quality system based on the international standard ISO 9001:2000 series
of standards.
The contents of the manual are divided into three major sections:
objectives, quality manuals, and standard operating procedures. The first
section addresses the definition of quality, basic changes, correspondence
between international standard ISO 9001 (1994) and ISO 9001:2000, and
the process of documentation development and application for registration
and certification.
The second section contains four template quality manuals written
in compliance with international standard ISO 9001:2000 to provide
the statement of company approach and declaration of interest as to
how the requirements of the ISO 9001:2001 quality management standard are to be addressed. This section is comprised of four sample
quality manuals presented as Model-1, Model-2, Model-3, and Model-4,
respectively.
100.10
Model-1
The quality manual is prepared and maintained in accordance with
ISO 9001:2000, without permissible exclusions.
Model-2
The ISO 9000 series of standards has been adopted by thousands of
companies worldwide since the introduction of registration and certification. Considering the fact that transition to the r evised standard
ISO 9001:2000 will take time, Model-2 can be used wher e quality
manual ISO 9001 already exists and needs to be revised in accordance
with the requirements of ISO 9001:2000. Reference is made to the
applicable clauses of ISO 9001 and ISO 9001:2000. No exclusions are
permitted in Model-2.
Model-3
This model was developed for companies already holding ISO 9002
registration/certification and intending to immediately comply with the
changes recommended in international standard ISO 9001:2000. Model-3
represents the revision of the ISO 9002 quality manual in accordance with
the applicable clauses of the ISO 9001:2000 standard. Sub-clause 7.3 of
design and/or development is excluded from the Model-2 quality manual.
Model-4
The last model is the quality manual for companies already registered,
certified and in compliance with the ISO 9003 (1994) standard. The adoption
of Model-4 will facilitate effective transition to the requirements of international standard ISO 9001:2000. Following are the permissible exclusions:
Sub-clause 7.1: planning of product realization
Sub-clause 7.2.3: customer communication
Sub-clause 7.3: design and development
Sub-clause 7.4: purchasing
Sub-clause 7.5.1: control of production and service provision
Sub-clause 7.5.2: validation of processes for production and service
provision
Sub-clause 7.5.3: identification and traceability
The Model-1 quality manual can be directly adopted by companies
planning to register/certify to international standard ISO 9001:2000 for the
first time. Model-2 is useful for companies in possession of ISO 9001
100.10
registration/certification who intend to revise their quality manual and

system. Organizations already holding ISO 9002 and ISO 9003 quality
manuals may refer to Model-3 and Model-4, respectively, to incorporate
changes into their existing ISO 9002 and ISO 9003 quality manuals in order
to be in compliance with the requirements of the ISO 9001:2000 standard.
The last section of this book provides a set of 20 explicit standard
operating procedures written in a global text to describe the elements of
the revised standard. The contents of the procedures can be specifically
tailored to an individual companys operations, and reference can be made
to specific documents and associated applicable procedures. Taking into
consideration the fact that thousands of companies are already registered
and certified in compliance with the ISO 9001 (1994) or ISO 9002 (1994)
or ISO 9003 (1994) international standards, reference is made to the
corresponding SOPs to indicate applicable clauses of both the second and
the third revisions of the ISO 9000 series of standards.
SL3089_frame_100.10.1 Page 7 Monday, May 7, 2001 11:10 AM
100.10.1
100.10.1
WHAT IS QUALITY?
The official definition of quality is, the totality of features and characteristics of a product or service that bear upon its ability to satisfy stated or
implied needs (ISO 8402). Well-planned design is one of the major
contributing factors to achieving quality within a product or service. It is
therefore necessary to carefully control critical elements of a companys
documentation system with particular reference to each phase of design
in order to ensure that the effects on the end products or services are
not disastrous and are based on customer requirements.
To be successful, an organization must offer services and products that
meet a well-defined purpose or need. A company must satisfy its users,
including delivery time scales. It should be ensured that applicable standards, statuary requirements, and specifications are in compliance. The
offered product or services should be within budget and provide value.
Companies should ensure that their total operations are carefully reviewed
before implementation to reduce the occurrence of error and quickly
correct any error inadvertently made. Control should be demonstrated on
changes through proactive communication and feedback loops between
the company and external interfaces. Training needs must be identified
to promote efficiency and cost-effectiveness.
Over the past decade, we have seen drastic changes in the world
around us. There has been more competition in terms of quality, and
companies have to do more work, accomplish targets, and be proactive
rather than reactive. All this must be accomplished with fewer people. In
addition, the quality must be better than ever, due to competitive forces
and consumer demands. Since the beginning of the new millennium, it
is evident that we are working in a global village where it is impossible
for a company to survive without offering quality products and services.
The quest to achieve excellence in products and services should be
every companys mission, which can only be achieved with a vision to
implement a documented quality system based on a globally accepted
standard (to overcome economic barriers). Compliance to global international standard ISO 9001:2000 will lead your company to:
Supply products that are totally fit for use
Satisfy its users/customers expectations and contractual requirements
Yield profits on the invested resources
Achieve and sustain defined levels of quality
Comply with applicable standards and specifications
Prevent defectives, rather than detect them
Provide value for money
100.10.1
Supply products within delivery time scales agreed upon/required

by the user/customer
Comply with environmental requirements
Work in harmony within an organization without productivity losses
100.10.2
12
100.10.2
CORRESPONDENCE BETWEEN ISO 9001:1994

AND ISO 9001:2000
A number of quality systems standards are in operation worldwide. Their
division into categories is based on the scope of their subject matter. ISO
(International Standardization Organization) is a Geneva-based worldwide
federation of national bodies that normally work together to prepare
international standards through technical committees (TC). Each member
body interested in a subject for which a TC has been established has the
right to be represented on that committee. International organizations,
governmental and nongovernmental, in liaison with the ISO, also participate in the work. The U.S. representative to the ISO is the American
National Standards Institute (ANSI).
The International ISO 9000:1994 series of standards has been established and is based on the British Standard 5750:1987 series, European
Standard EN 29000:1987 series, and Inter national Standard ISO
9000:1987 series. The third edition of ISO 9001 cancels and replaces
the second edition (ISO 9000:1994) together with ISO 9002:1994 and
ISO 9003:1994. It constitutes a revision of these documents. Those
organizations that have used ISO 9002:1994 and ISO 9003:1994 in the
past may use this revised international standard by excluding certain
requirements in accordance with Clause 1.2 of ISO 9001:2000. It should
be noted that where the exclusives in sub-clause 1.2 of ISO/FDIS
9001:2000 are exceeded, conformity to ISO/FDIS 9001:2000 shall not
be cleared. All requirements of the revised standard are generic and
are applicable to all organizations, regardless of type, size, and products
offered. If any requirements of this international standard cannot be
applied due to the nature of an organization, its products can be
considered for exclusion.
The publication of BS EN ISO 9001:2000 has implications for Council
Decision 93/465/EEC of July 22, 1993 concerning the modules for the
various phases of conformity assessment procedures and the rules for
affixing and using the CE conformity marking, which are intended to be
used in the technical harmonization directives. It is important to note that
the modules used in individual technical harmonization directives may
vary in some respects compared to those described in Council Decision
93/465/ECC. In all cases, it is the annex of the applicable directive(s) that
is legally binding. The principles set out in this foreword remain valid
regardless of these variations.
Three of the modules cited in the council decision, i.e., modules E,
D, and H, require that the manufacturer must operate an approved
quality system. The scope of the quality systems r equired by these
modules addresses:
100.10.2
13
Final product inspection and testing (module E)

Production, final inspection, and testing (module D)
Design manufacture, final product inspection, and testing (module H)
Council Decision 93/465/EEC specifies that conformity to the harmonized
standards EN 29001, EN 29002, or EN 29003 provides a presumption of
conformity to the relevant requirements of modules H, D, and E. EN
29001, EN 29002, and EN 29003 were suspended by EN ISO 9001:1994,
EN ISO 9002:1994, and EN ISO 9003:1994, respectively, which, in turn,
are now superseded by EN ISO 9001:2000.
Where organizations wish to implement quality management systems
in conformance with modules E, D, or H, they may use EN ISO 9001:2000.
In seeking compliance with modules D, E, or H, an organization may
exclude specific requirements.
Only those requirements in clause 7 of ISO 9001:2000 pertaining to
the difference between modules E, D, and H may be excluded while
retaining the presumption of conformity. Refer to Table 1.
It should be noted that where the exclusions described in sub-clause
1.2 of EN ISO 9001:2000 are exceeded, conformity to EN ISO 9001:2000
shall not be claimed. Table 2 and Table 3 are provided below to help
companies identify similarities and differences between ISO 9001 (1994)
and international standard ISO 9001:2000, respectively.
Table 2 is provided to help the readers of the manual understand the
basic changes and the correspondence between ISO 9001:1994 and
ISO 9001:2000.
Table 3 provides correspondence between the ISO 9001:2000 and
ISO 9001:1994.
14
100.10.2
Table 1
Module D
Permissible
Exclusions
Module E
Permissible Exclusions
Sub-clause 7.1: planning of

product realization
Sub-clause 7.2.3: customer
communication
Sub-clause 7.3: design and
development
Sub-clause 7.4: purchasing
Sub-clause 7.5.1: control of
production and service
provision
Sub-clause 7.5.2: validation of
processes for production and
service provision
Sub-clause 7.5.3: identification
and traceability
Sub-clause 7.3:
design and/or
development
Module H
Permissible
Exclusions
No exclusions
permitted
It should be noted that no explicit requirements in modules H, D, and E relate

to the concepts of customer satisfaction and continual improvement. As a
consequence, noncompliance with requirements of EN ISO 9001:2000, explicity
related to these concepts, does not infringe upon the presumption of conformity to the appropriate module.
Extracts from BS EN ISO 9001:2000 reproduced with permission of BSI under
licence number 2001SK/0060. Complete standards can be obtained by post from
BSI Customer Services, 389 Chiswick High Road, London W 4 4AL. (Tel +44 (0)
20 8996 9001).
Table 2
ISO 9001:1994
1.0
2.0
3.0
4.0
4.1
4.1.1
4.1.2
Scope
Normative reference
Definitions
Quality system requirements
(title only)
Management responsibility
(title only)
Quality policy
Organization (title only)
ISO 9001:2000
1.0
2.0
3.0
5.1 + 5.3 + 5.4.1
100.10.2
15
Table 2 (Continued)
ISO 9001:1994
ISO 9001:2000
4.1.2.1
4.1.2.2
4.1.2.3
4.1.3
4.2
4.2.1
Responsibility and authority

Resources
Management representative
Management review
Quality system (title)
General
5.5.1
5.1 + 6.1 + 6.2.1 + 6.3
5.5.2
5.6.1 + 5.6.2 + 5.6.3 + 8.5.1
4.2.2
4.2.3
4.3
4.3.1
4.3.2
4.3.3
4.3.4
4.4
4.4.1
4.4.2
4.4.3
Quality system procedures

Quality planning
Contract review (title only)
General
Review
Amendment to a contract
Records
Design control (title only)
General
Design and development planning
Organizational and technical
interfaces
Design input
Design output
Design review
Design verification
Design validation
Design changes
Document and data control
(title only)
General
Document and data approval and
issue
Document and data changes
Purchasing (title only)
General
Evaluation of subcontractors
Purchasing data
Verification of purchased product
Control of customer-supplied
product
4.4.4
4.4.5
4.4.6
4.4.7
4.4.8
4.4.9
4.5
4.5.1
4.5.2
4.5.3
4.6
4.6.1
4.6.2
4.6.3
4.6.4
4.7
4.1 + 4.2.1 + 4.2.2 + 5.1 +

5.4.1
4.2.1
5.4.2 + 6.2.1 + 7.1
5.2 + 7.2.1 + 7.2.2 + 7.2.3

7.2.2
7.2.2
7.3.1
7.3.1
7.2.1
7.3.3
7.3.1
7.3.1
7.3.1
7.3.7
+ 7.3.2
+ 7.3.4
+ 7.3.5
+ 7.3.6
4.2.1 + 4.2.3
4.2.3
4.2.3
7.4.1
7.4.2
7.4.3
7.5.4
16
100.10.2
Table 2 (Continued)
ISO 9001:1994
4.8
4.9
4.10
4.10.1
4.10.2
4.10.3
4.10.4
4.10.5
4.11
4.11.1
4.11.2
4.12
4.13
4.13.1
4.13.2
4.14
4.14.1
4.14.2
4.14.3
4.15
4.15.1
4.15.2
4.15.3
4.15.4
4.15.5
4.15.6
4.16
4.17
4.18
4.19
4.20
Product identification and

traceability
Process control
Inspection and testing (title only)
General
Receiving inspection and testing
In-process inspection and testing
Final inspection and testing
Inspection and test records
Control of inspection, measuring,
and test equipment (title only)
General
Control procedure
Inspection and test status
Control of nonconforming product
(title only)
General
Review and dispositioning of
nonconforming product
Corrective and preventive action
(title only)
General
Corrective action
Preventive action
Handling, storage, packaging,
preservation, and delivery
(title only)
General
Handling
Storage
Packaging
Preservation
Delivery
Control of quality records
Internal quality audits
Training
Servicing
Statistical techniques (title only)
ISO 9001:2000
7.5.3
6.3 + 6.4 + 7.1 + 7.5.1 + 7.5.2
+ 8.2.3
7.1 + 8.1
7.4.3 + 8.2.4
7.4.3 + 7.5.1 + 8.2.4
7.4.3 + 8.2.4
7.5.3 + 8.2.4
7.6
7.6
7.5.3
8.3
8.3
8.5.2 + 8.5.3
8.4 + 8.5.2
8.4 + 8.5.3
7.5.5
7.5.5
7.5.5
7.5.5
7.5.1 + 7.5.5
4.2.4
8.2.2 + 8.2.3
6.2.1 + 6.2.2
7.1 + 7.5.1
100.10.2
17
Table 2 (Continued)
ISO 9001:1994
4.20.1
4.20.2
Identification of need
Procedures
ISO 9001:2000
8.1 + 8.2.3 + 8.2.4 + 8.4

20 8996 9001).
Table 3
ISO 9001:2000
1.0
1.1
1.2
2.0
3.0
4.0
4.1
4.2
4.2.1
4.2.2
4.2.3
4.2.4
5.0
5.1
5.2
5.3
5.4
5.4.1
5.4.2
5.5
5.5.1
5.5.2
5.5.3
Scope
General
Application
Normative reference
Terms and definitions
Quality management system
(title only)
General requirements
Documentation requirements
(title only)
General
Quality manual
Control of documents
(title only)
Management commitment
Customer focus
Quality policy
Planning (title only)
Quality objectives
planning
Responsibility, authority, and
communication (title only)
Internal communication
ISO 9001:1994
1.0
2.0
3.0
4.2.1
4.2.1 + 4.5.1
4.2.1
4.5.1 + 4.5.2 + 4.5.3
4.16
4.1 + 4.1.2.2 + 4.2.1

4.3.2
4.1.1
4.1.1 + 4.2.1
4.2.3
4.1.2.1
4.1.2.3
18
100.10.2
Table 3 (Continued)
ISO 9001:2000
5.6
5.6.1
5.6.2
5.6.3
6.0
6.1
6.2
6.2.1
6.2.2
6.3
6.4
7.0
7.1
7.2
7.2.1
7.2.2
7.2.3
7.3
7.3.1
7.3.2
7.3.3
7.3.4
7.3.5
7.3.6
7.3.7
7.4
7.4.1
7.4.2
7.4.3
7.5
7.5.1
Management review (title only)

General
Review input
Review output
Resource management (title only)
Provision of resources
Human resources (title only)
General
Competence, awareness, and
training
Infrastructure
Work environment
Product realization (title only)
Planning of product realization
Customer-related processes
(title only)
Determination of requirements
related to the product
Review of requirements related to
the product
Customer communication
Design and development (title only)
Design and development inputs
Design and development outputs
Design and development review
Design and development verification
Design and development validation
Control of design and development
changes
Purchasing process
Purchasing information
Production and service provision
(title only)
Control of production and service
provision
ISO 9001:1994
4.1.3
4.1.3
4.1.3
4.1.3
4.1.2.2
4.1.2.2 + 4.2.3 + 4.18
4.18
4.1.2.2 + 4.9
4.9
4.2.3 + 4.9 + 4.10.1
4.3.2 + 4.3.3 + 4.3.4

4.3.2 + 4.3.3 + 4.3.4
4.3.2
4.4.2 + 4.4.3 + 4.4.6 + 4.4.7 +
4.4.8
4.4.4
4.4.5
4.4.6
4.4.7
4.4.8
4.4.9
4.6.2
4.6.3
4.6.4 + 4.10.2 + 4.10.3 +
4.10.4
4.9 + 4.10.3 + 4.15.6 + 4.19
100.10.2
19
Table 3 (Continued)
ISO 9001:2000
7.5.2
7.5.3
7.5.4
7.5.5
7.6
8.0
8.1
8.2
8.2.1
8.2.2
8.2.3
8.3
8.4
8.5
8.5.1
8.5.2
8.5.3
Validation of processes of production

and service provision
Identification and traceability
Customer property
Preservation of product
Control of monitoring and measuring
devices
Measurement, analysis, and
improvement (title only)
General
Monitoring and measurement
(title only)
Customer satisfaction
Internal audit
Monitoring and measurement of
processes
Control of nonconforming product
Analysis of data
Improvement (title only)
Continual improvement
Corrective action
Preventive action
ISO 9001:1994
4.9
4.8 + 4.10.5 + 4.12
4.7
4.15.2 + 4.15.3 + 4.15.4 +
4.15.5 + 4.15.6
4.11.1 + 4.11.2
4.10 + 4.17 + 4.20.1
4.17
4.9 + 4.17 + 4.20.1
4.13.1 + 4.13.2
4.14.2 + 4.14.3 + 4.20
4.1.3
4.14.1 + 4.14.2
4.14.1 + 4.14.3

20 8996 9001).
100.10.3
22
100.10.3
THE BASIC CHANGES

The third edition of ISO 9001 cancels and replaces the second edition of
ISO 9001:1994 together with ISO 9002:1994 and ISO 9003:1994. Those
organizations that have used ISO 9002:1994 and ISO 9003:1994 in the past
may use this revised international standard by excluding certain requirements in accordance with clause 1.2.
The revised and adopted module ISO 9001:2000 makes the quality
system management requirements extremely clear. The review of Tables
1 and 2, under the heading Correspondence between ISO 9001 (1994)
and ISO 9001:2000, reveals that the same processes are specified in
both standards, even though they have dif ferent names and subheadings. The quality system requirements in ISO 9001:2000 are comprehensively grouped under clause 7 with additional emphasis on
customer satisfaction and internal communication. Where exclusions
are made, claims of conformity to this international standard are not
acceptable unless these exclusions are limited to the requirements
within clause 7. Such exclusions do not affect the organizations ability
or responsibility to provide products that fulfill customer and applicable
regulatory requirements.
The quality management principles stated in ISO 9004 were taken into
consideration during the development of this international standard. This
standard promotes the adoption of a process appropriate when developing, implementing, and improving the effectiveness of a quality management system to enhance customer satisfaction by meeting customer
requirements. The following eight management principles are integrated
into the ISO 9001:1994 standard and revised as the third edition of
ISO 9001:2000.

Role of leadership
Involvement of employees
The business process approach
Systematic approach to management
A factual approach to decision making
Mutually beneficial relationship with supplier
It is important for an organization to understand current and future needs

and expectations, as well as quantify customer satisfaction and act on it.
Those in positions of leadership should deploy policies and verifiable
objectives, establish vision, and give direction to shared values. Management should set challenging goals and implement strategies to
100.10.3
23
achieve those goals, as well as empower qualified employees with a

documented system.
The standards emphasize creating personal ownership of an organizations goals by using the experience and knowledge of qualifi ed
and trained personnel with identified authority and responsibility to
continuously work toward process improvement. A system should be
established for the identification of internal and external customers and
suppliers of processes. Process activities should be focused to adequately use the personnel, materials, machines, and methods to demonstrate control. All processes within a system should be identified and
aligned for their interdependency with measurable organization goals
and objectives. Continuous improvement should be ensured with realistic and challenging goals, and adequate resources should be provided
to meet the companys needs in terms of people and equipment to
accomplish customer requirements. Continual improvement should be
ensured through management services, internal/external audits, and
corrective and preventive actions. The analysis of data and information
such as customer complaints, nonconfor ming products, and audits
should be conducted on continuous basis to enhance productivity and
minimize waste rework and rejections. Cost improvement projects
should be implemented.
Efforts should be made to establish strategic alliances and to ensure
joint development and the continuous improvement of products, processes, and systems. The company should ensure thorough review and
evaluation of the performance of subcontractors in order to meet customer requirements.
ISO 9000 defines system processes as activities that use resources to
transform input into output. Inputs to a process are often outputs from
other processes. Any activity or operation that receives inputs and converts
them to outputs can be considered a process. Almost all product and/or
service activities and operations are processes. For organizations to function, they have to define and manage numerous linked processes. Often,
the output from one process will directly form the input into the next
process. The systematic identification and management of the various
processes employed within an organization, and particularly the interactions between such processes, may be referred to as the process
approach to management.
The proposed new version of the international standard encourages the
adoption of the process approach for both the management of the organization and its processes and as a means of readily identifying and managing
opportunities for customer satisfaction with continuous improvement.
100.10.4
26
100.10.4
DOCUMENTATION AND REGISTRATION/CERTIFICATION

ISO 9001:2000 registrants are familiar with the phrase quality manual and
standard operating procedures. A company cannot comply with registration
requirements if there is no approved quality manual/standard operating
procedures/working formats and records. The quality manual documentation should be completed by the top management to ensure commitment
at all the appropriate levels within the organization. The quality policy,
goals, and objectives defined in the quality manual must be verifiable. The
applicable procedures should be established and documented by the company prior to the certification process. Normally, the development of a
quality manual and applicable procedures is the most time-consuming factor,
and the time may vary from small to large organizations. However, documentation time can be greatly reduced using these sample quality manuals
and standard operating procedures. Users should go through this text and
review their current systems in order to incorporate changes in these
electronic files, which may take 4 to 12 weeks. It is expected that the
documented quality standards will be in place and implemented at least
three months prior to the registration audit.
For the documentation development process, refer to Figure 1.
Figure 2 provides guidelines for the registration/certification process,
which is self-explanatory.
Figure 3 provides an ISO 9001:2000 documentation and certification
time line.
100.10.4
Review international
standard ISO 9000 Series
Development Manual
Review ISO 9001:2000
international standard
Review customer and
statutory requirements
applicable to your
operations
Amend electronic files

provided on CD-ROM to
incorporate change as per
the companys operations
Provide training
Systems implemented
minimum 3 months
Perform audit
Conduct management
review
Contact certification body,

local office
Figure 1 The documentation development process.
27
28
Certification body
contacted
Questionnaire completed
and returned with
application forms
Pre-assessment
(optional)
Desk study
by certification body
Documentation amendment
if necessary
No
Recommended or approved
Yes
Recommended, approved
Surveillance every
six months
Figure 2 The assessment process.
Corrective action
Reassessment
100.10.4
SL3089_frame_100.10.4 Page 29 Tuesday, May 8, 2001 11:42 AM
100.10.4
Task
Responsibility
Company audit
questioner
Preparation of quality
manual (QM)
Finalization of quality
manual (QM)
Preparation of SOPs
(20)
Training of staff
ABC Company
1st
2nd
3rd
Month
4th
5th
ABC Company
ABC Company
ABC Company
ABC Company
Implementation of
procedure
Management review
ABC Company
ABC Company
Internal audit
ABC Company
Training of lead
auditors
Pre-inspection
Final inspection
ABC Company
ABC Company
ABC Company
Figure 3 ISO 9001:2000 documentation and certification schedule.
6th
7th
29
200.20.1
32
200.20.1
YOUR COMPANY NAME HERE

QUALITY ASSURANCE DEPARTMENT
QUALITY SYSTEMS MANUAL
MODEL - 1
PREPARED AND MAINTAINED IN ACCORDANCE WITH
ISO 9001:2000
Written by:
Checked by:
Approved by:
Date Supersedes
Date Issued
Manual Serial No.
mm/dd/yyyy
mm/dd/yyyy
QM-1
DISTRIBUTED TO
1) Managing Director
2) Quality Assurance
3) Marketing
4) ISO Management Representative
5)
6)
Revision No: 0
CONTROLLED COPY NO.
Copy-1
Copy-2
Copy-3
Master
Reasons for Revision:

mm/dd/yy 1) First time issued for (your company name).
200.20.1
33
TABLE OF CONTENTS
QUALITY SYSTEMS MANUAL REFERS TO ISO 9001:2000
Contents
Quality Management Systems Requirement (title only) . . .
Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Normative Reference . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Terms and Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . .
Quality Management System (title only) . . . . . . . . . . . . . .
General Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . .
Documentation Requirements (title only) . . . . . . . . . . . . .
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Quality Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Control of Documents . . . . . . . . . . . . . . . . . . . . . . . . . . .
Control of Quality Records. . . . . . . . . . . . . . . . . . . . . . . .
Management Responsibility (title only) . . . . . . . . . . . . . . .
Management Commitment . . . . . . . . . . . . . . . . . . . . . . . .
Customer Focus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Quality Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Planning (title only) . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Quality Objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Quality Management System Planning . . . . . . . . . . . . . . .
Responsibility, Authority, and Communication (title only) .
Responsibility and Authority. . . . . . . . . . . . . . . . . . . . . . .
Management Representative . . . . . . . . . . . . . . . . . . . . . . .
Internal Communication . . . . . . . . . . . . . . . . . . . . . . . . . .
Management Review (title only) . . . . . . . . . . . . . . . . . . . .
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Review Input . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Review Output. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Resource Management (title only). . . . . . . . . . . . . . . . . . .
Provision of Resources . . . . . . . . . . . . . . . . . . . . . . . . . . .
Human Resources (title only) . . . . . . . . . . . . . . . . . . . . . .
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Competence, Awareness, and Training . . . . . . . . . . . . . . .
Clauses
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. .1.0
. .1.1
. .1.2
. .2.0
. .3.0
. .4.0
. .4.1
. .4.2
4.2.1
4.2.2
4.2.3
4.2.4
. .5.0
. .5.1
. .5.2
. .5.3
. .5.4
5.4.1
5.4.2
. .5.5
5.5.1
5.5.2
5.5.3
. .5.6
5.6.1
5.6.2
5.6.3
. .6.0
. .6.1
. .6.2
6.2.1
6.2.2
34
Infrastructure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Work Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Product Realization (title only) . . . . . . . . . . . . . . . . . . . . . . .
Planning of Product Realization . . . . . . . . . . . . . . . . . . . . . .
Customer-Related Processes (title only). . . . . . . . . . . . . . . . .
Determination of Requirements Related to the Product. . . . .
Review of Requirements Related to the Product . . . . . . . . . .
Customer Communication . . . . . . . . . . . . . . . . . . . . . . . . . .
Design and Development (title only) . . . . . . . . . . . . . . . . . .
Design and Development Planning . . . . . . . . . . . . . . . . . . .
Design and Development Inputs . . . . . . . . . . . . . . . . . . . . .
Design and Development Outputs . . . . . . . . . . . . . . . . . . . .
Design and Development Review. . . . . . . . . . . . . . . . . . . . .
Design and Development Verification. . . . . . . . . . . . . . . . . .
Design and Development Validation. . . . . . . . . . . . . . . . . . .
Control of Design and Development Changes . . . . . . . . . . .
Purchasing (title only) . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Purchasing Process. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Purchasing Information . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Verification of Purchased Product . . . . . . . . . . . . . . . . . . . . .
Production and Service Provision (title only) . . . . . . . . . . . .
Control of Production and Service Provision . . . . . . . . . . . .
Validation of Processes for Production and Service Provision
Identification and Tracebility . . . . . . . . . . . . . . . . . . . . . . . .
Customer Property . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Preservation of Product . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Control of Monitoring and Measuring Devices . . . . . . . . . . .
Measurement, Analysis, and Improvement (title only) . . . . . .
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Monitoring and Measurement (title only) . . . . . . . . . . . . . . .
Customer Satisfaction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Internal Audit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Monitoring and Measurement of Processes . . . . . . . . . . . . . .
Monitoring and Measurement of Product . . . . . . . . . . . . . . .
Control of Nonconforming Product . . . . . . . . . . . . . . . . . . .
Analysis of Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Improvement (title only) . . . . . . . . . . . . . . . . . . . . . . . . . . .
Continual Improvement . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Corrective Action . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Preventive Action. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Appendix I (Reference SOPs)
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200.20.1
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. .6.3
. .6.4
. .7.0
. .7.1
. .7.2
7.2.1
7.2.2
7.2.3
. .7.3
7.3.1
7.3.2
7.3.3
7.3.4
7.3.5
7.3.6
7.3.7
. .7.4
7.4.1
7.4.2
7.4.3
. .7.5
7.5.1
7.5.2
7.5.3
7.5.4
7.5.5
. .7.6
. .8.0
. .8.1
. .8.2
8.2.1
8.2.2
8.2.3
8.2.4
. .8.3
. .8.4
. .8.5
8.5.1
8.5.2
8.5.3
200.20.1
35

SCOPE
Correspondence clause of
ISO 9001:2000
Written by:
Clause 1.0
ISO 9001:1994
1.0 + 1.1
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
SCOPE
The quality system manual is applicable to (company name) products,
activities, and services and includes design manufacture and final product
inspection and testing.
GENERAL
The ISO 9001:2000 international standard adopted by (company name)
specifies requirements for a quality management system to demonstrate
the ability to consistently provide products that meet customer satisfaction
and applicable regulatory requirements. The objective is to enhance customer satisfaction through the effective application of the system, including
processes for continual improvement of the system. In this quality system
manual, the term product applies only to the product intended for, or
required by, a customer. It should be noted that no exclusion is permitted
in the adopted model.
36
200.20.1

APPLICATION
ISO 9001:2000
Written by:
Clause 1.0
ISO 9001:1994
1.2
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
APPLICATION
The requirements of ISO 9001:2000 international standards are generic
and are applicable to all the departments of (company name), their size,
nature of their operation, and the product or product part manufactured.
Where any requirement (s) of this international standard cannot be
applied due to the operations of (company name), its products are excluded.
Claims of conformity to this international standard where exclusions
are made are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organizations
ability or responsibility to provide products that fulfill our customers and
applicable regulatory requirements.
200.20.1
37

NORMATIVE REFERENCE
ISO 9001:2000
Written by:
Clause 2.0
ISO 9001:1994
2.0
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
NORMATIVE REFERENCE
The quality system manual contains provisions of the international standard ISO 9001:2000 and ISO 9001 (1994).
38
200.20.1

TERMS AND DEFINITIONS
ISO 9001:2000
Written by:
Clause 3.0
ISO 9001:1994
3.0
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 8
mm/dd/yyyy
mm/dd/yyyy

The following terms, used in this edition of ISO 9001 to describe the
supply chain, have been changed in the quality system manual and
applicable standard operating procedure to reflect the vocabulary currently used.
The term organization is replaced by the term supplier used in
ISO 9001:1994 and refers to the unit to which this international standard
applies. Also, the term supplier is replaced by the term subcontractor.
Throughout the text of this quality system manual and applicable
procedure, the term product also means service.
For the purposes of this international standard ISO 9001:2000, the terms
and definitions given in ISO 9000 are applicable.
200.20.1
39

ISO 9001:2000
Written by:
Clause 3.0
ISO 9001:1994
3.0
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 2 of 8
mm/dd/yyyy
mm/dd/yyyy
Analysis Certificate
The analysis certificate is the document that gives the results of the
inspection made on a representative sample taken from a product before
its delivery. It must contain the results of all checks in a list approved
jointly by the client and the supplier.
Auditor
A person who is qualified and authorized to perform all or any portion
of a quality system audit is an auditor.
Audit
An audit is a systematic and independent examination to deter mine
whether quality activities and related results comply with planned arrangements, and whether these arrangements are implemented effectively and
are suitable to achieve objectives.
Audit Organization
An audit organization is an organization that regularly conducts quality
assurance management system audits to a required standard.
Batch
A batch represents assignments of a batch of finished products to a client
as a function of that clients requirements.
40
200.20.1

ISO 9001:2000
Written by:
Clause 3.0
ISO 9001:1994
3.0
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 3 of 8
mm/dd/yyyy
mm/dd/yyyy
Conformity
Conformity means the state of a product satisfying specified requirements.
Documentation
Documentation refers to any recorded or pictorial information describing,
defining, specifying, reporting, or certifying activities, requirements, procedures, or results.
Documentation Level
The documentation level refers to the position of a quality document in
the quality assurance documentation system.
First Party Audits

Audits carried out internally by an organization are called first party audits.
Inspection
An inspection is an examination or measurement to verify whether an
item or activity conforms to a specified requirement.
Inspectors
Inspectors are appointed by the purchaser to provide advice on matters
relating to products and inspection and to verify the achievement of the
quality specified.
200.20.1
41

ISO 9001:2000
Written by:
Clause 3.0
ISO 9001:1994
3.0
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 4 of 8
mm/dd/yyyy
mm/dd/yyyy
Lead Auditor
An Auditor who is qualified and authorized to manage a quality system
audit is called a lead auditor.
Management Review
Management review is a compulsory evaluation carried out by general
management on the state and suitability of the quality system with respect
to quality policy and new objectives resulting from the changed situation.
Nonconformity
Nonconformity refers to the state of a product not satisfying specified
requirements.
Organization
An organization is a unit to which this international standard applies.
Provisional Auditor
A provisional auditor is a person who meets all requirements for registration except for audit experience.
Quality
Quality means all properties and characteristics of a service that make it
capable of satisfying a clients expressed or specified needs.
42
200.20.1

ISO 9001:2000
Written by:
Clause 3.0
ISO 9001:1994
3.0
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 5 of 8
mm/dd/yyyy
mm/dd/yyyy
Quality Audit
A quality audit is a methodical and independent examination in order to
determine if quality-related activities and results satisfy predetermined
requirements, and if these requirements are implemented efficiently and
are capable of achieving the objectives.
Quality Assurance
Quality assurance refers to all predetermined and systematic actions necessary to give appropriate confidence that a product or a service satisfies
given quality requirements.
Quality Control
Quality control is that part of good manufacturing practice concerned with
sampling, specifications, and testing. Its organization, documentation, and
release procedures ensure that the necessary and relevant tests are actually
carried out, that materials are not released for use and products released
for sale or supply, until their quality has been judged to be satisfactory.
Quality Manual
The quality manual is a document describing general measures taken by
the company to obtain quality in its products or services.
200.20.1
43

ISO 9001:2000
Written by:
Clause 3.0
ISO 9001:1994
3.0
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 6 of 8
mm/dd/yyyy
mm/dd/yyyy
Quality Planning
A document specifying the processes of the quality management system
(including the product realization processes) and the resources to be
applied to a specific product, project, or contract can be referred to as
quality plan.
Quality Policy
A quality policy includes the overall quality intentions and direction of
an organization as formally expressed by top management.
Quality (or Quality-Related) Record

The quality record refers to the filled-in documents proving that the quality
assurance and quality control actions have been done.
Quality System
The organizational structure, responsibilities, procedures, processes, and
resources for implementing quality management comprise the quality
system.
Quality Surveillance
Quality surveillance refers to the continued monitoring and verification of
the status of procedures, methods, conditions, processes, products and
services, and analysis of records in relation to stated references to ensure
that specified requirements for quality are being met.
44
200.20.1

ISO 9001:2000
Written by:
Clause 3.0
ISO 9001:1994
3.0
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 7 of 8
mm/dd/yyyy
mm/dd/yyyy
Representative Sample
A representative sample is a sample taken using a clearly defined procedure in order to obtain information about a batch.
Second Party Audits

Second party audits are audits of suppliers or potential suppliers undertaken directly by a purchasing organization including the purchase of
products by one company from another within the same group.
Specification
The specification is the document that specifies the requirements with
which the product and/or material must comply.
Supplier
The organization or company is also called the supplier.
Subcontractor
Any organization offering goods or services to the supplier is known as
a subcontractor.
Third Party Audits

Audits of organizations undertaken by an independent certification body
or similar organization are called third party audits.
200.20.1
45

ISO 9001:2000
Written by:
Clause 3.0
ISO 9001:1994
3.0
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 8 of 8
mm/dd/yyyy
mm/dd/yyyy
Traceability
Traceability is the capability of finding the history, use, or location of an
article by means of a recorded identification.
Validation
Validation is the act of checking a calculation or design through its stages
to verify that the assumptions made, input data, and method used have
produced a valid result.
Verification
The act of reviewing, inspecting, testing, checking, auditing, or otherwise
verifying and documenting whether items, processes, services or documents conform to specified requirements is known as verification.
This list is not conclusive as there are many other terms in general use
or contained in various standards and quality documents.
46
200.20.1

QUALITY MANAGEMENT SYSTEM Clause 4.2.1
ISO 9001:1994
4.0
ISO 9001:2000
Written by:
Checked by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Revision 0
Approved by:
Page 1 of 1
QUALITY MANAGEMENT SYSTEM

The quality management system is based on inter national standard
ISO 9001:2000, which can be effectively applied to (company name)
products, activities, and processes.
Reference Procedure [Number ISO-4.2, dated mm-dd-yyyy]
200.20.1
47

GENERAL REQUIREMENTS
ISO 9001:2000
Written by:
Clause 4.2.1
ISO 9001:1994
4.1
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
GENERAL REQUIREMENTS
(Company name) has established, documented, implemented, and maintained a quality management system and continually improved its effectiveness in accordance with the requirements of this international standard.
The organization has identified the process needed for the quality
management system and its application throughout the organization, and
has determined the sequence and interaction of these processes as well
as criteria and methods needed to ensure that both the operation and
control of these processes are effective. The top management has ensured
the availability of resources and information necessary to support the
operation and the monitoring of these processes, and has implemented
the actions necessary to achieve the desired results and continual improvement of these processes.
These processes, including management activities, pr ovision of
resources, product realization, and measurement, are managed by the
organization in accordance with the requirements of this international
standard.
Where an organization chooses to outsource any process that affects
product conformity with requirements, the organization ensures control
over such process. Control of such outsource processes is identified within
the quality management system.
48
200.20.1

DOCUMENTATION
REQUIREMENTS
ISO 9001:2000
Written by:
Clause 4.2.1 + 4.5.1 Revision 0

ISO 9001:1994
4.2
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
DOCUMENTATION REQUIREMENTS
The documentation requirements are fulfilled in accordance with international standard ISO 9001:2000. The documentation includes information
describing, defining, specifying, reporting, or certifying activities, requirements, procedures, or results.

