To create a basic awareness about Quality Management System

(QMS) based on ISO 9001:2008 standard.

Content:
Introduction
Definitions
Benefits of ISO 9001
Overview of ISO 9001:2008 Clause
What is ISO ?
Stands for, International Organization for Standardization (ISO)
Founded in 1947
Independent, non-governmental organization
Made up of member from the National Standard bodies of 163 countries
and 3368 technical bodies.
Central Secretariat in Geneva, Switzerland
Published over 19, 500 international standards covering almost all aspects
of Technology and Business
NAME
The International Organization for Standardization (ISO) would
have different acronyms in different Language (IOS in English,
OIN in French for Organization Internationale de Normalisation)
Decided to give it short form ISO
ISO is derived from the Greek word ISOS meaning Equal

ISO 9000:2005 QMS Fundamental and Vocabulary
ISO 9001:2008 QMS Requirements (For Certification)
ISO 9004:2009 Guideline (Beyond ISO 9001)
ISO 19011:20011 For Auditing (Internal and External Audits)
Family of related international standards and guidelines on Quality
Management and Quality assurance.
First published in 1987 (and continually updated) by the ISO
Standards are not specific to any industry or product.
This is a comprehensive set of standards and guideline for Quality
Management Systems.
ISO 9000 series of standards are developed by Technical
Committee ISO/TC 176, Quality management and quality
assurance.
It is System-Based not Product Based.
This is a distillation of Quality System that have been tried and
proven by the industry.

Amount of money, time and paperwork required.
Poor process selection and/or poor technical solutions might
result in poor quality performance. (Garbage in and Garbage
Out).
Having concept that we just need to satisfy the Auditor.
Prone to failure when a company is interested in certification
before Quality.
Mislead companies into thinking that certification means better
Quality.



Organization
Certification Bodies / Registrar
Bureau Veritas, BSI Global, URS
National Accreditation Bodies (NAB)
UKAS( UK), ANAB(USA), JAS-ANZ (Australia)
International Accreditation Forum (IAF)
Certification is known in some countries as
registration.
It means that an independent, external body has
audited an organization's management system and
verified that it conforms to the requirements specified
in the standard (ISO 9001).
ISO does not carry out certification and does not issue
or approve certificates,
Certification bodies themselves operate under another
quality standard, ISO/IEC 17021
Accreditation is like certification of the certification body.
It means the formal approval by a specialized body - an
accreditation body - that a certification body is competent to
carry out ISO 9001:2008 certification in specified business
sectors.
Certificates issued by accredited certification bodies - and
known as accredited certificates - may be perceived on
the market as having increased credibility.
ISO does not carry out or approve accreditation.
Accreditation bodies operate under ISO/IEC 17011.
A common sense way
of ORGANIZING &
MANAGING THE
BUSINESS
PROCESSES that
affect the quality of our
products and services

We gain a common understanding of how the important things get
done
We have a chance to capture our Best Practices
Our Internal audit system ensures we stay on track
Our Corrective Action system helps to fix problems
Continual Improvement becomes a way of life
A Quality Management System keeps us from moving backwards
and losing important knowledge that we gain over time
Changes are controlled

Documented QMS
MARKET PRESSURE
Tangible proof that the quality management system established
by our organization meets the requirements of and internationally
recognized standard.
Provide marketing edge over competitors
It enhanced customers satisfaction an loyalty; because it is
assured that their requirements are met.
Increased competitiveness and profitability as quality products
are being delivered and operational cost are reduced.
Once our system is developed and documented , all members of
the organization should follow the procedures or rules and make
improvements to the system.
Document our work procedures / systems
What we do
Who does do it
When we do it
How we do it
Ensure that the procedures are being followed in actual
PRACTICE.
Keep RECORDS, minutes of what you practice

Everyone is welcome!
Improve your process
Measure performance (see your procedure)
Look for ways to improve efficiencies
Look for ways to prevent errors
Suggest changes to procedures and
work instructions
Help finding solutions to problems
written in Corrective Action Requests
and Preventive Action Requests

