ISO 9001:2000

Clauses
1.
Scope
2.
Normative
Reference
3.
Terms &
Definitions
4.1
General
Requirements
4.1 a)
4.1 b)
4.1 c)

ISO 9001:2000 Cross Reference Map

Description

Related ITD Procedure

Quality Manual
Quality Manual

Scope of the QMS, areas covered and any exclusions identified

The normative reference ISO 9000:2000 (fundamentals/vocabulary) must be used in
conjunction with the standard itself
The terms and definitions given in ISO 9000 apply.

Quality Manual

This clause covers the requirement of the organisation to 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.

4.1 d)
4.1 e)
4.1 f)
4.2

Documentation
Requirements

5.

5.2

Management
Responsibility
Management
Commitment
Customer Focus

5.3

Quality Policy

5.4

Planning

5.1

5.5

The important issue here is that people must have the 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.
Specifically identifies the responsibility of top management and the need for effective
leadership
Top management shall provide evidence of its commitment to the development and
implementation of the QMS and continually improving its effectiveness
Top management shall ensure that customer requirements are determined and are met with
the aim of enhancing customer satisfaction
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
Top management shall ensure that the planning of the QMS is carried out in order to meet the
requirements of the standard as well as the quality objectives. The integrity of the QMS is
maintained when changes to the QMS are planned and implemented.
Top management shall ensure that responsibility and authorities are defined and
communicated within the organisation. Everybody should know what they are expected to do

Responsibility,
Authority &
ISO 9001:2000 Cross Reference Map

Quality Manual (Section 1.2 & 6)

Quality Manual (Section 6)
Each procedure under
Effectiveness Review section
Quality Manual (Section 4)
Quality Manual (Section 5) and
Management Review
ITD Corrective & Preventive
Action Procedure and
Management Review

Document Control
Procedure

Quality Manual (Section 3)

Quality Policy
Quality Policy
Quality Policy
Quality Manual (Sections
3.1 & 4)
Quality Manual (Section 3)

Revision Date: 1 July 05

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ISO 9001:2000
Clauses
Communication

5.6

Management
Review

Related ITD Procedure

Description
(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.
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.

ISO 9001:2000 Cross Reference Map

Quality Manual (Section 3)

Revision Date: 1 July 05

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ISO 9001:2000
Clauses
6.
Resource
Management
6.1
Provision of
Resources
6.2

Human
Resources

6.3

Infrastructure

6.4

Work
Environment
Planning of
Product
Realisation

7.1

7.2

Customer
Related
Processes

7.3

Design &
Development

Description

Related ITD Procedure

To ensure that the resources needed to both maintain and improve the QMS are available, and
also to carry out the work required in a manner that will satisfy customer requirements.
The organisation shall determine and provide resources needed to implement and maintain the
QMS and continually improve its effectiveness, and to enhance customer satisfaction by
meeting customer requirements
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
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.
The organisation shall determine and manage the work environment needed to achieve
conformity of service
The organisation shall plan and develop the processes needed for 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
The organisation shall determine customer requirements, 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.

Quality Manual (Section 4)

The organisation shall plan and control the design and 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.

ISO 9001:2000 Cross Reference Map

Quality Manual (Section

3.1, 3.4 & 4)
Quality Manual (Section 4)
& Training Procedure.

Quality Manual (Section 4)

Quality Manual (Section 4)

ITD Service Provision
Procedure

ITD Service Provision

Procedure & Quality
Manual (Section 2). ITD
Project Management &
System Development
Procedure
ITD Project Management &
System Development
Procedure

Revision Date: 1 July 05

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ISO 9001:2000
Clauses
7.4
Purchasing

7.5.1

Control of
production &
service provision

7.5.2

Validation of
processes for
production and
service provision
Identification &
Traceability

7.5.3

7.5.4
7.5.5

7.6

Customer
Property
Preservation of
Product
Control of
monitoring &
measuring
devices

Related ITD Procedure

Description
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 reevaluation 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.
This clause describes the various types of controls that you might need to have in place for the
delivery of service. These 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.
ITD do not have any processes where the resulting outputs cannot be verified by subsequent
monitoring and measuring, therefore this clause is excluded

Purchasing Procedure

Where appropriate, the organisation shall identify the 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.
The organisation shall identify, verify, protect and safeguard customer property provided for use
or incorporation into the product/service.
The organisation shall preserve the conformity of the product/service during internal processing
and delivery to the intended destination. This preservation shall include identification, handling,
packaging, storage and protection.

Equipment Management
Procedure

This means having confidence in the equipment used to check your work. This clause applies
to organisations where 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.

ISO 9001:2000 Cross Reference Map

Quality Manual (Section 6)

and related procedures
Excluded

Equipment Management
Procedure
Equipment Management
Procedure; Print Room
Procedure and Post Room
Procedure
Equipment Management
Procedure

Revision Date: 1 July 05

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ISO 9001:2000
Clauses
8.1
Measurement
Analysis &
Improvement

8.2.1

Customer
Satisfaction

8.2.2

Internal Audit

8.2.3

Monitoring &
Measurement of
Processes

8.2.4

Monitoring &
Measurement of
Product
Control of
Nonconforming
product

8.3

Description

Related ITD Procedure

This clause covers the wider monitoring, measurement, analysis and improvement of the
quality management system. The 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.
The organisation shall monitor information relating to customer 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!
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 nonconformities and their causes. Follow-up activities shall
include the verification of the actions taken and the reporting of verification results.
The organisation shall apply suitable methods for monitoring and measuring the QMS
processes. These methods shall 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.
There is considerable overlap between this clause and the previous one. In many cases the
same monitoring or measurement procedures will be adequate for the purposes of monitoring
or measuring both processes and products / services.

Quality Manual (Section 5)

The standard requires you to have ways to identify a product or service nonconformity 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 nonconforming product
is corrected it shall be subject to re-verification to demonstrate conformity to the requirements.

Quality Manual (Section 7),

Print Room Procedure,
Equipment Management
Procedure

ISO 9001:2000 Cross Reference Map

Quality Manual (Section 2)

Internal Audit Procedure

Quality Manual (Section 5)

Quality Manual (Section 5)

Revision Date: 1 July 05

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ISO 9001:2000
Clauses
8.4
Analysis of Data

8.5.1

Continual
Improvement

8.5.2

Corrective Action

8.5.3

Preventive
Action

Description

Related ITD Procedure

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

Quality Manual (Section 6)

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
organisations 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.
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
nonconformities and their causes; evaluating the need for action to prevent occurrence of
nonconformities; determining and implementing action needed; records of the results of action
taken; and reviewing preventive action taken.

ISO 9001:2000 Cross Reference Map

Quality Manual, Quality

Policy, Quality Objectives,
Management Review and
Corrective & Preventive
Action Procedure
Corrective & Preventive
Action Procedure

Corrective & Preventive

Action Procedure

Revision Date: 1 July 05

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