200.20.1
49

GENERAL
ISO 9001:2000
Written by:

ISO 9001:1994
4.2.1
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
GENERAL
The documented quality management system is comprised of the following
key documents, but is not limited to these components:

Quality policy and quality objectives

Quality system manual
Procedures required by this international standard
Documents needed by the organization to ensure the effective
planning, operation, and control of its processes
Quality records required by this international standard (see 4.2.4)
Documentation maintained in both hardware and software form
as appropriate

50
200.20.1

QUALITY MANUAL
ISO 9001:2000
Written by:
Clause 4.2.1
ISO 9001:1994
4.2.2
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
QUALITY MANUAL
(Company name) has established and maintained a quality system manual
to describe the scope of its quality management system, including details
of and justification for any exclusions (see 1.2). The documented procedures established for the quality management system, or reference to
them, and a description of the interaction between the processes of the
quality management system are included.
The need to achieve quality in activities, services, and products has
been recognized to ensure that the organization meets well-defined objectives, satisfies its users/customers expectations and contractual requirements, complies with applicable standards and specifications, and provides
value for money.
200.20.1
51

CONTROL OF DOCUMENTS
ISO 9001:2000
Written by:
Clause 4.5.1 + 4.5.2

+ 4.5.3
ISO 9001:1994
4.2.3
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
CONTROL OF DOCUMENTS
Procedures and documents required by the quality management system
are controlled. Quality records are a special type of document and are
controlled according to the requirements given in 4.2.4
The applicable documented procedure is established to define the
controls needed, to approve documents for adequacy prior to issue, to
review and update as necessary and reapprove documents, and to ensure
that changes and the current revision status of documents are identified.
It is ensured that relevant versions of applicable documents are available
at points of use as appropriate, and remain legible and readily identifiable.
The documents of external origin are identified, and their distribution is
controlled to prevent the unintended use of obsolete documents and to
apply suitable identification to them if they are withheld for any purpose.
52
200.20.1

CONTROL OF QUALTY RECORDS
ISO 9001:2000
Written by:
Clause 4.1.8
ISO 9001:1994
4.2.4
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
CONTROL OF QUALITY RECORDS

Quality records are identified, established, and maintained to provide
evidence of conformity to requirements and of the effective operation of
the quality management system. Quality records are legible, readily identifiable, and retrievable for quality records. A procedure is established to
define the controls needed for the identification, storage, protection,
retrieval, retention time, and disposition.
200.20.1
53

MANAGEMENT RESPONSIBILITY
ISO 9001:2000
Written by:
Revision 0
Clause 4.1 + 4.1.2.2

+ 4.2.1
ISO 9001:1994
5.0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 4
mm/dd/yyyy
mm/dd/yyyy
Management responsibilities are defined in correspondence with international standard ISO 9001:2000 to assist the management team in achieving
its quality aims, promote a reputation in the marketplace through customer
satisfaction, motivate staff toward pride in carrying out a job, and identify
control training needs, improve communication, and produce historical
records to confirm the level of quality system effectiveness and activity/service/product achievement. Management responsibilities are defined
in the following quality matrix Table 1. Individual companies can tailor
this table according to their specific setup.

54
200.20.1

ISO 9001:2000
Written by:
Clause 4.1 + 4.1.2.2

+ 4.2.1
ISO 9001:1994
5.0
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 2 of 4
mm/dd/yyyy
mm/dd/yyyy
The quality planning matrix is described in Table 1.

Table 1
Corresponding
Clause
ISO 9001:2000
ISO-9001:1994
CLAUSE
4.1
Management
responsibilities
4.2
Quality system
4.3
Contract review
4.4
Design control
4.5
Document and
data control
Function Concerned in the

Entity
ADM
QUA
PRD
QCD
SHP
MAI
PER
PDL
PUR
PAC
MKT
MPM
Element in the
Quality System
5.1 + 5.3 + 5.4.1 +

5.5.1
+ 6.1 + 6.2.1 + 6.3
5.5.2
5.6.1 + 5.6.2 +
5.6.3 + 8.5.1
4.1 + 4.2.1 + 4.2.2
+ 5.1 + 5.4.1
5.4.2 + 6.2.1 + 7.1
5.2 + 7.2.1 + 7.2.2
+ 7.2.3
7.3.1
7.2.1 + 7.3.2
7.3.3
7.3.4
7.3.5
7.3.6
7.3.7
4.2.1 + 4.2.3
X * * * * * * * * * * *
* X * * * * * * * * * *
* * * * * * X *
* * * X * *
* * * * * * * X * * * *
200.20.1
55

ISO 9001:2000
Written by:
Clause 4.1 + 4.1.2.2

+ 4.2.1
ISO 9001:1994
5.0
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 3 of 4
mm/dd/yyyy
mm/dd/yyyy
Table 1 (Continued)
Corresponding
Clause
ISO 9001:2000
ISO-9001:1994
CLAUSE
4.6
Purchasing
4.7
Control of
customersupplied
product
Product
identification
and traceability
Process control
4.8
4.9
4.10
Inspection and
testing
4.11
Inspection,
measurement,
and test
equipment
Inspection and
test status
4.12

Entity
ADM
QUA
PRD
QCD
SHP
MAI
PER
PDL
PUR
PAC
MKT
MPM
Element in the
Quality System
7.4.1
7.4.2
7.4.3
7.5.4
* * * * * X *
7.5.3
* * X * * * * * * *
6.3 + 6.4 + 7.1 +

7.5.1 + 7.5.2 +
8.2.3
7.1 + 8.1
7.4.3 + 8.2.4
7.5.1
7.5.3
7.6
* X * * *
7.5.3
X * * * *
X *
X * * *
* * * X * *
56
200.20.1

ISO 9001:2000
Written by:
Clause 4.1 + 4.1.2.2

+ 4.2.1
ISO 9001:1994
5.0
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 4 of 4
mm/dd/yyyy
mm/dd/yyyy
Table 1 (Continued)
Corresponding
Clause
ISO 9001:2000
ISO-9001:1994
CLAUSE
4.13
4.14
4.15
4.16
4.17
4.18
4.19
4.20
Control of
nonconforming
product
Corrective
actions
Handling, storage,
packaging,
preservation,
and delivery
Quality records
Internal quality
audits
Training
Servicing
Statistical
techniques

Entity
ADM
QUA
PRD
QCD
SHP
MAI
PER
PDL
PUR
PAC
MKT
MPM
Element in the
Quality System
8.3
* * * X * * * * * * *
8.5.2 + 8.5.3
8.4
7.5.5 + 7.5.1
* X * * * * * * * * * *
* * * * * X
4.2.4
8.2.2 + 8.2.3
* * * X * * * * * * * *
* X * * * * * * * * *
6.2.1 + 6.2.2
7.1 + 7.5.1
8.1 + 8.2.3 + 8.2.4
+ 8.4
* X * * * * X * * * * *
* * * * * * * * X *
* X * * *
X RESPONSIBLE FUNCTIONS, * FUNCTIONS CONCERNED, NOT APPLICABLE

Key:
ADM
PRD
SHP
PDL
PAC
MPM
=
=
=
=
=
=
Administration (Management)
Production
Shipping
Product Development Lab
Packaging
Materials Planning Manager
QUA
QCD
PER
PUR
MKT
MAI
=
=
=
=
=
=
Quality Assurance
Quality Control Department
Personnel
Purchase
Marketing
Maintenance
200.20.1
57

MANAGEMENT COMMITMENT
ISO 9001:2000
Written by:
Revision 0
Clause 4.1 + 4.1.2.2

+ 4.2.1
ISO 9001:1994
5.1
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
(Company name) has provided objective evidence of its commitment to
developing and implementing the quality management system, continually
improving its effectiveness through communicating to the organization the
importance of meeting customer as well as statutory and r egulatory
requirements, and establishing the quality policy and ensuring that quality
objectives are established. Adequate resources are provided and management reviews are conducted at specified frequencies.

58
200.20.1

CUSTOMER FOCUS
ISO 9001:2000
Written by:
Clause 4.3.2
ISO 9001:1994
5.2
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
CUSTOMER FOCUS
The organization has ensured that customer requirements are identified
and has met the acceptance criteria to achieve customer satisfaction (see
7.2.1 and 8.2.1)
The documented quality system is maintained to ensure that the
product conforms to the specified requirements and meets the expectations
and needs of the user, and that the product is continuously maintained
to the prescribed standard, specification, contract, and order agreement.
200.20.1
59

QUALITY POLICY
ISO 9001:2000
Written by:
Clause 4.1.1
ISO 9001:1994
5.3
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
QUALITY POLICY
(Company name) has established the quality policy, which is appropriate
to the purpose of the organization with a commitment to comply with
requirements and continually improve the effectiveness of the quality
management system. The quality policy provides a management commitment for establishing and reviewing quality objectives. The policy is
communicated and understood within the organization and is reviewed
on a periodic basis for its suitability.
(COMPANY NAME) POLICY

The organization will comply with the provisions of the current good
manufacturing practice (CGMP) for the fi nished pharmaceutical as
described in Code 210 of the Federal Regulation Curr ent Good
Manufacturing Practice in Manufacturing, Processing, Packaging, or Holding of Drugs.
Signature and Date
(Top Management)
ORGANIZATION CHART HERE

Describe a brief history of the company

Key positions summary
Location and number of employees
Brief responsibility of key personnel
Products, services, and activities offered
Organization chart
60
200.20.1

PLANNING
ISO 9001:2000
Written by:

ISO 9001:1994
5.4
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
PLANNING
(Company name) has ensured customer satisfaction while meeting regulatory requirements through effective planning at all levels.

Reference Procedure [Number ISO4.2, dated mm-dd-yyyy]
200.20.1
61

QUALITY OBJECTIVES
ISO 9001:2000
Written by:

ISO 9001:1994
5.4.1
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
QUALITY OBJECTIVES
Our organization has established the quality objectives, including those
needed to meet requirements for the product (see 7.1 a), relevant functions, and levels within the company. The quality objectives are quantifiable and consistent with the quality policy.

62
200.20.1

QUALITY MANAGEMENT SYSTEM Clause 4.2.3
PLANNING
ISO 9001:1994
5.4.2
ISO 9001:2000
Written by:
Checked by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Revision 0
Approved by:
Page 1 of 1
QUALITY MANAGEMENT SYSTEM PLANNING

Our organization has ensured that planning of the quality management
system is carried out to meet the requirements given in 4.1, as well as
the quality objectives, and the integrity of the quality management system
is maintained when changes to the quality management system ar e
planned and implemented.
200.20.1
63

RESPONSIBILITY, AUTHORITY,
Clause 4.1.2.1
AND COMMUNICATION
ISO 9001:1994
5.5
ISO 9001:2000
Written by:
Checked by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Revision 0
Approved by:
Page 1 of 1
RESPONSIBILITY, AUTHORITY, AND COMMUNICATION

Communication is conducted through identification of job responsibilities,
training, and awareness.
64
200.20.1

RESPONSIBILITY AND
AUTHORITY
ISO 9001:2000
Written by:
Clause 4.1.2.1
ISO 9001:1994
5.5.1
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
RESPONSIBILITY AND AUTHORITY

Top management has ensured that the responsibilities and authorities are
defined and communicated within the organization. The interrelations and
overlapping responsibilities are also communicated.
200.20.1
65

MANAGEMENT REPRESENTATIVE
ISO 9001:2000
Written by:
Clause 4.1.2.3
ISO 9001:1994
5.5.2
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
(Company name) has exclusively appointed a management representative
who, irrespective of other responsibilities, has the responsibility and
authority that includes:
Identifying processes and implementing and maintaining the quality
management system needed for quality management
Evaluating and reporting the performance of the quality management system and the needs for improvement
Creating the promotion of awareness of customer requirements
throughout the organization
66
200.20.1

INTERNAL COMMUNICATION
ISO 9001:2000
Written by:
Clause 4.1.2.3
ISO 9001:1994
5.5.3
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
INTERNAL COMMUNICATION
Appropriate communication procedures are established within the organization and are communicated regarding the effectiveness of the quality
management system.
200.20.1
67

MANAGEMENT REVIEW
ISO 9001:2000
Written by:
Clause 4.1.3
ISO 9001:1994
5.6
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
MANAGEMENT REVIEW
Management review provides an effective tool for company management
to review the effectiveness of the existing quality system.
68
200.20.1

GENERAL
ISO 9001:2000
Written by:
Clause 4.1.3
ISO 9001:1994
5.6.1
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
GENERAL
Our top management reviews the organizations quality management
system every quarter-year to ensure its continuing suitability, adequacy,
and effectiveness. This review includes assessing opportunities for
improvement and the need for changes to the quality management system,
including the quality policy and quality objectives. Records of the management reviews are maintained (see 4.2.4).
200.20.1
69

REVIEW INPUT
ISO 9001:2000
Written by:
Clause 4.1.3
ISO 9001:1994
5.6.2
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
REVIEW INPUT
The input for the management review includes exorbitant information
including, but not limited to:

Recommendations for improvement

Planned changes that could affect the quality management system
Status of preventive and corrective action
Follow-up actions from previous management reviews
Process performance and product conformity
Customer feedback
Results of audits
70
200.20.1

REVIEW OUTPUT
ISO 9001:2000
Written by:
Clause 4.1.3
ISO 9001:1994
5.6.3
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
REVIEW OUTPUT
The output from the management reviews include decisions and actions
related to improvement of the effectiveness of the quality management
system and its processes, improvement of the product related to customer
requirements, and resource needs.
200.20.1
71

RESOURCE MANAGEMENT
ISO 9001:2000
Written by:
Clause 4.1.1.2
ISO 9001:1994
6.0
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
RESOURCE MANAGEMENT
Adequate resources are managed to achieve the management objectives,
customer satisfaction, and product compliance.
72
200.20.1

PROVISION OF RESOURCES
ISO 9001:2000
Written by:
Clause 4.1.1.2
ISO 9001:1994
6.1
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
Our organization has determined and provided the necessary resources
needed to implement and maintain the quality management system and
continually improve its effectiveness, and to enhance customer satisfaction
by meeting customer requirements.
200.20.1
73

HUMAN RESOURCES
ISO 9001:2000
Written by:
Clause 4.1.1.2 +
4.2.3 + 4.16
ISO 9001:1994
6.2
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
HUMAN RESOURCES
The organization of planned human resources plays an important role in
the effectiveness of the quality system. The records of human resource
development are documented and maintained.

74
200.20.1

GENERAL
ISO 9001:2000
Written by:
Clause 4.1.1.2 +
4.2.3 + 4.16
ISO 9001:1994
6.2.1
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
GENERAL
Employees performing work affecting product quality are competent on
the basis of appropriate education, training, skills, and background experience.

200.20.1
75

COMPETENCE, AWARENESS,
AND TRAINING
ISO 9001:2000
Written by:
Clause 4.16
ISO 9001:1994
6.2.2
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
COMPETENCE, AWARENESS, AND TRAINING

(Company name) has determined the necessary competence for personnel
performing work affecting product quality, has provided training, or has
taken other action to satisfy these needs. Effectiveness of the actions taken
is evaluated, and it is ensured that the employees are aware of the
relevance and importance of their activities and how they contribute to
the achievement of the quality objectives. Records of education, training,
skills, and experience are appropriately maintained (see 4.2.4).
76
200.20.1

INFRASTRUCTURE
ISO 9001:2000
Written by:
Clause 4.1.2.2 + 4.9 Revision 0

ISO 9001:1994
6.3
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
INFRASTRUCTURE
(Company name) has determined, established, and maintained the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, but is not limited to, buildings, workspace, and
associated utilities. Process equipment, both hardware and software, and
supporting services such as transport or communication are reviewed and
established on a continuous basis.
200.20.1
77

WORK ENVIRONMENT
ISO 9001:2000
Written by:
Clause 4.9
ISO 9001:1994
6.4
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
WORK ENVIRONMENT
Top management has determined and managed the work environment
necessary to achieve conformity to product requirements such as temperature, humidity, etc.
78
200.20.1

PRODUCT REALIZATION
ISO 9001:2000
Written by:
Clause 4.2.3 + 4.9 +

4.10.1
ISO 9001:1994
7.0
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
PRODUCT REALIZATION
Product realization is achieved through effective planning to achieve
product requirements and quality objectives.

200.20.1
79

PLANNING OF PRODUCT
REALIZATION
ISO 9001:2000
Written by:
Clause 4.2.3 + 4.9 +

4.10.1
ISO 9001:1994
7.1
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
PLANNING OF PRODUCT REALIZATION

Top management plans and develops the processes needed for product
realization. Planning of product realization is consistent with the requirements of the other processes of the quality management system (see 4.1).
In planning product realization, the following elements are determined
appropriate:
Quality objectives and product requirements
Processes establishment, documents, and provision of resources
specific to the product
Verification, validation, monitoring, inspection, and test activities
specific to the product to fulfill requirements (see 4.2.4)
Records needed to provide evidence that the realization processes
and resulting product fulfill requirements (see 4.2.4)
The output of this planning is kept both in hardware and software form.

80
200.20.1

CUSTOMER-RELATED PROCESSES Clause 4.3.2 + 4.4.4 Revision 0
ISO 9001:1994
7.2
ISO 9001:2000
Written by:
Checked by:
Approved by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Page 1 of 1
CUSTOMER-RELATED PROCESSES
The organization ensures the understanding of current and future customer
needs and expectations through leadership, the involvement of people,
continual improvement, and a mutually beneficial relationship with the
supplier.

200.20.1
81

DETERMINATION OF
ISO 9001:1994
REQUIREMENTS RELATED TO
THE PRODUCT
7.2.1
ISO 9001:2000
Written by:
Checked by:
Approved by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Page 1 of 1
DETERMINATION OF REQUIREMENTS RELATED

TO THE PRODUCT
(Company name) has determined:
Customer-specified requirements, including delivery and postdelivery activities
Requirements necessary for specified use or known and intended
use but not stated by the customer
Regulatory and statutory requirements related to the product
Additional requirements determined by the organization, if any
82
200.20.1

REVIEW OF REQUIREMENTS
RELATED TO THE PRODUCT
ISO 9001:2000
Written by:
Clause 4.3.2 + 4.3.3

+ 4.3.4
ISO 9001:1994
7.2.2
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
REVIEW OF REQUIREMENTS RELATED TO THE PRODUCT

The organization reviews the requirements related to the product prior to
the organizations commitment to supply a product to the customer (e.g.,
submission of tenders, acceptance of contracts of orders, acceptance of
changes to contracts or orders) to ensure that:
Product requirements are defined
Contract or order requirements differing from those previously
expressed are resolved
The organization has the ability to meet the defined requirements
Records of the results of the review and actions arising from the review
are maintained (see 4.2.4).
The customer requirements are confirmed by the organization before
acceptance when the customer provides no documented statement of
requirement.
If product requirements are changed, the organization ensures that
relevant documents are amended and that relevant personnel are made
aware of the changed requirements.
200.20.1
83

CUSTOMER COMMUNICATION
ISO 9001:2000
Written by:
Clause 4.3.2
ISO 9001:1994
7.2.3
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
(Company name) has established and implemented effective arrangements
for communicating with customers in relation to:
Product information
Inquiries, contracts, or order handling, including amendments
Customer feedback, including customer complaints
84
200.20.1

DESIGN AND DEVELOPMENT
ISO 9001:2000
Written by:
Clause 4.4.2 + 4.4.3

+ 4.4.6 + 4.4.7 + 4.4.8
ISO 9001:1994
7.3
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy

Design and development are carried out through effective quality planning.
Both products and services are considered, with particular reference to
customer focus.
200.20.1
85

PLANNING
ISO 9001:2000
Written by:
Clause 4.4.2 + 4.4.3

+ 4.4.6 + 4.4.7 + 4.4.8
ISO 9001:1994
7.3.1
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
DESIGN AND DEVELOPMENT PLANNING

The design and development of the product is controlled, and the design
and development stages are defined. The review, verification, and validation that are appropriate to each design and development stage, and the
responsibilities and authorities for design and development are clearly
defined and assigned.
The interfaces between different groups involved in design and development are managed to ensure effective communication and clear assignment of responsibility.
Planning output is updated, as appropriate, as the design and development progress.
86
200.20.1

Clause 4.4.4
INPUTS
ISO 9001:1994
7.3.2
ISO 9001:2000
Written by:
Checked by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Revision 0
Approved by:
Page 1 of 1
DESIGN AND DEVELOPMENT INPUTS

Inputs related to product requirements are determined and records are
maintained (see 4.2.4) and include, but are not limited to, the following:

Functional and performance requirements

Applicable statutory and regulatory requirements
Information derived from previous similar designs where applicable
Other requirements essential for design and development
These inputs are reviewed for adequacy. Requirements are completed to

ensure they are unambiguous and not in conflict with each other.
200.20.1
87

Clause 4.4.5
OUTPUTS
ISO 9001:1994
7.3.3
ISO 9001:2000
Written by:
Checked by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Revision 0
Approved by:
Page 1 of 1
DESIGN AND DEVELOPMENT OUTPUTS

The outputs of design and development are provided in a form that
enables verification against the design and development input and are
approved prior to release.
Design and development outputs:
Meet the input requirements for design and development
Provide appropriate information for purchasing, production, and
service provision
Contain or reference product acceptance criteria
Specify the characteristics of the product that are essential for its
safe and proper use
88
200.20.1

Clause 4.4.6
REVIEW
ISO 9001:1994
7.3.4
ISO 9001:2000
Written by:
Checked by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Revision 0
Approved by:
Page 1 of 1
DESIGN AND DEVELOPMENT REVIEW

Systematic reviews of design and development are conducted at suitable stages.
The ability of the results of design and development to fulfill requirements is evaluated to identify any problems and propose necessary actions.
The representatives of functions concerned with the design and development stages participate in a review. They record the results of the
review and any necessary actions that are to be taken (see 4.2.4).
200.20.1
89

Clause 4.4.7
VERIFICATION
ISO 9001:1994
7.3.5
ISO 9001:2000
Written by:
Checked by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Revision 0
Approved by:
Page 1 of 1
DESIGN AND DEVELOPMENT VERIFICATION

Verification is performed to ensure that the design and development
outputs have satisfied the design and development input requirements.
Records of the results of the verification and any necessary actions that
are to be taken (see 4.2.4).
90
200.20.1

Clause 4.4.8
VALIDATION
ISO 9001:1994
7.3.6
ISO 9001:2000
Written by:
Checked by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Revision 0
Approved by:
Page 1 of 1
DESIGN AND DEVELOPMENT VALIDATION

Design and development validation is performed in accordance with
planned arrangements (see 7.3.1) to ensure that the resulting product is
capable of fulfilling the requirements for the specified or known intended
use or application. Wherever practicable, validation is completed prior to
the delivery or implementation of the product. Records of the results of
validation and any necessary actions are maintained (see 4.2.4).
200.20.1
91

CONTROL OF DESIGN AND
DEVELOPMENT CHANGES
ISO 9001:2000
Written by:
Clause 4.4.9
ISO 9001:1994
7.3.7
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
CONTROL OF DESIGN AND DEVELOPMENT CHANGES

Design and development changes are identified, and records are maintained. The changes are reviewed, verified, and validated as appropriate
and are approved before implementation. The review of design and
development changes includes evaluation of the effect of the changes on
constituent parts and the delivered product.
Records of the results of the review of changes and any necessary
actions are maintained (see 4.2.4).
92
200.20.1

PURCHASING
ISO 9001:2000
Written by:
Clause 4.6.2
ISO 9001:1994
7.4
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
PURCHASING
Quality purchasing is achieved through procurement from approved vendor sources.
200.20.1
93

PURCHASING PROCESS
ISO 9001:2000
Written by:
Clause 4.6.2
ISO 9001:1994
7.4.1
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
PURCHASING PROCESS
The company ensures that the purchased product conforms to specified
purchase requirements. The type and extent of control applied to the
supplier and the purchased product is dependent upon the effect of the
purchased product on subsequent product realization or the final product.
94
200.20.1

PURCHASING INFORMATION
ISO 9001:2000
Written by:
Clause 4.6.3
ISO 9001:1994
7.4.2
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
PURCHASING INFORMATION
Purchasing information is established to describe the product to be purchased, including, where appropriate:
Requirements for the approval of the product, procedures, processes, and equipment
Requirements for the qualification of personnel and quality management system requirements
The organization ensures the adequacy of specified purchase requirements prior to their communication to the supplier.
200.20.1
95

VERIFICATION OF PURCHASED
PRODUCT
ISO 9001:2000
Written by:
Clause 4.6.4 + 4.10.2

+ 4.10.3 + 4.10.4
ISO 9001:1994
7.4.3
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
VERIFICATION OF PURCHASED PRODUCT

(Company name) has established and implemented the inspection or other
activities necessary for ensuring that the purchased product meets specified
purchase requirements.
Where the organization or its customer intends to perform verification
at the supplier premises, the organization states the intended verification
arrangements and method of product release in the purchasing information.

96
200.20.1

PRODUCTION AND SERVICE
PROVISION
ISO 9001:2000
Written by:
Clause 4.9 + 4.103 +

4.15.6 + 4.19
ISO 9001:1994
7.5
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
PRODUCTION AND SERVICE PROVISION

(Company name) carried out production and service provisions under
controlled conditions as adequate.
Reference
Reference
Reference
Reference
Procedure
Procedure
Procedure
Procedure
[Number
[Number
[Number
[Number
ISO-4.9, dated mm-dd-yyyy]

200.20.1
97

CONTROL OF PRODUCTION
AND SERVICE PROVISION
ISO 9001:2000
Written by:
Clause 4.9 + 4.10.3

+ 4.15.6 + 4.19
ISO 9001:1994
7.5.1
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
CONTROL OF PRODUCTION AND SERVICE PROVISION

The company has planned and carried out production and service provisions under controlled conditions as applicable, including, but not limited
to, the availability of information that describes the characteristics of the
product, the availability of work instructions, the use of suitable equipment, the availability and use of monitoring and measuring devices, and
the implementation of monitoring and measurement, and the implementation of release, delivery, and postdelivery activities.
Reference
Reference
Reference
Reference
Procedure
Procedure
Procedure
Procedure
[Number
[Number
[Number
[Number

98
200.20.1

VALIDATION OF PROCESSES FOR Clause 4.9
PRODUCTION AND SERVICE
ISO 9001:1994
PROVISION
7.5.2
ISO 9001:2000
Written by:
Checked by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Revision 0
Approved by:
Page 1 of 1
VALIDATION OF PROCESSES FOR PRODUCTION

AND SERVICE PROVISION
Any process for production and service provision, where the resulting
output cannot be verified by subsequent monitoring or measurement,
must be validated. Specific consideration is given to the processes where
deficiencies become apparent only after the product is in use or the service
has been delivered
The planned results are achieved through validation and, where applicable, through:

Defined criteria for review and approval of the processes

Approval of equipment and qualifications of personnel
Use of specific methods and procedures
Records (see 4.2.4) maintenance
Planning and conducting revalidation
200.20.1
99

IDENTIFICATION AND
TRACEABILITY
ISO 9001:2000
Written by:
Clause 4.8 + 4.10.5

+ 4.12
ISO 9001:1994
7.5.3
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
IDENTIFICATION AND TRACEABILITY

Where appropriate, (company name) identifies the product by suitable
means throughout product realization.
The product status with respect to monitoring and measurement
requirements is identified.
The unique identification of the product (see 4.2.4) is controlled and
recorded by assigning a specific batch number to each product.

100
200.20.1

CUSTOMER PROPERTY
ISO 9001:2000
Written by:
Clause 4.7
ISO 9001:1994
7.5.4
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
CUSTOMER PROPERTY
The company identifies, verifies, protects, and safeguards customer property provided for use or incorporation into the product, including intellectual property. If any customer property is lost, damaged, or otherwise
found to be unsuitable for use, that is reported to the customer and records
are maintained (see 4.2.4).
200.20.1
101

PRESERVATION OF PRODUCT
ISO 9001:2000
Written by:
Revision 0
Clause 4.15.2 +
4.15.3 + 4.15.4 + 4.15.5
+ 4.15.6
ISO 9001:1994
7.5.5
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
PRESERVATION OF PRODUCT
The conformity of the product and its constituents is preserved during
internal processing and delivery to the intended destination. This preservation includes identification, handling, packaging, storage, and protection.
102
200.20.1

CONTROL OF MONITORING
AND MEASURING DEVICES
ISO 9001:2000
Written by:
Clause 4.11.1 +
4.11.2
ISO 9001:1994
7.6
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
CONTROL OF MONITORING AND MEASURING DEVICES

The company has established processes to ensure that monitoring and
measurement necessary to be undertaken to provide evidence of product
conformity to its requirements is carried out in a manner consistent with
the monitoring and measurement requirements (see 7.2.1).
As appropriate, measuring equipment is:
Calibrated or verified at specified intervals, or prior to use, against
measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used
for calibration or verification is recorded.
Adjusted or re-adjusted where necessary
Identified to enable the calibration status to be determined
Protected from adjustments that would invalidate the measurement result
Protected to avoid damage and deterioration during handling,
maintenance, and storage
In addition, when the equipment is found not to conform to requirements, the organization takes appropriate action regarding the equipment
and any product affected. Records of the results of calibration and verification are maintained (see 4.2.4). The organization assesses and records
the validity of the previous measuring results.
The ability of computer software to satisfy the intended application is
confirmed prior to initial use when used in the monitoring and measurement of specified requirements.
Note: See ISO 10012-1 and ISO 10012-2 for guidance.
200.20.1
103

MEASUREMENT, ANALYSIS, AND
IMPROVEMENT
ISO 9001:2000
Written by:
Clause 4.10 + 4.17 +

4.20.1
ISO 9001:1994
8.0
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
MEASUREMENT, ANALYSIS, AND IMPROVEMENT

The organization has ensured continual improvement in the effectiveness
of the quality management system through management review (measurement and analysis), internal and external audits, and corrective actions.

104
200.20.1

GENERAL
ISO 9001:2000
Written by:
Clause 4.10 + 4.17 +

4.20.1
ISO 9001:1994
8.1
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
GENERAL
The company has planned and implemented the monitoring, measurement, analysis, and improvement processes needed to demonstrated conformity of the product and has ensured conformity of the quality
management system, continuity of improvement, and the effectiveness of
the quality management system.
This includes determination of applicable methods and statistical techniques used.

200.20.1
105

MONITORING AND
MEASUREMENT
ISO 9001:2000
Written by:
Clause 4.9 + 4.17 +

4.20.1
ISO 9001:1994
8.2
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
MONITORING AND MEASUREMENT

The adequate monitoring and measurements are conducted to ensure
customer satisfaction and product specification compliance.
Reference
Reference
Reference
Reference
Procedure
Procedure
Procedure
Procedure
[Number-ISO-4.9, dated mm-dd-yyyy]

106
200.20.1

CUSTOMER SATISFACTION
ISO 9001:2000
Written by:
Clause 4.9 + 4.17 +

4.10
ISO 9001:1994
8.2.1
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
CUSTOMER SATISFACTION
Suitable methods are used for obtaining information regarding customer
perception as to whether the company has fulfilled customer requirements through:
Internal audits
Monitoring and measurement of processes
Monitoring and measurement of products
Reference Procedure [Number-ISO-4.9, dated mm-dd-yyyy]

200.20.1
107

INTERNAL AUDIT
ISO 9001:2000
Written by:
Clause 4.17
ISO 9001:1994
8.2.2
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
INTERNAL AUDIT
(Company name) conducts internal audits at specified intervals to determine whether the quality management system:
Is effectively implemented and maintained
Conforms to the planned arrangements (see 7.1), the requirements
of the international standards, and the quality management system
requirements established by the organization
Programmed audits are conducted to consider the status and importance of the processes and areas to be audited and the results of previous
audits. The audit criteria, scope, frequency, and methods are defined. The
selection of auditors and conduct of audits ensures objectivity and impartiality of the audit process. Auditors do not audit their own work.
The responsibilities and requirements for planning and conducting
audits and for reporting results and maintaining records (see 4.2.4) are
defined in a documented procedure.
The management staff responsible for the area being audited ensures
that actions are taken without undue delay to eliminate detected nonconformities and their causes. Follow-up activities include the verification of
actions taken and the reporting of verification results (see 8.5.2).
Note: See ISO 10011-1, ISO 10011-2, and ISO 10011-3 for guidance.
108
200.20.1

MONITORING AND
MEASUREMENT OF PROCESSES
ISO 9001:2000
Written by:
Clause 4.9 + 4.17 +

4.20.1
ISO 9001:1994
8.2.3
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
MONITORING AND MEASUREMENT OF PROCESSES

Suitable methods for monitoring and, where applicable, measurement of
the quality management system processes are applied to demonstrate the
ability of the processes to achieve planned results. When planned results
are not achieved, corrective action is taken, as appropriate, to ensure
conformity of the product.

200.20.1
109

MONITORING AND
MEASUREMENT OF PRODUCT
ISO 9001:2000
Written by:
Clause 4.1.2 + 4.10.3

+ 4.10.4 + 4.10.5 +
4.2.1
ISO 9001:1994
8.2.4
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
MONITORING AND MEASUREMENT OF PRODUCT

The product requirements are fulfilled through monitoring and measuring
the characteristics of the product.
Evidence of conformity with the acceptance criteria are maintained.
Records indicate the person (s) authorizing release of the product (see 4.2.4).
Product release and service delivery do not proceed until all the planned
arrangements (see 7.1) have been satisfactorily completed, unless otherwise
approved by a relevant authority and, where applicable, approved by the
customer.

