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AWARENESS PROGRAMME ON ISO 9001

What is Quality ?

Fitness for purpose.

Product reliability
Products conformance to specifications
ISO Definition:
Totality of characteristics of an entity that bears on the capability to satisfy the stated
or/and implied needs

What is ISO?

ISO is an international organization which deals with standardization it called as

"International Organization for Standardization

What is ISO 900?

The ISO 9000 is family of standards; the exact same standard across the globe even though
they are called by different names. Each member country has their own entity authorized by ISO
to manage the standards, but they are all the same exact ISO 9000 quality documents and set
of requirements.

INDIA IS/ISO 9001:2008 (Bureau of Indian Standards)

Australia - AS/NZS ISO 9001:2008 (Standards Australia)

United States - ANSI ISO 9001:2008 (American National Standards Institute)

United Kingdom - BSI ISO 9001:2008 (British Standards Institution)

The ISO 9000 series of quality - related documents was created by the International
Organization for Standardization (ISO) as international requirements for quality management
systems. Now that ISO 9000 is in more than 178 countries with over one million registrations it
is common in the business world.
The ISO 9000 standards are a set of international quality management system standards and
guidelines. The term ISO9000 refers to a group of quality management standards which are
process standards (not product standards). They were originally introduced as ISO 9000:1987.
People often say "ISO 9000 certified", but what they mean is they have met the requirements
of the ISO 9001 standard.
The ISO 9000 series is not industry specific and is applicable to any manufacturing or service
organization. It is managed by Technical Committee (TC) 176, comprised of international
members from many industries and backgrounds.
What is ISO 9001?
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ISO 9001:2008 is part of the ISO 9000 family of standards, and is the
document that lists the requirements an organization must meet to become ISO 9001
Registered.

ISO9001 is an internationally recognized Quality Management System.

ISO
9001 does NOT define the actual quality of your product or service. The standard helps you
achieve consistent results and continually improve the process. Thus, if you can make a good
product most of the time, this helps you make it all of the time. It's just a series of good, basic
business practice.
What is Quality Management System?
Quality Management System is set of policies-processes and procedures required for planning
and execution(product development-services) in the core business area of the organization i.e.
the areas that can impact the organizations ability to meet customers requirements). ISO
9001:2008 is an example of Quality Management System.
A complete ISO 9001 Quality Management System MUST address all therequirements of
ISO9001 and more specifically must meet the ISO 9001 DOCUMENTATION REQUIREMENTS.
What is a CORE BUSINESS PROCESS?

What is PROCESS APPROACH?

ISO 9001 uses a process oriented approach. ISO 9001:2008 examines about 21 processes in its
scope.Quality Management System as a whole is a process. In a process there are inputs- on which
some actions are done which converts inputs to out put.
Operation
performed

inputs

Out
puts

A Process
A Process approach enables the organization to meet the customer requirements and deliver
goods / services under continual improvement
What is a document ?
A document is written communiqu to transmit the information. Thus Communication of Information : as a
tool for information transmission and communication. The type and extent of the documentation will depend on
the nature of the organizations products and processes, the degree of formality of communication systems
and the level of communication skills within the organization, and the organizational culture.
b) Evidence of conformity : provision of evidence that what was planned, has actually been done.
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c) Knowledge sharing :- to disseminate and preserve the organizations experiences. A typical example would
be a technical specification, which can be used as a base for design and development of a new product.

What documentation is required for ISO 9001 Quality Management System?

ISO 9001:2008 Documentation Requirements
ISO 9001:2008 clause 4.1 General requirements requires an organization to establish, document, implement,
and maintain a quality management system and continually improve its effectiveness in accordance with the
requirements of this International Standard Clause 4.2.1 General explains that the quality management
system documentation shall include:
a) documented statements of a Quality Policy and Quality Objectives;
b) a Quality Manual
c) Documented Procedures (MANDATORY) required by this International Standard
d) Documents Needed By The Organization To Ensure The Effective Planning, Operation And
Control Of Its Processes, and
e) records required by this International Standard;
The notes after Clause 4.2 make it clear that where the standard specifically requires a documented
procedure, the procedure has to be established, documented, implemented and maintained. It also
emphasizes that the extent of the QMS documentation may differ from one organization to another due to:
the size of organization and type of activities;
the complexity of processes and their interactions, and
the competence of personnel.
All the documents that form part of the QMS have to be controlled in accordance with clause 4.2.3 of ISO
9001:2008, or, for the particular case of records, according to clause 4.2.4.

