ISO 9001:2000

UNIT 5 ISO 9001:2000 - STRUCTURE

Structure
5.0 Objectives
5.1 Introduction
5.2 Documentation Structure of ISO 9001: 2000
5.2.1 Quality Manual
5.2.2 Mandatory Procedures
5.2.3 Standard Operating Procedures (SOPs)
5.2.4 Process Definition Documents
5.2.5 Work Instructions
5.2.6 Miscellaneous Documents
5.2.7 Formats and Records
5.3 ISO 9001:2000 Clauses
5.4 Let Us Sum Up
5.5 Key Words
5.6 Answers to Check Your Progress Exercises
5.7 Suggested Reading

5.0 OBJECTIVES
After reading this unit, we shall be able to:
• outline the structure of ISO 9001: 2000; and
• explain the functionality of each element and their interrelationships with
each other.

5.1 INTRODUCTION
The central focus of ISO certification is the preparation, development and
implementation of Quality Management System (QMS) in an organization.
ISO 9001:2001 is implementation and certification standard in ISO 9000
series. ISO 9001: 2000 standard on Quality Management System Requirements
was published on 15th December, 2000 as the second revision of the standard.
The standard was initially published in 1987. It consisted at that time of series
of standards including ISO 9001: 1987, ISO 9002: 1987, ISO 9003: 1987, etc.
The standard was revised in 1994. However, the structure remained
unchanged. In 1998, ISO published eight QMS principles on which the current
standard is based. The three standards viz., 9001, 9002 and 9003 were
integrated in ISO 9001: 2000. This is supported by ISO 9000: 2005
(vocabulary of terms used in ISO 9001: 2005) and ISO 9004: 2000, a guideline
document for performance improvement.
In this edition, it has been proclaimed that PDCA (Plan-Do-Check-Act) cycle
is to be used as a tool for implementation and improvement of the Quality
Management System. The focus was shifted from product manufacturing
organisations to product and service offering organisations. The emphasis is
on performance improvement as compared to earlier emphasis on
conformance. The documentation has been optimized because of adoption of
process approach. The standard is expected to be used as a universal tool for
organisations ranging from hotels to hospitals and micro-scale organisations to
multinational corporations.
In this Unit, we shall study the documentation structure and main clauses of
the ISO 9001:2000.
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 ISO 9001:2000 - Structure
5.2 DOCUMENTATION STRUCTURE OF
ISO 9001:2000
The documentation structure generally consists of different hierarchical levels.
The contents of different hierarchical levels are as follows:
1) Quality Manual
2) Mandatory Procedures
3) Standard Operating Procedures
4) Process Definition Documents
5) Work Instructions
6) Miscellaneous Documents
7) Formats and Records

Quality Manual

Mandatory Procedures

Standard Operating Procedures

Process Definition Documents

Work Instructions

Miscellaneous Documents

Formats and Records

5.2.1 Quality Manual

Quality manual is a document which explains how the requirements of ISO
9001:2000 are planned to be fulfilled by the organisation taking into
consideration the type of product/service offered, complexity of processing
methods, competence of operating personnel and number of sites where the
Quality Management System is implemented.
The manual also contains the general information about the organisation like:
• Establishment and evolution over the years.
• The position in the supply chain.
• The suppliers and customers in the chain.
• The site related details.
• Quality policy and related objectives.
• Organisation chart.
• Applicable statutory and regulatory requirements.
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ISO 9001:2000 • The structure of QMS documentation.
• The site map from external and internal point of view.
• Roles and responsibilities.
• Details of external resources utilized.
The manual gives reference to or contains all the elements of the QMS
documentation. It acts as a reference document for training of new team
members of the organisation, communicating the QMS overview to National
and International customers and as a supporting document during any statutory
and regulatory interaction.
The manual is required to be reviewed periodically by the top management in
management review meetings. The relevant inputs to be reviewed in the
meeting are required to be collected from different processes constituting the
Quality Management System.

