Introduction to ISO 9001:2008

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Clause 1:
Clause 2:
Clause 3:
Clause 4 to 8:

Scope
Normative Reference
Terms and Definition
Requirements

INTRODUCTION
0.1

General

Adoption of QMS is a strategic decision of an Organisation

Design & implementation of Organisations QMS is influenced by:
a)
b)
c)
d)
e)
f)

Organisational environment, changes in it and risks associated with

that environment
Its varying needs
Its particular objectives
Products it provides
Processes it employs
Its size and Organisational structure

QMS requirements are complementary to requirements for products.

Notes are for guidance/ clarification
This standard can be used by internal/ external parties to assess
organization's ability to meet customer, statutory and regulatory
requirements
applicable to product and organization's
own
requirements.

INTRODUCTION
0.2

Process Approach

An activity or set of activities using resources and managed in order to

enable transformation of inputs into outputs, can be considered as a
Process.
Often, output from one process directly forms the input to the next
process.

Application of a system of processes, together with the identification and

interactions of these processes and their management to produce the
desired results, can be termed as the Process Approach

INTRODUCTION
Advantages of Process Approach
Ongoing control over linkage between individual processes within the
system of processes as well as over their combination and interaction.
When used within a QMS, such approach emphasises importance of:

Understanding and meeting requirements

Need to consider processes in terms of added value
Obtaining results of process performance and effectiveness
Continual improvement of processes based on objective
measurement

1.1 SCOPE - GENERAL

Specifies requirements for QMS where an Organisation:

needs top demonstrate its ability to consistently provide product

meeting customer and applicable statutory and regulatory
requirements

Aims to enhance customer satisfaction by effective system

implementation, including processes for continual system
improvement and assurance to customer and applicable statutory
and regulatory requirements

Note: 1
a) Product applies only to product intended for or required by
customer
b) Any intended output resulting from product realisation process
Note: 2
Statutory and regulatory requirements can be termed as legal
requirements

1.2 SCOPE - APPLICATION

Requirements of the standard are generic and applicable to
all organisations, regardless of type, size and product
provided
Exclusions are permitted within Clause 7 only
Exclusions shall not affect the Organisations ability and
responsibility to provide product meeting customer, statutory
and regulatory requirements

NORMATIVE REFERENCE

`ISO
9000:2005,
Quality
Management
Fundamentals and vocabulary applies

System

TERMS AND DEFINITIONS

Terms and definitions given in ISO 9000 apply

Wherever the term Product occurs, it can also mean
Service

Quality management system

4.1. General requirements

The organisation shall Establish, Document,
Implement and Maintain a Quality Management
System and continually improve its effectiveness
in accordance with the requirements of this
International Standard

4.1 General Requirements

The organisation shall:
a)
Determine the processes necessary for QMS and their
b)

c)

d)

e)

f)

application
Determine the sequence and interaction of these processes
Determine criteria & methods to ensure effective operation &
control of the processes
Ensure availability of resources and information needed to
support the operation & monitoring of the processes
Monitor, measure wherever applicable, and analyse
processes
Implement actions necessary to achieve planned results &
continual improvement

Manage the processes in accordance with the standard

Ensure control of outsourced processes affecting product
conformity
Identify type & extent of control on outsourced processes
within the QMS

4.1 General Requirements

Note 1: Processes needed for QMS to include processes for management activity,
provision of resources, product realization and measurement analysis &
improvement.

Note 2: Outsourced Process is a process needed for QMS which is to be

performed by an external body
Note 3: Ensuring control over Outsourced Processes does not absolve the
organisation of the responsibility of conformity to all customer, statutory and
regulatory requirements. Organisation to identify type and extent of control.

