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1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN ISO 9001:2000 The E
2、uropean Standard EN ISO 9001:2000 has the status of a British Standard ICS 03.120.10 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Quality management systems Requirements This British Standard, having been prepared under the direction of the Management Systems Sector Committ
3、ee, was published under the authority of the Standards Committee and comes into effect on 15 December 2000 BSI 12-2000 ISBN 0 580 36837 8 BS EN ISO 9001:2000 Amendments issued since publication Amd. No.DateComments National foreword This British Standard is the official English language version of E
4、N ISO 9001:2000. It is identical with ISO 9001:2000. It supersedes BS EN ISO 9001:1994, BS EN ISO 9002:1994 and BS EN ISO 9003:1994 which are now obsolescent. For detailed information on the ISO 9000:2000 family of standards, including Frequently Asked Questions, Transition Planning Guidance and Gui
5、dance on the Documentation Requirements of ISO 9001:2000 please refer to the following websites which are updated on a regular basis: www.bsi.org.uk/iso-tc176-sc2 carries detailed information on the ISO 9001/ISO 9004 revision programme; www.iso.ch carries general information regarding the ISO 9000:2
6、000 series revision programme; www.tc176.org includes general information on the structure and work programme of ISO/TC176 including links to related password-protected and public websites. The UK participation in its preparation was entrusted by Technical Committee QS/1, Quality management and qual
7、ity assurance procedures, to Subcommittee QS/1/-/18, Consistent pair of QM and QA standards, which has the responsibility to: aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the U
8、K interests informed; monitor related international and European developments and promulgate them in the UK. A list of organizations represented on this subcommittee can be obtained on request to its secretary. Cross-references Attention is drawn to the fact that CEN and CENELEC Standards normally i
9、nclude an annex which lists normative references to international publications with their corresponding European publications. The British Standards which implement these international or European publications may be found in the BSI Standards Catalogue under the section entitled International Stand
10、ards Correspondence Index, or by using the Find facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard
11、does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, the EN ISO title page, the EN ISO foreword page (2 pages), a blank page, the ISO title page, pages ii to vii, a blank page, pages 1 to 23, the annex ZA page, an i
12、nside back cover and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 9001 December 2000 ICS 00.012.10Supersedes EN ISO 9001:1994, EN ISO 9002:1994 and EN ISO 9003:1994 English vers
13、ion Quality management systems - Requirements (ISO 9001:2000) Systmes de management de la qualit - Exigences (ISO 9001:2000) Qualittsmanagementsysteme - Forderungen (ISO 9001:2000) This European Standard was approved by CEN on 15 December 2000. CEN members are bound to comply with the CEN/CENELEC In
14、ternal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Management Centre or to any CEN membe
15、r. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the official versions. CEN members ar
16、e the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUR
17、OPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2000 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 9001:2000 E Foreword The text of the International Standard ISO 9001:2000 has been prepared
18、by Technical Committee ISO/TC 176 “Quality management and quality assurance“, Subcommittee 2 “Quality systems”. The transposition into a European Standard has been managed by the CEN Management Centre (CMC) with the assistance of CEN/BT WG 107. This European Standard supersedes EN ISO 9001:1994, EN
19、ISO 9002:1994 and EN ISO 9003:1994. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by June 2001, and conflicting national standards shall be withdrawn at the latest by June 2001. NOTE The following
20、is specifically intended for organizations that need to comply with “New Approach” European Directives in order to affix CE marking on their products and to the other parties involved in that process. The publication of EN ISO 9001:2000 has implications for Council Decision 93/465/EEC of 22 July 199
21、3 concerning the modules for the various phases of the conformity assessment procedures and the rules for affixing and use of the CE conformity marking, which are intended to be used in the technical harmonization directives. It is important to note that the modules used in individual technical harm
22、onization directives may vary in some respects compared to those described in Council Decision 93/465/EEC. In all cases, it is the annex of the applicable directive(s) which is legally binding. The principles set out in this foreword remain valid regardless of these variations. Three of the modules