110
200.20.1

CONTROL OF
Clause 4.13.1 +
NONCONFORMING PRODUCT 4.13.2
ISO 9001:1994
8.3
ISO 9001:2000
Written by:
Checked by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Revision 0
Approved by:
Page 1 of 1
CONTROL OF NONCONFORMING PRODUCT

A product that does not conform to product requirements is identified
and controlled to prevent its unintended use or delivery. The controls and
related responsibilities and authorities for dealing with a nonconforming
product are defined in a documented procedure.
Records of the nature of nonconformities and any subsequent actions
taken, including concessions obtained, are maintained (see 4.2.4).
When the nonconforming product is corrected, it is subjected to
reverification to demonstrate conformity to the requirements.
When a nonconforming product is detected after delivery or use of
the product has begun, the organization takes action appropriate to the
effects of the nonconformity.
200.20.1
111

ANALYSIS OF DATA
ISO 9001:2000
Written by:
Clause 4.14.2 +
4.14.3 + 4.20
ISO 9001:1994
8.4
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
ANALYSIS OF DATA
The data generated as a result of monitoring and measurement and from
other relevant sources are analyzed to demonstrate the suitability and effectiveness of the quality management system and for continual improvement.
The data is broadly based and includes, but is not limited to:
Customer satisfaction (see 8.2.1)
Conformance to product requirements (see 7.2.1)
Characteristics and trends of processes and products, including
opportunities for preventive action, and suppliers

112
200.20.1

IMPROVEMENT
ISO 9001:2000
Written by:
Clause 4.1.3
ISO 9001:1994
8.5
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
IMPROVEMENT
The organizations top management ensures continuous improvement
through creating personal ownership of the organizations goals, by using
its peoples knowledge and experience, and through education achieved as
a result of involvement in operational decisions and process improvement.
200.20.1
113

CONTINUAL IMPROVEMENT
ISO 9001:2000
Written by:
Clause 4.1.3
ISO 9001:1994
8.5.1
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
The organization intends to continually improve the effectiveness of the
quality management system through the use of the quality policy, quality
objectives, audit results, analysis of data, corrective and preventive actions,
and management review.
114
200.20.1

CORRECTIVE ACTION
ISO 9001:2000
Written by:
Clause 4.14.1 +
4.14.2
ISO 9001:1994
8.5.2
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
CORRECTIVE ACTION
Actions are taken to eliminate the cause of nonconformities in order to
prevent recurrence. Suitable corrective actions are initiated to counter the
effects of the nonconformities.
200.20.1
115

PREVENTIVE ACTION
ISO 9001:2000
Written by:
Clause 4.14.1 +
4.14.3
ISO 9001:1994
8.5.3
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
PREVENTIVE ACTION
A documented procedure is established to define requirements for:
Determining potential nonconformities and their causes
Evaluating the need for action to pr event the occurrence of
nonconformities
Determining and implementing actions needed
Records of results of actions taken (see 4.2.4) and reviewing any
preventive action taken
200.20.1
117
APPENDIX I:
Reference SOPs
Subject
Quality management systems

requirement (title only)
Scope
General
Application
Normative reference
(title only)
Documentation
requirements (title only)
General
Clauses
Ref. SOP
No.
Revision
No.
Issued On
1.0
1.1
1.2
2.0
3.0
4.0
ISO-4.1
ISO-4.1
ISO-4.1
ISO-4.1
ISO-4.1
ISO-4.1
New
New
New
New
New
New
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
4.1
4.2
New
New
New
New
New
New
New
New
New
New
New
New
New
New
New
New
New
New
New
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
Quality objectives
5.4.1

planning
Management review
(title only)
General
Review input
5.4.2
ISO-4.2
ISO-4.2
ISO-4.5
ISO-4.2
ISO-4.5
ISO-4.2
ISO-4.5
ISO-4.1
ISO-4.1
ISO-4.2
ISO-4.1
ISO-4.2
ISO-4.3
ISO-4.1
ISO-4.1
ISO-4.2
ISO-4.1
ISO-4.2
ISO-4.2
5.5
ISO-4.1
New
mm/dd/yy
5.5.1
5.5.2
5.5.3
5.6
ISO-4.1
ISO-4.1
ISO-4.1
ISO-4.1
New
New
New
New
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
5.6.1
5.6.2
ISO-4.1
ISO-4.1
New
New
mm/dd/yy
mm/dd/yy
Quality manual
(title only)
Customer focus
Quality policy
4.2.1
4.2.2
4.2.3
4.2.4
5.0
5.1
5.2
5.3
5.4
118
200.20.1
APPENDIX I:
Reference SOPs (Continued)
Subject
Clauses
Ref. SOP
No.
Revision
No.
Issued On
Review output
Resource management
(title only)
5.6.3
6.0
ISO-4.1
ISO-4.1
New
New
mm/dd/yy
mm/dd/yy
6.1
6.2
General
6.2.1

training
Infrastructure
Work environment
Product realization
(title only)
6.2.2
ISO-4.1
ISO-4.1
ISO-4.2
ISO-4.16
ISO-4.1
ISO-4.2
ISO-4.16
New
New
New
New
New
New
New
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
7.2.1
ISO-4.9
ISO-4.9
ISO-4.2
ISO-4.9
ISO-4.10
ISO-4.2
ISO-4.9
ISO-4.10
ISO-4.3
ISO-4.4
ISO-4.3
New
New
New
New
New
New
New
New
New
New
New
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
7.2.2
ISO-4.3
New
mm/dd/yy
7.2.3
7.3
ISO-4.3
ISO-4.4
New
New
mm/dd/yy
mm/dd/yy
7.3.1
ISO-4.4
New
mm/dd/yy
7.3.2
ISO-4.4
New
mm/dd/yy
7.3.3
ISO-4.4
New
mm/dd/yy
7.3.4
ISO-4.4
New
mm/dd/yy
7.3.5
ISO-4.4
New
mm/dd/yy
6.3
6.4
7.0
Planning of product
realization
7.1
(title only)
Determination of
requirements related to the
product
Review of requirements
Design and development
(title only)
planning
inputs
outputs
review
verification
7.2
200.20.1
119
APPENDIX I:
Clauses
Ref. SOP
No.
Revision
No.
Issued On

validation
Control of design and
development changes
Purchasing process
Verification of purchased
product
Production and service
provision (title only)
7.3.6
ISO-4.4
New
mm/dd/yy
7.3.7
ISO-4.4
New
mm/dd/yy
7.4
7.4.1
7.4.2
7.4.3
Control of production and

service provision
7.5.1
Validation of processes of
provision
Control of monitoring and
measuring devices
7.5.2
ISO-4.6
ISO-4.6
ISO-4.6
ISO-4.6
ISO-4.10
ISO-4.9
ISO-4.10
ISO-4.15
ISO-4.19
ISO-4.9
ISO-4.10
ISO-4.15
ISO-4.19
ISO-4.9
New
New
New
New
New
New
New
New
New
New
New
New
New
New
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
7.5.5
7.6
ISO-4.15
ISO-4.11
New
New
mm/dd/yy
mm/dd/yy
7.5.3
Customer property
7.5.4
8.0
ISO-4.8
ISO-4.10
ISO-4.12
ISO-4.7
ISO-4.10
ISO-4.17
ISO-4.20
ISO-4.10
ISO-4.17
ISO-4.20
ISO-4.9
ISO-4.10
ISO-4.17
ISO-4.20
ISO-4.9
ISO-4.10
New
New
New
New
New
New
New
New
New
New
New
New
New
New
New
New
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
Subject
7.5
General
8.1
Monitoring and
measurement (title only)
8.2
8.2.1
120
200.20.1
APPENDIX I:
Subject
Clauses
Internal audit
Monitoring and
measurement of processes
8.2.2
8.2.3
Monitoring and
measurement of products
8.2.4
Control of nonconforming
product
Analysis of data
8.3

Corrective action
Preventive action
8.4
8.5
8.5.1
8.5.2
8.5.3
Ref. SOP
No.
Revision
No.
Issued On
ISO-4.17
ISO-4.9
ISO-4.17
ISO-4.20
ISO-4.1
ISO-4.2
ISO-4.10
ISO-4.13
New
New
New
New
New
New
New
New
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
ISO-4.14
ISO-4.20
ISO-4.1
ISO-4.1
ISO-4.14
ISO-4.14
New
New
New
New
New
New
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
200.20.2
122
200.20.2

MODEL - 2
ISO 9001:2000
PREPARED AFTER INCORPORATION OF CHANGES IN
ISO 9001 MANUAL
Written by:
Checked by:
Approved by:
Date Supersedes
Date Issued
Manual Serial No.
mm/dd/yyyy
mm/dd/yyyy
QM-2
DISTRIBUTED TO
3) Marketing
5)
6)
Revision No: 0
CONTROLLED COPY NO.
Copy-1
Copy-2
Copy-3
Master

mm/dd/yy 1) First time issued for (your company name)
200.20.2
123
TABLE OF CONTENTS
PREPARED AFTER INCORPORATION OF CHANGES
IN ISO 9001 QUALITY MANUAL
Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . .
Scope and Field of Application . . . . . . . . .
References . . . . . . . . . . . . . . . . . . . . . . . . .
Definitions . . . . . . . . . . . . . . . . . . . . . . . . .
Quality Management System . . . . . . . . . . .
Quality Policy . . . . . . . . . . . . . . . . . . . . . .
Organization . . . . . . . . . . . . . . . . . . . . . . .
Responsibility and Authority. . . . . . . . . . . .
Resources . . . . . . . . . . . . . . . . . . . . . . . . .
Management Representative . . . . . . . . . . . .
Management Review . . . . . . . . . . . . . . . . .
Quality System. . . . . . . . . . . . . . . . . . . . . .
Contract Review. . . . . . . . . . . . . . . . . . . . .
Design Control. . . . . . . . . . . . . . . . . . . . . .
Document and Data Control . . . . . . . . . . .
Purchasing . . . . . . . . . . . . . . . . . . . . . . . . .
Customer-Supplied Product . . . . . . . . . . . .
Product Identification and Traceability . . . .
Process Control . . . . . . . . . . . . . . . . . . . . .
Inspection and Testing . . . . . . . . . . . . . . . .
Inspection and Test Status . . . . . . . . . . . . .
Control of Nonconforming Product . . . . . .
Corrective Action . . . . . . . . . . . . . . . . . . . .
Handling, Storage, Packing, and Delivery . .
Quality Records . . . . . . . . . . . . . . . . . . . . .
Internal Quality Audits . . . . . . . . . . . . . . . .
Training . . . . . . . . . . . . . . . . . . . . . . . . . . .
Servicing . . . . . . . . . . . . . . . . . . . . . . . . .
Statistical Techniques . . . . . . . . . . . . . . . . .
Appendix II (Reference SOPs)
Clauses
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. . .0.0
. . .1.1
. . .2.0
. . .3.0
. . .4.0
. 4.1.1
. 4.1.2
4.1.2.1
4.1.2.2
4.1.2.3
. 4.1.3
. . .4.2
. . .4.3
. . .4.4
. . .4.5
. . .4.6
. . .4.7
. . .4.8
. . .4.9
. . 4.10
. . 4.11
. . 4.12
. . 4.13
. . 4.14
. . 4.15
. . 4.16
. . 4.17
. . 4.18
. . 4.19
. . 4.20
124
200.20.2

INTRODUCTION
ISO 9001:2000
Written by:
Clause 0.0,
ISO 9001:1994
0.0
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
INTRODUCTION
It is in the interest of (company name) to ensure that a management
system describing its total operations is carefully thought out and implemented so that the likelihood of error is reduced. This can only be achieved
by implementing a quality system specific to the companys requirements
or the standard, which has global recognition in general.
This manual provides references to the organizational structure,
responsibilities, procedures, work instructions, and resources that have
been established to affect to the company policy and documented
quality objectives.
The requirements of this manual are aimed at the prevention of quality
failures and the maintenance of a system that provides the most effective
and efficient means of achieving the documented objectives.
The company has revised the existing ISO 9001 quality manual, and
the contents of this manual refer to international standard ISO 9001:2000.
No exclusions of the quality system requirements are permitted.
200.20.2
125

SCOPE AND FIELD OF
APPLICATION
ISO 9001:2000
Written by:
Clause 1.1,
ISO 9001:1994
1.1
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
SCOPE AND FIELD OF APPLICATION

Worldwide, there are a number of quality systems standards in operation.
Their division into categories is based on the scope of their subject matter.
ISO (International Standardization Organization) is a Geneva-based,
worldwide federation of national bodies that normally work together to
prepare international standards through technical committees (TC). Each
member body interested in a subject for which a TC has been established
has the right to be represented on that committee. International organizations, governmental and nongovernmental, in liaison with the ISO, also
participate in the work. The U.S. representative to the ISO is the American
National Standards Institute (ANSI)
The international standard ISO 9001:1994 was established by Technical
Committee ISO/TC 178, and is based on the British standard 5750:1987
series, European standard EN 29000:1987 series, and international standard
ISO 9000:1987 series.
This third edition of ISO 9001 cancels and replaces the second edition
(ISO 9001:1994) together with ISO 9002:1994 and ISO 9003:1994. It constitutes a technical revision of these documents. The quality manual QM2 is revised in accordance with the corresponding changes specified in
the third edition of ISO 9001:2000.
The international standard ISO 9001:2000 specifies quality system
requirements for use where a contract between the company and customers
requires demonstration of the capability to design and supply the product
in compliance with the applicable regulatory requirements and customer
satisfaction. The contents of the adopted standard refer to design, manufacture, and final product inspection and testing. No exclusions permitted.
126
200.20.2

REFERENCES
ISO 9001:2000
Written by:
Clause 2.0,
ISO 9001:1994
2.0
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
REFERENCES
ANSI/ASQCA3, Quality Systems Terminology
ISO 8402-1986, Quality Vocabulary
ANSI/ASQCQ 90-1987, Quality Management and Quality Assurance
Standards Guidelines for Selection and Use
ISO 9000-1987, Quality Management and Quality Assurance Standard - Guides for Selection and Use
ISO 9001:1994, Quality System Model for Quality Assurance in
Design, Development, Production, Installation, and Servicing
ISO 9001:2000, Quality Management System Requirements. Design,
Manufacture, and Final Product Inspection and Testing.
200.20.2
127

DEFINITIONS
ISO 9001:2000
Written by:
Clause 3.0,
ISO 9001:1994
3.0
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 7
mm/dd/yyyy
mm/dd/yyyy
DEFINITIONS
For the purpose of standard ISO/FDIS 9001:2000E, the terms and definitions given in ISO 9000 apply.
The analysis certificate is a document that gives the results of the inspection
made on a representative sample taken from a product before its delivery.
It must contain the results of all checks in a list approved jointly by the
client and the supplier.
Auditor
A person who is qualified and authorized to perform all or any portion
of a quality system audit is called an auditor.
Audit
Audit Organization
An organization that regularly conducts quality assurance management
system audits to a required standard is known as an audit organization.
128
200.20.2

DEFINITIONS
ISO 9001:2000
Written by:
Clause 3.0,
ISO 9001:1994
3.0
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 2 of 7
mm/dd/yyyy
mm/dd/yyyy
Batch
A batch refers to assignments of a batch of finished products to a client
Conformity
Conformity refers to the state of a product satisfying specified requirements.
Documentation
Documentation means any recorded or pictorial information describing,
defining, specifying, reporting, or certifying activities, requirements, procedures, or results.
Documentation Level
The position of a quality document in the quality assurance documentation
system is its documentation level.
First Party Audits

Audits carried out internally by an organization are known as first party
audits.
Inspection
Inspection refers to examination or measurement to verify whether an
200.20.2
129

DEFINITIONS
ISO 9001:2000
Written by:
Clause 3.0,
ISO 9001:1994
3.0
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 3 of 7
mm/dd/yyyy
mm/dd/yyyy
Inspectors
relating to product and inspection and to verify the achievement of the
quality specified.
Lead Auditor
An auditor who is qualified and authorized to manage a quality system
audit is known as a lead auditor.
Management Review
The management review is a compulsory evaluation carried out by general
Nonconformity
requirements.
Organization
Provisional Auditor
A person who meets all requirements for registration except for audit
experience is known as a provisional auditor.
130
200.20.2

DEFINITIONS
ISO 9001:2000
Written by:
Clause 3.0,
ISO 9001:1994
3.0
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 4 of 7
mm/dd/yyyy
mm/dd/yyyy
Quality
Quality refers to all properties and characteristics of a service that make
it capable of satisfying a clients expressed or specified needs.
Quality Audit
Quality Assurance
Quality Control
Quality control is that part of good manufacturing practice which is
concerned with sampling, specifications, and testing. Organization, documentation, and release procedures ensure that the necessary and relevant
tests are actually carried out, and that materials are not released for use,
and that products are not released for sale or supply, until their quality
has been judged to be satisfactory.
Quality Manual
the company to ensure that quality of its products or services.
200.20.2
131

DEFINITIONS
ISO 9001:2000
Written by:
Clause 3.0,
ISO 9001:1994
3.0
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 5 of 7
mm/dd/yyyy
mm/dd/yyyy
Quality Planning
quality plan.
Quality Policy
The overall quality intentions and direction of an organization formally
expressed by top management is called the quality policy.

The quality record refers to the filled-in record documents proving that
the quality assurance and quality control actions have been done.
Quality System
The quality system consists of the organizational structure, responsibilities, procedures, processes, and resources for implementing quality
management.
132
200.20.2

DEFINITIONS
ISO 9001:2000
Written by:
Clause 3.0,
ISO 9001:1994
3.0
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 6 of 7
mm/dd/yyyy
mm/dd/yyyy
The representative sample is a sample taken using a clearly defi ned
procedure in order to obtain information about a batch.
Second Party Audits

Specification
Specification refers to a document that specifies the requirements with
which the product and/or material must comply.
Third Party Audits

or similar organization are known as third party audits.
Traceability
Validation
The act of checking a calculation or design through its stages to verify
that the assumptions made, input data, and method used have produced
a valid result is known as validation.
200.20.2
133

DEFINITIONS
ISO 9001:2000
Written by:
Clause 3.0,
ISO 9001:1994
3.0
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 7 of 7
mm/dd/yyyy
mm/dd/yyyy
Verification
Verification refers to the act of reviewing, inspecting, testing, checking,
auditing, or otherwise verifying and documenting whether items, processes, services, or documents conform to specified requirements.
134
200.20.2

QUALITY MANAGEMENT SYSTEM Clause 4.0,
ISO 9001:1994
4.0
ISO 9001:2000
Written by:
Checked by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Revision 0
Approved by:
Page 1 of 4
The contents of the ISO 9001:1994 international standards are described

below in correspondence with ISO 9001:2001 to define quality system
requirements and management responsibilities.
Clause
1.0
2.0
3.0
4.0
4.1
4.1.1
4.1.2
4.1.2.1
4.1.2.2
4.1.2.3
4.1.3
4.2
4.2.1
4.2.2
4.2.3
4.3
4.3.1
4.3.2
4.3.3
4.3.4
4.4
4.4.1
ISO 9001:1994
Scope
Normative reference
Definitions
(title only)
(title only)
Quality policy
Resources
Management review
General
Quality planning
General
Review
Records
Design control (title only)
General
ISO 9001:2000
1.0
2.0
3.0
5.1 + 5.3 + 5.4.1

5.5.1
5.1 + 6.1 + 6.2.1 + 6.3
5.5.2
5.6.1 + 5.6.2 + 5.6.3 + 8.5.1
4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1
4.2.1
5.4.2 + 6.2.1 + 7.1
5.2 + 7.2.1 + 7.2.2 + 7.2.3

7.2.2
7.2.2
200.20.2
135

ISO 9001:1994
4.0
ISO 9001:2000
Written by:
Checked by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Revision 0
Approved by:
Page 2 of 4
Correspondence between ISO 9001:1994 and ISO 9001:2000 (Continued)

Clause
4.4.2
4.4.3
ISO 9001:1994
4.9

interfaces
Design input
Design output
Design review
Design verification
Design validation
Design changes
(title only)
General
issue
General
Purchasing data
product
traceability
Process control
4.10
4.4.4
4.4.5
4.4.6
4.4.7
4.4.8
4.4.9
4.5
4.5.1
4.5.2
4.5.3
4.6
4.6.1
4.6.2
4.6.3
4.6.4
4.7
4.8
ISO 9001:2000
7.3.1
7.3.1
7.2.1
7.3.3
7.3.1
7.3.1
7.3.1
7.3.7
+ 7.3.2
+ 7.3.4
+ 7.3.5
+ 7.3.6
4.2.1 + 4.2.3
4.2.3
4.2.3
7.4.1
7.4.2
7.4.3
7.5.4
7.5.3
6.3 + 6.4 + 7.1 + 7.5.1 + 7.5.2 +
8.2.3
136
200.20.2

ISO 9001:1994
4.0
ISO 9001:2000
Written by:
Checked by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Revision 0
Approved by:
Page 3 of 4

Clause
ISO 9001:1994
4.10.1
4.10.2
4.10.3
4.10.4
4.10.5
4.11
General
General
Control procedure
product (title only)
General
(title only)
General
Corrective action
Preventive action
(title only)
General
Handling
Storage
Packaging
4.11.1
4.11.2
4.12
4.13
4.13.1
4.13.2
4.14
4.14.1
4.14.2
4.14.3
4.15
4.15.1
4.15.2
4.15.3
4.15.4
ISO 9001:2000
7.1 + 8.1
7.4.3 + 8.2.4
7.4.3 + 7.5.1 + 8.2.4
7.4.3 + 8.2.4
7.5.3 + 8.2.4
7.6
7.6
7.5.3
8.3
8.3
8.5.2 + 8.5.3
8.4 + 8.5.2
8.4 + 8.5.3
7.5.5
7.5.5
7.5.5
200.20.2
137

ISO 9001:1994
4.0
ISO 9001:2000
Written by:
Checked by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Revision 0
Approved by:
Page 4 of 4

Clause
4.15.5
4.15.6
4.16
4.17
4.18
4.19
4.20
4.20.1
4.20.2
ISO 9001:1994
Preservation
Delivery
Training
Servicing
Procedures
ISO 9001:2000
7.5.5
7.5.1 + 7.5.5
4.2.4
8.2.2 + 8.2.3
6.2.1 + 6.2.2
7.1 + 7.5.1
8.1 + 8.2.3 + 8.2.4 + 8.4
138
200.20.2

QUALITY POLICY
ISO 9001:2000
Written by:
Clause 4.1.1,
ISO 9001:1994
5.1 + 5.3 + 5.4.1
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 2
mm/dd/yyyy
mm/dd/yyyy
QUALITY POLICY
[Quality policy statement here]
[Should be by top management]
Top management has provided evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by
1. Ensuring the availability of resources
2. Conducting management reviews and ensuring that quality objectives are established
3. Establishing the quality policy
4. Communicating to the organization the importance of meeting
customer as well as statutory and regulatory requirements
Quality Policy
Our immediate and long-term success is dependent on the following
elements:
Compling with customers provided specifications
Following standard operating procedures
Meeting the registration requirements of the regulatory bodies
200.20.2
139

QUALITY POLICY
ISO 9001:2000
Written by:
Clause 4.1.1,
ISO 9001:1994
5.1 + 5.3 + 5.4.1
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 2 of 2
mm/dd/yyyy
mm/dd/yyyy
The quality path, to which we have all been firmly committed for many
years, will lead us to maintain the ISO 9001: 2000 certification. Our quality
objective is ambitious but realistic. It involves teamwork and is a challenge
that we accept together. Our future depends on it.
It is ensured that the quality policy is appropriate to the purpose of
the organization and includes a commitment to comply with requirements
and continually improve the effectiveness of the quality management
system. The policy provides a framework for establishing and reviewing
quality objectives, communicated and understood within the organization,
and is reviewed for continuing suitability.
Quality Objectives
It is ensured that quality objectives, including those needed to meet
requirements for product compliance, are established at relevant functions
and levels within the organization. The quality objectives are measurable
and consistent with the quality policy.
Signature
Designation of the Head of the Company
140
200.20.2

ORGANIZATION
ISO 9001:2000
Written by:
Clause 4.1.2,
ISO 9001:1994
Title (only)
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy

Describe the site organization chart of your company and the number of
employees. Describe departments involved, field of activity, interrelationships, definitions, and terminologies used within the company.
The (company name) head office is located at (address), and is
currently involved in the manufacturing of the following products/services.
Provide list of products.
Provide list of services.
The company specializes in the production of (provide details).
The plant organization is shown in the chart on the following page.
The key functions of the departments are as follows.
The common quality associated terms used in the company are described
below.
200.20.2
141

RESPONSIBILITY AND
AUTHORITY
ISO 9001:2000
Written by:
Clause 4.1.2.1,
ISO 9001:1994
5.5.1
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
ORGANIZATIONAL RESPONSIBILITY AND AUTHORITY

Every employee whose work may ultimately affect product quality and
service has the responsibility, authority, and organizational freedom to:
1. Identify and record product- or service-related problems
2. Recommend, initiate, or provide solutions through systemic review
and approvals
3. Initiate corrective action to prevent the occurrence of product
nonconformity
4. Verify the implementation of solutions
5. Monitor and control further processing, delivery, or installation of
a nonconforming product or service until the deficiency or unsatisfactory condition has been corrected
The management has ensured that the responsibilities, authorities, and
their interrelation are defined and communicated within the organization.
142
200.20.2

RESOURCES
ISO 9001:2000
Written by:
Clause 4.1.2.2,
ISO 9001:1994
5.1 + 6.1 + 6.2.1 + 6.3
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 2
mm/dd/yyyy
mm/dd/yyyy
RESOURCES
Personnel performing work affecting product quality are competent and
are selected on the basis of appropriate education, training, skills, and
experience.
INFRASTRUCTURE
The organiztion has determined, provided, and maintained the infrastructure needed to achieve conformity to product requirements. The basic
infrastructure includes buildings, workspace and associated utilities, process equipment, both hardware and software, and supporting services
such as transport or communication.
The top management of (company name) is committed to the development
and implementation of the quality management system and continually
improving its effectiveness by:
1.
2.
3.
4.
5.
Ensuring the availability of resources

Conducting management reviews
Ensuring that quality objectives are established
Establishing the quality policy
Communicating to the organization the importance of meeting
customer as well as statutory and regulatory requirements
200.20.2
143

RESOURCES
ISO 9001:2000
Written by:
Clause 4.1.2.2,
ISO 9001:1994
5.1 + 6.1 + 6.2.1 + 6.3
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 2 of 2
mm/dd/yyyy
mm/dd/yyyy
The management has determined and provided the resources needed to
implement and maintain the quality management system, continually
improve its effectiveness, and enhance customer satisfaction by meeting
customer requirements.
144
200.20.2

MANAGEMENT REPRESENTATIVE Clause 4.1.2.3,
ISO 9001:1994
5.5.2
ISO 9001:2000
Written by:
Checked by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Revision 0
Approved by:
Page 1 of 1
The [quality assurance manager] is appointed as the management representative and has the defined authority and responsibility, irrespective of
other responsibilities, to ensure that the requirements of all pertinent
standards are implemented and maintained.
The management representative has the full responsibility for:
1. Ensuring that processes needed for the quality management system
are established, implemented, and maintained
2. Reporting to top management on the performance of the quality
management system and any need for improvement
3. Ensuring the promotion of awareness of customer requirements
throughout the organization
4. Forming a liaison with external parties on matters relating to the
quality management system
200.20.2
145

MANAGEMENT REVIEW
ISO 9001:2000
Written by:
Clause 4.1.3,
Revision 0
ISO 9001:1994
5.6.1 + 5.6.2 + 5.6.3 + 8.5.1
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 2
mm/dd/yyyy
mm/dd/yyyy
MANAGEMENT REVIEW
The quality system is reviewed on a quarterly basis through management
reviews to ensure continuing suitability and effectiveness. The data and
results of the input and output reviews are recorded and maintained.
This review includes assessing opportunities for improvement and the
need for changes to the quality management system, including the quality
policy and quality objectives.
REVIEW INPUT
The input to the management review includes information on:
1.
2.
3.
4.
5.
6.
7.
Results of audits
Customer feedback
Process performance and product conformity
Status of preventive and corrective action
Follow-up actions from previous management reviews
Planned changes that could affect the quality management system
Recommendations for improvement
146
200.20.2

MANAGEMENT REVIEW
ISO 9001:2000
Written by:
Clause 4.1.3,
Revision 0
ISO 9001:1994
5.6.1 + 5.6.2 + 5.6.3 + 8.5.1
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 2 of 2
mm/dd/yyyy
mm/dd/yyyy
REVIEW OUTPUT
The output from the management review includes decisions and actions
related to:
1. Improvement of the effectiveness of the quality management system and its processes
2. Improvement of the product related to customer requirements
3. Resource needs
The organization continually improves the effectiveness of the quality
management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions, and
management reviews.
200.20.2
147

QUALITY SYSTEM
ISO 9001:2000
Written by:
Clause 4.2,
Revision 0
ISO 9001:1994
4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 + 5.4.2 + 6.2.1
+ 7.1
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 6
mm/dd/yyyy
mm/dd/yyyy
GENERAL
A quality management system is established, maintained, and documented
as a means to ensure that products and services conform to specified
requirements. This quality system is designed to comply with the
ISO 9001:2000 standard. The quality systems responsibilities are tabulated
in Table 1 (amend the table as relevant to your company).
Table 1
Correspondence
Clause
ISO 9001:2000
ISO-9001 CLAUSE
4.1
Management
responsibilities
4.2
Quality system
4.3
Contract review
Function Concerned in the Entity

ADM
QUA
PRD
QCD
SHP
MAI
PER
PDL
PUR
PAC
MKT
MPM
Element in the
Quality System
5.1 + 5.3 + 5.4.1

+ 5.5.1
+ 6.1 + 6.2.1 +
6.3
5.5.2
5.6.1 + 5.6.2 +
5.6.3 + 8.5.1
4.1 + 4.2.1 +
4.2.2 + 5.1 +
5.4.1
5.4.2 + 6.2.1 +
7.1
5.2 + 7.2.1 +
7.2.2 + 7.2.3
X * * * * * * * * * * *
* X * * * * * * * * * *
* * * * * * X *
148
200.20.2

QUALITY SYSTEM
Clause 4.2,
Revision 0
ISO 9001:1994
4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 + 5.4.2 + 6.2.1
+ 7.1
Checked by:
Approved by:
ISO 9001:2000
Written by:
Date Supersedes
Date Issue
Page 2 of 6
mm/dd/yyyy
mm/dd/yyyy
Table 1 (Continued)
Correspondence
Clause
ISO 9001:2000
ISO-9001 CLAUSE
4.4
Design control
4.5
Document and
data control
Purchasing
4.6
4.7
4.8
4.9
Control of
customersupplied
product
Product
identification
and traceability
Process control

ADM
QUA
PRD
QCD
SHP
MAI
PER
PDL
PUR
PAC
MKT
MPM
Element in the
Quality System
7.3.1
7.2.1 + 7.3.2
7.3.3
7.3.4
7.3.5
7.3.6
7.3.7
4.2.1 + 4.2.3
* * * X * *
* * * * * * * X * * * *
7.4.1
7.4.2
7.4.3
7.5.4
* * * * * X *
7.5.3
* * X * * * * * * *
6.3 + 6.4 + 7.1 +

7.5.1 + 7.5.2 +
8.2.3
* X * * *
X *
200.20.2
149

QUALITY SYSTEM
Clause 4.2,
Revision 0
ISO 9001:1994
4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 + 4.2.1 + 5.4.2
+ 6.2.1 + 7.1
Checked by:
Approved by:
ISO 9001:2000
Written by:
Date Supersedes
Date Issue
Page 3 of 6
mm/dd/yyyy
mm/dd/yyyy
Table 1 (Continued)
Correspondence
Clause
ISO 9001:2000
ISO-9001 CLAUSE
4.10
Inspection and
testing
4.11
Inspection,
measurement,
and test
equipment
Inspection and
test status
Control of
nonconforming
product
Corrective
actions
Handling, storage,
packaging,
preservation,
and delivery
Quality records
Internal quality
audits
Training
4.12
4.13
4.14
4.15
4.16
4.17
4.18

ADM
QUA
PRD
QCD
SHP
MAI
PER
PDL
PUR
PAC
MKT
MPM
Element in the
Quality System
7.1 + 8.1
7.4.3 + 8.2.4
7.5.1
7.5.3
7.6
X * * *
7.5.3
X * * * *
8.3
* * * X * * * * * * *
8.5.2 + 8.5.3
8.4
7.5.5 + 7.5.1
* X * * * * * * * * * *
* * * X * *
* * * * * X
4.2.4
8.2.2 + 8.2.3
* * * X * * * * * * * *
* X * * * * * * * * *
6.2.1 + 6.2.2
* X * * * * X * * * * *
150
200.20.2

QUALITY SYSTEM
ISO 9001:2000
Written by:
Clause 4.2,
Revision 0
ISO 9001:1994
4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 + 4.2.1 + 5.4.2
+ 6.2.1 + 7.1
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 4 of 6
mm/dd/yyyy
mm/dd/yyyy
Table 1 (Continued)
Correspondence
Clause
ISO 9001:2000
ISO-9001 CLAUSE
4.19
4.20
Servicing
Statistical
techniques

ADM
QUA
PRD
QCD
SHP
MAI
PER
PDL
PUR
PAC
MKT
MPM
Element in the
Quality System
7.1 + 7.5.1
8.1 + 8.2.3 +
8.2.4 + 8.4
* * * * * * * * X *
* X * * *

Key:
ADM
PRD
SHP
PDL
PAC
MPM
=
=
=
=
=
=
Production
Shipping
Packaging
QUA
QCD
PER
PUR
MKT
MAI
=
=
=
=
=
=
Quality Assurance
Personnel
Purchase
Marketing
Maintenance
QUALITY SYSTEM PROCEDURES

The organization has identified the processes needed for the quality
management system and their application throughout the organization.
These processes are managed by the organization in accordance with
the requirements of these international standards. The quality management
system documentation is reviewed, updated, and maintained both in
hardware and software form.
200.20.2
151

QUALITY SYSTEM
ISO 9001:2000
Written by:
Clause 4.2,
Revision 0
ISO 9001:1994
4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 + 5.4.2 + 6.2.1
+ 7.1
Checked by:
Approved by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Page 5 of 6
CONTROL MANUAL
The scope of the quality management system includes details of and
justification for any exclusions, the documented procedures established for
the quality management system, or reference to them, and a description of
the interaction between the processes of the quality management system.
The organization has committed to the development and implementation of
the quality management system and continually improving its effectiveness.
QUALITY OBJECTIVES
(Company name) has ensured that quality objectives, including those
needed to meet requirements for products, are established at relevant
functions and levels within the organization. The quality objectives are
measurable and consistent with the quality policy.
DOCUMENTATION
Documented quality system procedures and instructions are prepared to
meet the requirements of all pertinent standards.
This manual is reviewed, revised (as required), and reapproved annually.
Quality planning is performed by the quality assurance department to
fully meet specified requirements. Procedures and instructions for quality
are kept current to conform to specified requirements.
Quality records are properly prepared and identified and can be in
any form or medium.
152
200.20.2

QUALITY SYSTEM
ISO 9001:2000
Written by:
Clause 4.2,
Revision 0
ISO 9001:1994
4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 + 5.4.2 + 6.2.1
+ 7.1
Checked by:
Approved by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Page 6 of 6
IMPLEMENTATION
[Quality assurance system] procedures and instructions are updated as needed.
When needed to achieve the required standard of quality, quality control,
inspection techniques, and instrumentation are updated. As needed to
achieve the required quality, any controls, processes, inspection equipment,
fixtures, total production resources, and skills are identified and acquired.
Standards of acceptability for all features and requirements are clear,
complete, and understood (including those that contain a subjective element). The production process, product installation, inspection, and test
procedures are compatible with the design and requirements.
All quality system procedures and instruction changes are properly
documented.
QUALITY PLANNING
The planning of the quality management system is carried out in order
to meet the requirements given in 4.1 as well as the quality objectives,
and the integrity of the quality management system is maintained when
changes to the quality management system are planned and implemented.
It is ensured that personnel performing work affecting product quality
are competent on the basis of appropriate education, training, skills, and
experience.
PLANNING OF PRODUCTION REALIZATION

The organization has planned and developed the processes needed for
product realization. Planning of product realization is consistent with the
requirements of the other processes of the quality management system.
200.20.2
153

CONTRACT REVIEW
ISO 9001:2000
Written by:
Clause 4.3,
Revision 0
ISO 9001:1994
5.2 + 7.2.1 + 7.2.2 + 7.2.3
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
CONTRACT REVIEW
Procedures for contract review are established and maintained.
The [order entry department] ensures that our customers requirements
are adequately defined and documented.
[Production control planners] ensure that the plant has the capability
to meet contractual requirements.
[Customer service] ensures that a method for solving contractual differences has been developed and is in use.
CUSTOMER FOCUS
It is ensured that the product shall meet the customer requirements.

TO THE PRODUCT
The organization determines requirements specified by the customer,
requirements not stated by the customer but necessary for specifi ed
use or known and intended use, r egulatory requirements, and any
additional requirements.
The organization determines and implements effective arrangements for
communicating with customers.
Reference Procedure [Number- ISO-4.3, dated mm-dd-yyyy]
154
200.20.2

DESIGN CONTROL
ISO 9001:2000
Written by:
Clause 4.4,
Revision 0
ISO 9001:1994
7.2.1 + 7.3.1 + 7.3.2 + 7.3.3 + 7.3.4 + 7.3.5 +
7.3.6 + 7.3.7
Checked by:
Approved by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Page 1 of 4
GENERAL
Procedures are established and maintained to control and verify the design
of the product and service in order to ensure the specified requirements
are met.

The [design department] identifies the responsibility for each design and
development activity.
Design and verification activities are planned and assigned to qualified
staff equipped with adequate resources.
Organizational and technical interfaces between different groups are
identified, and the necessary information is documented, transmitted, and
regularly reviewed.
The organization plans and controls the design and development of
the product.
DESIGN INPUT
The [design department] and [plant product engineering] ensure that
the design input requirements relating to the product are identified,
documented, and their selection is reviewed to ensure adequacy. Incomplete, ambiguous, or conflicting requirements are resolved when defining these requirements.
200.20.2
155

DESIGN CONTROL
ISO 9001:2000
Written by:
Clause 4.4,
Revision 0
ISO 9001:1994
7.2.1 + 7.3.1 + 7.3.2 + 7.3.3 + 7.3.4 + 7.3.5 +
7.3.6 + 7.3.7
Checked by:
Approved by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Page 2 of 4
DESIGN OUTPUT
The [design department] and [plant product engineering] ensure that the
design output meets the design input requirements.
Design output is documented and expressed in terms of requirements,
calculations, and analysis.
Engineering drawings and/or specifications contain or refer to acceptance criteria.
Design output conforms to appropriate regulatory requirements [e.g.,
put names of agencies here], whether or not these have been stated in
the input information.
Engineering drawings and/or specifications identify those characteristics of the design that are crucial to the safe and proper functioning of
the product.
DESIGN REVIEW
The organization plans and controls the design and development of the
product. During the design and development planning, the organization
determines the design and development stages, the review, verification,
and validation that are appropriate to each design and development stage,
and the responsibilities and authorities for design and development.