4.2 Documentation Requirements

4.2.1 General

QMS documentation must include:

Documented statement of Quality policy & objectives
Documented procedures and records required by
standard
Documents,
including records, determined by
organization to be necessary to ensure effective
planning, operation & control processes
Note 1 Term documented procedure means that it must be established, documented, implemented

and maintained. A single document may address requirements for one or more processes. A
procedure may be covered by more than one document.
Note 2 Extent of documentation may differ due to

Size & type of Organization, Complexity & Interaction of processes, Competence of personnel
Note 3 Documentation may be in any type of media

4.2 Documentation Requirements

4.2.2. Quality manual
Quality manual must include as minimum:

The scope of QMS including details of, and

justification for any exclusions
Documented procedures or reference to them
Description of the interaction between the
processes of the QMS

4.2 Documentation Requirements

4.2.3. Control of documents
Documented procedures Controls needed
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Approve documents for adequacy, prior to issue

Review, update as necessary and re-approve documents to
identify the changes and the current revision status of
documents
To ensure documents remain legible, readily identifiable
Ensure relevant versions of applicable documents are available
at points of use
Ensure that documents of external origin determined by the
Organisation to be necessary for the planning and operation of
the QMS are identified and distribution controlled
Obsolete documents are prevented from unintended use and
identified if kept for any reason

4.2 Documentation Requirements

4.2.4. Control of records

Records are a special type of document

Records established
to provide evidence of
conformity to requirements and of the effective
operation of the QMS shall be controlled.

Establish documented procedure to define

controls needed for identification, storage,
protection, retrieval, retention time and
disposition of records.

Records shall remain legible, readily identifiable

and retrievable

5
5.1
5.2
5.3
5.4
5.5

Management responsibility

Management commitment
Customer focus
Quality policy
Planning
Responsibility, authority and
communication
5.6 Management review

Management responsibility
5.1 Management commitment

Top Management shall provide evidence of commitment

to the development, implementation and continually
improving effectivenes of QMS by:

communicating the importance of meeting customer and

statutory and regulatory requirements

establishing quality policy & objectives

management reviews

provision of resources

Management responsibility

5.2 Customer focus

Top Management shall ensure that customer
requirements are determined and are met with the
aim of enhancing customer satisfaction

5.3 Quality Policy

Top Management to ensure Quality Policy:

a) Is appropriate to the purpose of the organization
b) Includes commitment to comply with requirements &
continually improve the effectiveness of the QMS
c) Provides framework for establishing & reviewing quality

objectives
d) Is communicated and understood within the organization

e) is reviewed for continuing suitability

Management responsibility

5.4 Planning
5.4.1 Quality Objectives
Top Management to ensure quality objectives are

established at relevant functions and levels

Objectives must be documented, measurable &
consistent with the quality policy

Shall include those needed to meet requirements

for product

Management responsibility
5.4.2 QMS planning

Top Management to ensure:

Planning of the QMS is carried out in order to
meet requirements given in 4.1, as well as the
quality objectives
The integrity of the QMS is maintained when
changes are planned and implemented

Management responsibility

5.5 Responsibility, authority and communication

5.5.1 Responsibility and authorities shall be defined and
communicated within the organisation

5.5.2 Management Representative

Member of the Organisations management who, irrespective of
other responsibilities, has responsibility and authority that
includes;
Ensuring that processes needed for the QMS are established,
implemented and maintained
Reporting
on performance of QMS including needs for
improvement
Ensuring the promotion of awareness of customer needs &
requirements
Note:

5.5.3

Responsibility includes liaison with Certification body

Internal

communication

Ensure appropriate
communication
processes
are
established within
the
organization and communication takes place regarding the
processes of the QMS and their effectiveness

Management responsibility
5.6 Management Review

5.6.1 General - Review of the QMS by top management at

planned intervals to :

ensure QMS suitability, adequacy & effectiveness

assess opportunities for improvement

evaluate the need for changes to QMS including policy &

objectives

5.6.2 Review input - Review performance and improvement

opportunities related to:

Audit results
Customer feedback
Process performance & Product conformity
Status of preventive and corrective actions
Follow up actions from earlier reviews
Changes that could affect the QMS
Recommendations for improvement