# Check Your Progress Exercise 1

Note: a) Use the space below for your answers.
b) Check your answers with those given at the end of the unit.
1) Enumerate different hierarchical levels as outlined is ISO 9001:2000
documentation structure.
……………………………………………………………………….………
……………………………………………………………………………….
……………………………………………………………………………….
……………………………………………………………………….………
……………………………………………………………………………….
2) What is the purpose of Quality Manual?
……………………………………………………………………….………
……………………………………………………………………………….
……………………………………………………………………………….
……………………………………………………………………….………
……………………………………………………………………………….

5.2.2 Mandatory Procedures

The following documented procedures are required to be established and
maintained.
• Control of documents
• Control of records
• Internal audit
• Control of non-conformity
• Corrective action

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• Preventive action ISO 9001:2000 - Structure

The contents of the documented procedures are as follows:

• Control of documents: This procedure contains information related to
approval of documents, re-approval of documents, identification of
changes, identification of current revision status, availability of relevant
versions at points of use, legibility, documents of external origin and
management of obsolete documents.
• A master list of documents is prepared which gives details like document
name, document number, issue date, current revision number and date,
information about preparation, review and approval of the documents.
• Control of records: This procedure defines controls needed for the
identification, storage, protection, retrieval, retention time and disposal of
records. A master list of records is prepared which gives details like -
record name, associated format number and issue date, version of record
(soft/hard), record originating process, etc.
• Internal audits: This procedure contains the responsibility and
requirements for planning and conducting audits, and for reporting results
and records. It also contains the details of competence of the internal audit
team members.
• Control of non-conforming product: This procedure contains the
information about the identification and assessment of potentially non-
conforming end products to determine their proper handling and review of
the corrections carried out. It also specifies the records required to be
maintained.
• Corrective action: This procedure contains information related to review
of non-conformities (including customer complaints), review of trends in
monitoring results, determination of causes of non-conformities, evaluating
the need for the action, determining and implementing the actions needed,
recording the results and reviewing corrective actions taken.
• Preventive action: This procedure contains information related to review
of potential non-conformities (including customer complaints), review of
trends in monitoring results, determination of causes of potential non-
conformities, evaluating the need for the action, determining and
implementing the actions needed, recording the results and reviewing
corrective actions taken.

5.2.3 Standard Operating Procedures (SOPs)

The following SOPs are generally maintained:
• Procedure for training
• Procedure for maintenance
• Procedure for identification and traceability
• Procedure for handling potentially non-conforming product
• Procedure for purchase

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ISO 9001:2000 • Procedure for verification of purchased product
• Procedure for raw material stores
• Procedure for finished goods stores
• Procedure for dispatch
• Procedure for handling customer complaints

5.2.4 Process Definition Documents

These documents define the identified processes in following terms to ensure
that process approach is followed:
• Process ID (Name and number)
• Process purpose and scope
• Process objectives
• Process owner
• Process organisation
• Process resources
• Process input methods and outputs
• Process tracking
• Process documents and records
• Process effectiveness

5.2.5 Work Instructions

These documents provide instructional guidance to operational personnel for
carrying out micro-activities outlined in different SOPs. The details of the
contents depend on the competence of the operating personnel, complexity of
the process and the nature of product/service. These documents should be
accessible to the operating personnel preferably near their work area. These
documents should be available in the (local) language, which the operational
workforce understands. These documents are to be drafted with the help of the
operational personnel and may contain the pictorial presentation of work
activities so that non-conformities are avoided.

5.2.6 Miscellaneous Documents

Following important miscellaneous documents are required to be maintained.
• Statutory and regulatory requirements
• Documents of external origin
• Quality policy
• Quality objectives
• List of available resources

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• List of role-wise necessary competence ISO 9001:2000 - Structure

• Customer requirements
• Technical documents (research articles etc.)

5.2.7 Formats and Records

Following records are required to be maintained in pre-determined formats as
an evidence of activities carried out as per defined quality management system:
• Current competence of all concerned
• Calibration of measuring and monitoring instruments
• Outcome of internal audits
• Output of management review
• Corrective actions
• Training and effectiveness of training given
• Product design input determination
• Product design review
• Product design verification
• Product design validation
• Product design change review
• Corrections of non-conforming product
• Verification of purchased product
• Identification of product where traceability is a requirement
• Release of end product
• Receipt and issue of material/products in stores
• Maintenance (breakdown and preventive)
• Quality objective tracking
• Document change control
• Document distribution