At suitable stages, systematic reviews of design and development are
conducted.
156
200.20.2

DESIGN CONTROL
ISO 9001:2000
Written by:
Clause 4.4,
Revision 0
ISO 9001:1994
7.2.1 + 7.3.1 + 7.3.2 + 7.3.3 + 7.3.4 + 7.3.5 +
7.3.6 + 7.3.7
Checked by:
Approved by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Page 3 of 4
DESIGN VERIFICATION
Design verification is assigned to the [research and development department] and is planned, established, and documented.
[Engineering standard practice instructions] ensure that design output
meets the design input requirements by means of designing control
measures such as:
1.
2.
3.
4.
Holding and recording design reviews

Undertaking qualification tests and demonstrations
Carrying out alternative calculations
Comparing the new design with a similar proven design, if available
Design verification is performed to ensure that the design and development outputs have satisfied the design and development input requirements. Records of the results of the verification and any necessary actions
are maintained.
DESIGN VALIDATION
Design and development validation is performed in accordance with
planned arrangement to ensure that the resulting product is capable of
fulfilling the requirements for the specified or known intended use or
application. Wherever practicable, validation is completed prior to the
delivery or implementation of the product. Records of the results of
validation and any necessary actions are maintained.
200.20.2
157

DESIGN CONTROL
ISO 9001:2000
Written by:
Clause 4.4,
Revision 0
ISO 9001:1994
7.2.1 + 7.3.1 + 7.3.2 + 7.3.3 + 7.3.4 + 7.3.5 +
7.3.6 + 7.3.7
Checked by:
Approved by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Page 4 of 4
DESIGN CHANGES
[Engineering standard practice instructions] are established and maintained
for the identification, documentation, and appropriate review and approval
of all changes and modifications.
158
200.20.2

DOCUMENT AND DATA
CONTROL
ISO 9001:2000
Written by:
Clause 4.5,
ISO 9001:1994
4.2.1 + 4.2.3
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 2
mm/dd/yyyy
mm/dd/yyyy
GENERAL
The quality management system documentation includes quality policy, a
quality manual, and documented procedures required by this international
standard and quality standards.
DOCUMENT, DATA APPROVAL, AND ISSUES

[Engineering standard practice instructions] are established and maintained
to control all documents and data that relate to the standards requirements.
These documents are reviewed and approved for adequacy by authorized
personnel prior to being issued.
Current revisions of documents are identified by the [master list] on
the computer system.
The [master list] and the [manufacturing plant procedures] ensure that
the pertinent issues of appropriate documents are available at all locations
where operations essential to the effective functioning of the quality system
are performed.
The [manufacturing plant procedures] ensure that obsolete documents
are promptly removed from all points of issue or use.
200.20.2
159

DOCUMENT AND DATA
CONTROL
ISO 9001:2000
Written by:
Clause 4.5,
ISO 9001:1994
4.2.1 + 4.2.3
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 2 of 2
mm/dd/yyyy
mm/dd/yyyy
DOCUMENT AND DATA CHANGES

Document changes/modifications are reviewed and approved by the
[design department], which has access to all pertinent background information upon which to base its review and approval.
The change and the nature of the change are identified on the document or on an appropriate attachment, unless it is not practicable.
Documents are reissued promptly after changes are made.
Documents required by the quality management system are controlled.
A documented procedure is established to define the controls needed.
160
200.20.2

PURCHASING
ISO 9001:2000
Written by:
Clause 4.6,
ISO 9001:1994
7.4.1 + 7.4.2 + 7.4.3
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 2
mm/dd/yyyy
mm/dd/yyyy
GENERAL
The [purchasing] and [quality assurance departments] ensure that purchased products conform to specified requirements.
VENDOR ASSESSMENT
Vendors are selected on the basis of their ability to meet quality requirements. An approved vendor list is established and maintained. Only
approved vendors are used.
Vendors are approved based on [parts qualification report] and performance as to the type of product and service being purchased. Vendor
evaluation ensures that the vendor has effective quality system controls.
PURCHASING DATA
The [buyers] review and approve purchase orders for adequacy of specified
requirements prior to release. Purchasing documents contain data clearly
describing the product ordered, including, where applicable:
1. The type, class, style, grade, or other precise identification
2. The title or other positive identification, applicable issue of specifications, drawings, process requirements, inspection instructions,
and other relevant technical data, including requirements for
approval or qualification of product, procedures, process equipment, and personnel
3. The title, number, and issue date of the specification to be applied
to the product
200.20.2
161

PURCHASING
ISO 9001:2000
Written by:
Clause 4.6,
ISO 9001:1994
7.4.1 + 7.4.2 + 7.4.3
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 2 of 2
mm/dd/yyyy
mm/dd/yyyy

Our customer or our customers representatives are afforded the right to
verify at the source or upon receipt that the purchased product conforms
to the specified requirements. Product verification by the customer does
not absolve our operation of the responsibility to provide a fully acceptable
product, nor does it preclude subsequent rejection. When our customer
carries out product verification at a vendors plant, such verification is
used as evidence of effective quality control of the vendor.
Reference Procedure [Number ISO-4.6 dated mm-dd-yyyy]
162
200.20.2

CUSTOMER-SUPPLIED PRODUCT Clause 4.7,
ISO 9001:1994
7.5.4
ISO 9001:2000
Written by:
Checked by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Revision 0
Approved by:
Page 1 of 1
CUSTOMER-SUPPLIED PRODUCT
Customer-supplied products are verified, stored, and maintained to prevent
deterioration or loss. It is ensured that:
A customer-supplied product is prevented from deterioration or loss.
The nonconforming customer-supplied product is segregated from
the production streams recorded and reported to the customer.
The contract describes the conditions of handling the customersupplied product (or by other documented specification).
Customer property includes intellectual property rights.
200.20.2
163

PRODUCT IDENTIFICATION
AND TRACEABILITY
ISO 9001:2000
Written by:
Clause 4.8,
ISO 9001:1994
7.5.3
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
The identification of the product is established and maintained for all
products to all applicable drawings, specifications, or other documents
during all stages of production, delivery, and installation.
PRODUCT TRACEABILITY
Where traceability is specified, the product and subassemblies of the
product have unique recorded identification.
164
200.20.2

PROCESS CONTROL
ISO 9001:2000
Written by:
Clause 4.9,
Revision 0
ISO 9001:1994
6.3 + 6.4 + 7.1 + 7.5.1 + 7.5.2 + 8.2.3
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 2
mm/dd/yyyy
mm/dd/yyyy
PROCESS CONTROL
Production operations, which directly affect quality, are identified and
planned to ensure that these processes are carried out under controlled
conditions. Controlled conditions shall include the following:
1. Documented work instructions defining the manner of production
and installation, where the absence of instructions would adversely
affect quality
2. Use of suitable production and installation equipment, a suitable
working environment, compliance with reference standards, codes,
and quality plans
3. Monitoring and control of suitable process and product characteristics during production and installation
4. The approval of processes and equipment, as appropriate
5. Engineering drawings and inspection plans stipulating the acceptance and rejection criteria
6. Availability of suitable buildings and workplaces
SPECIAL PROCESSES
These are processes, the results of which cannot be fully verified by
subsequent inspection and testing of the product and where, for example, process deficiencies may become apparent only after the product
is in use. Accordingly, continuous monitoring and/or compliance with
documented procedures are required to ensure that the specified requirements are met. Records are maintained for all qualified process equipment and personnel.
200.20.2
165

PROCESS CONTROL
ISO 9001:2000
Written by:
Clause 4.9,
Revision 0
ISO 9001:1994
6.3 + 6.4 + 7.1 + 7.5.1 + 7.5.2 + 8.2.3
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 2 of 2
mm/dd/yyyy
mm/dd/yyyy

Planning of product realization is consistent with the requirements of the
other processes of the quality management system, and the organization
determines the elements as appropriate.
166
200.20.2

INSPECTION AND TESTING
ISO 9001:2000
Written by:
Clause 4.10,
Revision 0
ISO 9001:1994
7.1 + 7.4.3 + 7.5.1 + 7.5.3 + 8.1 + 8.2
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 3
mm/dd/yyyy
mm/dd/yyyy
GENERAL
The organization has planned and developed the processes needed for
product realization. Planning of product realization is consistent with the
requirements of the other processes of the quality management system
and considers monitoring, measurement, analysis, and improvement processes needed.
RECEIVING INSPECTION AND TEST

Consideration is given to the control exercised at the source and documented evidence of quality conformance provided. All incoming materials are inspected or otherwise verified as to conforming to specified
requirements before being released for use to production. This verification is in accordance with the quality plan or documented procedures.
All incoming materials released for urgent production purposes are
positively identified and recorded in order to permit immediate recall
in the event of nonconformance.
The organization monitors and measures the characteristics of the
product to verify that product requirements are fulfilled. This is carried
out at appropriate stages of the product realization process in accordance
with the planned arrangements.
200.20.2
167

ISO 9001:2000
Written by:
Clause 4.10,
Revision 0
ISO 9001:1994
7.1 + 7.4.3 + 7.5.1 + 7.5.3 + 8.1 + 8.2
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 2 of 3
mm/dd/yyyy
mm/dd/yyyy
IN-PROCESS INSPECTION AND TESTING

All in-process inspection and test requirements, as specified by contract,
are controlled by these means:
1. Inspecting, testing, and identifying the product as required by the
quality plan or documented procedures
2. Establishing product conformance to specified requirements by use
of process monitoring and control methods
3. Holding the product until the required inspection and tests have
been completed or necessary reports have been received and
verified (except when the product is released under positive recall
procedures); release under positive recall procedures does not
preclude the activities of (1) above.
4. Identifying a nonconforming product
5. Considering controlled conditions, as applicable
FINAL INSPECTION AND TESTING

The [quality plan] ensures that all specified inspections and tests, including
those specified either upon receipt of the product or in process, have
been carried out and that all data meet the specified requirements.
All final inspections and testing are performed in accordance with the
[quality plan and specifications] to complete the evidence of product
conformance to the specified requirements.
No product is shipped until all specified requirements have been
satisfactorily completed and the associated data and documentation are
complete and authorized.
168
200.20.2

ISO 9001:2000
Written by:
Clause 4.10,
Revision 0
ISO 9001:1994
7.1 + 7.4.3 + 7.5.1 + 7.5.3 + 8.1 + 8.2
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 3 of 3
mm/dd/yyyy
mm/dd/yyyy
INSPECTION AND TEST RECORDS

[Inspection records] are maintained in order to provide evidence that the
product has passed an inspection and/or test with defined acceptance
criteria.

Where appropriate, the organization identifies the product by suitable
means throughout product realization.
200.20.2
169

INSPECTION, MEASURING, AND Clause 4.11,
TEST EQUIPMENT
ISO 9001:1994
7.6
ISO 9001:2000
Written by:
Checked by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Revision 0
Approved by:
Page 1 of 2
INSPECTION, MEASURING, AND TEST EQUIPMENT

The [calibration system] controls, calibrates, and maintains inspection,
measuring, and test equipment to demonstrate the conformance of the
product to the specified requirements. Equipment is used in such a manner
so as to ensure that measurement uncertainty is known and is consistent
with the required measurement capability. The measurements made are
identified, the accuracy is stated, and the appropriate inspection, measuring, and test equipment is used.
[Calibration procedures] are established and maintained to include
details of equipment type, identification number, location, frequency of
checks, check method, acceptance criteria, and the action to be taken
when check results are unsatisfactory. Calibration records are maintained,
and calibration environmental conditions are controlled.
All inspection, measuring, and test equipment is capable of the accuracy
and precision necessary. Prior to use, all inspection, measuring, and test
equipment is identified, calibrated, and adjusted as required. Calibration
and adjustments are made are against standards of certified equipment,
traceable to the National Institute of Standards and Technology (NIST, where
no such standard exists, the basis used for calibration is documented).
Inspection, measuring, and test equipment is identified with a suitable
indicator or approved identification record to show the calibration status.
When inspection, measuring, and test equipment is found to be out
of calibration, an assessment of the validity of previous inspections and
tests are made and documented.
The accuracy and fitness for use of inspection, measuring, and test
equipment are maintained by controlling the handling, preservation, and
storage of the equipment.
Inspection, measuring, and test equipment and test facilities, including
both test hardware and test software, are safeguarded from adjustments
that would invalidate the calibration setting.
170
200.20.2

TEST EQUIPMENT
ISO 9001:1994
7.6
ISO 9001:2000
Written by:
Checked by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Revision 0
Approved by:
Page 2 of 2
Test hardware (e.g., jigs, fixtures, templates, and patterns) or test

software is checked to ensure capability of verifying the acceptability of
the product, prior to release, for use during production or installation.
Such hardware and software is controlled by periodic checks. Records
are maintained.
In addition, the organization assesses and records the validity of the
previous measuring results when the equipment is found not to conform
to requirements. The organization takes appropriate action on the equipment and any product affected. Records of the results of calibration and
verification are maintained.
Reference Procedure [Number ISO-4.11, dated mm-dd-yyyyy]
200.20.2
171

INSPECTION AND TEST STATUS
ISO 9001:2000
Written by:
Clause 4.12,
ISO 9001:1994
7.6.3
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy

The inspection and test status of the product is identified by markings,
authorized tags, labels, routing cards, inspection records, test software,
and physical location, which indicate the conformance or nonconformance
of the product with regard to inspection and tests performed.
The identification of inspection and test status is maintained, as necessary, throughout production and installation of the product to ensure
that only product that has passed the required inspection and test is
shipped, used, or installed.
Records identify the inspection authority responsible for the release of
conforming product.
172
200.20.2

CONTROL OF
Clause 4.13,
NONCONFORMING PRODUCT ISO 9001:1994
8.3
ISO 9001:2000
Written by:
Checked by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Revision 0
Approved by:
Page 1 of 2

Nonconforming product is controlled to ensure that any product that does
not conform to specified requirements is prevented from inadvertent use
or installation.
The [procedures] provide for identification, documentation, evaluation,
and segregation when practical, as well as disposition of nonconforming
product and notification to the functions concerned.
NONCONFORMITY REVIEW AND DISPOSITION

The responsibility for review and authority for the disposition of nonconforming product is assigned to a [material review board]. Nonconforming
product is reviewed in accordance with [material review board procedures].
Disposition of nonconforming product may be:
1.
2.
3.
4.
5.
Rework to meet the specified requirements

Accept with repair by concession
Accept without repair by concession
Regrade for alternative applications
Scrap
Where required by contract, the proposed use or repair of any product

that does not conform to specified requirements is reported for concession
to the customer or the customers representative. The description of
nonconformity that has been accepted, as well as repairs, is recorded to
denote the actual condition.
Repaired and reworked products are reinspected in accordance with
the [quality plan].
200.20.2
173

CONTROL OF
Clause 4.13,
8.3
ISO 9001:2000
Written by:
Checked by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Revision 0
Approved by:
Page 2 of 2
When nonconforming product is detected after delivery or use has

begun, the organization takes action appropriate to the effects of the
nonconformity.
174
200.20.2

CORRECTIVE ACTION
ISO 9001:2000
Written by:
Clause 4.14,
ISO 9001:1994
8.4 + 8.5.2 + 8.5.3
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
CORRECTIVE ACTION
[Corrective action procedures] are established, documented, and maintained. They include:
1. Investigating the cause of nonconforming product and the corrective action needed to prevent recurrence
2. Analyzing all processes, work operations, concessions, quality
records, service reports, and customer complaints to detect and
eliminate potential causes of nonconforming product
3. Initiating preventive actions to deal with problems to a level
corresponding to the risk encountered
4. Applying controls to ensure corrective actions are taken and that
they are effective
5. Implementing and recording changes in procedures resulting from
corrective action
The organization initiates actions to eliminate the causes of potential
nonconformities in order to prevent their occurrence. Preventive actions
appropriate to the effects of the potential problem are initiated as
appropriate.
200.20.2
175

HANDLING, STORAGE,
PACKING, AND DELIVERY
ISO 9001:2000
Written by:
Clause 4.15,
ISO 9001:1994
7.5.1 + 7.5.5
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
HANDLING, STORAGE, PACKING, AND DELIVERY

[Warehouse procedures] are established, documented, and maintained for
the handling, storage, packaging, and delivery of the product.
[Warehouse procedures] establish the methods and means of handling
to prevent damage or deterioration.
[Storage areas] or stock rooms are provided to prevent damage or
deterioration of the product, pending use or delivery. Appropriate methods
for authorizing receipt and dispatch to and from such areas are stipulated.
The condition of any product in stock is assessed at appropriate intervals.
[Packing system] establishes the processes of packing, preserving, and
marking, to the extent necessary, to ensure conformance to specified
requirements and identifies, preserves, and segregates all product from
the time of receipt until the plants responsibility ceases.
[Shipping system] provides for the protection of the product through
the delivery of the product to its final destination.
176
200.20.2

QUALITY RECORDS
ISO 9001:2000
Written by:
Clause 4.16,
ISO 9001:1994
4.2.4
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
QUALITY RECORDS
Quality records are established and maintained to provide evidence of
conformity to requirements and of the effective operation of the quality
management system.
Quality records are made available for evaluation by the customer or
the customers representative for an agreed period.
All quality records are legible and identifiable to the product involved.
Quality records are stored and maintained in such a way that they are
readily retrievable in storage facilities, which minimizes deterioration and
prevents loss.
Quality records are maintained to demonstrate achievement of the
required quality and the effective operation of the quality system.
The retention time of quality records is according to the record
retention policy.
[Record procedures] are established and maintained for the identifying, collecting, indexing, filing, storing, maintaining, and disposing of
quality records.
200.20.2
177

INTERNAL QUALITY AUDITS
ISO 9001:2000
Written by:
Clause 4.17,
ISO 9001:1994
8.2.2 + 8.2.3
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy

A comprehensive system of planned and documented internal quality audits
is established to verify whether quality activities comply with planned
arrangements and to determine the effectiveness of the quality system.
Audits are scheduled on the basis of the status and importance of
the activity.
The audits and the follow-up actions are carried out in accordance
with ANSI/ASQC Q1-1986 or ISO 10011-1, ISO 11-1, and ISO 10011-3.
The results of the audit are documented and brought to the attention
of the personnel with responsibility in the area audited. The management
personnel responsible for that area take timely corrective action for the
deficiencies found by the audit.
The selection of auditors and conduct of audits ensure the objectivity
and impartiality of the audit process.
178
200.20.2

TRAINING
ISO 9001:2000
Written by:
Clause 4.18,
ISO 9001:1994
6.2.1 + 6.2.2
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
TRAINING
Procedures are established and maintained for identifying the training
needs and providing for the training of all personnel performing activities
affecting quality. Personnel performing specific assigned tasks are qualified
on the basis of appropriate education, training, and/or experience, as
required. Training records are maintained.
200.20.2
179

SERVICING
ISO 9001:2000
Written by:
Clause 4.19,
ISO 9001:1994
7.1 + 7.5.1
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
SERVICING
Where servicing is specified in the contract, procedures are established
and maintained for performing and verifying that service meets the specified requirements.
The organization plans and carries out production and service provisions under controlled conditions as applicable.
180
200.20.2

STATISTICAL TECHNIQUES
ISO 9001:2000
Written by:
Clause 4.20,
Revision 0
ISO 9001:1994
8.1 + 8.2.3 + 8.2.3 + 8.4
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
Where appropriate, procedures are established for identifying adequate
statistical techniques required for verifying the acceptability of process
capability and product characteristics.
The organization determines, collects, and analyses appropriate data
to demonstrate the suitability and effectiveness of the quality management
system and to evaluate where continual improvement to the quality
management system can be made.
200.20.2
181
Appendix II
Reference SOPs
Subject

Scope
General
Application
Normative reference
(title only)
Documentation
General
Clauses
ISO 9001
:2000
Ref. SOP
No
Revision
No.
Issued On
1.0
1.1
1.2
2.0
3.0
4.0
ISO-4.1
ISO-4.1
ISO-4.1
ISO-4.1
ISO-4.1
ISO-4.1
New
New
New
New
New
New
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
4.1
4.2
New
New
New
New
New
New
New
New
New
New
New
New
New
New
New
New
New
New
New
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
Quality manual
(title only)
4.2.2
4.2.3
4.2.4
5.0
Customer focus
Quality policy
5.2
5.3
5.4
Quality objectives
5.4.1

planning
Management review
(title only)
General
5.4.2
ISO-4.2
ISO-4.2
ISO-4.5
ISO-4.2
ISO-4.5
ISO-4.2
ISO-4.5
ISO-4.1
ISO-4.1
ISO-4.2
ISO-4.1
ISO-4.2
ISO-4.3
ISO-4.1
ISO-4.1
ISO-4.2
ISO-4.1
ISO-4.2
ISO-4.2
5.5
ISO-4.1
New
mm/dd/yy
5.5.1
5.5.2
5.5.3
5.6
ISO-4.1
ISO-4.1
ISO-4.1
ISO-4.1
New
New
New
New
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
5.6.1
ISO-4.1
New
mm/dd/yy
4.2.1
5.1
182
200.20.2
Appendix II
Clauses
ISO 9001
:2000
Ref. SOP
No
Revision
No.
Issued On
Review input
Review output
Resource management
(title only)
5.6.2
5.6.3
6.0
ISO-4.1
ISO-4.1
ISO-4.1
New
New
New
mm/dd/yy
mm/dd/yy
mm/dd/yy
6.1
6.2
General
6.2.1

training
Infrastructure
Work environment
Product realization
(title only)
6.2.2
ISO-4.1
ISO-4.1
ISO-4.2
ISO-4.16
ISO-4.1
ISO-4.2
ISO-4.16
New
New
New
New
New
New
New
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
Planning of product
realization
7.1
(title only)
Determination of
product
(title only)
planning
inputs
outputs
review
7.2
7.2.1
ISO-4.9
ISO-4.9
ISO-4.2
ISO-4.9
ISO-4.10
ISO-4.2
ISO-4.9
ISO-4.10
ISO-4.3
ISO-4.4
ISO-4.3
New
New
New
New
New
New
New
New
New
New
New
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
7.2.2
ISO-4.3
New
mm/dd/yy
7.2.3
7.3
ISO-4.3
ISO-4.4
New
New
mm/dd/yy
mm/dd/yy
7.3.1
ISO-4.4
New
mm/dd/yy
7.3.2
ISO-4.4
New
mm/dd/yy
7.3.3
ISO-4.4
New
mm/dd/yy
7.3.4
ISO-4.4
New
mm/dd/yy
Subject
6.3
6.4
7.0
200.20.2
183
Appendix II
Clauses
ISO 9001
:2000
Ref. SOP
No
Revision
No.
Issued On

verification
validation
development changes
Purchasing process
product
7.3.5
ISO-4.4
New
mm/dd/yy
7.3.6
ISO-4.4
New
mm/dd/yy
7.3.7
ISO-4.4
New
mm/dd/yy
7.4
7.4.1
7.4.2
7.4.3

service provision
7.5.1
provision
7.5.2
ISO-4.6
ISO-4.6
ISO-4.6
ISO-4.6
ISO-4.10
ISO-4.9
ISO-4.10
ISO-4.15
ISO-4.19
ISO-4.9
ISO-4.10
ISO-4.15
ISO-4.19
ISO-4.9
New
New
New
New
New
New
New
New
New
New
New
New
New
New
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
Customer property
measuring devices
7.5.4
7.5.5
7.6
ISO-4.8
ISO-4.10
ISO-4.12
ISO-4.7
ISO-4.15
ISO-4.11
New
New
New
New
New
New
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
General
8.1
ISO-4.10
ISO-4.17
ISO-4.20
ISO-4.10
ISO-4.17
ISO-4.20
New
New
New
New
New
New
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
Subject
7.5
7.5.3
8.0
184
200.20.2
Appendix II
Subject
Clauses
ISO 9001
:2000
Monitoring and
8.2
8.2.1
Internal audit
Monitoring and
8.2.2
8.2.3
Monitoring and
8.2.4
product
Analysis of data
8.3

Corrective action
Preventive action
8.5
8.5.1
8.5.2
8.5.3
8.4
Ref. SOP
No
Revision
No.
Issued On
ISO-4.9
ISO-4.10
ISO-4.17
ISO-4.20
ISO-4.9
ISO-4.10
ISO-4.17
ISO-4.9
ISO-4.17
ISO-4.20
ISO-4.1
ISO-4.2
ISO-4.10
ISO-4.13
New
New
New
New
New
New
New
New
New
New
New
New
New
New
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
ISO-4.14
ISO-4.20
ISO-4.1
ISO-4.1
ISO-4.14
ISO-4.14
New
New
New
New
New
New
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
200.20.3
186
200.20.3

MODEL - 3
ISO 9001:2000
ISO 9002 MANUAL
Written by:
Checked by:
Approved by:
Date Supersedes
Date Issued
Manual Serial No.
mm/dd/yyyy
mm/dd/yyyy
QM-3
DISTRIBUTED TO
3) Marketing
5)
6)
Revision No: 0
CONTROLLED COPY NO.
Copy-1
Copy-2
Copy-3
Master

200.20.3
187
TABLE OF CONTENTS
Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . .
References . . . . . . . . . . . . . . . . . . . . . . . . .
Definitions . . . . . . . . . . . . . . . . . . . . . . . . .
Quality Policy . . . . . . . . . . . . . . . . . . . . . .
Organization . . . . . . . . . . . . . . . . . . . . . . .
Resources . . . . . . . . . . . . . . . . . . . . . . . . .
Quality System. . . . . . . . . . . . . . . . . . . . . .
Contract Review. . . . . . . . . . . . . . . . . . . . .
Design Control (not applicable) . . . . . . . . .
Purchasing . . . . . . . . . . . . . . . . . . . . . . . . .
Process Control . . . . . . . . . . . . . . . . . . . . .
Quality Records . . . . . . . . . . . . . . . . . . . . .
Training . . . . . . . . . . . . . . . . . . . . . . . . . . .
Servicing . . . . . . . . . . . . . . . . . . . . . . . . . .
Appendix III (Reference SOPs)
Clauses
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. . .0.0
. . .1.1
. . .2.0
. . .3.0
. . .4.0
. 4.1.1
. 4.1.2
4.1.2.1
4.1.2.2
4.1.2.3
. 4.1.3
. . .4.2
. . .4.3
. . .4.4
. . .4.5
. . .4.6
. . .4.7
. . .4.8
. . .4.9
. . 4.10
. . 4.11
. . 4.12
. . 4.13
. . 4.14
. . 4.15
. . 4.16
. . 4.17
. . 4.18
. . 4.19
. . 4.20
188
200.20.3

INTRODUCTION
ISO 9001:2000
Written by:
Clause 0.0,
ISO 9002:1994
0.0
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
INTRODUCTION
This manual provides a written description of the organization and policies
of the quality system.
Changes may be made to this manual only after being approved by
the manager of quality assurance or an authorized representative.
The system is designed to provide controls to assure that product
quality meets or exceeds the quality requirements and expectations of our
customers. The system is designed to provide controls for the prevention
of nonconforming parts, early detection of discrepancies, and corrective
action to ensure consistent delivery of a quality product.
The contents of this manual r efer to inter national standard
ISO 9001:2000 prepared after incorporation of corresponding changes in
quality manual ISO 9002 (1994).
The manual provides customer-focused leadership with continual
improvement through involvement of employees within a strong communication matrix.
200.20.3
189

SCOPE AND FIELD OF
APPLICATION
ISO 9001:2000
Written by:
Clause 1.0,
ISO 9002:1994
1.0
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy

(Company name) is in compliance with the requirements of an international standard ISO 9002:1994 quality system model for quality assurance in production and installation. However, the second edition (ISO
9002:1994), together with ISO 9001:1994 and ISO 9003:1994, is cancelled
and replaced by a third edition of the ISO 9001:2000 module. It constitutes
a technical revision of these documents. The quality manual QM-3 is
prepared in accordance with the corresponding changes specified in the
third edition of ISO 9001:2000.
The international standard ISO 9001:2000 specifies quality system
requirements for use where a contract between the company and customers requires the demonstration of capability to produce and supply
the product in compliance with the applicable regulatory requirements.
The sub-clause 7.3, design and/or development, is excluded.
The contents and the elements of this ISO 9002 quality system manual
are revised in accordance with the requirements of international standard
ISO 9001:2000.
190
200.20.3

REFERENCES
ISO 9001:2000
Written by:
Clause 2.0,
ISO 9002:1994
2.0
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
REFERENCES
ISO 9000-1987, Quality Management and Quality Assurance Standard Guides for Selection and Use
ISO 9002: 1994, Quality System Model for Quality Assurance in
Production and Installation
ISO 9001:2000, Quality Management System Requirements
200.20.3
191

DEFINITIONS
ISO 9001:2000
Written by:
Clause 3.0,
ISO 9002:1994
3.0
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 7
mm/dd/yyyy
mm/dd/yyyy
DEFINITIONS
For the purpose of standard ISO 9001:2000, the terms and definitions given
in ISO 9000 apply.
An analysis certificate is a document that gives the results of the inspection
Auditor
An auditor is a person who is qualified and authorized to perform all or
any portion of a quality system audit.
Audit
Audit Organization
An audit organization is an organization that regularly conducts quality
assurance management system audits to a required standard.
192
200.20.3

DEFINITIONS
ISO 9001:2000
Written by:
Clause 3.0,
ISO 9002:1994
3.0
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 2 of 7
mm/dd/yyyy
mm/dd/yyyy
Batch
A batch refers to assignments of a batch of finished products to a client
Conformity
Documentation
Documentation means any recorded or pictorial information describing,
defining, specifying, reporting, or certifying activities, requirements, procedures or results.
Documentation Level
First Party Audits

Audits carried out internally by an organization are known as first party
audits.
Inspection
200.20.3
193

DEFINITIONS
ISO 9001:2000
Written by:
Clause 3.0,
ISO 9002:1994
3.0
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 3 of 7
mm/dd/yyyy
mm/dd/yyyy
Inspectors
relating to the product and inspection and to verify the achievement of
the quality specified.
Lead Auditor
An auditor who is qualified and authorized to manage a quality system
audit is a lead auditor.
Management Review
A management review is a compulsory evaluation carried out by general
Nonconformity
requirements.
Organization
Provisional Auditor
A provisional auditor is a person who meets all requirements for registration except for audit experience.
194
200.20.3

DEFINITIONS
ISO 9001:2000
Written by:
Clause 3.0,
ISO 9002:1994
3.0
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 4 of 7
mm/dd/yyyy
mm/dd/yyyy
Quality
Quality Audit
Quality Assurance
Quality Control
Quality control is that part of good manufacturing practice which is
concerned with sampling, specifications, and testing. Organization, documentation, and release procedures ensure that the necessary and relevant
tests are actually carried out, and that materials are not released for use,
nor products released for sale or supply, until their quality has been
judged to be satisfactory.
Quality Manual
the company to ensure quality in its products or services.
200.20.3
195

DEFINITIONS
ISO 9001:2000
Written by:
Clause 3.0,
ISO 9002:1994
3.0
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 5 of 7
mm/dd/yyyy
mm/dd/yyyy
Quality Planning
quality plan.
Quality Policy
expressed by top management are its quality policy.

The quality record is the filled-in record documents proving that the quality
assurance and quality control actions have been done.
Quality System
The quality systems refers to the organizational structure, responsibilities, procedures, processes, and resources for implementing quality
management.
Quality surveillance means the continued monitoring and verification of
196
200.20.3

DEFINITIONS
ISO 9001:2000
Written by:
Clause 3.0,
ISO 9002:1994
3.0
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 6 of 7
mm/dd/yyyy
mm/dd/yyyy
Second Party Audits

Specification
A specification is a document that specifies the requirements with which
the product and/or material must comply.
Third Party Audits

or similar organization are called third party audits.
Traceability
Traceability refers to the capability of finding the history, use, or location
of an article by means of a recorded identification.
Validation
The act of checking a calculation or design through its stages to verify
that the assumptions made, input data, and method used have produced
a valid result is known as validation.
200.20.3
197

DEFINITIONS
ISO 9001:2000
Written by:
Clause 3.0,
ISO 9002:1994
3.0
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 7 of 7
mm/dd/yyyy
mm/dd/yyyy
Verification
Verification is the act of reviewing, inspecting, testing, checking, auditing,
or otherwise verifying and documenting whether items, processes, services, or documents conform to specified requirements.
The list is not conclusive as there are many others terms in general use
or contained in various standards and quality documents.
198
200.20.3

QUALITY MANAGEMENT
SYSTEM
ISO 9001:2000
Written by:
Clause 4.0,
ISO 9002:1994
4.0
Revision 0
Checked by:
Approved by:
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below in correspondence with ISO 9001:2001 standards to define quality
system requirements and management responsibilities.
Clause
1.0
2.0
3.0
4.0
4.1
4.1.1
4.1.2
4.1.2.1
4.1.2.2
4.1.2.3
4.1.3
4.2
4.2.1
4.2.2
4.2.3
4.3
4.3.1
4.3.2
4.3.3
4.3.4
4.4
4.4.1
ISO 9002:1994
Scope
Normative reference
Definitions
(title only)
(title only)
Quality policy
Resources
Management review
General
Quality planning
General
Review
Records
Design control (not applicable)
General (not applicable)
ISO 9001:2000
1.0
2.0
3.0
5.1 + 5.3 + 5.4.1

5.5.1
5.1 + 6.1 + 6.2.1 + 6.3
5.5.2
5.6.1 + 5.6.2 + 5.6.3 + 8.5.1
4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1
4.2.1
5.4.2 + 6.2.1 + 7.1
5.2 + 7.2.1 + 7.2.2 + 7.2.3

7.2.2
7.2.2
200.20.3
199

QUALITY MANAGEMENT
SYSTEM
ISO 9001:2000
Written by:
Clause 4.0,
ISO 9002:1994
4.0
Revision 0
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Date Supersedes
Date Issue
Page 2 of 4
mm/dd/yyyy
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Clause
4.4.2
4.4.3
4.4.4
4.4.5
4.4.6
4.4.7
4.4.8
4.4.9
4.5
4.5.1
4.5.2
4.5.3
4.6
4.6.1
4.6.2
4.6.3
4.6.4
4.7
4.8
ISO 9002:1994

(not applicable)
interfaces (not applicable)
Design input (not applicable)
Design output (not applicable)
Design review (not applicable)
Design verification (not
applicable)
Design validation (not applicable)
Design changes (not applicable)
(title only)
General
issue
General
Purchasing data
product
traceability
ISO 9001:2000
7.3.1 (not applicable)

7.2.1
7.3.3
7.3.1
7.3.1
+ 7.3.2 (not applicable)

(not applicable)
7.3.1 + 7.3.6 (not applicable)

4.2.1 + 4.2.3
4.2.3
4.2.3
7.4.1
7.4.2
7.4.3
7.5.4
7.5.3
200
200.20.3

QUALITY MANAGEMENT
SYSTEM
ISO 9001:2000
Written by:
Clause 4.0,
ISO 9002:1994
4.0
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 3 of 4
mm/dd/yyyy
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Clause
ISO 9002:1994
4.9
Process control
4.10
4.10.1
4.10.2
4.10.3
4.10.4
4.10.5
4.11

General
General
Control procedure
General
(title only)
General
Corrective action
Preventive action
(title only)
General
4.11.1
4.11.2
4.12
4.13
4.13.1
4.13.2
4.14
4.14.1
4.14.2
4.14.3
4.15
4.15.1
ISO 9001:2000
6.3 + 6.4 + 7.1 + 7.5.1 + 7.5.2 +

8.2.3
7.1 + 8.1
7.4.3 + 8.2.4
7.4.3 + 7.5.1 + 8.2.4
7.4.3 + 8.2.4
7.5.3 + 8.2.4
7.6
7.6
7.5.3
8.3
8.3
8.5.2 + 8.5.3
8.4 + 8.5.2
8.4 + 8.5.3
200.20.3
201

QUALITY MANAGEMENT
SYSTEM
ISO 9001:2000
Written by:
Clause 4.0,
ISO 9002:1994
4.0
Revision 0
Checked by:
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Date Supersedes
Date Issue
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Clause
4.15.2
4.15.3
4.15.4
4.15.5
4.15.6
4.16
4.17
4.18
4.19
4.20
4.20.1
4.20.2
ISO 9002:1994
Handling
Storage
Packaging
Preservation
Delivery
Training
Servicing
Procedures
ISO 9001:2000
7.5.5
7.5.5
7.5.5
7.5.5
7.5.1 + 7.5.5.
4.2.4
8.2.2 + 8.2.3
6.2.1 + 6.2.2
7.1 + 7.5.1
8.1 + 8.2.3 + 8.2.4 + 8.4
202
200.20.3

QUALITY POLICY
ISO 9001:2000
Written by:
Clause 4.1.1,
ISO 9002:1994
5.1 + 5.3 + 5.4.1
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 2
mm/dd/yyyy
mm/dd/yyyy
QUALITY POLICY
Our policy is to meet or exceed our customers quality needs and expectations today and concurrently anticipate the requirements of tomorrow.
Quality control and quality assurance are vital links in the production and
assembly process. Quality is planned and built into every [YOUR PRODUCT HERE] made at [YOUR COMPANY NAME HERE].
Our mission is to build a relationship with our customers and suppliers
to ensure that quality is never compromised
Our immediate and long-term success is dependent on supplying our
customers with precision machined parts and products that fully meet
their needs, on time, every time, at a fair price. We know that we are not
alone in this effort. We must work with our customers to get all information
necessary to make sure that we can understand all their requirements.
We must work with our suppliers to make sure that all purchased materials
and services fully meet the requirements.
200.20.3
203

QUALITY POLICY
ISO 9001:2000
Written by:
Clause 4.1.1,
ISO 9002:1994
5.1 + 5.3 + 5.4.1
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 2 of 2
mm/dd/yyyy
mm/dd/yyyy
QUALITY OBJECTIVES
The quality objectives defined are measurable and consistent with the
quality policy and are based on:

The role of leadership
The involvement of people
The business process approach
A systematic approach to management
A factual approach to decision making
Mutually beneficial supplier relationship
Signature
204
200.20.3

ORGANIZATION
ISO 9001:2000
Written by:
Clause 4.1.2,
ISO 9002:1994
Title (only)
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy

Provide an organization chart of your company. Describe departments
involved, field of activity, interrelationships, definitions, and terminology
used within the company. Provide information as relevant:

Company introduction
Nature of products manufactured
Key departments and functions
Organization chart
List of quality-related definitions
200.20.3
205

RESPONSIBILITY AND
AUTHORITY
ISO 9001:2000
Written by:
Clause 4.1.2.1,
ISO 9002:1994
5.5.1
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy

Every employee who manages, performs, or verifies work affecting quality
has the responsibility, authority, and organizational freedom to:

Initiate action to prevent the occurrence of product nonconformity

Identify and record any product or service problems
Initiate, recommend, or provide solutions through designated channels
Verify the implementation of solutions
Control further processing, delivery, or installation of nonconforming product or service until the deficiency or unsatisfactory condition has been corrected
206
200.20.3

RESOURCES
ISO 9001:2000
Written by:
Clause 4.1.2.2,
ISO 9002:1994
5.1 + 6.1 + 6.2.1 + 6.3
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
RESOURCES
The quality assurance department is assigned the management of verification of product quality.
All relevant departments are provided with adequate resources and
trained personnel for the activities related to product realization including
inspection, test, monitoring of the design, production, installation, and
servicing of the process and/or product. Verification and audit activities
are carried out by personnel independent of those having direct responsibility for the work being performed.
GENERAL
The areas to maintain and enhance the product quality are identified, and
for necessary competence of the employees, adequate in-house, outside
training programs are conducted to satisfy these needs. The records of
actions initiated are maintained.
INFRASTRUCTURE
(Company name) ensures the conformity of product requirements by the
customers and provides adequate infrastructure in terms of workplace, area,
utilities, processing equipment, computers, and means of transportation.
The management has ensured its commitment by providing availability of
skilled resources and communication of quality policies and objectives to
the employees to meet customer and regulatory requirements. Efforts are
made for continual improvement to ensure customer satisfaction.
200.20.3
207

ISO 9002:1994
5.5.2
ISO 9001:2000
Written by:
Checked by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Revision 0
Approved by:
Page 1 of 1
The [quality assurance manager] is the management representative and
has the defined authority and responsibility for ensuring that the requirements of all pertinent standards are implemented, verified, and maintained.
208
200.20.3

MANAGEMENT REVIEW
ISO 9001:2000
Written by:
Clause 4.1.3,
Revision 0
ISO 9002:1994
5.6.1 + 5.6.2 + 5.6.3 + 8.5.1
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 2
mm/dd/yyyy
mm/dd/yyyy
MANAGEMENT REVIEW
The entire quality system is reviewed every quarter-year through management reviews to ensure continuing suitability and effectiveness. The data
and results of the reviews are recorded and maintained.
(Company name) has appointed an ISO-9002 system coordinator (management representative) who is independent and has defined authority to
verify the product quality.
The periodic management reviews ensure continuing suitability, adequacy, and effectiveness of the overall quality system, including assessment
of areas for improvement, changes in existing policies, and objectives for
further improvement.
REVIEW INPUT
The agenda of the management review meetings is based on follow-up
actions from previous reviews, proposed and planned changes to inculcate
further improvement, customer feedback resulted through effective communication and results of the previous audits, and the corrective and
preventive action taken.
200.20.3
209

MANAGEMENT REVIEW
ISO 9001:2000
Written by:
Clause 4.1.3,
Revision 0
ISO 9002:1994
5.6.1 + 5.6.2 + 5.6.3 + 8.5.1
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 2 of 2
mm/dd/yyyy
mm/dd/yyyy
REVIEW OUTPUT
The decisions made lead to provide adequate resources in terms of
buildings, equipment, utilities, and communication means to ensure customer requirements are met on a continuous basis.
The application of an effective quality system supported with quality
policies, objectives, reviews, and corrective action ensures continual
improvement and adds value to the customer product. The product offered
meets the expectations and needs of the user and the pr oduct is
continuously maintained to the prescribed standard/specification/contact/order agreement.
210
200.20.3

QUALITY SYSTEM
ISO 9001:2000
Written by:
Clause 4.2,
Revision 0
ISO 9002:1994
4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 + 5.4.2 + 6.2.1
+ 7.1
Checked by:
Approved by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Page 1 of 7
GENERAL
This manual documents the quality system, which is based on the exclusion of clause 7.3, revised in accordance with international standard
ISO 9001:2000. It is implemented throughout the company and understood
at all levels. The entire system is reviewed at least once a year by
management reviews to ensure that the system is effective. The system is
designed to ensure that:
Products meet or exceed customer expectations.
Emphasis is placed on problem presentation rather than dependent
on detection after occurrence.
Causes of the problem are found and comprehensive corrections
are made.
Feedback is generated to be used for product and process design.
Constant improvement of the product and process is enhanced.
200.20.3
211

QUALITY SYSTEM
ISO 9001:2000
Written by:
Clause 4.2,
Revision 0
ISO 9002:1994
4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 + 5.4.2 + 6.2.1
+ 7.1
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 2 of 7
mm/dd/yyyy
mm/dd/yyyy
The quality system responsibilities are tabulated in Table 1. Amend the

table as relevant your company.
Table 1
ISO-9002 Clause*
4.1
Management
responsibilities
4.2
Quality system
4.3
Contract review
4.4
Design control
(not applicable)
Correspondence
clause
ISO 9001:2000