Management responsibility

5.6.3 Review output

Output to include decisions and actions related to:

Improvement of the effectiveness of the QMS and its

processes
Improvement of product related to customer
requirements
Resource needs

Results of management review must be recorded

Resource Management

6.1 Provision of resources

6.2 Human resources - Competence, awareness and training
6.3 Infrastructure
6.4 Work environment

6.1 Provision of resources

Determine & provide the resources needed to:
implement, maintain the QMS and continually
improve its effectiveness
enhance customer satisfaction by meeting
customer requirements

6
6.2.1 General

Resource Management
6.2 Human Resources

Personnel performing work affecting conformity to product

requirements must be competent on the basis of appropriate
education, training, skills and experience

6.2.2 Competence, training and awareness

Determine

the necessary competence of personnel performing

work affecting conformity to product requirements
Where applicable provide training or take other actions to
achieve the necessary competence
Evaluate the effectiveness of action taken
Ensure personnel are aware of relevance and importance of
their activities and contribution to achieving objectives
Maintain appropriate records of education, training, skills
and experience

Human Resources
Competence considerations:

Future demands
Anticipated management and workforce succession needs
Changes in the processes and equipment
Individual competencies needed
Statutory and regulatory requirements, standards, directives

Awareness

Company Vision
Policy & objectives
Organizational change & development
Improvement activities
Creativity & Innovation
Impact on society
Introductory/ Refresher programmes

Resource Management

6.3 Infrastructure
Identify, provide & maintain the infrastructure needed to achieve
product conformity. Infrastructure includes, as applicable:
buildings, workspace & associated facilities
equipment ( hardware & software )
supporting services (transport, communication or information
system)

6.4 Work environment - Determine and manage the work

environment needed to achieve conformity to product
requirements

Work environment relates to conditions under which work

is performed, like:

physical,
environmental and other factors such as:
noise, temperature, humidity, lighting, weather etc.

Product Realization

7.1 Planning of product realization

7.2 Customer related processes
7.3 Design & Development

7.4 Purchasing
7.5 Production & Service provision
7.6 Control of Monitoring & Measuring Equipment

Note: Exclusions are allowed only within this

clause

Product Realization

7.1 Planning of product realization

Organisation shall plan and develop processes needed for product
realisation. Planning shall be consistent with requirements of
other processes of the QMS

Planning must determine as appropriate: ( Quality Plan)

quality

objectives and requirements for the product

the need to establish processes and documents, to provide
resources specific to the product
verification,
validation,
monitoring,
measurement
inspection & test activities specific to product & acceptance
criteria
Records needed as evidence of conformity to product
requirement

Product Realization

7.2 Customer related processes

7.2.1 Determination of requirements related to product
7.2.2 Review of requirements related to product
7.2.3 Customer communication

Product Realization

7.2.1 Determination of requirements related to product

Organization must determine:

Requirements specified by the customer including delivery &

post delivery activities
Requirements not specified but necessary for specified or
intended use, where known
Statutory and regulatory requirements applicable to product
Any additional requirements considered necessary by the
organisation

Note: Post delivery actions include warranty provision, contractual obligations

like maintenance service and supplementary services like recycling or
final disposal

Product Realization

7.2.2 Review requirements related to the product

Review identified requirements before commitment to supply
Product ( submission of tender, on receipt of order, amendment to
order) and ensure that:

product requirements are defined

differences between tender & contract are resolved

organization has ability to meet the requirements

Record the results of review and actions arising from the review
Where customer provides no documented requirements, document
requirements before acceptance
Documentation to be amended for any changes & personnel made
aware of changed requirements

Product Realization

7.2.3 Customer communication

Determine and implement effective arrangements
communication with customers relating to :