5.3 ISO 9001:2000 CLAUSES

The standard is divided in eight main clauses (Table 5.1) as listed below:
1) Scope
2) Normative references
3) Terms and definitions
4) Quality Management System
5) Management Responsibility
6) Resource Management
7) Product realization
8) Measurement, analysis and improvements
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ISO 9001:2000 Table 5.1: Main Clauses of ISO 9001:2000

ISO 9001:2000 Clauses Description

1. Scope Scope of the QMS, areas covered and any exclusions identified.

2. Normative Reference The normative reference ISO 9000:2000 (fundamentals/

vocabulary) must be used in conjunction with the standard itself.

3. Terms and Definitions The terms and definitions given in ISO 9000 apply.

4.1 General This clause covers the requirement of the organisation to

Requirements actually set up a quality management system, and broadly sets
out the activities associated with this. The organisation shall
document, implement and maintain a Quality Management
System (QMS) and continually improve its effectiveness in
accordance with the requirements of the standard.

4.2 Documentation The important issue here is that people must have the
Requirements information they need to do their job. The QMS must include
quality policy, quality objectives, quality manual, documented
procedures, documents to ensure the effective planning,
operation and control of its processes, and records. All
documents are required to be controlled. Also required is the
control of records, i.e. identification, storage, protection,
retrieval, retention time and disposition of records.

5. Management Specifically identifies the responsibility of top management and

Responsibility the need for effective leadership.

5.1 Management Top management shall provide evidence of its commitment to

Commitment the development and implementation of the QMS and
continually improving its effectiveness.

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 A Quality Policy establishes a commitment to quality, a

commitment to continuous improvement, the context for quality
objectives and how the objectives relate to customer
requirements.

5.5 Responsibility, Top management shall ensure that responsibility and authorities
Authority and are defined and communicated within the organisation.
Communication Everybody should know what they are expected to do
(responsibilities) and what they are allowed to do (authorities).
They should understand how these responsibilities and
authorities relate to each other. A Management representative
needs to be appointed who has responsibility for the QMS.
Appropriate communication processes need to be established,
and the effectiveness of the QMS must be communicated to the
organisation.

5.6 Management Review The QMS must be reviewed at planned intervals, to ensure its
continuing suitability, adequacy and effectiveness. Records from
the review must be maintained. The review inputs and outputs
must be clearly stated.

6. Resource To ensure that the resources needed to both maintain and

Management improve the QMS are available, and also to carry out the work
required in a manner that will satisfy customer requirements.

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 ISO 9001:2000 - Structure
ISO 9001:2000 Clauses Description

6.1 Provision of The organisation shall determine and provide resources needed
Resources to implement and maintain the QMS and continually improve its
effectiveness, and to enhance customer satisfaction by meeting
customer requirements.

6.2 Human Resources Personnel performing work, affecting quality of service shall be
competent on the basis of appropriate education, training, skill
and experience. The organisation must determine the necessary
competence and provide training to satisfy these. They must
evaluate the effectiveness of the training and maintain
appropriate records. They must also 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.

6.3 Infrastructure The organisation shall determine, provide and maintain the
infrastructure needed to perform work. Infrastructure includes
buildings, workspace, utilities, equipment and supporting
services. This means determining and providing for current
infrastructure requirements and planning for expected future
needs.

6.4 Work Environment The organisation shall determine and manage the work
environment needed to achieve conformity of service.

7.1 Planning of Product The organisation shall plan and develop the processes needed for
Realisation service realisation. This includes the need to establish processes,
documents, and provide resources specific to the service;
required verification, validation, monitoring, inspection and test
activities specific to the service, and also the records needed to
provide evidence that the realisation processes and resulting
service meet the requirements.

7.2 Customer Related The organisation shall determine customer requirements,

Processes statutory and regulatory requirements and any additional
requirements determined by the organisation, and review these
requirements. Records resulting from the review and actions
arising should be maintained. This clause focuses mainly on the
service provided, but can cover additional factors such as
regulatory or legal requirements, and unspecified customer
expectations.