What is Quality Manual ?

Quality Manual is first level of documentation in Quality Management System.

What is to be given Quality Manual ?

A good Quality Manual must have:
a)
b)
c)
d)
e)
f)

Description on scope of QMS

Explains the applicable requirements of ISO 9001
Explanation of exclusion clauses
Reference of quality procedures & related records
Flow charts of series & interactions of processes.
Quality Poloicy & Quality Objectives

What is the use of Quality Manual ?

a) Conveys the managements expectations for quality from organization.
b) Reveals organizations conformity to ISO9001 requirements.
c) Serves as a measure for managenets expectations for
a. IQA
b. TCA
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c. CUSTOMERS AUDITS
a)

QUALITY POLICY & QUALITY OBJECTIVES

b) FORMS FORMATES & RECORDS

Quality Policy
It is a brief statement or document that gives the information of organization top managements
intentions about quality and sets out or defines the quality objectives of the organization. It shows the
commitment of the top management to meet them and continually improve them. It shoul provide an
out line for creating-stating and measuring the performance w.r.t. the stated quality objectives
Quality Objectives
Quality Objectives are measurable steps to achieve your quality policy. They are either determined
as you create your QMS or in the Management review meetings.
It is the best way to ask yourself what will you do to the goal stated in the quality policy.
The quality objectives should be SMART
Procedures/ Work Instructions/forms & Formats
Procedure gives the way how to do a process and a process may be a single activity or a set of
activities. Procedure gives the way to handle processes. A procedure is documented and control.
ISO requires mini mum six mandatory procedure. Others are optional and are about 21-23
depending on the activities of the organization.
A procedure and WI are almost one and the same thing.

The Wheel of time is ever moving. Changes in all sphere of life are inevitable. Management concepts
are also changing with time.
Under the integrative school of Quality Management thought, some new concepts have emerged
which are more innovative in character. These are Total Quality Management (TQM), Business
Process Reengineering (BPR). Total Productive Maintenance (TPM), Learning Organizations
Concept (LOC), 6 Sigma Quality and World Class Excellence (WCE) Services. It can be mentioned
here that all school of management were relevant in their time. During this phase of economic
changes where mergers / take overs / amalgamations / satellite organizations, sub contracted
manufacturing and consortium etc. are the order of the day, organizations have to be in a state of Total
Fitness of Quality, Productivity and speedy of response and delivery and efficient working and result
oriented.
The fast changing environments with globalization is driving the Indian economy to match the quality
and cost to international competition; at this juncture Indian organizations have to gear up themselves
to think globally and act locally with efficiency.

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In order to achieve this; a shift in management perspective is required from small q (product quality)
to big Q (total quality) consistently, which is achievable by ISO 9000 Quality Management System
(QMS).
ISO 9000 Quality Management Systems provides the foundation on which organizations can build
their Total Quality Organization of World Class Model.
REVISED ISO 9000 STANDARDS
ISO 9000 Series of Quality Management System standards were developed by the International
Organization for Standardization (ISO) based in Geneva, Switzerland. These standards were evolved
by consensus with the participation of more than 164 countries including India, in the year 1987.
These were revised in 1994,2000 and 2008 ISO 9000 standards series include the following:
ISO 9000: 2005 Concepts and Terminology
ISO 9001:2008 Quality Management Systems Requirements
ISO 9004: 2009 Quality Management Systems : Guidelines for performance Improvements and
sustained success.
ISO 9000 standards are generic in nature applicable to all types and all sizes of organizations and
sectors. More than hundred only countries have adopted these systems in industry and services.
ISO 9001 : 2008 SCOPE
ISO 9001 standard specifies requirements for Quality Management System where an organization:

Needs to demonstrate its ability to consistently provide product that meets customers and
applicable regulatory requirements.
Aims to enhance customer satisfaction through the effective application of the system,
including processes for continual improvement of the system and assurance of conformity to
customer and applicable regulatory and statutory requirements.