Product information

Enquiry,

contract

&

order

handling

amendments

Customer feedback including complaints

for

including

Product Realization

7.3 Design & Development

7.3.1 Design & Development Planning
7.3.2 Design & Development Inputs
7.3.3 Design & Development Outputs
7.3.4 Design & Development Review
7.3.5 Design & Development Verification

7.3.6 Design & Development Validation

7.3.7 Control of Design & Development Changes

Product Realization

7.3.1 Design & Development Planning

Organisation shall plan & control D & D of the product

During D & D planning, organisation shall determine:

D & D stages

required review, verification and validation at each stage

responsibilities & authorities for D & D

Manage interfaces between groups for effective communication &
clear responsibility assignment

Planning output to be updated as the D & D progresses

NOTE: D & D review, verification and validation have distinct purposes.

They can be conducted and recorded separately or in any
combination, as suitable for the product and the Organisation

Product Realization

7.3.2 Design & Development Inputs

Determine & record inputs related to product requirements

including :

functional & performance requirements

applicable statutory and regulatory requirements
information derived from previous similar designs
any other requirement essential for D&D

Review inputs for adequacy

Requirements must be complete, unambiguous and not in conflict

with each other

Product Realization

7.3.3 Design & Development Outputs

D & D output shall be in a form suitable for verification against
D&D input and shall be approved prior to release

D & D output shall:

meet the input requirements
provide information for purchasing, production and service
provision
contain or reference acceptance criteria
Specify product characteristics essential for its proper & safe
use
Note: Info. For product & service provision can include details for
preservation of product

7.3.4 Design & Development Review

At suitable stages perform systematic reviews of D & D to :

evaluate the ability of results to meet requirements
identify any problem and propose necessary actions
Involve all functions concerned in such reviews
Record the results and any necessary actions

Product Realization

7.3.5 Design & Development Verification

Verify D & D to ensure that outputs have met the input requirements

Record the results of verification and necessary actions

7.3.6 Design & Development Validation

Perform D & D validation to confirm that product is capable of

meeting the requirements for the specified or intended use, where
known

Wherever applicable validation to be completed prior to delivery or

implementation of thje product

Results of validation and necessary actions must be recorded

Product Realization

7.3.7 Control of Design and Development Changes

D&D changes must be identified and records maintained

Changes must be reviewed, verified and validated as appropriate and

approved before implementation

Review of D&D changes shall include evaluation of effect of changes

on constituent parts and product already delivered

Record results of review of changes and any necessary actions

Product Realization

7.4 Purchasing
7.4.1 Purchasing process
7.4.2 Purchasing information
7.4.3 Verification of purchased product

7.4.1 Purchasing process

Ensure that purchased product conforms to specified requirements

Type & extent of control on supplier depends on effect purchased
product may have on product realization or the final product
Evaluate and select suppliers based on their ability to supply
product in accordance to requirements
Establish criteria for selection, evaluation and re-evaluation of
suppliers
Results of evaluation and any necessary actions must be
recorded

Product Realization

7.4.2 Purchasing information

Purchasing information must describe the product to be purchased
including where appropriate :
requirements for approval of product, procedures, processes and
equipment
requirements for qualification of personnel
quality management system requirements
Ensure adequacy of specified purchase requirements prior to their
communication to supplier

7.4.3 Verification of purchased product

Establish & implement inspection or other activities necessary to
ensure purchased product meets specified purchase requirements
Where organization or its customer propose verification at suppliers
premises, organization must specify in purchasing information :
verification arrangements
method of product release

Product Realization

7.5 Production and service provision

7.5.1
7.5.2
7.5.3
7.5.4
7.5.5

Control of production and service provision

Validation of processes for production and service provision
Identification & traceability
Customer property
Preservation of product

7.5.1 Control of production and service provision

Plan and carry out production & service provision under controlled
conditions which include as applicable :
a) availability of information describing product characteristics
b) availability of work instructions, as necessary
c) the use of suitable equipment
d) availability & use of measuring & monitoring equipment
e) implementation of monitoring and measurement
f) the implementation of product release, delivery and post delivery
activities