7.3 Design and The organisation shall plan and control the design and
Development development of its service. This requires determining the design
and development stages, the review, verification and validation
of each stage, and the responsibilities and authorities for design
and development. This clause requires you to have controls for
the design processes and to establish a disciplined approach to
the design process. The design process should include inputs,
outputs, review, verification and validation. Design and
development changes also need to be identified and records
maintained.

7.4 Purchasing The organisation shall ensure that purchased product conforms
to specified purchase requirements. The organisation shall
evaluate and select suppliers based on their ability to supply
product in accordance with these requirements. Criteria for
selection, evaluation and re-evaluation shall be established.
Records of results of evaluation shall be maintained. The
organisation shall also establish and implement the inspection or
other activities necessary (verification) for ensuring that
purchased product meets specified requirements.

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ISO 9001:2000
ISO 9001:2000 Clauses Description

7.5.1 Control of This clause describes the various types of controls that you
Production and Service might need to have in place for the delivery of service. These
Provision include the availability of information that describes the service,
the availability of work instructions, the use of suitable
equipment, the availability of monitoring and measuring devices
and the implementation of monitoring and measurement.

7.5.2 Validation of This clause describes why and how you should validate the
processes for Production processes where the resulting output is not immediately evident
and Service Provision after completion of the process.

7.5.3 Identification and Where appropriate, the organisation shall identify the
Traceability product/service by suitable means. Where traceability is a
requirement, the organisation shall control and record the unique
identification of the product/service. Identification is knowing
what the product or service resulting from a particular process is.
Where you need to identify a product/service, the methods used
and the records to be kept need to be defined? Traceability is
knowing where a product /service came from.

7.5.4 Customer Property The organisation shall identify, verify, protect and safeguard
customer property provided for use or incorporation into the
product/service.

7.5.5 Preservation of The organisation shall preserve the conformity of the

Product product/service during internal processing and delivery to the
intended destination. This preservation shall include
identification, handling, packaging, storage and protection.

7.6 Control of This means having confidence in the equipment used to check
Monitoring and your work. This clause applies to organisations where
Measuring Devices monitoring devices and measuring equipment are used to verify
that what you are providing meets your customer requirements.
Monitoring implies observation and supervision activities.
Measurement considers the determination of a quantity,
magnitude or dimension. Where necessary to ensure valid
results, measuring equipment shall be calibrated, adjusted,
safeguarded and protected from damage and deterioration.

8.1 Measurement This clause covers the wider monitoring, measurement, analysis
Analysis and and improvement of the quality management system. The
Improvement organisation shall plan and implement the monitoring,
measurement, analysis and improvement processes needed to
demonstrate conformity of the product/service, to ensure
conformity of the QMS and to continually improve the
effectiveness of the QMS. This shall include determination of
applicable methods, including statistical techniques, and the
extent of their use.

8.2.1 Customer The organisation shall monitor information relating to customer

Satisfaction perception as to whether they have met customer requirements.
The methods for obtaining and using this information shall be
determined. Monitoring of customer satisfaction should be
performed on an ongoing basis, as customers’ perceptions of
performance change over time. The results of the customer
satisfaction monitoring should be addressed in the management
review and continual improvement activities, to identify and
implement those changes which will improve the relationship
with customers. Note: Satisfaction is not the opposite of
dissatisfaction. Satisfaction can produce a neutral response
whereas dissatisfaction can produce a strong negative response.

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 ISO 9001:2000 - Structure
ISO 9001:2000 Clauses Description

8.2.2 Internal Audit The organisation shall conduct internal audits at planned
intervals to determine whether the QMS conforms to the
standard and to the QMS requirements established by the
organisation, and is effectively implemented and maintained.
The responsibilities and requirements for planning and
conducting audits, and for reporting results and maintaining
records shall be defined in a documented procedure.
Management must ensure that actions are taken without undue
delay to eliminate detected non-conformities and their causes.
Follow-up activities shall include the verification of the actions
taken and the reporting of verification results.

8.2.3 Monitoring and The organisation shall apply suitable methods for monitoring
Measurement of and measuring the QMS processes. These methods shall
Processes demonstrate the ability of the processes to achieve planned
results. When planned results are not achieved, corrective action
shall be taken, as appropriate, to ensure conformity of the
service.