ISO 9001: 2008 KEY ISSUES

Demonstrated commitment and leadership by top management

Customer satisfaction
Process Approach
Measurable Performance
Prevention rather than Correction.
Continual Improvement
Compliance to statutory & regulatory requirements.

QUALITY MANAGEMENT PRINCIPLES

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Eight quality management principles from the basis for the quality management system standard
within the ISO 9000 family. These are:
1. Customers focus
Organization depends on their customers and therefore should understand current and future customer
needs, should meet customer requirements and strive to exceed customer expectations.
2. Leadership
Leaders establish unity of purpose and direction of the organization. They should create and maintain
the internal environment in which people can become fully involved in achieving the organizations
objectives.
3. Involvement of people
People at all levels are the essence of an organization and their full involvement enables their ability
to be used for the organizations benefit.

4. Process approach
A desired result is achieved more efficiency when activities and related resources are managed as a
process. ISO 9001 uses a process oriented approach. ISO 9001:2008 examines about 21 processes
in its scope.Quality Management System as a whole is a process. In a process there are inputs- on
which some actions are done which converts inputs to out put.

inputs

Operation
performed

Out
puts

A Process
A Process approach enables the organization to meet the customer requirements and deliver
goods / services under continual improvement

5. System approach to management

Identifying, understanding and managing interrelated processes as a system contributes to the
organizations effectiveness and efficiency in achieving its objectives
6. Continual improvement

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Continual improvement of the organizations overall performance should be a permanent objective of
the organization.
7. Factual approach to decision making
Effective decisions are based on the analysis of data and information.
8. Mutually benefits supplier relationships
An organizer and its supplier are interdependent and a mutually beneficial relationship enhances the
ability of both to create value.
These principles shall be explained in subsequent relevant sections.

ISO- 9000 QUALITY MANAGEMENT SYSTEM ADVANTAGES

1. A systemic environment for management of processes.
2. Consistency in working.
3. Measurability of performance
4. Customer focus and increased customer satisfaction.
5. Built in mechanism for management control leading to improved organizational efficiency
improvement
6. Focus on continual improvement
7. Proactive approach
8. Empowerment, training and motivation of all employees.
9. International recognition and credibility providing a clear marketing edge over competitors.

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DOCUMENTATION
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WORKSHOP

QUALITY MANAGEMENT SYSTEM DOCUMENTATION

A Variety of documents are normally used by organizations to describe the working system and its
control covering its various operations, in particular covering quality related matters. These may
normally include operational manuals, standard operating procedures (SOP), Quality Assurance
Planes (QAP), Check Sheets etc.
ISO 9001:2008 standards is quite flexible as far as documentation requirements are concerned and it
is dependent on the nature of the organization, products and services, the skills and experience of the
workforce and needs of the customer. Documented systems may be paper based or electronic based.
Documentation Required as per ISO 9001:2008
Documentation required to be developed as per ISO 9001:2008 includes :

Quality Policy and Quality Objectives

Quality Manual

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Procedures ( 6 Mandatory Procedures)

Documents as needs by the organization to ensure the effective planning, operation and control
of its processes
Records as specified
Benefits of a Documented Quality System
-

Document instructions avoid misunderstandings and enable consistency of activities to be

maintained.
Documentation is an important part in effective planning and review.
It is essential in communicating and standardizing operations across departments and areas of
the organization.
Assist in training.
Used as evidence of conformity to requirements.
Can be used to assist audits.
Can be used to enable improvement to be implemented.
Can be used to demonstrate the process controls to customers.
Give reassurance to management of the control of processes.
Can be used to identify opportunities for improvement.
Can be used to define responsibilities

Quality Policy
Quality Policy provided the overall philosophy, intentions and directions of the top management as
regards quality. The standard requires that the policy:
-

Is appropriate to the purpose of the organization.

Includes a commitment to comply with requirements and to continual improvement of the
system.
Provides a framework for established and reviewing quality objectives.
Is communicated and understood within the organization.
Is reviewed for continuing suitability.

Quality Objectives
Quality Objectives are framed, based on Quality Policy to deploy the various elements of the policy.
The standard requires that the quality objectives are:
-

Established at relevant functions and levels within the organization.