ADM
QUA
PRD
QCD
SHP
MAI
PER
PDL
PUR
PAC
MKT
MPM
Element in the
Quality System
5.1 + 5.3 + 5.4.1

+ 5.5.1
+ 6.1 + 6.2.1 +
6.3
5.5.2 + 5.6.1 +
5.6.2 + 5.6.3 +
8.5.1
4.1 + 4.2.1 +
4.2.2 + 5.1 +
5.4.1
5.4.2 + 6.2.1 +
7.1
5.2 + 7.2.1 +
7.2.2 + 7.2.3
X * * * * * * * * * * *
7.2.1, (7.3.1 +
7.3.2, 7.3.3, 7.3.4,
7.3.5, 7.3.6, 7.3.7)
* X * * * * * * * * * *
* * * * * * X *
(not
applicable)
4.5
Document and
data control
4.2.1 + 4.2.3
* * * * * * * X * * * *
212
200.20.3

QUALITY SYSTEM
Clause 4.2,
Revision 0
ISO 9002:1994
4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 + 5.4.2 + 6.2.1
+ 7.1
Checked by:
Approved by:
ISO 9001:2000
Written by:
Date Supersedes
Date Issue
Page 3 of 7
mm/dd/yyyy
mm/dd/yyyy
Table 1 (Continued)
ISO-9002 Clause*
4.6
Purchasing
4.7
Control of
customersupplied
product
Product
identification
and traceability
Process control
4.8
4.9
4.10
Inspection and
testing
4.11
Inspection,
measurement,
and test
equipment
Inspection and
test status
Control of
nonconforming
product
4.12
4.13
Correspondence
clause
ISO 9001:2000

ADM
QUA
PRD
QCD
SHP
MAI
PER
PDL
PUR
PAC
MKT
MPM
Element in the
Quality System
7.4.1, 7.4.2,
7.4.3
7.5.4
* * * * * X *
7.5.3
* * X * * * * * * *
6.3 + 6.4 + 7.1 +

7.5.1 + 7.5.2 +
8.2.3
7.1 + 8.1 + .4.3
+ 8.2.4 + 7.5.1
+ 7.5.3
7.6
* X * * *
X * * *
7.5.3
X * * * *
8.3
* * * X * * * * * * *
X *
* * * X * *
200.20.3
213

QUALITY SYSTEM
ISO 9001:2000
Written by:
Clause 4.2,
Revision 0
ISO 9002:1994
4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 + 5.4.2 + 6.2.1
+ 7.1
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 4 of 7
mm/dd/yyyy
mm/dd/yyyy
Table 1 (Continued)
ISO-9002 Clause*
4.14
4.15
4.16
4.17
4.18
4.19
4.20
Corrective
actions
Handling storage,
packaging,
preservation,
and delivery
Quality records
Internal quality
audits
Training
Servicing (not
applicable)
Statistical
techniques
Correspondence
clause
ISO 9001:2000
8.5.2 + 8.5.3
8.4
7.5.5 + 7.5.1

ADM
QUA
PRD
QCD
SHP
MAI
PER
PDL
PUR
PAC
MKT
MPM
Element in the
Quality System
* X * * * * * * * * * *
* * * * * X
4.2.4
8.2.2 + 8.2.3
* * * X * * * * * * * *
* X * * * * * * * * *
6.2.1 + 6.2.2
7.1 + 7.5.1
* X * * * * X * * * * *
* * * * * * * * X *
8.1 + 8.2.3 +
8.2.4 + 8.4
* X * * *

Key:
ADM
PRD
SHP
PDL
PAC
MPM
=
=
=
=
=
=
Production
Shipping
Packaging
QUA
QCD
PER
PUR
MKT
MAI
=
=
=
=
=
=
Quality Assurance
Personnel
Purchase
Marketing
Maintenance
The elements not relevant are described as not applicable."
214
200.20.3

QUALITY SYSTEM
ISO 9001:2000
Written by:
Clause 4.2,
Revision 0
ISO 9002:1994
4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 + 5.4.2 + 6.2.1
+ 7.1
Checked by:
Approved by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Page 5 of 7
QUALITY SYSTEM PROCEDURES

The procedures required by this international standard are identified,
documented, and maintained to ensure system integrity and continuous
effectiveness and improvement. The documentation is maintained both
in physical and electronic form as suitable to the companys operations.
CONTROL MANUAL
The quality manual describes in detail the scope and justifi cation for
any exclusions made and the reference to the documented procedures
established and maintained. The quality manual and procedures further
describe the interactions between the elements of the quality management system.
The quality policy, objectives, and supporting procedures are implemented, and the top management ensures their effectiveness through
periodic reviews and effective communication.
QUALITY OBJECTIVES
Measurable quality objectives are defined to meet the customer-focused
requirements at relevant applicable levels within the company.
200.20.3
215

QUALITY SYSTEM
ISO 9001:2000
Written by:
Clause 4.2,
Revision 0
ISO 9002:1994
4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 + 5.4.2 + 6.2.1
+ 7.1
Checked by:
Approved by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Page 6 of 7
DOCUMENTATION
An adequate documentation level is established to ensure compliance to
this international standard. The documentation includes:
Quality policy/manual
Standard operating procedures
Applicable formats used for planning, operations, and in-process
control
Product technical dossier
Electronic records
IMPLEMENTATION
All quality system procedures and instructions are implemented to ensure
effectiveness of the quality management system. To ensure continual
improvement, facilities, equipment, and documents are reviewed and
approved for implementation. The compatibility of the process with the
production facilities and infrastructure is ensured to achieve product
realization in compliance with the customer requirements. The implementation is achieved through:
Planning of product realization
Determination of requirements related to the product
Communication
216
200.20.3

QUALITY SYSTEM
ISO 9001:2000
Written by:
Clause 4.2,
Revision 0
ISO 9002:1994
4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 + 5.4.2 + 6.2.1
+ 7.1
Checked by:
Approved by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Page 7 of 7
QUALITY PLANNING
The elements of quality planning are based on quality objectives. The
changes to the management system are maintained proactively.
PLANNING OF PRODUCT REALIZATION

Planning of product realization exclusively addresses requirements of the
quality management system (see 4.1). The company has determined the
following as appropriate:

Determination of requirements related to product
Review of requirements related to the product
Design and development (if applicable)
Design and development planning (if applicable)
Design and development inputs (if applicable)
Design and development outputs (if applicable)
Design and development review (if applicable)
Design and development verification (if applicable)
Design and development validation (if applicable)
Control of design and development changes (if applicable)
Module D: Permissable exclusions

Sub-clause 7.3: design and/or development
200.20.3
217

CONTRACT REVIEW
ISO 9001:2000
Written by:
Clause 4.3,
Revision 0
ISO 9002:1994
5.2 + 7.2.1 + 7.2.2 + 7.2.3
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
CONTRACT REVIEW
Every order, when received, is checked to ensure that the specifics of the
order are the same as what was specified at the time of quotation.
When there is any discrepancy or the order is not the same as the
tender, the discrepancy will be reconciled before any work is done.
Before production begins, every order is checked to ensure that all
pertinent information is available to the production.
CUSTOMER FOCUS
(Company name) ensures to identify, determine, and meet the customer
requirements.

TO THE PRODUCT
The product requirements are defined and resolved if different from those
previously ordered. The records of reviews are maintained. The changes
made are communicated and reconfirmed.
(Company name) has determined and implemented effective communication procedures regarding product information and feedback regarding
customer complaints.
218
200.20.3

DESIGN CONTROL
ISO 9001:2000
Written by:
Clause 4.4,
Revision 0
ISO 9002:1994
7.2.1 + 7.3.1 + 7.3.2 + 7.3.3 + 7.3.4 + 7.3.5 +
7.3.6 + 7.3.7
Checked by:
Approved by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Page 1 of 2
GENERAL
Not applicable/justify.

DESIGN INPUT
DESIGN OUTPUT
200.20.3
219

DESIGN CONTROL
ISO 9001:2000
Written by:
Clause 4.4,
Revision 0
ISO 9002:1994
7.2.1 + 7.3.1 + 7.3.2 + 7.3.3 + 7.3.4 + 7.3.5 +
7.3.6 + 7.3.7
Checked by:
Approved by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Page 2 of 2
DESIGN REVIEW

DESIGN VERIFICATION
DESIGN VALIDATION
DESIGN CHANGES
220
200.20.3

DOCUMENT AND DATA
CONTROL
ISO 9001:2000
Written by:
Clause 4.5,
ISO 9002:1994
4.2.1 + 4.2.3
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 2
mm/dd/yyyy
mm/dd/yyyy
GENERAL
The organization has defined, documented, and implemented the procedures needed to ensure effective planning, operational controls, and the
associated processes. The key elements include quality policy, objectives,
and the applicable procedures.
DOCUMENT AND DATA APPROVAL AND ISSUES

The documents are reviewed for their adequacy before approval. The
document control system is designed to ensure that the information used
in the production of the product or parts is clear, complete, correct, and
current. No changes can be made without authorization. The system
operates within a contractual constraint that requires all products or parts
to be built to blueprints, drawings, or other specifications. All personnel
are required to immediately report any discrepancy to the proper supervisor so that corrective action can be taken. Documentation shall include
one or more of the following, but is not limited to:

Drawings
Blueprints
Inspection instructions
Work instructions
Operation sheets
Test procedures
Operational procedures
Quality assurance procedures
Formulations
Common practices
200.20.3
221

DOCUMENT AND DATA
CONTROL
ISO 9001:2000
Written by:
Clause 4.5,
ISO 9002:1994
4.2.1 + 4.2.3
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 2 of 2
mm/dd/yyyy
mm/dd/yyyy

Product and document changes are reviewed to verify that there is no
degradation of quality. Document changes are distributed at the proper
time to the appropriate point in the system to ensure that work and
functions are accomplished in accordance with requirements.
222
200.20.3

PURCHASING
ISO 9001:2000
Written by:
Clause 4.6,
ISO 9002:1994
7.4.1 + 7.4.2 + 7.4.3
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 2
mm/dd/yyyy
mm/dd/yyyy
GENERAL
The purchasing system is designed to ensure that purchased material
conforms to specified requirements.
VENDOR ASSESSMENT
Vendors are approved based on their performance as to the type of product
and service being purchased. An approved vendors list is kept. One or
more of the following data are used for basis of approval:

Demonstrated capability
Demonstrated performance
Documented quality system
Test reports or certifications
PURCHASING DATA
Purchasing documents are reviewed for adequacy of specified requirements prior to release. Purchasing documents contain data clearly describing the product ordered, including, where applicable:
The verification requirements and reports on the material for
release and shipment
The type, class, grade, or other precise identification
The title or other positive identification and applicable issues of
specifications, drawings, process requirements, inspection instructions, or other relevant technical data
The title, number, and issue date of the quality system standard
to be applied to the product
200.20.3
223

PURCHASING
ISO 9001:2000
Written by:
Clause 4.6,
ISO 9002:1994
7.4.1 + 7.4.2 + 7.4.3
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 2 of 2
mm/dd/yyyy
mm/dd/yyyy

Strict control of nonconforming purchased material is maintained and
information is fed back to purchasing and the vendor for corrective action.
The customer or our customer representative is afforded the right to
verify at the source or upon receipt that the purchased product conforms
to the specified requirements. At any stage of production, the customer
or our customer representative is afforded access to our location to verify
product conformance and, when necessary, is accommodated with verification personnel and equipment.
224
200.20.3

CUSTOMER-SUPPLIED PRODUCT Clause 4.7,
ISO 9002:1994
7.5.4
ISO 9001:2000
Written by:
Checked by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Revision 0
Approved by:
Page 1 of 1
The products received from the customers are verified, stored, and maintained to prevent deterioration or loss. The conditions of handling and
use of customer-supplied product are spelled out in the contract or by
other documented specifications. Any customer-supplied product that
becomes nonconforming is segregated from the production stream,
recorded, and reported to the customer.
200.20.3
225

AND TRACEABILITY
ISO 9001:2000
Written by:
Clause 4.8,
ISO 9002:1994
7.5.3
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
Products and parts are identified to all applicable drawings, specifications,
or other documents throughout all stages of production and delivery. For
identification, suitable means are used throughout the product realization
and with reference to monitoring and measurement requirements.
When traceability is specified, the product or parts have unique identification.
226
200.20.3

PROCESS CONTROL
ISO 9001:2000
Written by:
Clause 4.9,
Revision 0
ISO 9002:1994
6.3 + 6.4 + 7.1 + 7.5.1 + 7.5.2 + 8.2.3
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 2
mm/dd/yyyy
mm/dd/yyyy
PROCESS CONTROL
Production operations are planned and verified to ensure that they are
proceeding under controlled conditions in the specified manner and
sequence.
Before production begins, all tooling, filtering, programming, inspection equipment, and procedures are verified.
Production operations are controlled by blueprints, drawings, documented work instructions, specifications, formulations, or proven numerical controlled software.
Work instructions are sufficiently detailed to accomplish the task. Where
applicable, they include one or more of the following:

Function to be performed
Sequence of operations
Inspection points
Equipment and tools, their set-up, speeds, feed, and processes
Raw material types and size
Blueprints, drawing number and revision number
Sketches or working drawings
Specifications
Formulations
The above must be explicit, clear, accurate, and to the current revision
level.
Common practices that apply during production are documented and
controlled.
200.20.3
227

PROCESS CONTROL
ISO 9001:2000
Written by:
Clause 4.9,
Revision 0
ISO 9002:1994
6.3 + 6.4 + 7.1 + 7.5.1 + 7.5.2 + 8.2.3
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 2 of 2
mm/dd/yyyy
mm/dd/yyyy
SPECIAL PROCESSES
Special process control (of processes that have parameters that affect product
characteristics and may not be easily or economically measured by normal
in-process or final inspection and test, or that may exhibit inferior performance only after use) will be by one or more of the following:
Periodic verification of the accuracy and variability of the equipment used in making the product, e.g., welder settings
Periodic verification of the continuing capabilities of the operators
to meet specific quality requirements, e.g., welder certification
Periodic verification of the environment, time, temperature, or other
factors affecting quality, e.g., time at temperature of annealing,
hardening, or heat-treating

(Company name) plans and develops the processes needed for product
realization and ensures availability of infrastructure and suitable work
environment. Quality objectives as appropriate to the companys product
and services are defined. Records are maintained to demonstrate that the
resulting product fulfills the customers contractual requirements to ensure
customer satisfaction.
228
200.20.3

ISO 9001:2000
Written by:
Clause 4.10,
Revision 0
ISO 9002:1994
7.1 + 7.4.3 + 7.5.1 + 7.5.3 + 8.1 + 8.2
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 2
mm/dd/yyyy
mm/dd/yyyy
GENERAL
Inspection is used at appropriate points in the production process to
ensure conformity of the product or parts.
A receiving inspection is performed on incoming material, where
applicable, to ensure that the incoming material conforms to requirements. Inspection is performed to the degree and extent needed to
determine acceptability.
In-process inspection is employed at appropriate points in the process. The quality plan or an inspection plan specifi es the type of
inspection. Inspection points may include, but are not limited to one or
more of the following:

Setup and first piece inspection

Inspection by machine operator
Inspection by automatic gages or automatic test equipment
Fixed inspection stations at intervals throughout the process
Patrol inspection by an inspector following an established procedure or inspection plan
Inspections after specified production operations have been
performed
Final inspection and test, as appropriate, are performed to ensure
product and part requirements. Final inspection may be one or more of
the following:

First article inspection

Acceptance sampling
According to a quality plan
100% inspection
200.20.3
229

ISO 9001:2000
Written by:
Clause 4.10,
Revision 0
ISO 9002:1994
7.1 + 7.4.3 + 7.5.1 + 7.5.3 + 8.1 + 8.2
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 2 of 2
mm/dd/yyyy
mm/dd/yyyy
RECEIVING INSPECTION AND TEST

The incoming materials are inspected to ensure compliance with the
materials specification. The nonconforming materials are rejected. The
facility is provided to the customers to perform specific verification test
at the company premises.

The in-process inspection and testing is carried out in accordance with
the approved test methods, work instructions, and qualified equipment.
For in-process control, statistical sampling techniques are used as appropriate.
230
200.20.3

ISO 9001:2000
Written by:
Clause 4.10,
Revision 0
ISO 9002:1994
7.1 + 7.4.3 + 7.5.1 + 7.5.3 + 8.1 + 8.2
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy

The finished product compliance is ensured in accordance with customer
specifications. Where possible, quality plans are used and records are
maintained.

The records of inspection and testing are maintained to ensure that the
finished product meets the customer specifications.

Throughout product realization, the product identification and traceability
are ensured using appropriate means.
200.20.3
231

TEST EQUIPMENT
ISO 9002:1994
7.6
ISO 9001:2000
Written by:
Checked by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Revision 0
Approved by:
Page 1 of 1

Measuring tools and gages are of the type, range accuracy, and precision
appropriate to the product, parts, and process.
The calibration system ensures that the measuring and test equipment
is calibrated, adjusted, repaired, or replaced prior to becoming inaccurate.
Procedures are in place to ensure that the measurement and inspection
processes are in a state of control, and that the uncertainties associated
with the measurement are suitably small, so as to have a negligible effect
on decisions or actions based on inspection results or measurements.
Measuring and test equipment, tooling masters, gages, jigs, and fixtures
used to control manufacturing or as a media of inspection are:
Proven accurate prior to use
Calibrated periodically or prior to use to master standards traceable
to the NIST (National Institute for Standards and Technology)
Uniquely identified and, where practical, marked with calibration status
Stored in a restricted area with appropriate control of environment,
issuance, and recall
Segregated and identified when out of adjustment, calibration,
or obsolete
When inspection, measuring, or test equipment is found to be out of
calibration, an evaluation is made to determine the validity of previous
inspection or test results and a decision is made as to the need for reinspection or retest.
232
200.20.3

ISO 9001:2000
Written by:
Clause 4.12,
ISO 9002:1994
7.6.3
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy

The inspection and test status of the product or parts are clearly identified
by marking, tags, labels, inspection records, test reports, shop travelers,
physical location, or other suitable means that indicate the conformance
or nonconformance of the product. Records show the inspection authority
that determined the status.
200.20.3
233

CONTROL OF
Clause 4.13,
8.3
ISO 9001:2000
Written by:
Checked by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Revision 0
Approved by:
Page 1 of 1

Nonconforming material is positively identified and controlled.
Nonconforming material is:
Identified with a clear mark such as a hold or reject tag or stamp
Segregated from the work stream or placed in a designated holding
area; when practical, the access is restricted to those with authority
to make disposition

Nonconforming product is reviewed by authorized personnel to make
disposition and request corrective action. The product is resubmitted
through the regular inspection channels for acceptance, if approved for
release because of rework or a use as is with waiver disposition.
234
200.20.3

CORRECTIVE ACTION
ISO 9001:2000
Written by:
Clause 4.14,
ISO 9002:1994
8.4 + 8.5.2 + 8.5.3
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
CORRECTIVE ACTION
When nonconformances occur, the corrective action plan is activated.
Anyone seeing the need for corrective action is responsible for reporting
the problem to the proper supervisor or manager. Merely correcting the
particular unsatisfactory product does not achieve corrective action. If
possible, the root cause of the unsatisfactory condition is determined, and
a proposed remedy is put in place. The effectiveness of the corrective
action is verified.
Corrective actions may include any or all of the following, according
to the situation:
Investigating the cause of the nonconforming product or service
and the remedy needed to prevent recurrence
Analyzing all processes, work operations, concessions, quality
records, and customer complaints to detect and eliminate potential
causes of nonconforming product or service
Taking preventive actions to deal with problems to the level
corresponding to the risk encountered
Applying controls to ensure that corrective actions are taken and
that they are effective
Recording changes in procedures resulting in the remedy
200.20.3
235

HANDLING, STORAGE,
ISO 9001:2000
Written by:
Clause 4.15,
ISO 9002:1994
7.5.1 + 7.5.5
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
HANDLING, STORAGE, PACKING, AND DELIVERY

The product is handled, stored, packaged, preserved, and delivered in
such a way to prevent damage or deterioration through all processes
including delivery of the product to the final destination.
236
200.20.3

QUALITY RECORDS
ISO 9001:2000
Written by:
Clause 4.16,
ISO 9002:1994
4.2.4
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
QUALITY RECORDS
Quality records are maintained to demonstrate achievement of the required
quality and the effectiveness of the quality system.
Quality records are:
Legible and identifiable to the product involved
Stored and maintained in such a way that they are readily retrievable
Stored in facilities that minimize deterioration and prevent loss
Made available for evaluation to the customers representative for
an agreed upon period
Retained for a period of three (3) years after the work is completed,
or such a period as agreed on by the customer
Stored as electronic data where practical.
200.20.3
237

ISO 9001:2000
Written by:
Clause 4.17,
ISO 9002:1994
8.2.2 + 8.2.3
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy

Quality audits are performed to evaluate the effectiveness of the quality
system as well as the level of product conformance.
Quality audits are:

Scheduled on the basis of the status and importance of the activity

Used to determine the effectiveness of the quality system or activity.
Planned, to be sure that the audit itself is effective
Documented and reviewed with the personnel responsible for the
area being audited
Not complete until adequate corrective action is taken, when
necessary
Conducted using ISO 10011 as guidelines
238
200.20.3

TRAINING
ISO 9001:2000
Written by:
Clause 4.18,
ISO 9002:1994
6.2.1 + 6.2.2
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
TRAINING
Consistent training is used to meet the needs of and provide training for
all personnel-performed activities affecting quality. All personnel are provided with training on good quality performance and are aware of the
consequences of poor quality.
200.20.3
239

SERVICING
ISO 9001:2000
Written by:
Clause 4.19,
ISO 9002:1994
7.1 + 7.5.1
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
SERVICING
Where servicing is specified in the contract, procedures are established
and maintained for performing and verifying that the service meets the
specified requirements.
240
200.20.3

ISO 9001:2000
Written by:
Clause 4.20,
Revision 0
ISO 9002:1994
8.1 + 8.2.3 + 8.2.3 + 8.4
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
The need for the use of statistical techniques is determined for each job.
When statistics are needed, instructions are made available at the work
location. Good quality engineering practices are in place before statistical
techniques are started.
200.20.3
241
Appendix III
Reference SOPs
Subject
Quality management
systems requirement
(title only)
Scope
General
Application
Normative reference
Quality management
system (title only)
Documentation
requirements
(title only)
General
Clauses
ISO 9001:2000
Ref. SOP
No.
1.0
1.1
1.2
2.0
3.0
4.0
ISO-4.1
ISO-4.1
ISO-4.1
ISO-4.1
ISO-4.1
ISO-4.1
New
New
New
New
New
New
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
4.1
4.2
ISO-4.2
ISO-4.2
ISO-4.5
New
New
New
mm/dd/yy
mm/dd/yy
mm/dd/yy
4.2.1
ISO-4.2
ISO-4.5
ISO-4.2
ISO-4.5
ISO-4.1
New
New
New
New
New
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
5.0
ISO-4.1
ISO-4.2
New
New
mm/dd/yy
mm/dd/yy
5.1
New
New
New
New
New
New
New
New
New
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
New
mm/dd/yy
Quality manual
Control of quality
records
Management
responsibility
(title only)
Management
commitment
Customer focus
Quality policy
4.2.2
4.2.3
4.2.4
5.2
5.3
5.4
Quality objectives
5.4.1
Quality management
system planning
Responsibility,
authority, and
communication
(title only)
5.4.2
ISO-4.1
ISO-4.2
ISO-4.3
ISO-4.1
ISO-4.1
ISO-4.2
ISO-4.1
ISO-4.2
ISO-4.2
5.5
ISO-4.1
Revision
No.
Issued On
242
200.20.3
Appendix III
Clauses
ISO 9001:2000
Ref. SOP
No.
Responsibility and
authority
Management
representative
Internal
communication
Management review
(title only)
General
Review input
Review output
Resource
management
(title only)
Human resources
(title only)
5.5.1
ISO-4.1
New
mm/dd/yy
5.5.2
ISO-4.1
New
mm/dd/yy
5.5.3
ISO-4.1
New
mm/dd/yy
5.6
ISO-4.1
New
mm/dd/yy
5.6.1
5.6.2
5.6.3
6.0
ISO-4.1
ISO-4.1
ISO-4.1
ISO-4.1
New
New
New
New
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
6.1
6.2
General
6.2.1
Competence,
awareness, and
training
Infrastructure
Work environment
Product realization
(title only)
6.2.2
ISO-4.1
ISO-4.1
ISO-4.2
ISO-4.16
ISO-4.1
ISO-4.2
ISO-4.16
New
New
New
New
New
New
New
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
Planning of product
realization
7.1
Customer-related
processes (title only)
Determination of
requirements related
to the product
7.2
ISO-4.9
ISO-4.9
ISO-4.2
ISO-4.9
ISO-4.10
ISO-4.2
ISO-4.9
ISO-4.10
ISO-4.3
ISO-4.4
ISO-4.3
New
New
New
New
New
New
New
New
New
New
New
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
Subject
6.3
6.4
7.0
7.2.1
Revision
No.
Issued On
200.20.3
243
Appendix III
Subject
Review of
requirements related
to the product
Customer
communication
Design and
development
(title only)
Design and
development
planning (not
applicable)
Design and
development inputs
(not applicable)
Design and
development
outputs (not
applicable)
Design and
development review
(not applicable)
Design and
development
verification (not
applicable)
Design and
development
validation (not
applicable)
development
changes (not
applicable)
Purchasing process
EP = Exclusion Permitted
Clauses
ISO 9001:2000
Ref. SOP
No.
Revision
No.
7.2.2
ISO-4.3
New
mm/dd/yy
7.2.3
ISO-4.3
New
mm/dd/yy
7.3
ISO-4.4
New
mm/dd/yy
7.3.1
EP
EP
EP
7.3.2
EP
EP
EP
7.3.3
EP
EP
EP
7.3.4
EP
EP
EP
7.3.5
EP
EP
EP
7.3.6
EP
EP
EP
7.3.7
EP
EP
EP
7.4
7.4.1
ISO-4.6
ISO-4.6
New
New
mm/dd/yy
mm/dd/yy
Issued On
244
200.20.3
Appendix III
Clauses
ISO 9001:2000
Ref. SOP
No.
Purchasing
information
Verification of
purchased product
Production and
service provision
(title only)
7.4.2
ISO-4.6
New
mm/dd/yy
7.4.3
Control of production
and service provision
7.5.1
Validation of
processes of
production and
service provision
Identification and
traceability
7.5.2
ISO-4.6
ISO-4.10
ISO-4.9
ISO-4.10
ISO-4.15
ISO-4.19
ISO-4.9
ISO-4.10
ISO-4.15
ISO-4.19
ISO-4.9
New
New
New
New
New
New
New
New
New
New
New
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
Customer property
Preservation of
product
Control of monitoring
and measuring
devices
Measurement,
analysis, and
improvement
(title only)
General
7.5.4
7.5.5
ISO-4.8
ISO-4.10
ISO-4.12
ISO-4.7
ISO-4.15
New
New
New
New
New
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
7.6
ISO-4.11
New
mm/dd/yy
8.0
ISO-4.10
ISO-4.17
ISO-4.20
New
New
New
mm/dd/yy
mm/dd/yy
mm/dd/yy
8.1
Monitoring and
measurement
(title only)
8.2
8.2.1
ISO-4.10
ISO-4.17
ISO-4.20
ISO-4.9
ISO-4.10
ISO-4.17
ISO-4.20
ISO-4.9
ISO-4.10
New
New
New
New
New
New
New
New
New
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
Subject
7.5
7.5.3
Revision
No.
Issued On
200.20.3
245
Appendix III
Clauses
ISO 9001:2000
Ref. SOP
No.
Internal audit
Monitoring and
measurement of
processes
Monitoring and
measurement of
products
Control of
nonconforming
product
Analysis of data
8.2.2
8.2.3
ISO-4.17
ISO-4.9
ISO-4.17
ISO-4.20
ISO-4.1
ISO-4.2
ISO-4.10
ISO-4.13
New
New
New
New
New
New
New
New
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
Improvement
(title only)
Continual
improvement
Corrective action
Preventive action
8.5
ISO-4.14
ISO-4.20
ISO-4.1
New
New
New
mm/dd/yy
mm/dd/yy
mm/dd/yy
8.5.1
ISO-4.1
New
mm/dd/yy
8.5.2
8.5.3
ISO-4.14
ISO-4.14
New
New
mm/dd/yy
mm/dd/yy
Subject
8.2.4
8.3
8.4
Revision
No.
Issued On
200.20.4
248
200.20.4

MODEL - 4
ISO 9001:2000
ISO 9003 MANUAL
Written by:
Checked by:
Approved by:
Date Supersedes
Date Issued
Manual Serial No.
mm/dd/yyyy
mm/dd/yyyy
QM-4
DISTRIBUTED TO
3) Marketing
4) ISO Company Representative
5)
6)
Revision No: 0
CONTROLLED COPY NO.
Copy-1
Copy-2
Copy-3
Master

200.20.4
249
TABLE OF CONTENTS
Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . .
References . . . . . . . . . . . . . . . . . . . . . . . . .
Definitions . . . . . . . . . . . . . . . . . . . . . . . . .
Quality Policy . . . . . . . . . . . . . . . . . . . . . .
Organization . . . . . . . . . . . . . . . . . . . . . . .
Resources . . . . . . . . . . . . . . . . . . . . . . . . .
Quality System. . . . . . . . . . . . . . . . . . . . . .
Contract Review. . . . . . . . . . . . . . . . . . . . .
Design Control (not applicable) . . . . . . . . .
Purchasing (not applicable) . . . . . . . . . . . .
Process Control (not applicable) . . . . . . . .
Quality Records . . . . . . . . . . . . . . . . . . . . .
Training . . . . . . . . . . . . . . . . . . . . . . . . . . .
Servicing (not applicable). . . . . . . . . . . . . .
Appendix IV (Reference SOPs)
Clauses
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. . .0.0
. . .1.1
. . .2.0
. . .3.0
. . .4.0
. 4.1.1
. .4.1.2
4.1.2.1
4.1.2.2
4.1.2.3
. 4.1.3
. . .4.2
. . .4.3
. . .4.4
. . .4.5
. . .4.6
. . .4.7
. . .4.8
. . .4.9
. . 4.10
. . 4.11
. . 4.12
. . 4.13
. . 4.14
. . 4.15
. . 4.16
. . 4.17
. . 4.18
. . 4.19
. . 4.20
250
200.20.4

INTRODUCTION
ISO 9001:2000
Written by:
Clause 0.0,
ISO 9003:1994
0.0
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
INTRODUCTION
This manual provides reference to the organizational quality management
system to ensure consistency, reproduceability, and continuous improvement in the companys operations with a particular reference to customer
satisfaction and to meet regulatory requirements as appropriate. The
manual refers to the elements of international standard ISO 9001:2000
incorporated in the already existing ISO 9003 (1994) quality manual.
200.20.4
251

SCOPE AND FIELD OF
APPLICATION
ISO 9001:2000
Written by:
Clause 1.0,
ISO 9003:1994
1.1
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy

The international standard ISO 9003:1994 was established by Technical
Committee ISO/TC 178, and is based on British standard 5750:1987 series,
European standard EN 29000: 1987 series, and international standards ISO
9000:1987 series. The standard was adopted by the company to provide
objective evidence that the companys operations of final product inspection and testing are in compliance with the requirement of this standard.
However, this third edition canceled and replaced the second edition (ISO
9003:1994). The quality manual QM-4 is revised in accordance with the
corresponding changes specified in the third edition of ISO 9001:2000 to
specify quality system requirements for use where a contract between the
company and customer requires the demonstration of capability of final
product inspection and testing with customer satisfaction. The permissible
exclusions are made to:
Sub-clause
Sub-clause
Sub-clause
Sub-clause
Sub-clause
Sub-clause
Sub-clause
7.1
7.2.3
7.3
7.4
7.5.1
7.5.2
7.5.3
252
200.20.4

REFERENCES
ISO 9001:2000
Written by:
Clause 2.0,
ISO 9003:1994
2.0
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
REFERENCES
ISO 9000-1987, Quality Management and Quality Assurance Standard Guides for Selection and Use
ISO 9003:1994, Quality System Model for Quality Assurance in
Final Inspection and Test
ISO 9001:2000 module, Quality Management System Requirements
200.20.4
253

DEFINITIONS
ISO 9001:2000
Written by:
Clause 3.0,
ISO 9003:1994
3.0
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 7
mm/dd/yyyy
mm/dd/yyyy
DEFINITIONS
For the purpose of standard ISO 9001:2000, the terms and definitions given
in ISO 9000 apply.
The following terms, used in this edition of ISO 9001 to describe the
supply chain, have been changed in the quality systems manual and applicable
standard operating procedure to reflect the vocabulary currently used.
The term organization is replaced by the term supplier used in
ISO 9001:1994, and refers to the unit to which this international standard
applies. Also, the term supplier is replaced by the term subcontractor.
Throughout the text of this quality systems manual and applicable
procedures the term product also means service.
ANALYSIS CERTIFICATE
An analysis certificate is a document that gives the results of the inspection
AUDITOR
An auditor is a person who is qualified and authorized to perform all or
any portion of a quality system audit.
Audit
whether quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and
254
200.20.4

DEFINITIONS
ISO 9001:2000
Written by:
Clause 3.0,
ISO 9003:1994
3.0
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 2 of 7
mm/dd/yyyy
mm/dd/yyyy
Audit Organization
An organization that regularly conducts quality assurance management
system audits to a required standard is known as an audit organization.
Batch
Batch refers to assignments of a batch of finished products to a client as
a function of that clients requirements.
Conformity
Documentation
Documentation is any recorded or pictorial information describing, defining, specifying, reporting, or certifying activities, requirements, procedures,
or results.
Documentation Level
First Party Audits

Audits carried out internally by an organization are called first party audits.
200.20.4
255

DEFINITIONS
ISO 9001:2000
Written by:
Clause 3.0,
ISO 9003:1994
3.0
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 3 of 7
mm/dd/yyyy
mm/dd/yyyy
Inspection
Inspectors
relating to the product and inspection and to verify the achievement of
the quality specified.
Lead Auditor
A lead auditor is an auditor who is qualified and authorized to manage
a quality system audit.
Management Review
Management review is a compulsory evaluation carried out by general
Nonconformity
requirements.
Organization
256
200.20.4

DEFINITIONS
ISO 9001:2000
Written by:
Clause 3.0,
ISO 9003:1994
3.0
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 4 of 7
mm/dd/yyyy
mm/dd/yyyy
Provisional Auditor
A person who meets all requirements for registration except for audit
experience is a provisional auditor.
Quality
Quality Audit
Quality Assurance
Quality Control
Quality control is that part of good manufacturing practice concerned
with sampling, specifications, and testing. Its organization, documentation, and release procedures ensure that the necessary and relevant tests
are actually carried out and that materials are not released for use, nor
products released for sale or supply, until their quality has been judged
to be satisfactory.
200.20.4
257

DEFINITIONS
ISO 9001:2000
Written by:
Clause 3.0,
ISO 9003:1994
3.0
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 5 of 7
mm/dd/yyyy
mm/dd/yyyy
Quality Manual
A quality manual is a document describing general measures taken by
the company to obtain quality in its products or services.
Quality Planning
quality plan.
Quality Policy
expressed by top management are its quality policy.