8.2.4 Monitoring and There is considerable overlap between this clause and the
Measurement of Product previous one. In many cases, the same monitoring or
measurement procedures will be adequate for the purposes of
monitoring or measuring processes and products/services.

8.3 Control of Non- The standard requires you to have ways to identify a product or
conforming product service non-conformity and to decide what to do about it. You
need to have a documented procedure describing how you
comply with the requirements and to record any such activities.
When non-conforming product is corrected it shall be subject to
re-verification to demonstrate conformity to the requirements.

8.4 Analysis of Data Analysing data is an essential activity for any possible
improvement in the quality management system, in the
processes and in the product/service. The organisation shall
determine, collect and analyse appropriate data to demonstrate
the suitability and effectiveness of the QMS and to evaluate
where continual improvement of the effectiveness of the QMS
can be made. This shall include data generated as a result of
monitoring and measurement and from other relevant sources.
The analysis of data shall provide information on customer
satisfaction; conformity of product/service requirements;
characteristics and trends of processes and products including
opportunities for preventive action; and suppliers.

8.5.1 Continual Continual improvement is the process of taking actions on a

Improvement recurring basis to implement agreed solutions that should bring
positive benefits. The organisation shall continually improve the
effectiveness of the QMS through the use of the quality policy,
quality objectives, audit results, analysis of data, corrective and
preventive actions and management review.

8.5.2 Corrective Action Corrective action is an important improvement activity.

Corrective action identifies measures needed to correct
identified problems. It seeks to eliminate permanently, the
causes and consequent effects of problems that could have a
negative impact on business results; the organisation’s
products/services, processes and QMS; and the satisfaction of
customers. Corrective action involves finding the cause of a
particular problem and then putting in place the necessary
actions to prevent it from recurring.

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ISO 9001:2000
ISO 9001:2000 Clauses Description

8.5.3 Preventive Action Preventive action seeks to prevent the occurrence of potential
problems that could have a negative effect on business results,
products/services, processes, QMS or customer satisfaction. A
documented procedure shall define requirements for determining
potential non-conformities and their causes; evaluating the need
for action to prevent occurrence of non-conformities;
determining and implementing action needed; records of the
results of action taken; and reviewing preventive action taken.

# Check Your Progress Exercise 2

Note: a) Use the space below for your answers.
b) Check your answers with those given at the end of the unit.
1) What are the mandatory procedures as per ISO 9001:2000? Group them
under three relevant groups.
……………………………………………………………………….………
……………………………………………………………………….………
……………………………………………………………………….………
……………………………………………………………………………….

2) Name six records required to be maintained as per ISO 9001:2000 related

to a product.
……………………………………………………………………….………
……………………………………………………………………….………
……………………………………………………………………………….
……………………………………………………………………………….

3) List the salient changes effected in ISO 9001:2000 as compared to year

1994 version of ISO 9001.
……………………………………………………………………….………
……………………………………………………………………….………
……………………………………………………………………….………
……………………………………………………………………………….

4) List the layers in the structure of a typical quality management system and
briefly explain the role of each layer.
……………………………………………………………………….………
……………………………………………………………………………….
……………………………………………………………………….………
……………………………………………………………………………….
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5) List two major clauses (and sub-clauses therein) pertaining to management ISO 9001:2000 - Structure
domain in ISO 9001:2000.
……………………………………………………………………….………
……………………………………………………………………….………
……………………………………………………………………….………
……………………………………………………………………………….

5.4 LET US SUM UP

The objective of ISO certification is to implement quality management system
in organization. The documentation structure consists of seven layers. It starts
with macro level quality manual through procedures and process plans, etc., to
micro-level records which are maintained on formats. The eight clauses given
in the standards are: (i) Scope, (ii) Normative references, (iii) Terms and
definitions, (iv) Quality Management System, (v) Management Responsibility,
(vi) Resource Management, (vii) Product realization, and (viii) Measurement,
analysis and improvements. The important clauses pertaining to management
domain are management responsibility and resource management.
This Unit prepares us to go into the depth of the documentation structure and
clauses which will familiarize us with the use or application of the standard.