Say what youll do!
Do what you say!
(Disciplined Use of System)
Prove It!
Improve It!
Everyone!
Everywhere!
Every Time!
The Spirit of the QMS Way
Do What You Say!!!!!
Follow the established system (documented information)
Ask for clarification if confusing
Help other people to understand the system
Improve your job, your process, the system!
What Do You Do If a Process Is Wrong?
Stop
Get the process changed
Participate in Quality Improvement Opportunities

The degree to which a set
of inherent characteristic
fulfills requirements.
Fitness for the Purpose
Conformance to Requirements
Customer Satisfaction
All activities of overall Management function
that determine Quality Policy, Objectives &
Responsibility, & Implement them by means
of Quality Planning, Quality Control, Quality
Assurance & Quality Improvement.
A common sense way of
ORGANIZING & MANAGING
THE BUSINESS PROCESSES
that affect the quality of our
products and services
Quality Assurance
Quality Assurance is a set of
activities intended to
establish confidence that
quality requirements will be
met.
Quality in Process
Proactive in nature
Example: Process checklists,
Audits, Methodology etc.
Quality Control
Quality control is a set of
activities intended to ensure
that quality requirements are
actually being met.
Quality in Product
Reactive in Nature
Example: Inspection, Testing
Process etc.
Quality Management System Uses both Quality Assurance and Quality Control
8 Principle of Quality Management
Organizations depend on their Customers
and therefore should:

Understand current and future customer
Needs;
Meet customer Requirements and
Strive to exceed customer Expectations.
Leaders should:

Establish unity of purpose and Direction
of the organization &
Create and maintain the internal
environment in which people can become
fully Involved in achieving the
organizations objectives.
People at all levels are the essence of an
organization and
Their full involvement enables their
abilities to be used for the organizations
benefit.
Organizations need to do more than simply
monitor process outputs (typically through
inspection activities):
They must also control all process inputs, (people,
facilities, equipment, material & methods) &
They must establish appropriate controls over the
transformation activities (if desired results are to
be achieved consistently and efficiently).
Process
The Steps You Do to
Accomplish
Something
Output
Supplier Customer
Input
A Simple Process Model
- Activity that transforms Input into Output
Resources:
People
Facilities/Equipment
Material
Methods
Result:
Product
Services
Performance

Your
Process
Act
Do Plan
Check

Continual
Improvement
The Plan-do-Check-Act (PDCA) methodology applies to all processes
Deploy and conform with plan
Activities
Controls
Documentation
Resources
Objectives
Analyze/review
Decide/change
Improve effectiveness
Measure and
monitor for conformity
and effectiveness
Organizations must understand a system is a
set of interrelated processes, and the output of
one process is the input to one or more
subsequent processes, so ...
It is critical to manage the white space (or
interface) between processes to ensure that
the overall system is effective
Quality
Management
System is a key
part of the entire
business system
Asset-creating
Processes
Finance
Acquisition
IT, Facilities,
Equipment
HR
Customers
Business
Processes
Core Processes
(create customer value)
Support Processes
Maintenance
Manage Information
HR Maintenance
Financial Transactions

Environmental Management
Manage External Relations
Manage Performance
Manage Improvement & Change

Business System
Sales
Process
Design
Process
Purchasing
Process
Receiving
Process
Delivery
Process
Production
Process
Process Combined to Make a System
Process A
Process C
Input A
O
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p
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t

A

C
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l

Output A
C
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Output C
C
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Process B Output B
Input B
Input C
Continual improvement of
the organizations overall
performance should be a
permanent objective;
Improvement must be a
planned activity if the
organization desires to
improve overall
performance and
capabilities.
Effective decisions are:

