ISO 10005-2005.pdf

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INTERNATIONAL
STANDARD
ISO
10005
Second edition
2005-06-01
Quality management systems —
Guidelines for quality plans
Systèmes de management de la qualité — Lignes directrices pour les
plans qualité
Reference number
ISO 10005:2005(E)
© ISO 2005
ISO 10005:2005(E)
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© ISO 2005
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Published in Switzerland
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© ISO 2005 – All rights reserved
ISO 10005:2005(E)
Contents
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Scope ....................................................................................................................................................
Normative references ..........................................................................................................................
Terms and definitions ..........................................................................................................................
Development of a quality plan ............................................................................................................
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4.1 Identifying the need for the quality plan ...........................................................................................
4.2 Inputs to the quality plan ....................................................................................................................
4.3 Scope of the quality plan ....................................................................................................................
4.4 Preparation of the quality plan ...........................................................................................................
5
Content of the quality plan .................................................................................................................
5.1 General .................................................................................................................................................
5.2 Scope ....................................................................................................................................................
5.3 Quality plan inputs ..............................................................................................................................
5.4 Quality objectives ................................................................................................................................
5.5 Management responsibilities .............................................................................................................
5.6 Control of documents and data .........................................................................................................
5.7 Control of records ...............................................................................................................................
5.8 Resources ............................................................................................................................................
5.9 Requirements ......................................................................................................................................
5.10
5.11
5.12
5.13
5.14
5.15
5.16
5.17
5.18
5.19
6
Customer communication ................................................................................................................
Design and development ..................................................................................................................
Purchasing .........................................................................................................................................
Production and service provision ....................................................................................................
Identification and traceability .........................................................................................................
Customer property ..........................................................................................................................
Preservation of product ..................................................................................................................
Control of nonconforming product ................................................................................................
Monitoring and measurement ........................................................................................................
Audits ...............................................................................................................................................
Review, acceptance, implementation and revision of the quality plan .........................................
6.1 Review and acceptance of the quality plan ....................................................................................
6.2 Implementation of the quality plan ..................................................................................................
6.3 Revision of the quality plan ..............................................................................................................
6.4 Feedback and improvement .............................................................................................................
Annex A
(informative)
Simplified examples of formats for the presentation of quality plans ............
Annex B
(informative)
Correspondence between ISO 10005:2005 and ISO 9001:2000 .......................
Bibliography ...............................................................................................................................................
© ISO 2005 – All rights reserved
iii
ISO 10005:2005(E)
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 2.
The main task of technical committees is to prepare International Standards. 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 document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 10005 was prepared by Technical Committee ISO/TC 176,
Quality management and quality assurance,
Subcommittee SC 2,
Quality systems.
This second edition cancels and replaces the first edition (ISO 10005:1995). It constitutes a technical revision of
that edition, taking into account ISO 9000:2000, ISO 9001:2000 and ISO 9004:2000.
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© ISO 2005 – All rights reserved
ISO 10005:2005(E)
Introduction
This International Standard was prepared to address the need for guidance on quality plans, either in the
context of an established quality management system or as an independent management activity. In either
case, quality plans provide a means of relating specific requirements of the process, product, project or contract
to work methods and practices that support product realization. The quality plan should be compatible with
other associated plans that may be prepared.
Among the benefits of establishing a quality plan are the increased confidence that requirements will be met,
greater assurance that processes are in control and the motivation it can give to those involved. It may also give
insight into opportunities for improvement.
This International Standard does not replace the guidance given in ISO 9004 or in industry-specific documents.
Where quality plans are required for project applications, the guidance provided in this International Standard is
intended to be complementary to the guidance provided in ISO 10006.
In terms of the process model shown in Figure 1, quality management system planning applies to the whole
model. Quality plans, however, apply primarily to the path from customer requirements, through product
realization and product, to customer satisfaction.
Figure 1 — Model of a process-based quality management system
© ISO 2005 – All rights reserved
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