The quality record refers to the filled-in record documents proving that
the quality assurance and quality control actions have been done.
Quality System
The organizational structure, responsibilities, procedures, processes,
and resources for implementing quality management comprise the
quality system.
258
200.20.4

DEFINITIONS
ISO 9001:2000
Written by:
Clause 3.0,
ISO 9003:1994
3.0
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 6 of 7
mm/dd/yyyy
mm/dd/yyyy
Second Party Audits

Specification
The specification is a document that specifies the requirements with which
the product and/or material must comply.
Supplier
The supplier is the organization or company.
Subcontractor
Any organization offering goods or services to the supplier is called a
subcontractor.
200.20.4
259

DEFINITIONS
ISO 9001:2000
Written by:
Clause 3.0,
ISO 9003:1994
3.0
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 7 of 7
mm/dd/yyyy
mm/dd/yyyy
Third Party Audits

Third party audits are audits of organizations undertaken by an independent certification body or similar organization.
Traceability
Validation
Validation is the act of checking a calculation or design through its stages
to verify that the assumptions made, input data, and method used have
produced a valid result.
Verification
Verification is the act of reviewing, inspecting, testing, checking, auditing,
or otherwise verifying and documenting whether items, processes, services, or documents conform to specified requirements.
The list is not conclusive as there are many other definitions in general
use or contained in various standards and quality documents.
260
200.20.4

ISO 9003:1994
4.0
ISO 9001:2000
Written by:
Checked by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Revision 0
Approved by:
Page 1 of 4

below in correspondence with ISO 9001:2001 to define quality system
requirements and management responsibilities. The permissible exclusions
are grouped in a bracket and indicated as not applicable.
Correspondence between ISO 9003:1994 and ISO 9001: 2000
Clause
1.0
2.0
3.0
4.0
ISO 9003:1994
4.1.1
4.1.2
4.1.2.1
4.1.2.2
4.1.2.3
4.1.3
4.2
4.2.1
4.2.2
4.2.3
Scope
Normative reference
Definitions
(title only)
(title only)
Quality policy
Resources
Management review
General
Quality planning
4.3
4.3.1
4.3.2

General
Review
4.3.3
4.1
ISO 9001:2000
1.0
2.0
3.0
5.1 + 5.3 + 5.4.1

5.5.1
5.1 + 6.1 + 6.2.1 + 6.3
5.5.2
5.6.1 + 5.6.2 + 5.6.3 + 8.5.1
4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1
4.2.1
5.4.2 + 6.2.1 + (7.1, not
applicable)
5.2 + 7.2.1 + 7.2.2 + (7.2.3, not

applicable)
7.2.2
200.20.4
261

ISO 9003:1994
4.0
ISO 9001:2000
Written by:
Checked by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Revision 0
Approved by:
Page 2 of 4

Clause
4.3.4
4.4
4.4.1
4.4.2
4.4.3
4.4.4
4.4.5
4.4.6
4.4.7
4.4.8
4.4.9
4.5
4.5.1
4.5.2
4.5.3
4.6
4.6.1
4.6.2
4.6.3
4.6.4
ISO 9003:1994
Records
Design control (not applicable)
(not applicable)
interfaces (not applicable)
Design input (not applicable)
Design output (not applicable)
Design review (not applicable)
Design verification (not
applicable)
Design validation (not applicable)
Design changes (not applicable)
(title only)
General
issue
Purchasing (not applicable)
Evaluation of subcontractors (not
applicable)
Purchasing data (not applicable)
(not applicable)
ISO 9001:2000
7.2.2
(7.3.1, not applicable)

7.2.1 + (7.3.2, not applicable)
(7.3.1 + 7.3.4, not applicable)
4.2.1 + 4.2.3
4.2.3
4.2.3

262
200.20.4

ISO 9003:1994
4.0
ISO 9001:2000
Written by:
Checked by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Revision 0
Approved by:
Page 3 of 4

Clause
4.7
ISO 9003:1994
4.9
product
traceability
Process control (not applicable)
4.10
4.10.1
4.10.2
4.10.3

General
4.10.4
4.10.5
4.11

General
Control procedure
General
(title only)
General
Corrective action
4.8
4.11.1
4.11.2
4.12
4.13
4.13.1
4.13.2
4.14
4.14.1
4.14.2
ISO 9001:2000
7.5.4
7.5.3
8.2.3 + 6.3 + 6.4 + (7.1 + 7.5.1
+ 7.5.2, not applicable)
8.1 + (7.1, not applicable)
(7.4.3, not applicable) + 8.2.4
+ 8.2.4
7.4.3 + 8.2.4
7.5.3 + 8.2.4
7.6
7.6
8.3
8.3
8.5.2 + 8.5.3
8.4 + 8.5.2
200.20.4
263

ISO 9003:1994
4.0
ISO 9001:2000
Written by:
Checked by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Revision 0
Approved by:
Page 4 of 4

Clause
4.14.3
4.15
4.15.1
4.15.2
4.15.3
4.15.4
4.15.5
4.15.6
4.16
4.17
4.18
4.19
4.20
4.20.1
4.20.2
ISO 9003:1994
Preventive action
(title only)
General
Handling
Storage
Packaging
Preservation
Delivery
Training
Servicing (not applicable)
Procedures
ISO 9001:2000
8.4 + 8.5.3
7.5.5
7.5.5
7.5.5
7.5.5
7.5.5 + (7.5.1, not applicable)
4.2.4
8.2.2 + 8.2.3
6.2.1 + 6.2.2
(7.1 + 7.5.1, not applicable)
8.1 + 8.2.3 + 8.2.4 + 8.4
264
200.20.4

QUALITY POLICY
ISO 9001:2000
Written by:
Clause 4.1.1,
ISO 9003:1994
5.1 + 5.3 + 5.4.1
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 2
mm/dd/yyyy
mm/dd/yyyy
QUALITY POLICY
(Company name) management has defined and documented its policy
and objectives for, and commitment to, quality. (Company name) has
ensured that this policy is understood, implemented, and maintained at
all levels in the organization.
We believe that this approach is essential for the company in the long
term. Moreover, with the support of trained and motivated personnel, this
objective will enable us to continue making progress.
The management believes in the effectiveness of a quality assurance
system based on complying with the provisions of ISO 9003 and our
principle of continual progress through defect prevention and improvement. This system is managed by our quality assurance department, whose
role is to implement and maintain a structure and control its evolution in
order to:
Adapt our organization to satisfy existing standards and modify it
whenever necessary
Write the necessary procedures and manuals, then keep them up
to date
Perform personnel qualification and keep it updated with time
Ensure that personnel are qualified and provide further training
according to our plan
Correct omissions by corrective and preventive actions and monitor
their effectiveness
200.20.4
265

QUALITY POLICY
ISO 9001:2000
Written by:
Clause 4.1.1,
ISO 9003:1994
5.1 + 5.3 + 5.4.1
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 2 of 2
mm/dd/yyyy
mm/dd/yyyy
Quality Objectives
It is ensured that quality objectives, including those needed to meet
requirements for product compliance, are established at relevant functions
and levels within the organization. The quality objectives are measurable
and consistent with the quality policy.
Signature
266
200.20.4

ORGANIZATION
ISO 9001:2000
Written by:
Clause 4.1.2,
ISO 9003:1994
Title (only)
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy

Provide an organogram of your company. Provide a brief history of the
company, the products and services offered by the company, and the
departments responsible.
Provide a brief history of the company.
Provide a summary of services and products provided by the
company.
Describe the key departments involved and their functions in brief.
Provide an organogram.
Provide definitions of quality-related terms used in the manual and
applicable procedures.
200.20.4
267

RESPONSIBILITY AND
AUTHORITY
ISO 9001:2000
Written by:
Clause 4.1.2.1,
ISO 9003:1994
5.5.1
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy

The responsibility, authority, and the interrelation of all personnel who
manage, perform, and verify work affecting quality are defined in the
applicable standard operating procedures.
The quality has been defined, particularly for personnel who need the
organizational freedom and authority to:
Verify the implementation of solutions through audits
Identify and record products or services associated quality problems
Provide solutions through designated channels
Initiate and recommend corrective action to prevent the occurrence
of product nonconformity
Demonstrate control over further processing, delivery, or installation
of nonconforming product until the deficiency or unsatisfactory condition
has been corrected.
268
200.20.4

RESOURCES
ISO 9001:2000
Written by:
Clause 4.1.2.2,
ISO 9003:1994
5.1 + 6.1 + 6.2.1 + 6.3
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
RESOURCES
(Company name) has identified in-house verification requirements, provided adequate resources, and assigned trained personnel for verification
activities (see 4.18). Verification activities include inspection, test, and
monitoring of the design production, installation, and servicing of the
process and/or product; and design reviews and audits of the quality
system, process, and/or products to be carried out by personnel independent of those having direct responsibility for the work being performed.
For verification activities, the organization critically follows the requirements specified for the competence, awareness, and training for personnel
performing quality-related work who may affect the end results. The
actions taken are reviewed for their effectiveness.
INFRASTRUCTURE
The provisions for buildings, equipment, and personnel are determined
and provided as appropriate to the companys operations.
Top management is committed to meeting the customer and regulatory
requirements. Systematic and structured planning ensures identification
and availability of resources, implementation of quality policy throughout
the organization, and achievement of management objectives in a timely
manner without compromising customer requirements.
200.20.4
269

ISO 9003:1994
5.5.2
ISO 9001:2000
Written by:
Checked by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Revision 0
Approved by:
Page 1 of 1
(Company name) has appointed a management representative who,
irrespective of other responsibilities, has defined authority and responsibility for ensuring that the requirements of this standard are implemented and maintained.
270
200.20.4

MANAGEMENT REVIEW
ISO 9001:2000
Written by:
Clause 4.1.3,
Revision 0
ISO 9003:1994
5.6.1 + 5.6.2 + 5.6.3 + 8.5.1
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 2
mm/dd/yyyy
mm/dd/yyyy
MANAGEMENT REVIEW
The quality system in place is reviewed annually and, when necessary,
is subject to management reviews to ensure continuing suitability and
effectiveness. The data and results of the reviews are recorded and
maintained.
REVIEW INPUT
The management reviews are conducted with a planned agenda to
provide direction for the companys quality operations. Input fr om
outside and inside sources are welcome to ensure continuous improvement. The audit findings and areas of quality concern are discussed. It
is ensured that corrective and preventive measures are taken on time.
The review input includes statistical evaluation of process performance
and product conformity.
200.20.4
271

MANAGEMENT REVIEW
ISO 9001:2000
Written by:
Clause 4.1.3,
Revision 0
ISO 9003:1994
5.6.1 + 5.6.2 + 5.6.3 + 8.5.1
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 2 of 2
mm/dd/yyyy
mm/dd/yyyy
REVIEW OUTPUT
The decisions made in the management review committee meetings are
followed to ensure:
Infrastructure and resources availability
Review of customer requirements
Continuous improvement and effectiveness of the documented
system
The quality policies, objectives, and documented pr ocedures are
reviewed at specified frequency, and corrective actions are initiated to
ensure continual improvement based on audit findings and review of
analytical data.
272
200.20.4

QUALITY SYSTEM
ISO 9001:2000
Written by:
Clause 4.2,
Revision 0
ISO 9003:1994
4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 + 5.4.2 + 6.2.1
+ 7.1
Checked by:
Approved by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Page 1 of 8
GENERAL
(Company name) has established and maintained a documented quality
system as a means of ensuring that the product conforms to specified
requirements. This includes:
The clarification of standards of acceptability for all features and
requirements, including those that contain a subjective element
The identification of any measurement requirement involving capability that exceeds the known state-of-the-art in sufficient time for
the needed capability to be developed
The identification and acquisition of any controls, processes,
inspection equipment, fixtures, total production resources, and
skills that may be needed to achieve the required quality
The preparation of documented quality system procedures and
instructions in accordance with the requirements of this standard
The preparation of quality plans and a quality manual in accordance with the specified requirements
The updating, as necessary, of quality control, inspection, and
testing techniques, including the development of new instrumentation
The effective implementation of the documented quality system
procedures and instructions
The responsibilities in the quality system are described in Table 1.
Amend the table as relevant to your company. Permissible exclusions are
marked as not applicable.
200.20.4
273

QUALITY SYSTEM
ISO 9001:2000
Written by:
Clause 4.2,
Revision 0
ISO 9003:1994
4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 + 4.2.1 + 5.4.2
+ 6.2.1 + 7.1
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 2 of 8
mm/dd/yyyy
mm/dd/yyyy

Table 1
ISO 9001 Clause
4.1
Management
responsibilities
4.2
Quality system
4.3
Contract review
4.4
Design control
(not applicable)
4.5
Document and
data control
Correspondence
Clause
ISO 9001:2000
5.1 + 5.3 + 5.4.1

+ 5.5.1
+ 6.1 + 6.2.1 +
6.3 + 5.5.2
5.6.1 + 5.6.2 +
5.6.3 + 8.5.1
4.1 + 4.2.1 +
4.2.2 + 5.1 +
5.4.1
5.4.2 + 6.2.1 +
(7.1, not
applicable)
5.2 + 7.2.1 +
7.2.2 + (7.2.3,
not
applicable)
7.2.1, (7.3.1 +
7.3.2 + 7.3.3 +
7.3.4
7.3.5 + 7.3.6 +
7.3.7, not
applicable)
4.2.1 + 4.2.3

ADM
QUA
PRD
QCD
SHP
MAI
PER
PDL
PUR
PAC
MKT
MPM
Element in the
Quality System
X * * * * * * * * * * *
* X * * * * * * * * * *
* * * * * * X *
* * * * * * * X * * * *
274
200.20.4

QUALITY SYSTEM
ISO 9001:2000
Written by:
Clause 4.2,
Revision 0
ISO 9003:1994
4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 + 4.2.1 + 5.4.2
+ 6.2.1 + 7.1
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 3 of 8
mm/dd/yyyy
mm/dd/yyyy
Table 1 (Continued)
ISO 9001 Clause
Correspondence
Clause
ISO 9001:2000
4.6
Purchasing
4.7
Control of
customersupplied product
7.5.3 (not
Product
identification and applicable)
traceability
Process control
6.3 + 6.4 + 7.1
(not applicable)
+ (7.5.1, not
applicable) +
7.5.2 + 8.2.3
Inspection and
7.1 + 8.1 (not
testing
applicable)
7.4.3. + (not
applicable)
7.5.1 (not
applicable)
7.5.3 (not
applicable)
8.2.4
4.8
4.9
4.10
7.4.1 (not
applicable)
7.4.2 (not
applicable)
7.4.3 (not
applicable)
7.5.4

ADM
QUA
PRD
QCD
SHP
MAI
PER
PDL
PUR
PAC
MKT
MPM
Element in the
Quality System
* * * * * X *
X *
* * X * * * * * * *
* X * * *
X * * *
200.20.4
275

QUALITY SYSTEM
Clause 4.2,
Revision 0
ISO 9003:1994
4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 + 4.2.1 + 5.4.2
+ 6.2.1 + 7.1
Checked by:
Approved by:
ISO 9001:2000
Written by:
Date Supersedes
Date Issue
Page 4 of 8
mm/dd/yyyy
mm/dd/yyyy
Table 1 (Continued)
ISO 9001 Clause
4.11
4.12
4.13
4.14
4.15
4.16
4.17
4.18
4.19
Inspection,
measurement,
and test
equipment
Inspection and
test status
Control of
nonconforming
product
Corrective actions
Handling, storage,
packaging,
preservation, and
delivery
Quality records
Internal quality
audits
Training
Servicing (not
applicable)
Correspondence
Clause
ISO 9001:2000

ADM
QUA
PRD
QCD
SHP
MAI
PER
PDL
PUR
PAC
MKT
MPM
Element in the
Quality System
7.6
* * * X * *
7.5.3 (not
applicable)
8.3
X * * * *
8.5.2 + 8.5.3
8.4
7.5.5 + 7.5.1
(not
applicable)
* X * * * * * * * * * *
4.2.4
8.2.2 + 8.2.3
* * * X * * * * * * * *
* X * * * * * * * * *
6.2.1 + 6.2.2
7.1 + 7.5.1 (not
applicable)
* X * * * * X * * * * *
* * * * * * * * X *
* * * X * * * * * * *
* * * * * X
276
200.20.4

QUALITY SYSTEM
ISO 9001:2000
Written by:
Clause 4.2,
Revision 0
ISO 9003:1994
4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 + 4.2.1 + 5.4.2
+ 6.2.1 + 7.1
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 5 of 8
mm/dd/yyyy
mm/dd/yyyy
Table 1 (Continued)
ISO 9001 Clause
4.20
Statistical
techniques
Correspondence
Clause
ISO 9001:2000
8.1 + 8.2.3 +
8.2.4 + 8.4

ADM
QUA
PRD
QCD
SHP
MAI
PER
PDL
PUR
PAC
MKT
MPM
Element in the
Quality System
* X * * *

Key:
ADM
PRD
SHP
PDL
PAC
MPM
=
=
=
=
=
=
Production
Shipping
Packaging
QUA
QCD
PER
PUR
MKT
MAI
=
=
=
=
=
=
Quality Assurance
Personnel
Purchase
Marketing
Maintenance
CONTROL MANUAL
The quality system manual provides descriptions of management efforts
and initiatives to ensure customer requirements are met with continuous
improvement in the final product inspection and testing activities. The
quality system manual and procedures:
Provide a documented system that contr ols the activity/service/product
Produce written procedures that define authority, responsibility,
and interfaces
Ensure that the activity/service/product meets all specified customer requirements
200.20.4
277

QUALITY SYSTEM
ISO 9001:2000
Written by:
Clause 4.2,
Revision 0
ISO 9003:1994
4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 + 4.2.1 + 5.4.2
+ 6.2.1 + 7.1
Checked by:
Approved by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Page 6 of 8
Promote a reputation in the marketplace through customer satisfaction

Provide a system to ensure that all nonconformities, errors, deficiencies, complaints, and quality problems are immediately identified, controlled, and dealt with through feedback loops
Promote efficiency and cost effectiveness
Motivate staff toward pride in carrying out their jobs
Promote improved industrial relations through interfaces and interdepartmental cooperation and input
Control all activity/service/product performance data through feedback analysis
Provide activity/service/product performance data through feedback analysis
Identify and control training needs
Show commitment to quality through maintaining constant quality
levels
Improve communications
Produce historical records to confirm levels of quality system
effectiveness and activity/service/product achievement
Provide information for employee induction
(Company name) has identified and assigned a management representative
to ensure quality policies are established with due consideration to customer focus. Management reviews are conducted to ensure that the defined
objectives are met.
QUALITY OBJECTIVES
The quality objectives are well defined to prevent defects or errors occurring
during the whole process and to prevent failure of the end product.
278
200.20.4

QUALITY SYSTEM
ISO 9001:2000
Written by:
Clause 4.2,
Revision 0
ISO 9003:1994
4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 + 4.2.1 + 5.4.2
+ 6.2.1 + 7.1
Checked by:
Approved by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Page 7 of 8
DOCUMENTATION
Documentation plays an important role in the effective control and implementation of quality management system requirements. The quality policy,
objective, and applicable procedures ensure to meet:

Mark a well-defined purpose or need

Meet regulatory requirements
Satisfy users/customers expectations
Supply a product that is totally fit for use
Documents that need to be controlled are:

The quality manual

Control procedures
Work instructions, including work orders and route cards
Quality plans
Drawings including as built
Specifications
Inspection and test plans or requirements (usually included in work
instructions and quality plans)
Records (inspection, quality, training, document control, calibration, and goods accepted and dispatched)
Purchasing specifications, orders, and acknowledgments
Quotes, tenders, contracts, and contract reviews
Audit plans and records
Management reviews
The quality records are identified, established, and maintained.
200.20.4
279

QUALITY SYSTEM
ISO 9001:2000
Written by:
Clause 4.2,
Revision 0
ISO 9003:1994
4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 + 4.2.1 + 5.4.2
+ 6.2.1 + 7.1
Checked by:
Approved by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Page 8 of 8
IMPLEMENTATION
Top management takes all necessary actions to implement the requirement
of this international standard with a particular focus on customer requirements.

The processes needed to achieve excellence are implemented.

Interaction and interfaces are identified.
Training needs are fulfilled.
Actions resulting from the management reviews are communicated
and implemented.
Sequences of interaction affecting the product quality are defined
and documented.
QUALITY PLANNING
The quality system requirements specified in clause 4.1 are achieved
through proactive planning. Changes made to the system are documented
and controlled.

Quality plans are made specific to the product, project, or contract as
appropriate to the companys operations. The records of quality plans are
maintained and include:
Determination of requirements related to the product
Review of requirements related to the product
280
200.20.4

CONTRACT REVIEW
ISO 9001:2000
Written by:
Clause 4.3,
ISO 9003:1994
5.2 + 7.2.1 + 7.2.2
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 2
mm/dd/yyyy
mm/dd/yyyy
CONTRACT REVIEW
(Company name) has established and maintained procedures for contract
review and for the coordination of these activities.
Each contract is reviewed to ensure that:
The requirements are adequately defined and documented.
Any requirements differing from those in the tender are resolved.
The ability of the supplier to meet contractual requirements is ensured.
The contract review activities, interfaces, and communication within
the suppliers organization are coordinated with the purchasers (clients)
organization, as appropriate.
CUSTOMER FOCUS
Appropriate methods including statistical techniques are used to monitor
the customer requirements and their fulfillment.

TO THE PRODUCT
The product requirements are reviewed before the contract or tender is
accepted. Product requirements are defined and communicated to the
personnel responsible for the quality production. The unresolved and
ambiguous issues are resolved and documented. The changes made in
the product specifications are approved before execution of the order.
Provisions are made for removing absolute drawings, procedures, work
instructions, and specifications from all work areas to ensure that they
are correctly authorized versions. Provisions are made for emergency
changes necessary to prevent the production of nonconforming material.
200.20.4
281

CONTRACT REVIEW
ISO 9001:2000
Written by:
Clause 4.3,
ISO 9003:1994
5.2 + 7.2.1 + 7.2.2
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 2 of 2
mm/dd/yyyy
mm/dd/yyyy
CUSTOMER COMMUNICATON
The product information is determined and communicated at all levels
as appropriate, including customer complaints, changes, revisions, and
final approvals.
282
200.20.4

DESIGN CONTROL
ISO 9001:2000
Written by:
Clause 4.4,
Revision 0
ISO 9003:1994
7.2.1 + 7.3.1 + 7.3.2 + 7.3.3 + 7.3.4 + 7.3.5 +
7.3.6 + 7.3.7
Checked by:
Approved by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Page 1 of 2
GENERAL

DESIGN INPUT
DESIGN OUTPUT
200.20.4
283

DESIGN CONTROL
ISO 9001:2000
Written by:
Clause 4.4,
Revision 0
ISO 9003:1994
7.2.1 + 7.3.1 + 7.3.2 + 7.3.3 + 7.3.4 + 7.3.5 +
7.3.6 + 7.3.7
Checked by:
Approved by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Page 2 of 2
DESIGN REVIEW

DESIGN VERIFICATION
DESIGN VALIDATION
DESIGN CHANGES
284
200.20.4
OUR COMPANY NAME HERE

DOCUMENT AND DATA
CONTROL
ISO 9001:2000
Written by:
Clause 4.5,
ISO 9003:1994
4.2.1 + 4.2.3
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
DOCUMENT, DATA APPROVAL, AND ISSUES

The procedure is established and maintained to control all documents and
data that relate to the requirements of this standard. These documents are
reviewed and approved for adequacy by authorized personnel prior to
issue. This control ensures that:
Obsolete documents are promptly removed from all points of issue
or use.
The pertinent issues of appropriate documents are available at all
locations where operations essential to the effective functioning of
the quality system are performed.

Changes to documents are reviewed and approved by the same functions/organizations that performed the original review and approval,
unless specifically designated otherwise. The designated organizations
have access to pertinent background information upon which to base
their review and approval.
Where practicable, the nature of the changes is identified in the
document or the appropriate attachments.
A master list is established to identify the current revision of documents
in order to preclude the use of nonapplicable documents.
Documents are reissued after a practical number of changes have been
made.
200.20.4

PURCHASING
ISO 9001:2000
Written by:
Clause 4.6,
ISO 9003:1994
7.4.1 + 7.4.2 + 7.4.3
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
GENERAL
VENDOR ASSESSMENT
PURCHASING DATA

285
286
200.20.4

CUSTOMER SUPPLIED PRODUCT Clause 4.7,
ISO 9003:1994
7.5.4
ISO 9001:2000
Written by:
Checked by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Revision 0
Approved by:
Page 1 of 1
(Company name) has established and maintained procedures for verification, storage, and maintenance of purchaser (client) supplied product
provided for incorporation into the supply. Any such product that is lost,
damaged, or is otherwise unsuitable for use is recorded and reported to
the purchaser (see 4.16).
Verification by the supplier does not absolve the purchaser of the
responsibility to provide an acceptable product.
200.20.4
287

AND TRACEABILITY
ISO 9001:2000
Written by:
Clause 4.8,
ISO 9003:1994
7.5.3
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
The procedure has been established and maintained for identifying the
product from applicable drawing specifications, or other documents, during all stages of production, delivery, and installation.
Where, and to the extent that, traceability is a specified requirement,
individual products or batches have a unique identification. This identification is recorded (see 4.16).
288
200.20.4

PROCESS CONTROL
ISO 9001:2000
Written by:
Clause 4.9,
Revision 0
ISO 9003:1994
6.3 + 6.4 + 7.1 + 7.5.1 + 7.5.2 + 8.2.3
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
PROCESS CONTROL
SPECIAL PROCESSES

200.20.4
289

ISO 9001:2000
Written by:
Clause 4.10,
Revision 0
ISO 9003:1994
7.1 + 7.4.3 + 7.5.1 + 7.5.3 + 8.1 + 8.2
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 2
mm/dd/yyyy
mm/dd/yyyy
GENERAL
RECEIVING INSPECTION AND TESTING
The incoming products are not used or processed (except in the circumstances described in 4.10.2.3) until they have been inspected or otherwise
verified as conforming to specified requirements. Verification is performed
in accordance with the quality plan or documented procedures.
Where incoming product is released for urgent production purposes,
it is positively identified and recorded (see 4.16) in order to permit
immediate recall and replacement in the event of nonconformance to
specified requirements.
In determining the amount and nature of the receiving inspection,
consideration is given to the control exercised at the source, and documented evidence of quality conformance is provided.

Nonconforming product is identified.
Hold the product until the required inspection and tests have been
completed or necessary reports have been received and verified,
except when the product is released under positive recall procedures (see 4.10.1). Release under positive recall procedures does
not preclude the inspection, testing, and identification of the product as required by the quality plan or documented procedures.
Product conformance is established to specified requirements by
use of process monitoring and control methods.
(Company name) inspects, tests, and identifies the product as
required by the quality plan or documented procedures.
290
200.20.4

ISO 9001:2000
Written by:
Clause 4.10,
Revision 0
ISO 9003:1994
7.1 + 7.4.3 + 7.5.1 + 7.5.3 + 8.1 + 8.2
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 2 of 2
mm/dd/yyyy
mm/dd/yyyy

The quality plan or documented procedures for final inspection and testing
require that all specified inspection and tests, including those specified
either on receipt of product or in-process, have been carried out and that
the data meet specified requirements.
(Company name) carries out all final inspection and testing in accordance
with the quality plan or documented procedures to complete the evidence
of conformance of the finished product to the specified requirements.
No product is dispatched until all the activities specified in the quality
plan or documented procedures have been satisfactorily completed and
the associated data and documentation are available and authorized.

(Company name) establishes and maintains records that give evidence
that the product has passed inspection and/or test with defined acceptance
criteria (see 4.16).

The identification and traceability is maintained to ensure product recall
in the event of nonconformity or for rework.
200.20.4
291

TEST EQUIPMENT
ISO 9003:1994
7.6
ISO 9001:2000
Written by:
Checked by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Revision 0
Approved by:
Page 1 of 2

(Company name) controls, calibrates, and maintain inspection, measuring, and test equipment, whether owned, on loan, or provided by the
client, to demonstrate the conformance of the product to the specified
requirements. Equipment is used in a manner that ensures that measurement uncertainty is known and is consistent with the r equired
measurement capability.
(Company name):
Assesses and documents the validity of previous inspection and
test results when inspection, measuring, and test equipment is
found to be out of calibration
Maintains calibration records for inspection, measuring, and test
equipment (see 4.16)
Identifies inspection, measuring, and test equipment with a suitable indicator or approved identification record to show the
calibration status
Ensures that the inspection, measuring, and test equipment is
capable of the accuracy and precision necessary
Establishes, documents, and maintains calibration procedures,
including details of equipment type, identification number, location,
frequency of checks, check method, acceptance criteria, and the
action to be taken when results are unsatisfactory
Identifies, calibrates, and adjusts all inspection, measuring, and
test equipment and devices that can affect product quality at
prescribed intervals or, prior to use, against certified equipment
having a known valid relationship to nationally recognized standards. Where no such standards exist, the basis used for calibration is documented.
292
200.20.4

TEST EQUIPMENT
ISO 9003:1994
7.6
ISO 9001:2000
Written by:
Checked by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Revision 0
Approved by:
Page 2 of 2
Identifies the measurements to be made and the accuracy required,

and selects the appropriate inspection, measuring, and test equipment
Ensures that the environmental conditions are suitable for the
calibrations, measurements, and tests being carried out
Ensures that the handling, preservation, and storage of inspection,
measuring, and test equipment is such that the accuracy and fitness
for use is maintained
Safeguards inspection, measuring, and test facilities, including both
test hardware and test software, from adjustments that would
invalidate the calibration setting.
Where test hardware (e.g., jigs, fixtures, templates, patterns) or test
software are used as suitable forms of inspection, they are checked to
prove that they are capable of verifying the acceptability of the product
prior to release for use during production and installation and are
rechecked at prescribed intervals. The extent and frequency of such checks
is established, and records are maintained as evidence of control (see
4.16). Measurement design data are made available when required by the
purchaser (client) or his/her representative for verification that the product
is functionally adequate.
200.20.4
293

ISO 9001:2000
Written by:
Clause 4.12,
ISO 9003:1994
7.6.3
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy

The inspection and test status of products is identified by using markings,
authorized stamps, tags, labels, routing cards, inspection records, test
software, physical location, or other suitable means to indicate the conformance or nonconformance of the product with regard to inspection
and tests performed. The identification of inspection and test status is
maintained, as necessary, throughout production and installation of the
product to ensure that only product that has passed the required inspections and tests is dispatched, used, or installed.
Records identify the inspection authority responsible for the release of
conforming product (see 4.16).
294
200.20.4

CONTROL OF
Clause 4.13,
8.3
ISO 9001:2000
Written by:
Checked by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Revision 0
Approved by:
Page 1 of 1

(Company name) has established and maintained procedures to ensure
that product that does not conform to specified requirements is prevented
from inadvertent use or installation, evaluated, segregated when practical,
disposed of, and the functions concerned are notified.

The responsibility for review and authority for the disposition of nonconforming product is defined.
Nonconforming product is reviewed in accordance with documented
procedures. It may be:

Reworked to meet the specified requirements

Accepted with or without repair by concession
Regraded for alternative application
Rejected or scrapped
Where required by the contract, the proposed use or repair of product

(see 4.13.1b) that does not conform to specified requirements is reported
for concession to the purchaser or the purchasers (client) representative.
The description of nonconformity or repairs that have been accepted is
recorded to denote that actual conditions do not, in fact, conform to the
acceptable standard (see 4.16).
Repaired and reworked product is reinspected in accordance with
documented procedures.
200.20.4
295

CORRECTIVE ACTION
ISO 9001:2000
Written by:
Clause 4.14,
ISO 9003:1994
8.4 + 8.5.2 + 8.5.3
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
CORRECTIVE ACTION
The procedure is established, documented, and maintained for:
Implementing and recording changes in procedures resulting from
corrective action
Applying controls to ensure that corrective actions are taken and
that they are effective
Initiating preventive actions to deal with problems to a level
corresponding to the risks encountered
Analyzing all processes, work operations, concessions, quality
records, service reports, and customer complaints to detect and
eliminate potential causes of nonconforming product
Investigating the cause of nonconforming product and the corrective action needed to prevent recurrence
296
200.20.4

HANDLING, STORAGE,
ISO 9001:2000
Written by:
Clause 4.15,
ISO 9003:1994
7.5.1 + 7.5.5
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 2
mm/dd/yyyy
mm/dd/yyyy
HANDLING, STORAGE, PACKAGING, AND DELIVERY

General
The procedure is established, documented, and maintained for handling,
storage, packaging, and delivery of the product.
Handling
The methods and means of handling that prevent damage or deterioration
are provided for the product.
Storage
The secured storage areas or stock rooms are provided to prevent damage
or deterioration of the product pending use or delivery. Appropriate
methods for authorizing receipt and the dispatch to and from such areas
is stipulated. In order to detect deterioration, the condition of the product
is assessed at appropriate intervals.
Packing
The packing, preservation, and marking processes (including materials
used) are controlled to the extent necessary to ensure that conformance
to specified requirements is identified, preserved, and segregated for all
products from the time of receipt until the responsibility ceases.
200.20.4
297

HANDLING, STORAGE,
ISO 9001:2000
Written by:
Clause 4.15,
ISO 9003:1994
7.5.1 + 7.5.5
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 2 of 2
mm/dd/yyyy
mm/dd/yyyy
Delivery
The arrangements are made for the protection of the quality of the product
after final inspection and test. Where contractually specified, this protection
is extended to include delivery to destination.
298
200.20.4

QUALITY RECORDS
ISO 9001:2000
Written by:
Clause 4.16,
ISO 9003:1994
4.2.4
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
QUALITY RECORDS
Quality records are maintained to demonstrate achievement of the required
quality and the effective operation of the quality system. Pertinent subcontractor quality records are an element of these data.
The procedure is established and maintained for identification, collection,
indexing, filing, storage, maintenance, and disposition of quality records.
All quality records are legible and identifiable to the product involved.
Quality records are stored and maintained in such a way that they are
readily retrievable in facilities that provide a suitable environment to
minimize deterioration or damage and to prevent loss. Retention times of
quality records have been established and recorded. Where agreed contractually, quality records are made available for evaluation by the purchaser (client) or the purchasers representative for an agreed upon period.
200.20.4
299

ISO 9001:2000
Written by:
Clause 4.17,
ISO 9003:1994
8.2.2 + 8.2.3
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy

The comprehensive system of planned and documented internal quality
audits is carried out to verify whether quality activities comply with planned
arrangements and to determine the effectiveness of the quality system.
The audits and follow-up actions are carried out in accordance with
documented procedures.
Audits are scheduled on the basis of the status and importance of
the activity.
The results of the audits are documented and brought to the attention
of the personnel having responsibility in the area audited. The management personnel responsible for the area takes timely corrective action for
the deficiencies found by the audits (see 4.1.3).
300
200.20.4

TRAINING
ISO 9001:2000
Written by:
Clause 4.18,
ISO 9003:1994
6.2.1 + 6.2.2
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
TRAINING
The procedure is established for identifying the training needs and to
provide for the training of all personnel performing activities affecting
quality. Personnel performing specific assigned tasks are qualified on the
basis of appropriate education, training, and/or experience, as required.
Appropriate records of training are maintained (see 4.16).
200.20.4

SERVICING
ISO 9001:2000
Written by:
Clause 4.19,
ISO 9003:1994
7.1 + 7.5.1
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
SERVICING
301
302
200.20.4

ISO 9001:2000
Written by:
Clause 4.20, ISO

9003:1994
8.1 + 8.2.3 + 8.4
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
Where appropriate, the procedure is established for identifying adequate
statistical techniques required for verifying the acceptability of process
capability and product characteristics.
200.20.4
303
Appendix IV
Reference SOPs
Subject

Scope
General
Application
Normative reference
(title only)
Documentation
General
Clauses
ISO 9001
:2000
Ref. SOP
No.
1.0
1.1
1.2
2.0
3.0
4.0
ISO-4.1
ISO-4.1
ISO-4.1
ISO-4.1
ISO-4.1
ISO-4.1
New
New
New
New
New
New
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
4.1
4.2
New
New
New
New
New
New
New
New
New
New
New
New
New
New
New
New
New
New
New
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
Revision
No.
Issued On
Quality manual
(title only)
4.2.2
4.2.3
4.2.4
5.0
Customer focus
Quality policy
5.2
5.3
5.4
Quality objectives
5.4.1

planning
Management review
(title only)
5.4.2
ISO-4.2
ISO-4.2
ISO-4.5
ISO-4.2
ISO-4.5
ISO-4.2
ISO-4.5
ISO-4.1
ISO-4.1
ISO-4.2
ISO-4.1
ISO-4.2
ISO-4.3
ISO-4.1
ISO-4.1
ISO-4.2
ISO-4.1
ISO-4.2
ISO-4.2
5.5
ISO-4.1
New
mm/dd/yy
5.5.1
5.5.2
5.5.3
5.6
ISO-4.1
ISO-4.1
ISO-4.1
ISO-4.1
New
New
New
New
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
4.2.1
5.1
304
200.20.4
Appendix IV
Clauses
ISO 9001
:2000
Ref. SOP
No.
General
Review input
Review output
Resource management
(title only)
5.6.1
5.6.2
5.6.3
6.0
ISO-4.1
ISO-4.1
ISO-4.1
ISO-4.1
New
New
New
New
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
6.1
6.2
General
6.2.1

training
Infrastructure
Work environment
Product realization
(title only)
6.2.2
ISO-4.1
ISO-4.1
ISO-4.2
ISO-4.16
ISO-4.1
ISO-4.2
ISO-4.16
New
New
New
New
New
New
New
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
ISO-4.9
ISO-4.9
ISO-4.2
ISO-4.9
ISO-4.10
EP
New
New
New
New
New
EP
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
EP
Subject
Planning of product
realization
(title only)
Determination of
product
(title only)
planning
inputs
outputs
6.3
6.4
7.0
7.1
7.2
Revision
No.
Issued On
7.2.1
ISO-4.3
ISO-4.4
ISO-4.3
New
New
New
mm/dd/yy
mm/dd/yy
mm/dd/yy
7.2.2
ISO-4.3
New
mm/dd/yy
7.2.3
7.3
EP
EP
EP
EP
EP
EP
7.3.1
EP
EP
EP
7.3.2
EP
EP
EP
7.3.3
EP
EP
EP
200.20.4
305
Appendix IV
Clauses
ISO 9001
:2000
Ref. SOP
No.
Revision
No.
Issued On

review
verification
validation
development changes
Purchasing process
product
7.3.4
EP
EP
EP
7.3.5
EP
EP
EP
7.3.6
EP
EP
EP
7.3.7
EP
EP
EP
7.4
7.4.1
7.4.2
7.4.3
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
7.5

service provision
provision
Customer property
measuring devices
7.5.1
ISO-4.9
ISO-4.10
ISO-4.15
ISO-4.19
EP
New
New
New
New
EP
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
EP
7.5.2
EP
EP
EP
7.5.3
7.5.4
7.5.5
7.6
EP
ISO-4.7
ISO-4.15
ISO-4.11
EP
New
New
New
EP
mm/dd/yy
mm/dd/yy
mm/dd/yy
8.0
ISO-4.10
ISO-4.17
ISO-4.20
ISO-4.10
ISO-4.17
ISO-4.20
ISO-4.9
ISO-4.10
ISO-4.17
ISO-4.20
New
New
New
New
New
New
New
New
New
New
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
Subject
General
8.1
Monitoring and
8.2
306
200.20.4
Appendix IV
Subject
Clauses
ISO 9001
:2000
8.2.1
Internal audit
Monitoring and
8.2.2
8.2.3
Monitoring and
8.2.4
product
Analysis of data
8.3

Corrective action
Preventive action
8.4
8.5
8.5.1
8.5.2
8.5.3
Ref. SOP
No.
Revision
No.
Issued On
ISO-4.9
ISO-4.10
ISO-4.17
ISO-4.9
ISO-4.17
ISO-4.20
ISO-4.1
ISO-4.2
ISO-4.10
ISO-4.13
New
New
New
New
New
New
New
New
New
New
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
ISO-4.14
ISO-4.20
ISO-4.1
ISO-4.1
ISO-4.14
ISO-4.14
New
New
New
New
New
New
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
mm/dd/yy
300.30.1
308
300.30.1
STANDARD OPERATING PROCEDURE

SUBJECT: MANAGEMENT RESPONSIBILITY
Corresponding Clause: ISO 9001:2000
Distributed To:
Written by:
SOP NO: ISO 4.1

5.1 + 5.3 + 5.4.1 + 5.5.1 + 5.5.2
+ 5.5.3 + 5.6 + 5.6.1 + 5.6.2 +
5.6.3 + 6.1 + 6.2.1 + 6.3 + 7.1
Based on:
Revision No.: New
ANSI/ASQC Q 9001-1994
Checked by:
Approved by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 1 of 4
PURPOSE
To describe the elements of management responsibility in accordance with
clause 4.1 of ISO 9001 and the corresponding clauses of international
standard ISO 9001:2000.
RESPONSIBILITY
It is the responsibility of all departmental managers or supervisors to
understand and implement management responsibilities described in the
procedure. The ISO 9000 systems coordinator (management representative) is responsible for SOP compliance.
PROCEDURE
1. The quality management policies and objectives are stated and
defined in the quality manual, numbers QM-1, QM-2, QM-3, and
QM-4, respectively (select any one of these as a model). The
contents described in the quality manual and applicable procedures
are relevant to the size of the departments within the organization,
the types of activities, the complexity of the process, and the
interactions and competence of the personnel.
2. The quality policy defines measurable quality goals and relates
needs/expectations, which include:
Meet contractual requirements/satisfy users
Comply with the companys standard operating procedures
300.30.1
309