Product Realization

7.5.2 Validation of processes

Processes where resulting output is not verifiable by subsequent
monitoring or measurement, and as a consequence deficiencies may
become apparent only after the product is in use or the service has been
delivered, must be validated to demonstrate ability of these processes to
achieve planned results
Arrangements must be established for these processes including, as
applicable :
criteria for review and approval of the process
approval of equipment
qualification of personnel
use of specific methods & procedures
requirements for records
re-validation

Considerations for Validation of processes :

High value products

Where deficiency will only be apparent when product is in use
Where process cannot be repeated
Where product verification is not possible

Product Realization

7.5.3 Identification and traceability

Where appropriate identify, product by suitable means, throughout

realization
Identify product status with respect to measurement & monitoring
requirements throughout product realisation
Where traceability is required, control the unique identification of the
product and maintain records

7.5.4 Customer property

Exercise care for customers property while it is under

organizations control or being used by organization
Identify, verify, protect & safeguard customer property provided
for use or incorporation into the product
Any customer property that is lost, damaged or found unsuitable
report to customer & maintain records

Note: Customer property includes intellectual property and personal

data

Product Realization

7.5.5 Preservation of product

Preserve product during internal processing and final delivery to

intended destination to maintain conformity to requirements

As applicable, preservation to include identification, handling,

packaging, storage and protection

Preservation also applies to constituent parts of a product

7.6 Control of measuring & monitoring equipment

Determine monitoring and measurement to be made &

measurement & monitoring equipment needed to provide evidence
of conformity of product
Establish processes to ensure measuring and monitoring is carried
out consistent with monitoring and measurement requirements

Product Realization

7.6 Control of measuring & monitoring equipment

Where necessary to ensure valid results, measuring equipment
shall:

Be calibrated or verified or both at specified intervals or prior to

use against international or national standards. Where no such
standard exist record the basis of calibration or verification

Adjust or re - adjust as necessary

Have identification in order to determine its calibration status

Be safeguarded from adjustments invalidating measurement

result

Be protected from damage or deterioration during handling,

maintenance & storage

Product Realization

7.6 Control of measuring & monitoring equipment contd.

Assess and record validity of previous results when equipment is

found not to conform to requirements.
Take appropriate action on the equipment and any product affected.

Maintain records of calibration and verification.

When used in the monitoring and measurement of specified
requirements, confirm ability of computer software to satisfy
intended application. This shall be undertaken prior to initial use and
reconfirmed as necessary
Note: Confirmation of ability of computer software to satisfy
intended application would include its verification and configuration
management to maintain its suitability for use.

Measurement, Analysis and Improvement

8.1 General
8.2 Monitoring/measurement
8.2.1 Customer satisfaction
8.2.2 Internal Audit
8.2.3 Monitoring & measurement of processes
8.2.4 Monitoring & measurement of product
8.3 Control of nonconforming product

8.4 Analysis of data

8.5 Improvement

8.5.1 Continual improvement

8.5.2 Corrective action
8.5.3 Preventive action

Measurement, Analysis and Improvement

8.1 General

Plan & implement measurement, monitoring analysis and

improvement processes needed to :
demonstrate conformity to product requirements
ensure conformity of QMS
continually improve the effectiveness of the QMS

This includes determination of applicable methods, including

statistical techniques, and the extent of their use

8.2.1 Customer satisfaction

Organization shall monitor information related to customer
perception as to whether the organization has met customer
requirements

The methods for obtaining and using this information must be

determined
Note: Customer perception can be obtained from Customer
satisfaction survey, Customer data on delivery, product
Quality, user opinion surveys, lost business analysis,
compliments, warranty clause, dealer reports

Measurement, Analysis and Improvement

8.2.2 Internal audit

Conduct internal audits at planned intervals to determine if :

Plan the audit programme considering :