Based on the analysis of data and
information.
An organization and its suppliers are
truly inter-dependent and
A mutually beneficial relationship
enhances the ability of both to create
value.
4. Quality
Management
System
6. Resource
Management
7.Product
Realization
8. Measurement
Analysis &
Improvement
5. Management
Responsibility
General
Requirement
Documentation
Requirement
Management
Commitment
Customer Focus
Quality Policy
Planning
Responsibility,
Authority &
Communication
Provision of
Resources
Human
Resources
Infrastructure
Work
Environment
Planning
Customer Related
Processes
Design and
Development
Purchasing
Production and
Service Provision
General
Monitoring and
Measurement
Control of NCP
Analysis of Data
Improvements
Management
Review
Control of Measuring
and Monitoring
Equipment
Thank you
1.1 General
Applicable, where an organization:
Needs to demonstrate its ability to provide product that meets customer
and applicable statutory and regulatory requirements, and
Aims to enhance customer satisfaction through the effective application
of the system, including processes for continual improvement of the
system and the assurance of conformity to the customer and applicable
regulatory requirements.



1.2 Application
Tailoring permitted subject to following condition: Exclusions
should not affect the organizations ability or responsibility, to
provide product that fulfills customer and applicable regulatory
requirements
Exclusions permitted only in clause 7.



ISO 9000 : Quality management system - Fundamentals
and Vocabulary


Terms and definitions given in ISO 9000 shall apply
Product also means service


4.1. General Requirement
Establish, document, implement and maintain quality
management system and
Continually improve the effectiveness of the quality
management system.

4.1. General Requirement
The organization shall:
a) Identify the processes (Include processes related clause 5,
6, 7 and 8, consider clause 1.2)
b) Determine the sequence and their interaction
c) Determine criteria and methods required to ensure that both
operation and control of these processes are effective.

4.1. General Requirement
The organization shall:
d) Ensure availability of resources and information to
support their operation and monitoring
e) Monitor, measure and analyze these processes
f) Implement actions necessary to achieve planned
results and continual improvement

Identify and ensure control over outsourced processes affecting
product conformity, within Quality Management System

(In 2008 two notes are added to clarify outsourcing)
DFC 4.1 Description of Interaction of Key QMS Processes
Top Management / MR
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Quality Production Purchase Marketing HRD Inf ormation Sy stem
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Conduct
Management
Reviews
DFC 5.6
Establish and
Improve QMS
QM
Provide Resources
Section 6.0
Conduct Internal
Audits
8.2.2 (P-IQA)
Plan and Maintain
Facilities
DFC 6.3
Qualifyand Train
Workforce
DFC 6.2
Maintain
Documents and
Records
4.2.3 (P-CD)
4.2.4 (P-CR)
Initiate Corrective and Preventive Actions
Section 8.5 (P-CPA)
Analyze Internal
Audit Data
Monitor Customer
satisfaction
8.2.1 (SOP 8.2.1)
Analyze Customer
Data
Plan & Control
Design
SOP 7.3
Analyze Product
Performance Data
Design
Identifyand ReviewProduct Requirements
Manage Customer
Communications
(Inquiries, Orders,
Amendments,
Feedbacks including
complaints)
DFC 7.2
Design?
Establish and Maintain Product Identification and Traceability
SOP 7.5.3
Preserve Product and
Control Customer Property
(Purchased Product, In-Process and Finished
Goods)
SOP 7.5.4 and SOP 7.5.5
Section 8.4 (DFC 8.4)
Analyze Supplier
Performance Data
Analyze Production
Process Data
Analyze Quality
(QA/QC) Data
Analyze Competency
Data
Analyze
Documentation
Control Nonconforming Product
Section 8.3 (P-NCP)
Monitor Production
Processes
Section 8.2.3
Monitor Product Quality
(Receiv ing, In-process and
Final Inspection)
Section 8.2.4
Control Monitoring and
Measuring Devices
SOP 7.6
Assure Supplier
Quality
SOP 7.4.1
Purchase Product
(Outsourced Products
and Serv ices)
SOP 7.4.2
Plan and Control
Production
DFC 7.1
(Producti Real izati on Cycl e)
DFC 7.5.1
(Sequence of Producti on
Processes)
SOP 7.5.1
(Planni ng and support
processes)
Develop Product
QualityPlans
SOP 7.1
Validate Special
Processes
SOP 7.5.2
No
Yes
DFC 7.2
Quality Manual Name of organization
Document ID: QM/ Rev . No.: 00/ Rev . Date: 01-04-2002/ Page 3 of 9
4.2.1 General
Quality policy and its objectives ( See 5.3, 5.4.1)
A quality manual (See 4.2.2)
Documented procedures
Documents required by the organization
Quality records required by the standard