Distributed To:
Written by:
SOP NO: ISO 4.1

5.1 + 5.3 + 5.4.1 + 5.5.1 + 5.5.2
+ 5.5.3 + 5.6 + 5.6.1 + 5.6.2 +
5.6.3 + 6.1 + 6.2.1 + 6.3 + 7.1
Based on:
Revision No.: New
Checked by:
Approved by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 2 of 4
3. The senior company management representative authorizes the

quality policy statement.
4. The responsibilities, authorities, and interrelationships of personnel
are fully described (provide your company organization chart) for
all quality activities in the quality manual as well as in the applicable
procedures described in the quality manual appendix and other
procedures applicable to your companys operations.
5. Each procedure fully describes the purpose, responsibility, authority, and interrelationships of personnel for all quality activities.
6. The responsibilities for personnel related to quality assurance functions are defined in the job description file.
7. The responsible personnel allocated for the management and verification of the following work activities are suitably qualified:
Contract review
Design review
System auditing/corrective action
Materials control
8. The quality manual is reviewed and revised at least once a year.
The master quality manual is kept with the ISO 9000 coordinator.
The distribution copies are stamped with a copy number The
recipients acknowledge the receipt and replacement.
9. Documents needed by the organization to ensure effective planning, operations, and control of processes are established.
10. Processes needed for the quality management system are referred to
in the manual and in the applicable procedures, including processes
for management activities, provision of resources, product realization,
and measurement. Where an organization chooses to outsource any
process that affects product conformity with requirements, the organization ensures control over that process. Control of such outsourced
processes is identified within the quality management system.
310
300.30.1

Distributed To:
Written by:
SOP NO: ISO 4.1

5.1 + 5.3 + 5.4.1 + 5.5.1 + 5.5.2
+ 5.5.3 + 5.6 + 5.6.1 + 5.6.2 +
5.6.3 + 6.1 + 6.2.1 + 6.3 + 7.1
Based on:
Revision No.: New
Checked by:
Approved by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 3 of 4
11. There is an appointed management representative quality assurance manager (ISO 9000 system coordinator), independent of
other functions, with the necessary authority and responsibility
to ensure that the requirements of the standard are implemented
and maintained.
12. The management representative provides information to the top
management relating to the performance of the quality management system.
13. The management representative is responsible for organizing the
management reviews of the quality systems, e.g., every three
months.
14. The management reviews are undertaken against defined/measurable goals and objectives, which incorporate:
Internal audit
Customer complaints
Nonconformance
Training
Contract review
15. Records of the management reviews are maintained.
16. The management reviews take into consideration customer needs
and expectations.
17. The distribution of the quality manual and standard operating
procedures is controlled.
18. The terms and definitions used in the development, demonstration,
and implementation of the quality system r efer to standard
ISO 9000.
300.30.1
311

Distributed To:
Written by:
SOP NO: ISO 4.1

5.1 + 5.3 + 5.4.1 + 5.5.1 + 5.5.2
+ 5.5.3 + 5.6 + 5.6.1 + 5.6.2 +
5.6.3 + 6.1 + 6.2.1 + 6.3 + 7.1
Based on:
Revision No.: New
Checked by:
Approved by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 4 of 4
DOCUMENTATION
1. Quality manual and applicable procedures/policy/objectives
2. Organization chart
3. Personnel qualification file (document describing the qualification
and experience required for each specific quality-related job)
4. Job description file
5. Internal audit reports (system)
6. Management review minutes
7. Management action plans
REASONS FOR REVISION

mm-dd-yy
1) First time issued for (your company name).
300.30.2
314
300.30.2

SUBJECT: QUALITY SYSTEMS
Distributed To:
Written by:
Based on:
ANSI/ASQC Q 90011994
Checked by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
SOP NO: ISO 4.2

4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1
+ 5.4.2 + 6.2.1 + 7.1
Revision No.: New
Approved by:
Page 1 of 8
PURPOSE
To describe the elements of the quality system in accordance with clause
4.2 of ISO 9001 and the corresponding clauses of international standard
ISO 9001:2000.
RESPONSIBILITY
procedure. The ISO 9000 systems coordinator (management representative) is responsible for SOP compliance.
PROCEDURE
The company has established and maintained the following documented
quality system as a means of ensuring that the product/services conform
to specified requirements of this international standard.
QUALITY SYSTEMS
1. Top management is committed to the development and implementation of the quality management system and to continually improving its effectiveness by:
Communicating to the organization the importance of meeting
customer, statutory, and regulatory requirements
Establishing the quality policy
Ensuring that quality objectives are established
Conducting management reviews and ensuring the availability
of resources
300.30.2
315

SUBJECT: QUALITY SYSTEM
Distributed To:
Written by:
Based on:
Checked by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
SOP NO: ISO 4.2

4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1
+ 5.4.2 + 6.2.1 + 7.1
Revision No.: New
Approved by:
Page 2 of 8
2. The quality objectives, including those needed to meet requirements for the product, are established at relevant functions and
levels within the organization. The quality objectives are measurable and consistent with the quality policy.
3. The key quality management system documentation includes:
Documented statements of the quality policy and quality objectives
A quality manual
Documented procedures required by this international standard
Documents needed by the organization to ensure the effective
planning, operation, and control of its processes
Quality records required by this international standard
4. The distribution of quality management system documentation is
controlled. The documented quality management system gives due
consideration to the following elements:
All resources and skills needed to achieve the required quality
The compatibility of procedures and applicable documentation
Updating of verification techniques and equipment
Identification and development of measurement requirements
that exceed present capabilities
Verification during product development
Defining levels of acceptable quality, including subjective
standards
Identification, preparation, and retention of quality records
Identifying the processes needed for the quality management
system and their application throughout the organization
Determination of the sequence and interaction of these processes
Determination of criteria and methods needed to ensure that
both the operation and control of these processes are effective
316
300.30.2

Distributed To:
Written by:
Based on:
Checked by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
5.
6.
7.
8.
9.
10.
SOP NO: ISO 4.2

4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1
+ 5.4.2 + 6.2.1 + 7.1
Revision No.: New
Approved by:
Page 3 of 8
Ensuring the availability of resources and information necessary

to support the operation and monitoring of these processes
Monitoring, measurement, and analysis of these processes and
implementation of actions necessary to achieve planned results
and continual improvement of these processes.
The quality manual outlines the structure of the quality management system and reference procedures.
The contents of the quality manual include:
The scope of the quality management system, including details
of and justification for any exclusions
The documented procedures established for the quality management system or reference to them
A description of the interaction between the processes of the
quality management system
The contents of the quality management system documentation
differ from one department to another due to:
The size of the department and type of activities
The complexity of processes and their interactions
The competence of personnel
The procedures/work instructions are documented, describing all
quality-related activities and authorities (provide details in a separate work instruction manual).
The processes needed for the quality management system referred
to above include processes for management activities, provision
of resources, product realization, and measurement.
Concerning the outsourced processes that affect product conformity
with requirements, the organization ensures their control and identification within the quality management system.
300.30.2
317

Distributed To:
Written by:
Based on:
Checked by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
SOP NO: ISO 4.2

4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1
+ 5.4.2 + 6.2.1 + 7.1
Revision No.: New
Approved by:
Page 4 of 8
11. The documentation is maintained both in hardware and software

form as appropriate to the companys operations.
12. Personnel performing work affecting product quality are competent
on the basis of appropriate education, training, skills, and experience.
13. The planning of the quality management system is carried out in
order to meet the quality objectives, maintain the system integrity
when changes to the quality management system are planned and
implemented, and develop the processes needed for product realization. Planning of product realization is consistent with the requirements of the other processes of the quality management system.
14. In planning product realization, the organization determines the
following, as appropriate:
Quality objectives and requirements for the product
The need to establish processes and documents and provide
resources specific to the product
Required verification, validation, monitoring, inspection, and test
activities specific to fulfill the product requirements
Records needed to provide evidence that the realization processes and resulting product fulfill requirements
15. Quality plans are prepared in accordance with the requirements
of the standard where applicable (provide details).
16. The output of this planning is maintained in a suitable for m
according to the organizations method of operations.
17. The responsibilities and authorities are defined in the following
quality matrix in Table 1, based on the ISO 9001, ISO 9002, and
ISO 9003 series of standards with a corresponding clause of international standard ISO 9001:2000. Amend the matrix to suit your
companys operations.
318
300.30.2

Distributed To:
Based on:
Checked by:
Written by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
SOP NO: ISO 4.2

4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1
+ 5.4.2 + 6.2.1 + 7.1
Revision No.: New
Approved by:
Page 5 of 8
RESPONSIBILITIES AND AUTHORITY IN THE QUALITY SYSTEM

Table 1
REF.
ISO
9002
REF.
ISO
9003
Corresponding
Clause
ISO 9001:2000
4.1
Management
responsibilities
APP
APP
4.2
Quality system
APP
APP
5.1 + 5.3 + 5.4.1

+ 5.5.1
+ 6.1 + 6.2.1 +
6.3
5.5.2
5.6.1 + 5.6.2 +
5.6.3 + 8.5.1
4.1 + 4.2.1 +
4.2.2 + 5.1 +
5.4.1
5.4.2 + 6.2.1 +
7.1
5.2 + 7.2.1 +
7.2.2 + 7.2.3
7.3.1
7.2.1 + 7.3.2
7.3.3
7.3.4
7.3.5
7.3.6
7.3.7
4.3
Contract review
APP
APP
4.4
Design control
NA
NA

ADM
QUA
PRD
QCD
SHP
MAI
PER
PDL
PUR
PAC
MKT
MPM
Elements in the Quality

System ISO 9001:1994
Clauses
X * * * * * * * * * * *
* X * * * * * * * *
*
*
* * * * * * X *
* * * X * *
300.30.2
319

Distributed To:
Based on:
Checked by:
Written by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
SOP NO: ISO 4.2

4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1
+ 5.4.2 + 6.2.1 + 7.1
Revision No.: New
Approved by:
Page 6 of 8
Table 1 (Continued)
REF.
ISO
9002
REF.
ISO
9003
Corresponding
Clause
ISO 9001:2000
4.5
APP
APP
4.2.1 + 4.2.3
* * * * * * * X * * * *
APP
NA
* * * * * X *
Control of
customersupplied
product
Product
identification
and traceability
Process control
APP
APP
7.4.1
7.4.2
7.4.3
7.5.4
APP
APP
7.5.3
* * X * * * * * * *
APP
NA
* X * * *
4.10
Inspection and
testing
APP
APP
4.11
Inspection,
measurement,
and test
equipment
Inspection and
test status
Control of
nonconforming
product
APP
APP
6.3 + 6.4 + 7.1 +

7.5.1 + 7.5.2 +
8.2.3
7.1 + 8.1
7.4.3 + 8.2.4
7.5.1
7.5.3
7.6
APP
APP
7.5.3
X * * * *
APP
APP
8.3
* * * X * * * * * * *
4.6
4.7
4.8
4.9
4.12
4.13
Document and
data control
Purchasing
ADM
QUA
PRD
QCD
SHP
MAI
PER
PDL
PUR
PAC
MKT
MPM

Clauses
X *
X * * *
* * * X * *
320
300.30.2

Distributed To:
Based on:
Checked by:
Written by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
SOP NO: ISO 4.2

4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1
+ 5.4.2 + 6.2.1 + 7.1
Revision No.: New
Approved by:
Page 7 of 8
Table 1 (Continued)
REF.
ISO
9002
REF.
ISO
9003
Corresponding
Clause
ISO 9001:2000
4.14
APP
APP
APP
APP
8.5.2 + 8.5.3
8.4
7.5.5 + 7.5.1
4.15
4.16
4.17
Corrective
actions
Handling,
storage,
packaging,
preservation,
and delivery
Quality records

ADM
QUA
PRD
QCD
SHP
MAI
PER
PDL
PUR
PAC
MKT
MPM

Clauses
* X * * * * * * * * * *
* * * * * X
APP
APP
4.2.4
APP
APP
8.2.2 + 8.2.3
4.18
Internal quality
audits
Training
APP
APP
6.2.1 + 6.2.2
4.19
Servicing
NA
NA
7.1 + 7.5.1
4.20
Statistical
techniques
APP
APP
8.1 + 8.2.3 +
8.2.4 + 8.4
* * * X * * * * * * * *
* X * * * * * * * * *
* X * * * * X * * * * *
* * * * * * * * X *
* X * * *
X RESPONSIBLE FUNCTIONS * FUNCTIONS CONCERNED NOT APPLICABLE

Key:
ADM
PRD
SHP
PDL
PAC
MPM
NA
=
=
=
=
=
=
=
Production
Shipping
Packaging
Not Applicable
QUA
QCD
PER
PUR
MKT
APP
MAI
=
=
=
=
=
=
=
Quality Assurance
Personnel
Purchase
Marketing
Applicable
Maintenance
300.30.2
321

Distributed To:
Written by:
Based on:
Checked by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
SOP NO: ISO 4.2

4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1
+ 5.4.2 + 6.2.1 + 7.1
Revision No.: New
Approved by:
Page 8 of 8
DOCUMENTATION
1.
2.
3.
4.
5.
Quality manual
Standard operating procedures/training records
Work instructions manual/training records
Training manual/training records
Equipment manual/training records

mm-dd-yy
300.30.3
324
300.30.3

SUBJECT: CONTRACT REVIEW
SOP NO: ISO 4.3
5.2 + 7.2.1 + 7.2.2 + 7.2.3
Revision No.: New
Distributed To:
Based on:
Written by:
Checked by:
Approved by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 1 of 4
PURPOSE
To describe the elements of contract review in accordance with clause
4.3 of ISO 9001 standard and corresponding clauses of an international
RESPONSIBILITY
It is the responsibility of the particular departmental managers and supervisors
concerned (marketing and sales) to understand and implement management
responsibilities described in the procedure. The ISO systems coordinator
(management representative) is responsible for SOP compliance.
PROCEDURE
1. The company has established and maintained a procedure for
contract review and for the coordination of these activities. The
company ensures that the following customer requirements are
determined and fulfilled with the aim of enhancing customer
satisfaction. A designated and authorized staff is responsible for
reviewing each contract to ensure:
The requirements are adequately defined and documented.
The tender, contract, order/delivery dates, and penalties are
agreed upon and accepted.
Verbal orders from the clients are documented and confirmed
before processing.
Any requirements differing from those in the tender are resolved.
The capacity to meet contractual requirements is reviewed and
documented.
300.30.3
325

SOP NO: ISO 4.3
5.2 + 7.2.1 + 7.2.2 + 7.2.3
Revision No.: New
Distributed To:
Based on:
Written by:
Checked by:
Approved by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 2 of 4
The appropriate departments are notified in writing of any

variations in the clients contract.
Requirements specified by the customer, including the requirements for delivery and postdelivery activities, are fulfilled.
Requirements not stated by the customer but necessary for
specified use or known and intended use are fulfilled.
2. The company reviews the requirements related to the product.
This review is conducted prior to the organizations commitment
to supply a product to the customer (e.g., submission of tenders,
acceptance of contracts of orders, acceptance of changes to contracts or orders) to ensure that:
Product requirements are defined.
Contract or order requirements differing from those previously
expressed are resolved.
The organization has the ability to meet the defined requirements.
Records of the results of the review and actions arising from
the review are maintained.
3. The review and approval arrangements include consideration of
(if applicable):
Program
Internal resources
External resources
Risk factors
Statutory/regulatory requirements related to the contract
Project stages and reviews
Documentation of project details
Record of contract review
Statutory and regulatory requirements related to the product
326
300.30.3

SOP NO: ISO 4.3
5.2 + 7.2.1 + 7.2.2 + 7.2.3
Revision No.: New
Distributed To:
Based on:
Written by:
Checked by:
Approved by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 3 of 4
4. The work plan identifies the following elements:

The client brief
Principal personnel, responsibilities, and authority
Other parties associated with the job
Principal stages of the project, including reviews and approvals
Arrangements for communication and consultation between the
parties
Specific project procedures, where needed
The job record/filing system
Final review and approval
5. The review includes any additional requirements determined by
the organization.
6. Where the customer provides no documented statement of requirements, the customer requirements are confirmed by the organization before acceptance.
7. Where product requirements are changed, the organization ensures
that relevant documents are amended and that relevant personnel
are made aware of the changed requirements.
8. In situations such as Internet sales, a formal review is impractical
for each order. Instead, the review covers product information
provided in the catalogues of advertising material.
9. Effective arrangements for communicating with customers are
maintained, with particular reference to:
Product information
Inquiries, contracts, or order handling, including amendments
Customer feedback, including customer complaints
300.30.3

SOP NO: ISO 4.3
5.2 + 7.2.1 + 7.2.2 + 7.2.3
Revision No.: New
Distributed To:
Based on:
Written by:
Checked by:
Approved by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 4 of 4
DOCUMENTATION

Purchase requisition from the clients

Quotation/agreement/contract
Approved purchase order
Material release certificate of analysis
Client acknowledgment of the goods
Customers goods receiving reports (clients)

mm-dd-yy
327
300.30.4
330
300.30.4

SUBJECT: DESIGN CONTROL
Distributed To:
Written by:
Based on:
Checked by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
SOP NO: ISO 4.4

7.3.1 + 7.3.2 + 7.3.4 + 7.3.5, 7.2.1
+ 7.3.3 + 7.3.6 + 7.3.7
Revision No.: New
Approved by:
Page 1 of 8
PURPOSE
To describe the design control procedure in accordance with clause 4.4 of
ISO 9001 and corresponding clauses of international standard ISO 9001:2000.
RESPONSIBILITY
It is the responsibility of the particular departmental managers or supervisors
concerned (product development) to understand and implement management responsibilities described in the procedure. The ISO systems coordinator (management representative) is responsible for SOP compliance.
PROCEDURE
The procedure has been established and maintained to control and verify
the design of the product services in order to ensure that the specified
requirements are met. Control of design is achieved through design,
planning, identification of design input, verification of design, stage output,
control of changes, and validation of the eventual product or service. Each
phase of design is carefully controlled to ensure that it achieves the
purchasers or product brief requirements.
1. The designing and development of the product is controlled.
2. During the design and development planning, the organization
determines the following:
The design and development stages
The review, verification, and validation that are appropriate to
each design and development stage
The responsibilities and authorities for design and development
300.30.4
331

Distributed To:
Written by:
Based on:
Checked by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
SOP NO: ISO 4.4

7.3.1 + 7.3.2 + 7.3.4 + 7.3.5, 7.2.1
+ 7.3.3 + 7.3.6 + 7.3.7
Revision No.: New
Approved by:
Page 2 of 8
3. The personnel supervising the design development are suitably

qualified/experienced.
4. The design scheme is traceable to the basis against which the
design has been prepared (if applicable).
The design route starts with the input of information to the
design team. This input is usually referred to as the design brief.
The brief may consist of information from simple verbal instructions to very detailed drawings and specifications.
Information for the brief comes from marketing, sales, and
customer requirements.
It is very important to ensure that the brief given to the design
team is transmitted formally to ensure that the design personnel
are aware of the requirements. This may require several meetings
with the customer to ensure that the requirements are perfectly
clear prior to starting any design work.
Changes to the design brief must be carefully controlled to assess
their cost and effect on work completed up to the point of
change.
5. The design scheme is reviewed to give due consideration to
contract review actions.
6. The design and development are reviewed at regular intervals in
accordance with the planned program.
7. Requirements for product development are determined and records
are maintained, including functional and performance requirements, applicable statutory and regulatory requirements, where
applicable, information derived from previous similar designs, and
other requirements essential for design and development.
8. The requirements are complete, unambiguous, and clear.
9. The operability, maintainability, reliability, safety, interchangeability, and spare parts aspects are suitably addressed.
332
300.30.4

Distributed To:
Written by:
Based on:
Checked by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
SOP NO: ISO 4.4

7.3.1 + 7.3.2 + 7.3.4 + 7.3.5, 7.2.1
+ 7.3.3 + 7.3.6 + 7.3.7
Revision No.: New
Approved by:
Page 3 of 8
10. The design and development responsibilities are clearly assigned.

11. The design function or team is responsible for translating the design
brief into drawings and technical specifications for materials, products, processes, and services that satisfy the customers expectations
at an acceptable cost, which reflects a return on capital invested.
12. Design tasks may be either subcontracted or carried out in-house.
Whichever is chosen, management is responsible for specifically
assigning tasks and responsibilities that shall include the requirements for achieving quality.
13. External design is controlled to the same extent as internal design.
Design staff have the necessary qualifications, experience, training,
and expertise to carry out the tasks assigned to them. This requires
verification prior to assigning tasks and responsibilities.
14. Design management establishes design programs with time-phased
checkpoints, which are relative to the product or service and
translate the customers needs and marketing information into clear
specifications.
15. The design program is determined by the product or service
application, complexity, technology, standardization, and past
proven designs compared to the risks involved. Safety, environmental, and other regulations shall be taken into account.
16. The following design factors are taken into consideration:
Product application
Design complexity
Technology being used
Degree of standardization
Compatibility with proven designs
Customer needs
Consideration of safety requirements
300.30.4
333

Distributed To:
Written by:
Based on:
Checked by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
17.
18.
19.
20.
21.
22.
23.
24.
25.
SOP NO: ISO 4.4

7.3.1 + 7.3.2 + 7.3.4 + 7.3.5, 7.2.1
+ 7.3.3 + 7.3.6 + 7.3.7
Revision No.: New
Approved by:
Page 4 of 8
Environmental and other regulations

The quality policy
Statutory requirements
The calculations, design, and drawings are rechecked.
The quality assurance quality requirements are unambiguous and
define the quality characteristics. Special requirements including
safeguards against misuse, reliability, maintainability, and serviceability throughout reasonable life expectancy will also be considered.
Product testing and measurement are specified and include:
Performance target values and tolerances
Acceptance/rejection criteria
Test and measurement methods and equipment
Computer software considerations (if used)
All relevant personnel are involved with the design review of the
design/functions.
Participants in such reviews include representatives of functions
concerned with the design and development stage(s) being
reviewed. Records of the results of the reviews and any necessary
actions are maintained.
The design reviews clearly indicate the scope of the review and
actions decided.
The actions completed are recorded.
Changes to the design are documented for proposing, reviewing,
approving, and implementing.
At suitable stages, systematic reviews of design and development
are conducted to evaluate the ability of the results of design and
development to fulfill requirements, identify any problems, and
propose necessary actions.
334
300.30.4

Distributed To:
Written by:
Based on:
Checked by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
SOP NO: ISO 4.4

7.3.1 + 7.3.2 + 7.3.4 + 7.3.5, 7.2.1
+ 7.3.3 + 7.3.6 + 7.3.7
Revision No.: New
Approved by:
Page 5 of 8
26. Changes to the design include review of interfaces.

27. The interfaces between different groups involved in design and
development are managed to ensure effective communication and
clear assignment of responsibility. Documentation is updated, as
appropriate, as the design and development progress.
28. Participants at each design review include representatives of all
functions affecting quality as appropriate to the phase being
reviewed.
29. The aim of each review is to ensure that the design is proceeding
according to plan and is meeting the specification or customer
requirements. The review may also identify and anticipate problem
areas or inadequacies and initiate corrective actions. It may also
review the adequacy of any corrective actions taken since the last
review took place.
30. It is prudent to raise an agenda for design reviews to ensure that
nothing is missed and that reviews do not overrun the time
allocated to them.
31. Elements of design plans and reviews include items pertaining to
customer needs and satisfaction.
Comparison of purchase needs expressed in the product brief
with technical specifications for materials, products, and processes
Verification of design through data and calculation checks and
validation of design through prototype tests, where applicable
Ability to perform under expected conditions of use and
environment
Considerations of unintended uses and misuses
Safety and environmental compatibility
Compliance with regulatory requirements, national and international standards, and corporate practices
300.30.4
335

Distributed To:
Written by:
Based on:
Checked by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
SOP NO: ISO 4.4

7.3.1 + 7.3.2 + 7.3.4 + 7.3.5, 7.2.1
+ 7.3.3 + 7.3.6 + 7.3.7
Revision No.: New
Approved by:
Page 6 of 8
32. The technical data of the design are used to provide instruction,
maintenance, and spare documentation at the production phase.
33. The materials used are standardized.
34. The information (reference literature) adequate for the scope of
work is maintained.
35. After completion of design, verification is performed to ensure that
the design and development outputs have satisfied the design and
development input requirements. Records of the results of the
verification and any necessary actions are maintained.
36. Design verification is carried out at sufficient planned stages by
applying analytical evaluation or other methods to ascertain that
the design stage output is achieving the design stage input requirement parameters. Methods of verification are:
FMEA, failure mode and effects analysis
Fault tree analysis
Risk audit
Inspection and test of prototypes or production samples
Independent evaluation to verify original calculations or to provide alternatives and/or perform tests to produce results for
comparison
Adequate numbers of samples are tested to ensure statistical confidence in the results.
37. Design evaluation of performance, reliability, durability, maintainability, and safety under expected operational and storage conditions is carried out.
38. Quality control techniques are applied to ensure and verify that
all design features are as intended and that any changes to the
design have been authorized, distributed, accomplished, and
recorded.
336
300.30.4

Distributed To:
Written by:
Based on:
Checked by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
SOP NO: ISO 4.4

7.3.1 + 7.3.2 + 7.3.4 + 7.3.5, 7.2.1
+ 7.3.3 + 7.3.6 + 7.3.7
Revision No.: New
Approved by:
Page 7 of 8
39. The results of verification, evaluation, and tests are recorded and
documented to provide evidence of conformance of the actual
design to the planned design. This allows for comparison of the
design input against the design output.
40. After completion, designs are validated/tested to ensure that they
meet customer needs/requirements. The design outputs ar e
approved prior to release to ensure that they:
Satisfy customer requirements
Meet the input requirements for design and development
Provide appropriate information for purchasing, production, and
service provision
Contain or reference product acceptance criteria
Specify the characteristics of the product that are essential for
its safe and proper use
41. The validation is performed in accordance with a planned arrangement to ensure that the resulting product is capable of fulfilling
the requirements for the specified or known intended use or
application. Wherever practicable, validation is completed prior
to the delivery or implementation of the product. Records of the
results of validation and any necessary actions are maintained.
42. The quality system provides for a review to determine whether
production capability and field support are adequate for the new
or redesigned product. Depending upon the type of product, the
review may cover the following points:
Availability and adequacy of installation, commissioning, operation, maintenance, and repair manuals
Existence of an adequate distribution and customer service
organization
Training of field personnel
300.30.4
337

Distributed To:
Written by:
Based on:
Checked by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
SOP NO: ISO 4.4

7.3.1 + 7.3.2 + 7.3.4 + 7.3.5, 7.2.1
+ 7.3.3 + 7.3.6 + 7.3.7
Revision No.: New
Approved by:
Page 8 of 8
Field trials (validation)

Certification of satisfactory completion of qualification tests
Physical inspection of early production units and their packaging
and labelling
Evidence of process capability to meet the specification production requirements
43. The feedback obtained from the clients is used effectively in the
development of future designs.
DOCUMENTATION
1.
2.
3.
4.
5.
6.
7.
Design input (request)

Design development data
Design reference material
Design change control form
Design output form data
Design verification data
Product development file

mm-dd-yy
300.30.5
340
300.30.5

SUBJECT: DOCUMENT AND DATA CONTROL
SOP NO: ISO 4.5
4.2.1 + 4.2.3
Revision No.: New
Distributed To:
Based on:
Written by:
Checked by:
Approved by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 1 of 6
PURPOSE
To describe the document and data control in accordance with clause 4.5 of
ISO 9001 and corresponding clauses of international standard ISO 9001:2000.
RESPONSIBILITY
It is the responsibility of all departmental managers to understand and
implement management responsibilities described in the procedure. The
ISO systems coordinator (management representative) is responsible for
SOP compliance.
PROCEDURE
1. The management has defined and documented its policy and
objectives for, and commitment to, quality. This policy is relevant
to the organizational goals and the expectations and needs of
customers. It is ensured that this policy is understood, implemented,
and maintained at all levels in the organization.
2. This requirement is achieved by raising and using the following
quality documentation.
a. Quality Assurance Manual: A statement of company quality
policy (signed by the chief executive) and a declaration of intent
as to how the requirements of the nominated quality management standards are addressed. The quality assurance manual
provides a description of senior and quality assurance management responsibilities and the scope of the service offered by
the organization. The manual contains organization charts (organograms) and key responsibilities of senior management.
300.30.5
341

SOP NO: ISO 4.5
4.2.1 + 4.2.3
Revision No.: New
Distributed To:
Based on:
Written by:
Checked by:
Approved by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 2 of 6
b. Detailed Procedures: Provides a listing of the authorized practices, responsibilities, and interfaces to be adopted in pursuit of
the companys activities, in particular those that relate to, or
follow on from, different departments. Responsibilities of middle
and junior management are described.
c. Work Instructions: Written instructions are used within departments and contain specific details of how particular tasks are
to be carried out. These are the backbone of the quality system
as they describe in great detail how the task is to be carried out.
d. Additional Contract Procedures: These are additional procedures for specific contracts and include precise purchaser
requirements, procedural matters in relation to outside organizations involved, and any additional controls required due to
the nature of the task or risk factor involved.
e. Quality Plans: Quality plans describe the strategy to assure the
required quality at each stage of the task without disproportionate
effort to produce the plan. Plans are made available early on in
the project, rather than a wallpapering exercise at the end to
suit the purchasers quality assurance representative. Quality plans
are used in contract situations where the purchaser or his/her
nominated representative wishes to control various phases of the
task. They nominate hold, stop, report, and documentation points
beyond which the supplier may not progress until given permission
to do so. The plans are drawn up by either the purchaser or the
supplier, depending on the contract or quality, and then approved.
3. Documents issued to casual users who will only use them for
reference, e.g., a purchaser, client, or customer, are clearly distinguished from those issued for the controlled copy circulation as
they need not be kept up to date. They are marked: uncontrolled
copy (will not be maintained), this copy will not be kept up to
date, or check for latest issue before use.
342
300.30.5

SOP NO: ISO 4.5
4.2.1 + 4.2.3
Revision No.: New
Distributed To:
Based on:
Written by:
Checked by:
Approved by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 3 of 6
4. The documentation can be in any form or type of medium as

appropriate to the companys operations.
5. Documents required by the quality management system are controlled. Quality records are a special type of document and are
controlled according to the requirements given in this international standard.
6. The status of documents is indicated in the current registers. The
documents are identified by a specific number and are available
at the appropriate workplaces.
7. The documents are legible and readily identifiable.
8. All of these documents are controlled, issued, and recorded. Special
attention must be paid to any changes to controlled documents as
lack of control can have disastrous effects at the point of use of
the document.
9. A clear definition of the controls is applied and included in the
procedures that govern the use of documents. This includes:
Responsibility for the creation, authorization, revision, and issuing of controlled documents
Formats to be used
Identification of issue, revision, or amendment status
Indentification of the reason for the change
Instructions for removal of superseded and obsolete documents
from the point of use
How marking up of superseded documents if retained in use
or on file is to be carried out
Record keeping requirements
Where computerized documents are held, procedures should
specify which is the master document the magnetic media
(diskette, hard disc, or tape) or the hard copy.
300.30.5
343

SOP NO: ISO 4.5
4.2.1 + 4.2.3
Revision No.: New
Distributed To:
Based on:
Written by:
Checked by:
Approved by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
Page 4 of 6
For most documents, these objectives are met by designating them

as controlled documents, which are:
Properly authorized by approved signatories
Serial numbered for identification
Issue/revision referenced and dated
Issued within a registered circulation
Subject to control of all changes
Updated to same distribution
Documents received from external organizations are recorded to
ensure traceability.
The documents affecting the product quality/services are adequately drafted, checked, and approved for adequacy prior to use.
Specifications/reports
QMS documents (manual and SOPs)
Methods or checklists in use are adequate and complete and
are referenced to the procedure number, revision number, and
issue date.
The same authorities that originally approved the documents
review the changes to in-house documents.
The changes made in the documents are documented.
The reasons for changes are suitably recorded.
The documents are formally issued to recipients to track their
purpose and status.
All recipients are kept posted with updated documents
The superseded documents are withdrawn from the workplace.
Master lists of documents applicable to each job are maintained
by the management representative.
The handling and storing of master documents is consistent with:
Traceability
Their preservation
344
300.30.5

SOP NO: ISO 4.5
4.2.1 + 4.2.3
Revision No.: New
Distributed To:
Based on:
Written by:
Checked by:
Approved by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 5 of 6
21. The classified documents are kept secured.

22. The discrepancies discovered at the workplace in the documents
are resolved and documented.
23. The documents are reviewed according to the specified frequency
(e.g., once per year) for verification, updated as necessary, and reapproved.
24. The changes relating to subcontract materials are approved by the
company.
25. The company evaluates the consequences of changes relating to
subcontract materials.
26. The consequences of alterations to interchangeability and spare
parts are made known to the customer.
27. The changes are reflected in:
User instruction literature
Spare parts lists
28. The incoming and outgoing correspondence is promptly handled
and the documents are traceable.
29. The standards and customer drawings/specifications are included
in the document control system.
30. To prevent the unidentified use of obsolete documents, suitable
identification is assigned if they are retained for any purpose.
31. The management representative is responsible for the production,
issue, and holding of documents. Table 1 provides the level and
types of documents implemented in the company.
32. The documents identified as quality records are kept secured
according to the shelf life determined and are easily retrievable.
Marketing
Sales and
Contracts
Design and
Development
Material
Control
Manufacture,
Engineering,
Planning
Accounts
Costing
Personnel
Training
Service and
After-Sales
Support
Quality Records
Written
Instructions To
Control Taks
Company
Procedures
Level 2
Work
Instruction/
Plans of Work
Level 3
Forms,
Records,
Documents,
Files
Level 4
Statement of
Policy,
Commitment,
Organization,
and
Responsiblities
Company
Practices,
Responsibilities,
and Interfaces
300.30.5
Quality
Manual
Level 1
Table 1 Quality Documentation Description

345
346
300.30.5

SOP NO: ISO 4.5
4.2.1 + 4.2.3
Revision No.: New
Distributed To:
Based on:
Written by:
Checked by:
Approved by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 6 of 6
DOCUMENTATION
1. SOPs distribution register
2. External and internal documents distribution register
3. Documents change control form

mm-dd-yy
300.30.6
348
300.30.6

SUBJECT: PURCHASING
SOP NO: ISO 4.6
7.4.1 + 7.4.2 + 7.4.3
Revision No.: New
Distributed To:
Based on:
Written by:
Checked by:
Approved by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 1 of 3
PURPOSE
To describe the purchasing requirement in accordance with clause 4.6
of ISO 9001 and corresponding clauses of inter national standard
ISO 9001:2000.
RESPONSIBILITY
It is the responsibility of all departmental managers or supervisors (purchasing) to understand and implement management r esponsibilities
described in the procedure. The ISO systems coordinator (management
representative) is responsible for SOP compliance.
PROCEDURE
1. The procedure has been established and implemented to ensure
that purchased product conforms to specified requirements.
2. The quality-related material requisitions are raised with material
specification, describing code number, and subjective and quantitative details. Purchasing information describes the product to be
purchased, including, where appropriate, requirements for
approval of product, procedures, processes and equipment,
requirements for qualification of personnel, and quality management system requirements.
3. The company ensures the adequacy of specified purchase requirements prior to their communication to the supplier.
4. The supplies and subcontractors are evaluated based on:
Quality certificate from the country of origin
Material certificate of analysis
300.30.6
349

SUBJECT: PURCHASING
SOP NO: ISO 4.6
7.4.1 + 7.4.2 + 7.4.3
Revision No.: New
Distributed To:
Based on:
Written by:
Checked by:
Approved by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
Page 2 of 3
In-house checking or sample sent from the supplier or subcontractor

Second party audit
Formal visit to the site
Audit by mail (quality questioner)
It is ensured that purchased product conforms to specified purchase
requirements. Criteria for selection, evaluation, and reevaluation
are established. Records of the results of evaluations and any
necessary actions arising from the evaluation are maintained.
The procedure for the audit of suppliers and subcontractors is
maintained (checklist suitable to the activity).
The approved list of suppliers for products affecting quality is
maintained (refer to the purchase manual).
The purchase orders are issued formally and recorded.
The purchase materials are listed according to class (classify as
appropriate):
Materials affecting the product quality
Materials not affecting the product quality
The type and extent of control applied to the supplier and the
purchased product depends upon the effect of the purchased
product on subsequent product realization or the final product.
Records of the results of the review of changes in specifications
and any necessary actions are maintained.
The purchased products are checked against the purchase order
for their identification and suitability (as appropriate).
All orders identify numbers and quality of materials.
The purchasing documents are reviewed for their adequacy prior
to release.
The materials received are inspected, verified, and documented.
The products supplied by the subcontractor are verified (describe
the procedure suitable for your company).
350
300.30.6

SUBJECT: PURCHASING
SOP NO: ISO 4.6
7.4.1 + 7.4.2 + 7.4.3
Revision No.: New
Distributed To:
Based on:
Written by:
Checked by:
Approved by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 3 of 3
16. Where the organization or customer intends to perform verification

at the suppliers premises, the organization states the intended
verification arrangements and method of product release in the
purchasing information.
DOCUMENTATION
1.
2.
3.
4.
5.
6.
Purchase requisition
Purchase order
Certificate of analysis (from the supplier or manufacturer)
Vendor approval records
Approved vendor list
Materials receiving reports

mm-dd-yy
300.30.7
352
300.30.7

SUBJECT: CONTROL OF CUSTOMER-SUPPLIED
SOP NO: ISO 4.7
PRODUCT
7.5.4
Revision No.: New
Distributed To:
Based on:
ANSI/ASQC Q 9001 1994
Written by:
Checked by:
Approved by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 1 of 2
PURPOSE
To describe the control of customer-supplied product in accordance with
clause 4.7 of ISO 9001 and the corresponding clause of international
RESPONSIBILITY
It is the responsibility of all departmental managers or supervisors (stores
and quality control) to understand and implement management responsibilities described in the procedure. The ISO systems coordinator (management representative) is responsible for SOP compliance.
PROCEDURE
1. The goods supplied by the customer are adequately examined
upon receipt (refer to the specification manual).
2. The purchaser-supplied products are kept segregated from other
similar goods in storage.
3. All goods are adequately identified using a code numbering system
(choose a method suitable to your company).
4. The responsibilities and duties of the customers personnel (coordinator) engaged in activities under company supervision relating to
the contract are clearly defined (establish procedures suitable to your
company and refer to the customer-supplied product manual).
5. The defects in customer-supplied product unsuitable for use in the
intended product are reported to the customer and records are
maintained.
300.30.7
353