5.5 KEY WORDS

Quality : Degree to which a set of inherent characteristics fulfils

requirements.
Requirement : Need or expectation that is stated, generally implied or
obligatory.
Quality : Management system to direct and control an organisation
Management with respect to quality.
System
Corrective : Action to eliminate the cause of a detected non-
Action conformity or other undesirable situation.
Preventive : Action to eliminate the cause of a potential non-
Action conformity or other undesirable potential situation.
Competence : Demonstrated ability to apply knowledge and skills.
Effectiveness : Extent to which planned activities are realized and
planned results achieved.
Product : Result of a process.
Document : Information and its supporting medium.
Record : Document stating results achieved or providing evidence
of activities performed.
Customer : Customer’s perception of the degree to which the
Satisfaction customer’s requirements have been fulfilled.
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ISO 9001:2000
# 5.6 ANSWERS TO CHECK YOUR PROGRESS
EXERCISES
Your answer should include following points:
Check Your Progress Exercise 1
1) ● Quality Manual
• Mandatory Procedures
• Standard Operating Procedures
• Process Definition Documents
• Work Instructions
• Miscellaneous Documents
• Formats and Records
2) Quality manual is a document which explains how the requirements of ISO
9001:2000 are planned to be fulfilled by the organisation taking into
consideration the type of product/service offered, complexity of processing
methods, competence of operating personnel and number of sites where the
Quality Management System is implemented.

Check Your Progress Exercise 2

1) The six mandatory procedures are:
• Control of documents
• Control of records
• Internal audit
• Control of non-conformity
• Corrective action
• Preventive action
They can be regrouped under following three groups:
i) Control of documents (including records), procedure.
ii) Internal audit, procedures.
iii) Non-conformance management, (including non-conforming products
and subsequent corrective and preventive actions), procedure.
2) Following six records are required to be maintained with regard to (w.r.t.) a
product:
i) Product design change review
ii) Corrections of non-conforming products
iii) Verification of purchased product
iv) Identification of product where traceability is a requirement
v) Release of end product
vi) Receipt and issue of material/products in stores.
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3) Following are the salient changes effected in ISO 9001:2000 vis-à-vis year ISO 9001:2000 - Structure
1994 version:
i) The standard is based on eight quality management principles.
ii) The focus has been shifted from product manufacturing organisations to
product and service offering organisations.
iii) The emphasis is on performance improvement as compared to earlier
emphasis on conformance.
iv) The documentation has been optimized because of adoption of process
approach.
v) PDCA cycle is to be used as a tool for implementation and
improvement of the Quality Management System.

4) Layers in the structure of a typical quality management system and role of

each layer is as follows:
i) Quality Manual – describes how an Organisation plans to fulfill ISO
9001:2000 requirements.
ii) Mandatory Procedures – describe how mandatory quality management
related activities are planned, documented for implementation.
iii) Standard Operating Procedures – describe how operational activities
are planned w.r.t. each key function.
iv) Process Definition Documents – describes how process approach is
evidenced in processes of quality management system.
v) Work Instructions – describe how micro-activities are to be carried out.
vi) Miscellaneous documents – describe the elements which are not part of
other documentation categories but are important in smooth functioning
of quality management system.
vii) Formats and records – give evidence of activities carried out as per
defined quality management system.

5) The two major ISO 9001:2000 clauses (and sub-clauses therein) pertaining
to management domain are as follows:
Clause 5 viz., Management responsibility and Clause 6 viz., Resource
management
The corresponding sub-clauses are:
Under “Management responsibility” as follows:
5.1 Management Commitment
5.2 Customer Focus
5.3 Quality Policy
5.4 Planning
5.5 Responsibility, Authority and Communication
5.6 Management Review
Under “Resource management” as follows:
6.1 Provision of Resources
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ISO 9001:2000 6.2 Human Resources
6.3 Infrastructure
6.4 Work Environment

5.7 SUGGESTED READING

http://www.iso.org

ISO 19011:2002 – Guidelines for Quality and /or Environmental Management

Systems Auditing.
ISO 9000:2000 – Quality Management Systems - Fundamentals and
Vocabulary.
ISO 10012:2003 – Quality Assurance Requirements for Measuring Equipment.
ISO 9004:2000 – Quality Management Systems - Guidelines for Performance
Improvements.
ISO 10013:1995 – Guidelines for Developing Quality Manuals.

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