4.2.2 Quality Manual
Standard requires organizations to prepare Quality
Manual detailing:
1. Scope, exclusions (see 1.2) and their justification
2. Documented procedures or reference to them
3. Descriptions of interaction between the processes


4.2.3 Control of documents:
Documented procedure is required for control of
documents. Standard requires:
1. Approve documents for adequacy prior to issue
2. Review, update and re-approve
3. Identify changes and current revision status
4. Ensure availability of relevant versions at points of use
4.2.3 Control of documents:
6. Ensure that documents are legible and identifiable
7. identify and control distribution of documents of
external origin
8. identify obsolete copies to prevent unintended use if
retained.


4.2.4 Control of Records:
1. Documented procedure is required for Identification, Storage,
Protection, Retrieval, Retention Time and Disposition of quality
records.
2. Records should provide evidence of conformity
3. Records should evidence effectiveness of QMS.
4. Records should be legible, identifiable and retrievable.
Legible: Clear, Comprehensive and Understandable (and not simply readable)


5.1 Management commitment:
Top management to provide evidence of its
commitment to the development, implementation and
its continual improvement by:
communicating to the organization the importance of
meeting customer as well as statutory and regulatory
requirements (see 7.2.1)
5.1 Management commitment:
Establishing Quality Policy (see 5.3),
Ensuring that Quality Objectives are established
(see 5.4.1 and 7.1a),
Conducting management reviews (see 5.6),
Ensuring the availability of resources (see 6.1)

Objective : Enhance Customer Satisfaction

What to do:
Determine customer requirements.
Fulfill customer requirements.

Note :
See 7.2.1 Product related requirements
See 8.2.1 Customer satisfaction

Responsibility : Top management

Top management should ensure that Quality Policy:
is appropriate to purpose of organization
includes a commitment to comply with
requirements and for continual improvement of
effectiveness of processes of quality
management system.

Responsibility : Top management
provides a framework for establishing and
reviewing quality objectives
is communicated and understood within the
organization, and
is reviewed for its continuing suitability.

5.4.1 Quality Objectives
Quality Objectives are required:
at relevant functions and levels
to be measurable (not necessarily quantifiable)
to be consistent with quality policy
to include product requirements (See 7.1a)

5.4.2 Quality Management System Planning
Planning of QMS to meet the requirements given in clause 4.1
Establish, document, implement and maintain quality
management system, and
Continually improve the effectiveness of the quality
management system.
Integrity of QMS should be maintained, when changes are
planned and implemented.

5.5.1 Responsibility and authority
Define and communicate :
Responsibilities
Authorities
Interrelations between various authorities
within the organization

Appoint a Management Representative for :
Ensuring that processes of QMS are established,
implemented and maintained.
Reporting to top management on performance and
need for improvement.
Ensuring the promotion of awareness of customer
requirements throughout the organization.

1. Processes to be established for communication
within the organization.
2. Internal communication may be documented,
verbal or through electronic media.
For example :
a. Amendment in customer requirements,
b. Purchasing information.

5.6.1 General
By top management, maintain records (See 4.2.4):
1. QMS should be reviewed at planned intervals
2. Verify continuing suitability of QMS
3. Verify adequacy of QMS
4. Verify effectiveness of QMS
5. Evaluate need for changes in QMS

5.6.2 Review input
Management review inputs should include:
1. Results of audits (internal quality audits, customer audits and third
party audits).
2. Customer feedback (including customer complaints) .
3. Process performance and product conformity.
4. Status of corrective and preventive actions.
5. Follow-up actions from previous management reviews.
6. Planned changes that could affect QMS
7. Recommendations for improvement


5.6.2 Review input
Notes:
1. Define periodicity of some or all the inputs.
2. Based on need, short reviews can be conducted for just one
or two points.
3. MR should submit report of performance of QMS and
suggestions for improvement prior to review.
4. Trends of process performance and product conformity
should form a part of review.