SUBJECT: CONTROL OF CUSTOMER-SUPPLIED
SOP NO: ISO 4.7
PRODUCT
7.5.4
Revision No.: New
Distributed To:
Based on:
ANSI/ASQC Q 9001 1994
Written by:
Checked by:
Approved by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 2 of 2
6. The customer-supplied product (while it is under company control

or being used by the company) is identified, verified, protected,
and safeguarded. Any customer property lost, damaged, or otherwise found to be unsuitable for use is reported to the customer
and records are maintained.
7. The lost and damaged customer-supplied products are reported to
the customer and records are maintained. Customer property
includes the intellectual property.
DOCUMENTATION
1.
2.
3.
4.
5.
6.
Customer-supplied product list

Customer-supplied product notification form
Test records
Maintenance records
Storage records
Specification manual for customer-supplied products.
Note: Verification by the supplier does not absolve the purchaser of the
responsibility to provide acceptable product.

mm-dd-yy
300.30.8
356
300.30.8

SUBJECT: PRODUCT IDENTIFICATION AND
SOP NO: ISO 4.8
TRACEABILITY
7.5.3
Revision No.: New
Distributed To:
Based on:
Written by:
Checked by:
Approved by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 1 of 2
PURPOSE
To describe the product identification and traceability in accordance with
clause 4.8 of ISO 9001 and the corresponding clause of international
RESPONSIBILITY
procedure. The ISO systems coordinator (management representative) is
responsible for SOP compliance.
PROCEDURE
1. The materials in the stores are identified by code number and,
upon receipt, are assigned specific lot number.
2. The materials are issued to the production line with specific lot
numbers against a particular batch number to be manufactured.
3. Each production batch is assigned a specific batch number.
4. The identification is carried throughout the production line with a
specific batch number.
5. The materials are clearly identified at dispatch and during production, processing, and installation.
6. The product status is identified with respect to monitoring and
measurement requirements.
7. The customer supplied materials are controlled using specific code
numbers that are traceable.
300.30.8
357

SUBJECT: PRODUCT IDENTIFICATION AND
SOP NO: ISO 4.8
TRACEABILITY
7.5.3
Revision No.: New
Distributed To:
Based on:
Written by:
Checked by:
Approved by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 2 of 2
8. The organization identifies, verifies, protects, and safeguards customer property provided for use or incorporation into the product
by maintaining its unique identity.
9. The customer property lost, damaged, or otherwise found to be
unsuitable for use is reported to the customer and records are
maintained.
10. The customer property includes intellectual property.
11. The quality records are identified and are traceable with their
unique identity according to SOP ISO-4.5 and ISO-4.16.
DOCUMENTATION
1.
2.
3.
4.
5.
6.
7.
Materials code list

Product code list
Batch number
Batch processing documents
Materials test reports
In-process test reports
Finished product test reports

mm-dd-yy
300.30.9
360
300.30.9

SUBJECT: PROCESS CONTROL
Distributed To:
Written by:
Based on:
Checked by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
SOP NO: ISO 4.9

6.3 + 6.4 + 7.1 + 7.5.1 + 7.5.2 +
8.2.3
Revision No.: New
Approved by:
Page 1 of 4
PURPOSE
To describe the process control in accordance with clause 4.9 of ISO 9001
standard and the corresponding clauses of inter national standard
ISO 9001:2000.
RESPONSIBILITY
This is the responsibility of all departmental managers or supervisors
(production) to understand and implement management responsibilities
PROCEDURE
1. The company has determined, provided, and maintained the infrastructure needed to achieve conformity to product requirements.
Infrastructure includes, for example:
Buildings, workspace, and associated utilities
Process equipment, both hardware and software
Supporting services such as transport or communication
2. The company plans and develops the processes needed for product
realization. Planning of product realization is consistent with the
requirements of the other processes of the quality management
system. In planning product realization, the organization determines the following as adequate:
300.30.9
361

Distributed To:
Written by:
Based on:
Checked by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
3.
4.
5.
6.
SOP NO: ISO 4.9

6.3 + 6.4 + 7.1 + 7.5.1 + 7.5.2 +
8.2.3
Revision No.: New
Approved by:
Page 2 of 4

activities specific to fulfill product requirements.
Records needed to provide evidence that the realization processes and resulting product fulfill requirements
The manufacturing operations are carried out under controlled
conditions as follows:
Production planning is made on a monthly basis.
Written procedures are followed for manufacturing.
Manufacturing is performed on suitable equipment.
Calibrated monitoring and measuring devices are available.
The production environment is controlled if necessary, e.g.,
temperature and humidity.
The manufacturing process is controlled using suitable, acceptable quality plans.
Release, delivery, and postdelivery activities are implemented.
The output of planning is maintained in a suitable form.
The organization validates the process for production and service
provision where the resulting output cannot be verified by subsequent monitoring or measurement (for processes where deficiencies become apparent only after the product is in use or the service
has been delivered).
The changes made during processing are suitably identified and
records are maintained. The changes are reviewed, verified, and
revalidated, as appropriate, and approved before further implementation. The review of design and development changes
includes evaluation of the effect of the changes on constituent
parts and the delivered product. Records of the results of the review
of changes and any necessary actions are maintained.
362
300.30.9

Distributed To:
Written by:
Based on:
Checked by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
SOP NO: ISO 4.9

6.3 + 6.4 + 7.1 + 7.5.1 + 7.5.2 +
8.2.3
Revision No.: New
Approved by:
Page 3 of 4
7. The validation of these processes includes, as applicable:

Defined criteria for review and approval of the processes
Approval of equipment and qualifications of personnel
Use of specific methods and procedures
Requirements for records and revalidation
8. The materials are used for process evaluation and records are
maintained.
9. The production manual includes:
Manufacturing direction
Compliance with reference standards (specifications)
Compliance with codes of practice (specifications)
Photographs or representative samples (if applicable)
Sampling procedures
10. The inspection is performed after each work operation that affects
quality, and corrective actions are initiated, as appropriate, to
ensure conformity of the product.
11. Alternatively, several steps are controlled by:
Monitoring process methods
Equipment control
Personnel involvement
12. The inspection methods and controls are corrected whenever their
unsuitability is demonstrated.
13. The special processes that form a part of production or inspection
are controlled.
14. The critical equipment affecting the product quality and process
capability is effectively maintained.
300.30.9
363

Distributed To:
Written by:
Based on:
Checked by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
SOP NO: ISO 4.9

6.3 + 6.4 + 7.1 + 7.5.1 + 7.5.2 +
8.2.3
Revision No.: New
Approved by:
Page 4 of 4
DOCUMENTATION
Production manual.

mm-dd-yy
300.30.10
366
300.30.10

SUBJECT: INSPECTION AND TESTING
Distributed To:
Written by:
Based on:
Checked by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
SOP NO: ISO 4.10

7.1 + 7.4.3 + 7.5.1 + 7.5.3 + 8.1
+ 8.2.4
Revision No.: New
Approved by:
Page 1 of 4
PURPOSE
To describe the inspection and testing in accordance with clause 4.10 of
ISO 9001 and the corresponding clauses of inter national standard
ISO 9001:2000.
RESPONSIBILITY
It is the responsibility of all departmental managers or supervisors (receiving inspection), in-process control, and quality control to understand and
implement management responsibilities described in the procedures. The
SOP compliance.
PROCEDURE
1. The materials received from the vendors are identified, assigned a
unique lot number, and documented.
2. The incoming goods and materials ar e checked against the
purchase order (or original specified requirement). If the company or its customer intends to per form verification at the
supplier premises, the company states the intended verification
arrangements and method of product release in the purchasing
information.
3. The company identifies the product by suitable means throughout
product realization. The product status with respect to monitoring
and measurement is identified. The finished product identification
and traceability are maintained and recorded.
300.30.10
367

Distributed To:
Written by:
Based on:
Checked by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
SOP NO: ISO 4.10

7.1 + 7.4.3 + 7.5.1 + 7.5.3 + 8.1,
8.2.4
Revision No.: New
Approved by:
Page 2 of 4
4. The incoming goods are inspected or tested and recorded against

the approved specifications.
5. The nonconforming goods or materials are marked, segregated,
and subsequently issued against a concession or returned for
replacement.
6. In addition to product realization, the company determines the
following as appropriate to their activities:
activities specific to fulfill product requirements
Records needed to provide evidence that the realization processes
and resulting product fulfill requirements in any suitable form
7. At each workstation, the documented procedures and/or work
instructions are available for in-process inspection.
8. The in-process inspection is carried out according to the approved
statistical sampling plans and acceptance criterias to:
Demonstrate conformity of the product
Ensure conformity of the quality management system and
continually improve the effectiveness of the quality management system
9. The company plans and carries out production and service provision under controlled conditions. Controlled conditions include, as
applicable:
The availability of information that describes the characteristics
of the product
The availability of work instructions
368
300.30.10

Distributed To:
Written by:
Based on:
Checked by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
10.
11.
12.
13.
14.
15.
16.
SOP NO: ISO 4.10

7.1 + 7.4.3 + 7.5.1 + 7.5.3 + 8.1,
8.2.4
Revision No.: New
Approved by:
Page 3 of 4
The use of suitable equipment

The availability and use of monitoring and measuring devices
The implementation of monitoring and measurement and the
implementation of release, delivery, and postdelivery activities
The nonconforming items are suitably identified by labels and
removed from the work area.
The nonconformances are immediately reported to the authority
responsible for their review.
The nonconformances brought about by machine malfunctions or
faulty machinery/test instruments are systematically rechecked,
upon rectification of such malfunctions or faults, and documented.
The control documents include a provision to initiate corrective
action in case of noncompliance.
The finished product is subject to final inspection/test to ensure
that the inspection/test requirements are met (refer to finished
product specifications).
The finished tests include (as relevant):
Procedure qualification tests
Equipment qualification tests
Prototype qualification tests
Proof tests
Commissioning test
Operational tests
The inspections/tests are performed in accordance with written
inspection/test procedures (as relevant):
Incorporate inspection/test requirements
Specify acceptance limits
Specify environmental conditions
The instruments used for inspection and testing are properly
calibrated (if applicable).
300.30.10
369

Distributed To:
Written by:
Based on:
Checked by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
SOP NO: ISO 4.10

7.1 + 7.4.3 + 7.5.1 + 7.5.3 + 8.1,
8.2.4
Revision No.: New
Approved by:
Page 4 of 4
The calibration procedures are based on the manufacturers

manual or made in-house.
The calibration records are maintained. After calibration, the
instruments are labeled to indicate status (calibration performed
on, by, date of calibration, and next calibration due on).
The instruments that are out of calibration are labeled to indicate
their status. The results of the products tested on the instruments
that are out of calibration are reevaluated after the calibration.
17. The documented inspection/test results are evaluated by authorized
personnel prior to the release of the products.
18. The hold points are described in inspection/test procedures and
are verified by an authorized staff if necessary.
19. The inspection/test personnel are either suitably qualified, have
sufficient relevant experience, or are trained to perform the task.
DOCUMENTATION
1.
2.
3.
4.
5.
6.
7.
8.
Production manual
In-process control records
Calibration records (as relevant)
Materials receiving reports
Materials specification manual
Materials nonconforming records
Final inspection records
Equipment manual

mm-dd-yy
300.30.11
372
300.30.11

SUBJECT: INSPECTION, MEASURING, AND TEST
EQUIPMENT
7.6
Distributed To:
Based on:
Written by:
Checked by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
SOP NO: ISO 4.11
Revision No.: New
Approved by:
Page 1 of 3
PURPOSE
To describe the inspection, measuring, and test equipment in accordance
with clause 4.11 of ISO 9001 and the corresponding clause of international
RESPONSIBILITY
It is the responsibility of all departmental managers and supervisors
(maintenance) to understand and implement management responsibilities
PROCEDURE
1. The monitoring and measurement activities and devices needed
to provide evidence of conformity are defined to ensure consistency with the requirements.
2. The measuring and test equipment and test software used for the
verification of product quality are selected based on:
Range
Type
Accuracy
Precision
300.30.11
373

EQUIPMENT
7.6
Distributed To:
Based on:
Written by:
Checked by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
SOP NO: ISO 4.11
Revision No.: New
Approved by:
Page 2 of 3
3. The equipment used for inspection and measurement/test equipment is identified by number or serial number (as necessary).
4. The following instruments affecting the product quality are on a
calibration and maintenance program (location and frequency is
described):
List (as relevant)
5. The initial and periodic calibration is performed against standards
that are traceable to national standards or another defined calibration basis.
6. Records are maintained in order to provide evidence of calibration
and maintenance status.
7. Any equipment that is found to be out of calibration is rectified.
8. In the event that any equipment is found to be out of calibration,
the results of the finished products released prior to that determination are reviewed for disposition.
9. The equipment is:
Adjusted or readjusted as necessary
Identified to enable the calibration status to be determined
Safeguarded from adjustments that would invalidate the measurement result
Protected from damage and deterioration during handling, maintenance, and storage
10. The ability of computer software to satisfy the intended application
is confirmed prior to initial use and reconfirmed as necessary, using
adequate means as appropriate.
374
300.30.11

EQUIPMENT
7.6
Distributed To:
Based on:
Written by:
Checked by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
SOP NO: ISO 4.11
Revision No.: New
Approved by:
Page 3 of 3
DOCUMENATION
1. Equipment preventive maintenance manual/records
2. Equipment calibration manual/records
3. Out of calibration/materials disposition form

mm-dd-yy
300.30.12
376
300.30.12

SUBJECT: INSPECTION AND TEST STATUS
SOP NO: ISO 4.12
7.5.3
Revision No.: New
Distributed To:
Based on:
Written by:
Checked by:
Approved by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 1 of 3
PURPOSE
To describe the inspection and test status in accordance with clause 4.12
of ISO 9001 standard and the corresponding clause of international standard ISO 9001:2000.
RESPONSIBILITY
It is the responsibility of all departmental managers or supervisors (production and shipping) to understand and implement management responsibilities described in the procedure. The ISO systems coordinator
PROCEDURE
1. The company identifies the product by suitable means throughout
product realization using a specific batch number.
2. The product status with respect to monitoring and measurement
is identified using the same batch number.
3. The inspection and test status of the product is identified by using
markings, authorized stamps, tags, labels, routing cards, inspection
records, test software, physical location, or other suitable means
to indicate the conformance or nonconformance of the product
with regard to inspection and tests performed.
4. The identification of the inspection and test status is maintained,
as necessary, throughout the production and installation of the
product to ensure that only product that has passed the required
inspections and tests is dispatched, used, or installed.
300.30.12
377

SOP NO: ISO 4.12
7.5.3
Revision No.: New
Distributed To:
Based on:
Written by:
Checked by:
Approved by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 2 of 3
5. The following measures are used for checking status:

Physical identification marks
Transfer of identification marks
Other methods (as relevant)
6. The markings are clearly applied.
7. When physical identification is not possible, other suitable methods
are used and recorded (provide details).
8. The production or manufacturing documents are maintained as the
product passes through various stages with specific identification,
i.e., batch number.
9. The marking are posted on the finished product to indicate the
positions that affect the function of the item or cause stress in the
material.
10. The manufacturing records identifying the inspections and test
status are maintained with a specific batch number.
11. The nonconforming items are identified by labels with a specific
batch number.
12. The authorized personnel responsible for the application and
removal of status markings are clearly identified.
13. The manufacturing direction is provided with literature indicating
the operating status of structures, systems, and components to
prevent inadvertent operation and mix-up.
14. Before the release system, all inspection and test operations are
ensured to have been satisfactorily completed, and all documentary
evidence is reviewed and completed with product identification
and traceability.
15. The system allows for release of the product by authorized personnel under the cover of a concession with complete identification
and traceability. Authorized personnel may release the products if
the finished product results are satisfactory.
378
300.30.12

SOP NO: ISO 4.12
7.5.3
Revision No.: New
Distributed To:
Based on:
Written by:
Checked by:
Approved by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 3 of 3
DOCUMENTATION
1.
2.
3.
4.
Labeling system manual/records

Production manual/records
Product manual
Quality control manual

mm-dd-yy
300.30.13
380
300.30.13

SUBJECT: CONTROL OF NONCONFORMING
PRODUCT
8.3
Distributed To:
Based on:
Written by:
Checked by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
SOP NO: ISO 4.13
Revision No.: New
Approved by:
Page 1 of 3
PURPOSE
To describe the control of nonconforming product in accordance with
clause 4.13 of ISO 9001 standard and the corresponding clause of international standard ISO 9001:2000.
RESPONSIBILITY
It is the responsibility of all departmental managers or supervisors (production and quality control) to understand and implement management
PROCEDURE
1. The nonconforming products are identified and segregated by
labels to indicate their pending disposition.
2. The organization ensures that product that does not conform to
product requirements is identified and controlled to prevent its
unintended use or delivery. The controls and related responsibilities
and authorities for dealing with nonconforming product are defined
in a documented procedure.
3. The organization deals with nonconforming product in one or
more of the following ways:
By taking action to eliminate the detected nonconformity
By authorizing its use, release, or acceptance under concession
by a relevant authority and, where applicable, by the customer
By taking action to preclude its original intended use or application
300.30.13
381

PRODUCT
8.3
Distributed To:
Based on:
Written by:
Checked by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
SOP NO: ISO 4.13
Revision No.: New
Approved by:
Page 2 of 3
4. All nonconformities have to be dealt with regardless of how

important an impact they may have on the established system. It
is common practice to categorize nonconformities into groups to
enable the speed of reaction to their rectification to be assessed.
5. They are categorized into the following groups:
5.1 Serious: A complete system element (standard requirement)
or a significant part of an element is missing or ineffective.
5.2 Requires attention: A minor lapse within the system has
occurred (the human element), which can quickly be put right.
Several minor lapses of the same content (incorrect issue of documentation in use in several areas) show a system breakdown and
are therefore regarded as serious and upgraded as such.
6. Records of the nature of nonconformities and any subsequent
actions taken, including concessions obtained, are maintained.
7. The products not meeting the specification are indicated to the
relevant personnel or customers in a timely manner.
8. The nonconformance report incorporates recommendations for
remedial action as appropriate.
9. The measures initiated ensure timely response to the nonconformance report by authorized personnel.
10. The agreed remedial actions are promptly implemented.
Rework
Disposal (rejection or release with notification)
11. The documented procedures/quality plans applicable to reworked
products are reviewed and approved by authorized personnel.
12. Adequate records are kept of the actions taken and the quality
compliance of the item upon completion of repair/rework.
13. The reworked items are issued after adequate verification review
and approval.
382
300.30.13

PRODUCT
8.3
Distributed To:
Based on:
Written by:
Checked by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
SOP NO: ISO 4.13
Revision No.: New
Approved by:
Page 3 of 3
14. The as built drawings are kept when necessary or when contractually required.
15. The changes to design requirements arising from nonconformance
follow the original design approval route.
16. Regarding any nonconforming product detected after delivery or
use, the company takes action appropriate to the effects of the
nonconformity.
17. The company strives to continually improve the effectiveness of
the quality management system through the use of the quality
policy, quality objectives, audit results, analysis of data, corrective
and preventive actions, and management review.
DOCUMENTATION
1. Nonconformance reports
2. Corrective action request forms/records
3. Rework disposition records

mm-dd-yy
300.30.14
384
300.30.14

SUBJECT: CORRECTIVE ACTION
SOP NO: ISO 4.14
8.4 + 8.5.1 + 8.5.2 + 8.5.3
Revision No.: New
Distributed To:
Based on:
Written by:
Checked by:
Approved by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 1 of 3
PURPOSE
To describe the elements of corrective action in accordance with clause
4.14 of ISO 9001 and corresponding clauses of international standard
ISO 9001:2000.
RESPONSIBILITY
It is the responsibility of all departmental managers or supervisors (mostly
production and quality control) to understand and implement management
PROCEDURE
1. The organization continually improves the effectiveness of the
quality management system through the use of the quality policy,
quality objectives, audit results, analysis of data, corrective and
preventive actions, and management review
2. The company determines, collects, and analyzes appropriate data to
demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the
quality management system can be made. This includes data generated as a result of monitoring and measurement and from other
relevant sources. The analysis of data provides information relating to:
Conformance to product requirements
300.30.14
385

SOP NO: ISO 4.14
8.4 + 8.5.1 + 8.5.2 + 8.5.3
Revision No.: New
Distributed To:
Based on:
Written by:
Checked by:
Approved by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
3.
4.
5.
6.
7.
Page 2 of 3
Characteristics and trends of processes and products including

opportunities for preventive action
Suppliers
The records of product and system defects are analyzed to identify
and eliminate potential areas of nonconformance. Nonconformance
handling programs are made and followed.
In the event of noncompliance, the effective corrective and preventive actions are established and documented.
The company initiates actions to eliminate the causes of nonconformities in order to prevent recurrence. Corrective actions appropriate to the effects of the nonconformities encountered are taken.
The nonconformity investigations include:
Reviewing nonconformities (including customer complaints)
Determining the causes of nonconformities
Evaluating the need for action to ensure that nonconformities
do not recur
Records of the results of actions taken
Reviewing any corrective actions taken
The noncompliance detected is extended for investigation and
corrective action (as relevant):
Within the process
Within work operation/instructions
Via service reports
Via customer complaints
The major, minor, and critical defectives that may adversely affect
quality are identified and checked.
386
300.30.14

SOP NO: ISO 4.14
8.4 + 8.5.1 + 8.5.2 + 8.5.3
Revision No.: New
Distributed To:
Based on:
Written by:
Checked by:
Approved by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 3 of 3
8. The corrective action causes and resolutions taken are recorded

(as appropriate).
Documented evidence of individual occurrence
Minutes of management meetings
Changes to procedures (reason for revision)
9. The preventive actions are established to prevent recurrence and
are recorded.
Determining potential nonconformities and their causes
Evaluating the need for action to prevent the occurrence of
nonconformities
Records of results of actions taken and reviewing any preventive
actions taken
10. The changes to procedures and other results of preventive actions
are presented at management review meetings.
DOCUMENTATION
1. Nonconformance reports
2. Minutes of management reviews
3. Change control records

mm-dd-yy
300.30.15
388
300.30.15

SUBJECT: HANDLING, STORAGE, PACKAGING,
SOP NO: ISO 4.15
PRESERVATION, AND DELIVERY
7.5.1 + 7.5.5
Revision No.: New
Distributed To:
Based on:
Written by:
Checked by:
Approved by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 1 of 3
PURPOSE
To describe the handling, storage, packaging, and delivery in accordance
with clause 4.15 of ISO 9001 and corresponding clauses of international
RESPONSIBILITY
It is the responsibility of all departmental managers and supervisors
(production, stores, and shipping) to understand and implement management responsibilities described in the procedure. The ISO systems coordinator (management representative) is responsible for SOP compliance.
PROCEDURE
1. The materials received and finished products are kept in a secured
store to prevent damage, deterioration, and loss.
Forklifts are used for transportation within the company (as
relevant).
The storage area is segregated, secured, temperature and humidity controlled, and provided with numbered shelves.
Transport between locations and to the site is carried out in
secured temperature and humidity-controlled trucks (as relevant).
2. The materials lot number or finished product batch number is
clearly identified with shelf number (location) at all times during
handling, storage, and shipping, as appropriate.
300.30.15
389

SOP NO: ISO 4.15
7.5.1 + 7.5.5
Revision No.: New
Distributed To:
Based on:
Written by:
Checked by:
Approved by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 2 of 3
3. The conformity of the product during internal processing and

delivery to the intended destination is ensured. This preservation
includes identification, handling, packaging, storage, and protection
including constituent parts of a product.
4. The production and service provisions are carried out under
controlled conditions. Controlled conditions include, as applicable:
of the product
The implementation of monitoring and measurement, and the
implementation of release, delivery, and postdelivery activities
5. The equipment used for lifting and special handling is inspected,
tested, identified, and recorded.
Records are kept of materials and equipment received.
Storage conditions of materials and equipment are maintained
where special cleanliness or environments are necessary.
6. The environmental conditions inside and outside storage areas and
around equipment are periodically monitored.
7. For transportation, a temperature-controlled national delivery system is used.
8. Alternatively, companies owning temperature-controlled trucks are
also used.
390
300.30.15

SOP NO: ISO 4.15
7.5.1 + 7.5.5
Revision No.: New
Distributed To:
Based on:
Written by:
Checked by:
Approved by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 3 of 3
DOCUMENTATION
1. Materials receiving records
2. Materials status/location records
3. Environmental monitoring records of stores

mm-dd-yy
300.30.16
392
300.30.16

SUBJECT: QUALITY RECORDS
SOP NO: ISO 4.16
4.2.4
Distributed To:
Based on:
Revision No.: New
Written by:
Checked by:
Approved by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 1 of 3
PURPOSE
To describe the quality records in accordance with clause 4.16 of ISO 9001
and the corresponding clause of international standard ISO 9001:2000.
RESPONSIBILITY
It is the responsibility of all departmental managers and supervisors to
PROCEDURE
1. The quality-related records are identified and kept according to
the specified shelf life and disposition procedure established.
Provide a list of quality records with shelf life (as relevant).
2. The quality record may include the following (as appropriate to
the companys operations):
Design records
Design reviews
Procurement records
Commissioning and operation records
Manufacturing records
Inspect and test records
Calibration records
Control procedures
Management reviews
Stability records of products
Material certificates
300.30.16
393

SOP NO: ISO 4.16
4.2.4
Distributed To:
Based on:
Revision No.: New
Written by:
Checked by:
Approved by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
3.
4.
5.
6.
7.
8.
9.
10.
Page 2 of 3
Nonconformance reports and concessions

Corrective actions
Audit plans and records
Quotes, tenders, contracts, and contract review
Purchasing specification
Drawings
Quality plans
The records are traceable with the plant/material to which they
relate.
The records are systematically filed and are readily retrievable.
The records are stored in a segregated and secured room to ensure
there will be no deterioration or loss of records.
The records on computers are subject to:
Periodic backup
Recoverable (backup is placed in a fireproof cabinet away from
the workplace)
The records are handled by authorized personnel to ensure
security and control possible contamination with viruses
Quality records are kept legible, readily identifiable, and retrievable.
The records furnished are consistent with relevant codes, standards,
and regulatory requirements.
The records that are shipped with equipment are suitably protected.
The contractual record requirements are identified and passed to
appropriate organizations.
DOCUMENTATION
1. Quality records list
2. Records retrieval audit reports
3. Computer system verification records
394
300.30.16

SOP NO: ISO 4.16
4.2.4
Distributed To:
Based on:
Revision No.: New
Written by:
Checked by:
Approved by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 3 of 3

mm-dd-yy
300.30.17
396
300.30.17

SUBJECT: INTERNAL QUALITY AUDITS
SOP NO: ISO 4.17
8.2.2 + 8.2.3
Distributed To:
Based on:
Revision No.: New
Written by:
Checked by:
Approved by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 1 of 4
PURPOSE
To describe the internal quality audits in accordance with clause 4.17
of ISO 9001 and corresponding clauses of inter national standard
ISO 9001:2000.
RESPONSIBILITY
SOP compliance.
PROCEDURE
1. The internal audits at planned intervals determine whether the
quality management system conforms to the planned arrangements
of the requirements of this international standard and to the quality
management system requirements established by the organization,
and are effectively implemented and maintained.
2. Follow-up activities include the verification of actions taken and
the reporting of verification results. The organization also applies
suitable methods for monitoring and, where applicable, measurement of the quality management system processes to demonstrate
the ability of the processes to achieve planned results. When
planned results are not achieved, correction and corrective action
are taken, as appropriate, to ensure conformity of the product.
3. The company quality system is audited once every year to:
Demonstrate conformity of the product
Ensure conformity of the quality management system
300.30.17
397

SOP NO: ISO 4.17
8.2.2 + 8.2.3
Distributed To:
Based on:
Revision No.: New
Written by:
Checked by:
Approved by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 2 of 4
Continually improve the effectiveness of the quality management system

Where applicable, statistical techniques are also used.
4. The main requirement of the audit team is to collect objective
evidence throughout the audit task by means of interviews with
the staff, examination of documents, and observation of activities
and conditions at the work or site. The following methods may
be used as a guideline or as appropriate to your companys
operations to achieve the audit aim:
4.1 Seek objective evidence that the system is functioning as
prescribed. Samples taken of the system allow the audit team
to obtain the required evidence.
4.2 Establish absolute proof to substantiate each nonconformity
found; therefore, always seek objective evidence when nonconformity is apparent. The occurrence discovered may be
the effect and not the cause. Objective evidence helps find
the proof of nonconformity.
4.3 Ensure that the responsibility, authority, and interrelationships of all personnel who manage, perform, and verify work
affecting quality are defined.
4.4 Ensure that each requirement (element) of the quality system
is documented to demonstrate that the system covers every
element/requirement and that each one is effective.
4.5 Review procedures and work instructions for completeness,
adequacy, and issue levels against a master list.
4.6 Verify evidence of implementation of procedures and instructions in the work areas. The procedures and instructions are
of required issue (revision), and their distribution is controlled.
4.7 Management, specialist, technician, evident staff, employee,
and operator training and qualification records are evident,
particularly when specialist skills are required, to ensure all
employees are adequately qualified.
398
300.30.17

SOP NO: ISO 4.17
8.2.2 + 8.2.3
Distributed To:
Based on:
Revision No.: New
Written by:
Checked by:
Approved by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
4.8
5.
6.
7.
8.
9.
10.
Page 3 of 4
Corrective actions undertaken to clear any previous nonconformities are followed up.
4.9 Work, which has been accepted, is selected at random and
examined, and the findings are compared with the appropriate requirements, basis for acceptance, and applicable
issue status.
4.10 Where processes are involved, the audit team should examine
process controls and records to establish conformance with
the specification.
4.11 Information gathered during interviews is checked by acquiring the same information from other independent sources
and checking the samples against each other for accuracy.
Throughout the entire audit, all the evidence collected in the form
of observations should be documented on the checklist. This
evidence is then examined to determine if there are any nonconformities that need to be reported.
An audit program is planned, taking into consideration the status
and importance of the processes and areas to be audited, as well
as the results of previous audits. The audit criteria, scope, frequency, and methods are defined. The standard operating procedures are also audited according to the plan.
Selection of auditors and conduct of audits ensures objectivity
and impartiality of the audit process. Auditors do not audit
their own work.
The responsibilities and requirements for planning and conducting
audits and for reporting results and maintaining records are defined
in a documented procedure.
The audits are conducted according to the checklist. The audit program includes time frame, area, and concerned responsible parties.
The findings of the audit are reported, and any noncompliance
found is attached to the report to initiate corrective actions and
preventive measures.
300.30.17
399

SOP NO: ISO 4.17
8.2.2 + 8.2.3
Distributed To:
Based on:
Revision No.: New
Written by:
Checked by:
Approved by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 4 of 4
11. The follow-up audit is made to close the audit findings.

12. The general audit of the housekeeping is performed every six
months. The findings are documented and the responsible parties
are informed to initiate corrective actions.
13. The audit performed is reviewed with senior management/involved parties.
14. Recommendations are made for the resolution of problems and
follow-up actions are delegated.
15. The corrective actions are closed out.
16. The results of audits are discussed during a management review
meeting.
17. The management responsible for the area being audited ensures
that actions are taken without undue delay to eliminate detected
nonconformities and their causes.
DOCUMENTATION
1. SOPs audit records
2. Corrective action reports
3. Management review records

mm-dd-yy
300.30.18
402
300.30.18

SUBJECT: TRAINING
SOP NO: ISO 4.18
6.2.1 + 6.2.2
Revision No.: New
Distributed To:
Based on:
Written by:
Checked by:
Approved by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 1 of 2
PURPOSE
To describe the training in accordance with clause 4.18 of ISO 9001 and
corresponding clauses of international standard ISO 9001:2000.
RESPONSIBILITY
SOP compliance.
PROCEDURE
1. All personnel are adequately trained for the functions they perform.
Personnel performing work affecting product quality are competent
on the basis of appropriate education, training, skills, and experience.
2. The training needs are effectively identified for personnel performing work affecting product quality.
Qualification
Previous experience
Training to be provided by the equipment supplier or in-house
senior staff
Procedure reading is part of the training records
3. The required level of qualification and experience is defined for
each quality-related job in the personnel qualification file.
4. The in-house training program is made every year and followed.
300.30.18
403

SUBJECT: TRAINING
SOP NO: ISO 4.18
6.2.1 + 6.2.2
Revision No.: New
Distributed To:
Based on:
Written by:
Checked by:
Approved by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 2 of 2
5. The employees are sent for outside training (if necessary or as

needed).
6. The training program ensures to:
Provide training or take other action to satisfy these needs
Evaluate the effectiveness of the action taken
Ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, and maintain appropriate records
of education, training, skills, and experience
7. The training and experience records are archived systematically
and are retrievable.
DOCUMENTATION
1. Personnel qualification file
2. Employee training record
3. Annual training program

mm-dd-yy
300.30.19
406
300.30.19

SUBJECT: SERVICING
SOP NO: ISO 4.19
7.5.1 + 7.1
Revision No.: New
Distributed To:
Based on:
Written by:
Checked by:
Approved by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 1 of 2
PURPOSE
To describe the servicing in accordance with clause 4.19 of ISO 9001 and
the corresponding clauses of international standard ISO 9001:2000.
RESPONSIBILITY
It is the responsibility of all departmental managers and supervisors to
PROCEDURE
1. The safety aspects of the product or service quality are identified.
2. For each product, the safety standards are identified and service
provisions are made under controlled conditions. Controlled conditions include, as applicable:
of the product
The implementation of monitoring and measurement and the
implementation of release, delivery, and postdelivery activities.
3. The products are subject to safety testing as per in-house procedure
(refer to the relevant procedure).
300.30.19
407

SUBJECT: SERVICING
SOP NO: ISO 4.19
7.5.1 + 7.1
Revision No.: New
Distributed To:
Based on:
Written by:
Checked by:
Approved by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 2 of 2
4. Safety warnings are issued to the customer.

Labeling the product
Within promotional literature
Within maintenance or operations manuals
5. The products found to be unsafe in use are investigated by an
authorized person.
6. The products are traceable by batch number and can be recalled.
7. The services provided are documented (refer to the servicing
manual).
8. The service records are maintained.
9. The servicing requirements are clearly defined, reviewed, and
approved by authorized personnel to ensure they have been conducted successfully.
10. The company plans and develops processes needed for product
realization as appropriate to ensure customer satisfaction.
Quality objectives
Resources and documents required for each specific product
Validation, verification, monitoring, inspection, and test activities
critical for product characteristics.
Documented records (for details, refer to SOP ISO-4.4).
DOCUMENTATION
Servicing manual/records.

mm-dd-yy
300.30.20
410
300.30.20

SUBJECT: STATISTICAL TECHNIQUES
SOP NO: ISO 4.20
8.1 + 8.2.3 + 8.4 + 8.2.4
Revision No.: New
Distributed To:
Based on:
Written by:
Checked by:
Approved by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 1 of 2
PURPOSE
To describe the elements of statistical technique in accordance with clause
4.20 of ISO 9001 and the corresponding clauses of international standard
ISO 9001:2000.
RESPONSIBILITY
It is the responsibility of all departmental managers or supervisors (production and in-process control) to understand and implement management
PROCEDURE
1. The statistical analysis is performed to:
Demonstrate the conformity of the product
Ensure conformity of the quality management system
Continually improve the effectiveness of the quality management system
2. Suitable statistical techniques are used to demonstrate the ability
of the process to achieve planned results. When planned results
are not achieved, correction and corrective actions are taken, as
appropriate, to ensure conformity of the product.
3. The statistical analysis provides information relating to:
Conformance to product requirements
Characteristics and trends of processes and products including
opportunities for preventive action and suppliers
300.30.20
411

SUBJECT: STATISTICAL TECHNIQUES
SOP NO: ISO 4.20
8.1 + 8.2.3 + 8.4 + 8.2.4
Revision No.: New
Distributed To:
Based on:
Written by:
Checked by:
Approved by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 2 of 2
4. The areas where statistical techniques are employed are:

Raw material sampling
Market analysis
Product design, including experiment analysis
Reliability and life testing
In-process control and finished product testing
5. For in-process control and determination of quality levels, inspection
plans and quality control charts are used (as relevant). For sampling
plans and acceptance criteria, Military Standard 105E is used.
6. The statistical analysis performed during the in-process control and
finished product test is verified by other authorized personnel prior
to release.
7. Product performance assessment is carried out using suitable statistical techniques as applicable.
8. The company collects and analyzes data to demonstrate the suitability
and effectiveness of the system on a continuous basis to ensure:
Effective internal and external communication
Product meets the customer and regulatory requirements
DOCUMENTATION
1. In-process control manual/statistical analysis records
2. Statistical sampling plans
3. Product assessment records

mm-dd-yy
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Minimum Video: 640480 256 color display
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INSTALLATION INSTRUCTION:
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2. Using My Computer or Windows Explorer, locate the letter that
designates the CD-ROM drive.
3. Double-click on the CD-ROM drive icon and select the folder of
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NOTE:
This product requires that Microsoft Word 97 or higher be

installed on your computer.
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CRC Press LLC warrants the physical disk(s) enclosed herein to be free of defects in materials
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CRC Press LLC specifically disclaims all other warranties, express or implied, including but not
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ISO 9001:2000

A COMPLETE GUIDE and CD-ROM

St. Lucie Press

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Library of Congress Cataloging-in-Publication Data

Visit the CRC Press Web site at www.crcpress.com

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ABOUT THE MANUAL

QUALITY SYSTEMS MANUALS

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ISO 9001:2000 Document Development Compliance Manual

Model-3: Quality Manual ISO 9001:2000

STANDARD OPERATING PROCEDURES

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What is Quality? ................................................................... 8

Standard Operating Procedures

Management Responsibility............................................. 308

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ISO 9001:2000 Document Development Compliance Manual

Servicing ........................................................................... 406

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ISO 9001:2000 Document Development Compliance Manual

company in possession of ISO 9001 registration/certification that

QUALITY MANUAL FORMAT

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Section, Clause: Each page of the quality manual has a box to

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ISO 9001:2000 Document Development Compliance Manual

Date Supersedes: Each page of the SOP is assigned a space to

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ISO 9001:2000 Document Development Compliance Manual

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ISO 9001:2000 Document Development Compliance Manual

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ISO 9001:2000 Document Development Compliance Manual

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ISO 9001:2000 Document Development Compliance Manual

registration/certification who intend to revise their quality manual and

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ISO 9001:2000 Document Development Compliance Manual

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ISO 9001:2000 Document Development Compliance Manual

Supply products within delivery time scales agreed upon/required

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CORRESPONDENCE BETWEEN ISO 9001:1994

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ISO 9001:2000 Document Development Compliance Manual

Final product inspection and testing (module E)

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