QMS conforms to the planned arrangements, requirements of the

standard and organizations requirements
QMS is effectively implemented & maintained
Status and importance of the processes and the areas
Results of previous audits

Define audit criteria, scope, frequency & methodologies

Select auditors to ensure objectivity and impartiality
Auditor must not audit own work
Establish documented procedure to define :

responsibilities & requirements for planning and conducting audits,

establishing records and reporting results

maintain audit records and their results

Ensure corrections and corrective actions are taken without undue

delay

Follow up to verify actions taken & report verification results

Note: See ISO19011 for guidance

Measurement, Analysis and Improvement

8.2.3 Monitoring and measurement of processes

Apply suitable methods for monitoring and, where applicable,

measurement of QMS processes
These methods shall demonstrate the ability of the processes to
achieve planned results
Where planned results are not achieved corrections and corrective
actions must be taken , as appropriate

Measurement, Analysis and Improvement

8.2.4 Monitoring and measurement of product

Monitor & measure product characteristics to verify conformity at

appropriate stages of realization processes in accordance with
planned arrangements
Records must indicate the person (s) authorizing release of the
product for delivery to customer
Product release and delivery of service to customer shall not proceed
until all the planned
arrangements have been satisfactorily
completed, unless otherwise approved by a relevant authority, and
where applicable by the customer

Measurement, Analysis and Improvement

8.3 Control of nonconforming product

Non conforming product must be identified and controlled to

prevent unintended use or delivery
Documented procedure to define controls and related responsibility
and authority shall be established.
Where applicable, Organization shall deal with nonconforming
product by one or more of the following ways :

taking action to eliminate detected nonconformity

authorizing use, release or acceptance under concession by a

relevant authority and where applicable by customer

taking action to preclude original intended use or application

when nonconformance is detected after delivery or use, take

appropriate action based on the effect or potential effect of the
nonconformance
When the nonconforming product is corrected it must be re - verified
to demonstrate conformity to requirements
Records of the nature of nonconformity and any subsequent
including concessions must be maintained

action

Measurement, Analysis and Improvement

8.4 Analysis of data

Determine, collect & analyse appropriate data to demonstrate the

suitability and effectiveness of QMS and to evaluate where continual
improvement of the QMS can be made

This shall include data resulting from measurement & monitoring &
other relevant sources

Data analysis shall provide information relating to:

customer satisfaction

conformity to product requirements

characteristics and trends of processes and products including

opportunities for preventive action
suppliers

Measurement, Analysis and Improvement

8.5 Improvement
8.5.1 Continual improvement
Organization shall continually improve the effectiveness of the QMS
through use of :

Quality Policy & Objectives

Audit results
Analysis of data
Corrective/Preventive actions
Management reviews

Measurement, Analysis and Improvement

8.5.2 Corrective action

Organization shall take actions to eliminate the causes of

nonconformities to prevent recurrence

Corrective actions appropriate to the impact of the problem

Documented procedure shall define requirements for :

reviewing nonconformities (including customer complaints)

determining the causes of nonconformities

evaluating the need for action to prevent recurrance

determining & implementing action needed

recording results of action taken

reviewing effectiveness of corrective action taken

Measurement, Analysis and Improvement

8.5.3 Preventive action

Organization shall determine action to eliminate the causes of
potential nonconformance to prevent occurrence
Actions shall be appropriate to the impact of the potential problem
Documented procedure must define the requirements for:

determining potential nonconformities & their causes

evaluating the need for action to prevent occurance

determining and implementing action needed

recording the results of action taken

reviewing effectiveness of preventive action taken

Model of ISO 9001 : 2008

Resource
management

Input

Measurement, Analysis &

Improvement

Product/
Service
realization

Product/
Service
Output

Satisfaction

Management
responsibility

Requirements

C
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S
T
O
M
E
R
S

Continual Improvement of the

Quality Management System

C
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S
T
O
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