Consistent with the quality policy.
Capable of being measured.
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The quality objectives shall include those needed to meet requirements for product.
Quality Manual
A manual is the normal means of mapping out the system and pointing the way to the user to find the
procedures that describe the way that the operations of the company are controlled and is a
requirements of the ISO 9001 : 200 standard. The standard under clause 4.2.2. requires that
A quality manual shall be established and maintained that includes the following- The scope of the quality management system, including details of, and justification for, any
exclusions.
- Documented procedures or reference to them,
- A description of the interaction between the processes of the quality management system.
A note for guidance state that the manual may be only a part of the organizations documentation.
Remembering that documentation may be in the form of flowcharts, electronic form or any other
media.
Procedures
Procedure is the written document explaining how a particular activity to be performed. As per

ISO9001:2008; there are six areas of Quality Management System of an organization for which
documented procedures are mandatory:
-

Document Control
Record Control
Internal Quality Audits
Control of Non-conforming Products
Corrective Actions
Preventive Actions

In addition to these, procedures can be developed and it is customary to develop, describing various
QMS activities. QMS procedures are normally the core of documentation used for the control of the
activities of the organization. They should described the responsibilities, authorities and
interrelationship of personnel involved, the forms to be used and the controls and performance criteria
to be applied. Each documented procedure should cover a logically separable part of the QMS.
The quality of procedures, the volume of each and nature of content, format, style of writing and
presentation should be determined by the organization to suit its purpose. Consistency of format
structure and style leads to users becoming familiar with the documents and makes them easier to use
and so increase the likelihood of systematic compliance with requirements.
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Documents as needed by the organization to ensure the effective planning, operation and
control of its processes
ISO 9001:2008 requires that the processes are identified and the sequence and interaction of
processes is planned. These may be supported by the criteria and methods usually in the form of
detailed instructions that describe the steps of the task to the person who would perform the task.
These are supported by the systems to measure, monitor and analyse these processes and implement
the actions necessary to achieve planned results and continual improvement. The extent and nature of
the process documentation and records should be appropriate to that organization.
These can be in various forms. The most common documents for this purpose are:
-

Procedures/ Procedure Manual (Textual, Tabular or flow charts)

Quality Planes
Work Instruction
Internal Circulars
Drawings (if applicable)
Check Sheets / Check Lists

Where the workforce is trained and qualified such as in a Hospital, the procedures may be few but
records many. In a manufacturing situation the procedures and instructions will be many.

The documentation should include the procedure required by the standard and be sufficient to ensure
the effective operation and control of its processes. It may be in any media.- i.e. hard copy soft copy
Flow charts etc.
Quality Plans
Documents that describe how the QMS is applied to a specific product, project or contract often
referred to as quality plans.
Work Instructions
Work Instructions provide instructions specific to a work station. These are normally used to
supplement a procedure.
Records
Records provide evidence of carrying out an activity or achieving a result. A number of such records
are mandated by the standard. Other will be developed by the organization based on complexity and
requirements of its processes.
Hierarchy of Documents
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There should be clear links between the levels of manual, procedures, working instructions and
records and clear links from the policy to the objectives and the means by which the objectives are
achieved. Normally the hierarchy of documents is as given below:
Quality Manual
Quality Procedures / Plans
Work Instructions, Guidelines,
Check Sheets, Specifications etc
Records Formats

Apex Level Document

Second Level Documents
Third Level Documents
Fourth Level Documents

This is explained by the following Documentation Triangle:

QUALITY MANUAL
PROCEDURE AND QUALITY PLANS
WORK INSTRUCTIONS, GUIDELINES ETC
RECORDS
The documentation can add value by clearly identifying requirements of the customer and other
interested parties enabling the communication of these needs to all concerned with meeting them.
They can provide an aid to the provision of training enabling repeatability and traceability of
activities, products and materials. They can provide evidence of control and can enable evaluation of
the effectiveness of the system. They can be used to demonstrate conformance to requirements.
Each organization can choose the extent of its documentation and the form or media to be used.
However a quality manual, quality policy, quality objectives and 6 procedures are required by the
standard. The documentation will be dependent on the size and type of organization, the complexity
of the products, customer requirements, applicable regulatory requirements, the ability of personnel
and the extent with which it is necessary to demonstrate fulfillment of requirements.

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