5.6.3 Review Output
Record (see 4.2.4) the decisions and actions finalized
during review. It may be relating to:
1. improvement of QMS and its processes.
2. improvement of product related to customer
requirements
3. resource needs
Note : Record actions and follow-ups.



6.1 Provision of resources
Determine and provide the resources needed.
To implement and maintain QMS and
continually improve effectiveness of QMS

Enhance customer satisfaction by meeting
customer requirements.

6.2.1 General
Personnel performing work affecting conformity to
product requirement shall be competent on the basis of:
1. Education
2. Training
3. Skills
4. Experience

The organization should:
Determine the necessary competence for personnel performing work
affecting product quality
Provide training or take other actions to satisfy these needs
Evaluate the effectiveness of actions taken
Ensure that employees are aware of the relevance and importance of
their activities and how they contribute to achievement of quality
objectives.
Maintain appropriate records of education, training, skills and experience
(see 4.2.4).


Determine, provide and maintain infrastructure
required to achieve product conformity.

What to consider:
Buildings, workspace and associated utilities.
Process equipment (hardware and software).
Supporting services (transportation,
communication, information system etc.)

Determine and manage work environment required to
achieve product conformity.

What to consider:
Ambient temperature of workspace
Availability of fresh air
Lighting, etc.

7.1 Planning of product realization
Process:
An activity that transforms inputs into outputs.

Product realization:
Sequence of processes and sub-processes required
to achieve the product is called product realization.


A document which describes how 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
as quality plan.

Organization should determine followings
Quality objectives and requirements for the product,
Need to establish processes
Documentation required
Resources needed
Verification and validation requirement
Monitoring, inspection and test requirements
Criteria for product acceptance
Records necessary to provide evidence of conformity of
realization processes and conformity of product (See
4.2.4)

7.2.1 Determination of requirements related to the
product
a) Specified by customer (including delivery and post
delivery activities)
b) Not specified by the customer but necessary for
specified use or known and intended use.


* Post delivery includes recycling, final disposal

7.2.1 Determination of requirements related to
the product
c) Statutory and regulatory requirements related to the
product and
d) any additional requirement determined by the
organization.



7.2.2 Review of requirements related to product
Ensure that
Product requirements are defined.
Contract or order requirements differing from those previously
expressed are resolved, and
Organization has ability to meet the requirements.
When: submitting tender or quotation, accepting contract or
order, accepting changes to orders



7.2.2 Review of requirements related to product
Ensure that
Record results of the review and actions arising from the
review.
In case of amendments (changes) in the requirements,
amend relevant documents
inform relevant personnel
Confirm, in case of verbal communication



7.2.3 Customer communication
Effective arrangements for communication required with
customer on following matters
Product Information
Enquiries, contracts or order handling, amendments
to orders
Customer feedback, including customer complaints

7.3.1 Design and development planning
Plan and control to determine:
Stages of design and development
Requirement of review, verification and validation as
appropriate to each stage
Responsibilities and Authorities
Manage interfaces between different groups involved in design and
development to ensure communication (see 5.5.3) and clear
assignment of responsibility (see 5.5.1)
Update planning output document, as appropriate, with progress in
design and development


7.3.2 Design and development inputs
Objective : To determine inputs relating to product requirements.
Determine and maintain records (See. 4.2.4)
to be reviewed for adequacy
to be complete and unambiguous
should not conflict with each other

7.3.2 Design and development inputs
Inputs should include
a) Functional and performance requirements
b) Applicable statutory and regulatory requirements.
c) Information derived from previous similar designs
d) Other essential requirements.