23、cited in Council Decision, i.e. modules E, D and H, require that “the manufacturer must operate an approved quality system”. The scope of the quality systems required by these modules addresses: - Final product inspection and testing (module E) - Production, final inspection and testing (module D),
24、- Design manufacture and final product inspection and testing (module H). Council decision 93/465/EEC specifies that conformity to the harmonized standards EN 29001, EN 29002 or EN 29003 provides a presumption of conformity to the relevant requirements of modules H, D and E. EN 29001, EN 29002 and E
25、N 29003 were superseded by EN ISO 9001:1994, EN ISO 9002:1994 and EN ISO 9003:1994 respectively, which in turn are now superseded by EN ISO 9001:2000. Where organizations wish to implement quality management systems in conformance with modules E, D or H, they may use EN ISO 9001:2000. In seeking com
26、pliance with modules D, E or H organizations may exclude specific requirements. Only those requirements in clause 7 of EN ISO 9001:2000 pertaining to the difference between modules E, D and H may be excluded whilst retaining the presumption of conformity. Module E Permissible exclusions Module D Per
27、missible exclusions Module H Permissible exclusions Sub-clause 7.1: planning of product realization Sub-clause 7.2.3: customer communication Sub-clause 7.3: design and development Sub-clause 7.4 purchasing Sub-clause 7.5.1: control of production and service provision Sub-clause 7.5.2: validation of
28、processes for production and service provision Sub-clause 7.5.3: Identification and traceability Sub-clause 7.3: design and development NO exclusions permitted It should be noted that no explicit requirements in modules H, D and E relate to the concepts of “customer satisfaction” and “continual impr
29、ovement”. As a consequence, non compliance with requirements of EN ISO 9001:2000 explicitly related to these concepts does not infringe upon the presumption of conformity to the appropriate module EN ISO 9001:2000 It should be noted that where the exclusions described in sub-clause 1.2 of EN ISO 900
30、1:2000 are exceeded, conformity to EN ISO 9001:2000 shall not be claimed. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germ
31、any, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of the International Standard ISO 9001:2000 has been approved by CEN as a European Standard without any modifications. NOTE: Normative refer
32、ences to International Standards are listed in annex ZA (normative). (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 comm
33、ittees. 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
34、International Electronical 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 bod
35、ies 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 i
36、dentifying 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
37、 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 revis
38、ed 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 Intern
39、ational Standard are for information only. EN ISO 9001:2000 EN ISO 9001:2000 INTERNATIONAL STANDARD ISO 9001 Third edition 2000-12-15 Reference number ISO 9001:2000(E) Quality management systems Requirements Systmes de management de la qualit Exigences EN ISO 9001:2000 ii EN ISO 9001:2000 iii Conten
40、tsPage 1Scope .1 1.1General 1 1.2Application .1 2Normative reference .1 3Terms and definitions 1 4Quality management system 2 4.1General requirements 2 4.2Documentation requirements 2 5Management responsibility .3 5.1Management commitment .3 5.2Customer focus .4 5.3Quality policy .4 5.4Planning .4 5
41、.5Responsibility, authority and communication 4 5.6Management review 5 6Resource management 5 6.1Provision of resources .5 6.2Human resources 6 6.3Infrastructure .6 6.4Work environment 6 7Product realization 6 7.1Planning of product realization 6 7.2Customer-related processes .7 7.3Design and develo
42、pment .8 7.4Purchasing .9 7.5Production and service provision .10 7.6Control of monitoring and measuring devices .11 8Measurement, analysis and improvement 11 8.1General 11 8.2Monitoring and measurement 11 8.3Control of nonconforming product .12 8.4Analysis of data .13 8.5Improvement 13 Annexes ACor
43、respondence between ISO 9001:2000 and ISO 14001:199615 BCorrespondence between ISO 9001:2000 and ISO 9001:1994 19 Bibliography.23 EN ISO 9001:2000 iv Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work
44、 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-governmen
45、tal, 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
46、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 Interna
47、tional 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
48、 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 e
49、xcluding 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. EN ISO 9001:2000 v Introduction 0.1General The adoption of a quality management system should be a strategic decision of an organ