INTERNATIONAL
STANDARD
ISO
9001
Third edition
2000-12-15
Reference number
ISO 9001:2000(E)
©
ISO 2000
Quality management systems —
Requirements
Systèmes de management de la qualité — Exigences
ISO 9001:2000(E)
ii
©
ISO 2000 – All rights reserved
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ISO 9001:2000(E)
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ISO 2000 – All rights reserved
iii
Contents Page
1 Scope ............................................................................................................................................................... 1
1.1 General .......................................................................................................................................................... 1
1.2 Application ..................................................................................................................................................... 1
2 Normative reference ......................................................................................................................................... 1
3 Terms and definitions ........................................................................................................................................ 1
4 Quality management system ............................................................................................................................ 2
4.1 General requirements .................................................................................................................................... 2
4.2 Documentation requirements ........................................................................................................................ 2
5 Management responsibility ............................................................................................................................... 3
5.1 Management commitment ............................................................................................................................. 3
5.2 Customer focus ............................................................................................................................................. 4
5.3 Quality policy ................................................................................................................................................. 4
5.4 Planning ......................................................................................................................................................... 4
5.5 Responsibility, authority and communication ................................................................................................ 4
5.6 Management review ...................................................................................................................................... 5
6 Resource management .................................................................................................................................... 5
6.1 Provision of resources ................................................................................................................................... 5
6.2 Human resources .......................................................................................................................................... 6
6.3 Infrastructure ................................................................................................................................................. 6
6.4 Work environment .......................................................................................................................................... 6
7 Product realization ............................................................................................................................................ 6
7.1 Planning of product realization ...................................................................................................................... 6
7.2 Customer-related processes ......................................................................................................................... 7
7.3 Design and development ............................................................................................................................... 8
7.4 Purchasing ..................................................................................................................................................... 9
7.5 Production and service provision ................................................................................................................. 10
7.6 Control of monitoring and measuring devices ............................................................................................. 11
8 Measurement, analysis and improvement ...................................................................................................... 11
8.1 General ........................................................................................................................................................ 11
8.2 Monitoring and measurement ...................................................................................................................... 11
8.3 Control of nonconforming product ............................................................................................................... 12
8.4 Analysis of data ........................................................................................................................................... 13
8.5 Improvement ................................................................................................................................................ 13
Annexes
A Correspondence between ISO 9001:2000 and ISO 14001:1996.................................................................... 15
B Correspondence between ISO 9001:2000 and ISO 9001:1994 .................................................................... 19
Bibliography........................................................................................................................................................... 23
ISO 9001:2000(E)
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ISO 2000 – All rights reserved
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO
member bodies). The work of preparing International Standards is normally carried out through ISO technical
committees. Each member body interested in a subject for which a technical committee has been established has
the right to be represented on that committee. International organizations, governmental and non-governmental, in
liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical
Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3.
Draft International Standards adopted by the technical committees are circulated to the member bodies for voting.
Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this International Standard may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
International Standard ISO 9001 was prepared by Technical Committee ISO/TC 176,
Quality management and
quality assurance
, Subcommittee SC 2,
Quality systems
.
This third edition of ISO 9001 cancels and replaces the second edition (ISO 9001:1994) together with
ISO 9002:1994 and ISO 9003:1994. It constitutes a technical revision of these documents. Those organizations
which have used ISO 9002:1994 and ISO 9003:1994 in the past may use this International Standard by excluding
certain requirements in accordance with 1.2.
The title of ISO 9001 has been revised in this edition and no longer includes the term “Quality assurance”. This
reflects the fact that the quality management system requirements specified in this edition of ISO 9001, in addition to
quality assurance of product, also aim to enhance customer satisfaction.
Annexes A and B of this International Standard are for information only.
ISO 9001:2000(E)
©
ISO 2000 – All rights reserved
v
Introduction
0.1 General
The adoption of a quality management system should be a strategic decision of an organization. The design and
implementation of an organization's quality management system is influenced by varying needs, particular
objectives, the products provided, the processes employed and the size and structure of the organization. It is not the
intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity
of documentation.
The quality management system requirements specified in this International Standard are complementary to
requirements for products. Information marked “NOTE” is for guidance in understanding or clarifying the associated
requirement.
This International Standard can be used by internal and external parties, including certification bodies, to assess the
organization's ability to meet customer, regulatory and the organization's own requirements.
The quality management principles stated in ISO 9000 and ISO 9004 have been taken into consideration during the
development of this International Standard.
0.2 Process approach
This International Standard promotes the adoption of a process approach when developing, implementing and
improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer
requirements.
For an organization to function effectively, it has to identify and manage numerous linked activities. An activity using
resources, and managed in order to enable the transformation of inputs into outputs, can be considered as a
process. Often the output from one process directly forms the input to the next.
The application of a system of processes within an organization, together with the identification and interactions of
these processes, and their management, can be referred to as the “process approach”.
An advantage of the process approach is the ongoing control that it provides over the linkage between the individual
processes within the system of processes, as well as over their combination and interaction.
When used within a quality management system, such an approach emphasizes the importance of
a) understanding and meeting requirements,
b) the need to consider processes in terms of added value,
c) obtaining results of process performance and effectiveness, and
d) continual improvement of processes based on objective measurement.
The model of a process-based quality management system shown in Figure 1 illustrates the process linkages
presented in clauses 4 to 8. This illustration shows that customers play a significant role in defining requirements as
inputs. Monitoring of customer satisfaction requires the evaluation of information relating to customer perception as
to whether the organization has met the customer requirements. The model shown in Figure 1 covers all the
requirements of this International Standard, but does not show processes at a detailed level.