7.3.2 Design and development outputs
Objective
a) To meet input requirements
b) Provide appropriate information for purchasing, production and
for service provision
c) Provide product acceptance criteria
d) Specify characteristics essential for its safe and proper use,
preservation.
e) Outputs Shall be approved prior to release

7.3.4 Design and development review
Objective
a) To evaluate the ability of the results to fulfill
requirements, and
b) To identify any problems and propose necessary
actions

7.3.4 Design and development review
When and How ?
At suitable stages, in a systematic manner
Review team to include functions concerned with
stage of being reviewed
Record result of review and actions (see 4.2.4)

7.3.5 Design and development Verification
Objective: Verification
To Verify that output satisfies input requirement
Requirement:
Records result of verification and necessary action
(see 4.2.4)

7.3.6 Design and development Verification
Objective: Validation
To ensure product capability to meet specified or known
intended use
How and When ?
1. To be planned (see 7.3.1)
2. Prior to delivery or prior to implementation
3. Record result of validation and necessary actions.


7.3.7 Design and development Changes
Objective
1. To identified and recorded (See 4.2.4)
2. To be reviewed, verified and validated (see 7.3.6)
3. To be approved before implementation
4. To include evaluation of effect of changes on constituent
parts and delivered products
5. Record result of review of changes and necessary actions
(See 4.2.4)


7.4.1 Purchasing process
1. Ensure that purchased product conforms to
specified purchase requirements.
2. Select suppliers based on their ability
3. Document criteria for selection, evaluation and re-
evaluation.
4. Define type and extent of control on supplier.

7.4.1 Purchasing process
Type and extent of control exercised on supplier should
depend on effect of purchased product on next process (see
7.1) or final product
Results of evaluation and necessary actions arising from
evaluation to be recorded (See 4.2.4).

7.4.2 Purchasing process
Purchasing information normally consists of:
a) Requirement of approval of product, procedures, processes
and equipment, as appropriate.
b) Requirement of qualification of personnel, if required.
c) Quality management system requirements.
d) Product verification arrangements (see 7.4.3)

7.4.3 Verification of purchased product
Establish and implement arrangements (inspection etc.)
for verification of purchased product.
This may consists of :
1. Total verification after receipt of product
2. Partial or total verification at suppliers premises by
organization or its customer.

7.5.1 Control of production and service provision
Plan and carry out under controlled conditions, that
includes:
a) Availability of information that describes the
characteristics of product,
b) Availability of work instructions, (Refer clause
4.2.1, Note 2)

7.5.1 Control of Production and service provision
Controlled Condition
c) use of suitable equipment,
d) availability and use of measuring and monitoring
equipment,
e) Implementation of monitoring and measurement
processes
f) Implementing release, delivery and post-delivery activity.

7.5.2 Validation of processes for production and
service provision
Applicable only on those processes where :
Quality of output can not be verified by subsequent
monitoring and measurement.
Deficiency will become apparent only when product is
in use or service is delivered.

7.5.2 Validation of processes for production and service
provision
The Validation should demonstrate
Ability to provide conforming product
Evidence of consistency in result
Achieve planned result
Criteria to decide about a process to be considered as Special
process depends on resources availability in an organization.

7.5.2 Validation of process for production and
service provision
Process Validation may include
1. Defined criteria for review and approval of processes
2. Approval of equipment and qualification of personnel
3. Use of specific methods and procedures
4. Process parameters and other details to be recorded
(see 4.2.4)
5. Re-validation (Frequency of validation)

7.5.3 Identification and Traceability
Identify the product (See 7.5.1)
Identify status with respect to monitoring and
measurement requirements (i.e. inspection and test
status)
Control and record the identification of product, if
traceability is a requirement (See 4.2.4).


What is customer property ?
Any product received from the customer or made available
by the customer to the organization or its representative for
production and service provision.
What is customer property ?
Any product received from the customer or made available
by the customer to the organization or its representative for
production and service provision.
What is customer property ?
Products to be incorporated in to the final product.
Products to enable processing or delivery of final
product.
Tools and equipment provided by the customer.
Products received from customer for post delivery
service operation.
What is customer property ?
Products (including tools) provided by customer at
customer premises to enable delivery of final product or
post-delivery operation.
Any type of intellectual property including concepts,
designs (or drawings) provided by customer. (Personal
data)
1. Identifying, Verifying, Protecting and Safe guarding
customer property.
2. Recording the occurrence of lost, damage or otherwise
finding un-suitability of use (See 4.2.4)
3. Reporting to customer, occurrence of lost, damage or
otherwise finding un-suitability of use
1. Apply suitable techniques for preserving the conformity
of product.
2. Also applicable to constituent parts of the product,
3. Requirement covers product identification, handling,
packaging, storage and protection.

What are monitoring and measurement equipment:
Physical
Software
Question paper, Checklist or questionnaire
used for measurement of competence of personnel,
customer satisfaction, effectiveness of QMS, used
during internal audit, etc.


Determine monitoring and measurements to be
undertaken.
Determine monitoring and measurement devices
needed.
Determine calibration (or verification) requirements
based on use,
Calibrate, traceable to national or international
standards if such standards exists, else record basis
used for calibration or verification. (See 4.2.4)

Identify calibration status.
Safeguard the devices from adjustments that could
invalidate the result.
Protect the devices from damage and deterioration
during handling, maintenance and storage.
Record the results
Validate conformity of previous results if device is
found out of calibration and take appropriate action on
the equipment and product affected.

8.1 General
What to do
1. Plan and implement monitoring, measurement,
analysis and improvement processes needed.
2. Include applicable methods and extent of their use.


8.1 General
Objective:
1. To demonstrate conformity of product
2. To ensure conformity of QMS, and
3. To continually improve the effectiveness of quality
management system.


8.2.1 Customer Satisfaction
1. An objective of QMS
2. One of the measurement of performance of QMS.
3. Monitor customer perception regarding fulfillment of
requirements.
4. Determine the methods for obtaining and using the
information on customer satisfaction.


8.2.2 Internal Audit
Objective
1. QMS conforms to planned arrangements (see7.1)
2. QMS conforms to the requirement of the standard
3. QMS conforms to the requirements of the organization
4. QMS: Effectively implemented and maintained


8.2.2 Internal Audit
Requirement:
1. Ensure objectivity and impartiality of audit.
2. Auditors shall not audit their own work.
3. Actions to be taken without undue delay.
4. Follow-up actions to verify actions taken and report
verification results (See 8.5.2).
5. Results of audit to be reported for management review
(See 5.6).


a. Audit Planning
b. Audit criteria
c. Audit scope
d. Audit frequency
e. Audit method
f. Responsibilities
g. Reporting results
h. Maintain records (4.2.4)

DOCUMENTED PROCEDURE IS REQUIRED TO DEFINE
a. status of processes
b. importance of processes
c. results of previous audits.
8.2.2 INTERNAL AUDIT
8.2.3 Monitoring and Measuring of processes:

Objective: Monitor and Measure Process
1. Apply suitable methods for monitoring and, where
applicable, for measurement.
2. Demonstrate ability of processes to achieve planned
results.
3. Make corrections, if required.
4. Take corrective action, if required,
5. Applicable to all the processes (see 4.1 & 7.1)

8.2.4 Monitoring and Measurement of Product
Monitor and measure product characteristics
1. At appropriate stages of product realization (7.1)
2. Record evidence of conformity against acceptance criteria.
3. Records to indicate authority responsible for release.
4. Product release and service delivery to proceed only when all
specified activities (see 7.1) have been completed, else
approval is required by relevant authority or customer.


8.3 Control of Nonconforming Product
Objective
1. To prevent unintended use or delivery of products
which does not conform to requirements.
2. To take appropriate action on consequences if non
conformity is detected after delivery.

8.3 Control of Nonconforming Product
Disposition could be:
a) To eliminate the detected nonconformity
b) Use, release or acceptance under concession (to be
authorized by relevant authority and, where applicable,
by customer)
c) Preclude its original intended use

8.3 Control of Nonconforming Product
Documented Procedure should cover:
1. Identifying nonconforming product
2. Recording the nature of nonconformities and subsequent
actions taken (See 4.2.4)
3. Responsibilities and authorities
4. Re-verification, when non-conformity is corrected, as per
specified requirements (see 8.2.4)

8.3 Control of Nonconforming Product
Documented Procedure should cover:
5. Allowing concessions
6. Obtaining concessions from the customer
7. Actions needed when nonconformity is detected after
delivery (these actions should be appropriate to the
effects, or potential effects of nonconformity)

8.3 Analysis of Data
Objective
To determine suitability and effectiveness of QMS
To identify areas of improvements and opportunities for
preventive action.
Requirement:
Determine, Collect and Analyze data

8.3 Analysis of Data
Area of Application ( not exhaustive list)
Customer satisfaction (see 8.2.1)
Conformance to product requirements (See 7.2.1)
Characteristics and trends of processes and products
Suppliers

8.4 Analysis of Data
Area of Application ( not exhaustive list)
Customer satisfaction (see 8.2.1)
Conformance to product requirements (See 7.2.1)
Characteristics and trends of processes and products
Suppliers

8.5 Improvement
8.5.1 Continual Improvement
1. Quality Policy (see 5.3)
2. Quality Objectives (see 5.4.1)
3. Audit results (see 8.2.2)
4. Analysis of data (see 8.4)
5. corrective action (see 8.5.2)
6. Preventive action (see 8.5.3)
7. Management review (see 5.6)


Correction:
Elimination of nonconformities.
Corrective action:
Actions taken to prevent the recurrence of nonconformities.
Preventive action:
Actions taken to prevent the potential occurrence of
nonconformities.
Review non conformities (including customer
complaints),
Determine the causes of non conformity,
Evaluate the need for actions to prevent recurrence of
nonconformities,
Determining and implementing the actions needed
(appropriate to their effects)
Recording results of action taken (see 4.2.4)
Reviewing the effectiveness of action taken

1. Determine potential non conformities
2. Determine the causes
3. Evaluate the need for action to prevent occurrence of
nonconformities.
4. Determining and implementing the actions needed
(appropriate to their effects)
5. Recording results of action taken (see 4.2.4)
6. Reviewing the effectiveness of action taken

Only six documented procedures are Mandatory
1. Control of documents (See 4.2.3)
2. Control of quality records (See 4.2.4)
3. Internal quality audit (See 8.2.2)
4. Control of nonconforming product (See 8.3)
5. Corrective action (See 8.5.2)
6. Preventive action (See 8.5.3)

Management review (clause 5.6.1)
Education, training, skills and experience (clause 6.2.2 e)
Evidence that the realization processes and resulting
product fulfill requirements (clause 7.1 d)
Results of the review of product requirements and actions
arising from the review (clause 7.2.2)
Design and development inputs (clause 7.3.2)


Result of design and development review and any necessary
actions (clause 7.3.4)
Result of design and development verification and any necessary
actions (clause 7.3.5)
Result of design and development validation and any necessary
actions (clause 7.3.6)
Result of design and development changes and any necessary
actions (clause 7.3.7)



Results of supplier evaluations and actions arising from the
evaluations (clause 7.4.1)
Validation of processes where the resulting output cannot
be verified by subsequent monitoring or measurement
(clause 7.5.2 d)
The unique identification of the product, where traceability
is a requirement (clause 7.5.3)
Customer property that is lost, damaged or otherwise found
to be unsuitable for use (clause 7.5.4)
Standards used for calibration or verification of measuring
equipment where no international or national measurement
standards exist (clause 7.6a)
Validity of previous results when measuring equipment is
found not to conform with its requirements (clause 7.6)







Results of calibration and verification of measuring
equipment (clause 7.6)
Internal audit results (clause 8.2.2)
Evidence of product conformity with the acceptance criteria
and indication of the authority responsible for the release of
the product (clause 8.2.4)

Nature of the product nonconformities and any subsequent
actions taken, including concessions obtained (clause 8.3)
Results of corrective action (clause 8.5.2)
Results of preventive actions (clause 8.5.3)