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1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN ISO 9004:2000 The E
2、uropean Standard EN ISO 9004:2000 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 Guidelines for performanceimprovements Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 10:48:36 GMT+00:00 2006
3、, Uncontrolled Copy, (c) BSI This British Standard, having been prepared under the direction of the Management Systems Sector Committee, was published under the authority of the Standards Committee and comes into effect on 15 December 2000 BSI 12-2000 ISBN 0 580 36838 6 BS EN ISO 9004:2000 Amendment
4、s issued since publication Amd. No.DateComments National foreword This British Standard is the official English language version of EN ISO 9004:2000. It is identical with ISO 9004:2000. It supersedes BS EN ISO 9004-1:1994 which is withdrawn. For detailed information on the ISO 9000:2000 family of st
5、andards, including Frequently Asked Questions, Transition Planning Guidance and Guidance 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
6、revision programme; www.iso.ch carries general information regarding the ISO 9000:2000 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
7、 preparation was entrusted by Technical Committee QS/1, Quality management and quality 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 com
8、mittee any enquiries on the interpretation, or proposals for change, and keep UK 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-refe
9、rences Attention is drawn to the fact that CEN and CENELEC Standards normally include 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 foun
10、d in the BSI Standards Catalogue under the section entitled International Standards 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
11、 responsible for their correct application. Compliance with a British Standard 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, the ISO title page, pages ii to vi
12、ii, pages 1 to 56, the annex ZA page and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 10:48:36 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPIS
13、CHE NORM EN ISO 9004 December 2000 ICS 00.012.10Supersedes EN ISO 9004-1:1994 English version Quality management systems - Guidelines for performance improvements (ISO 9004:2000) Systmes de management de la qualit - Lignes directrices pour lamlioration des performances (ISO 9004:2000) Qualittsmanage
14、mentsysteme - Leitfaden zur Leistungsverbesserung (ISO 9004:2000) This European Standard was approved by CEN on 15 December 2000. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standa
15、rd 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 member. This European Standard exists in three official versions (English, French, German). A version in any other langu
16、age 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 are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Ice
17、land, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2000 CENAll rights of exploitati
18、on in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 9004:2000 E Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 10:48:36 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Foreword The text of the International Standard ISO 9004:2000 has been prepared by Techn
19、ical Committee ISO/TC 176 “Quality management and quality assurance“, Subcommittee 2, “Quality systems”, in collaboration with the CEN Management Centre (CMC). This European Standard supersedes EN ISO 9004-1:1994. This European Standard shall be given the status of a national standard, either by pub
20、lication 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. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement thi
21、s European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of the International Standard ISO 9004:2000 has been ap
22、proved by CEN as a European Standard without any modifications. NOTE: Normative references 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
23、 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
24、, in liaison with ISO, also take part in the work. ISO collaborates closely with the 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 Interna
25、tional 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
26、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 9004 was prepared by Technical Committee ISO/TC 176, Quality management and quality assurance, Subcommittee SC 2, Quality systems. This second edi
27、tion of ISO 9004 cancels and replaces ISO 9004-1:1994, which has been technically revised. The title has been modified to reflect the comprehensiveness of the quality management system. Many of the existing International Standards within the ISO 9000 family will be reviewed for withdrawal, or for re
28、-issue as Technical Reports, as many of their provisions are incorporated into this International Standard. In comparison to previous editions, ISO 9001 and ISO 9004 now form a consistent pair of standards on quality management. ISO 9001 aims to give quality assurance of product and to enhance custo
29、mer satisfaction, while ISO 9004 uses a broader perspective of quality management to give guidance for performance improvement. Annexes A and B of this International Standard are for information only. EN ISO 9004:2000 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 10:48:36 GMT+00:00 2006, Un
30、controlled Copy, (c) BSI INTERNATIONAL STANDARD ISO 9004 Second edition 2000-12-15 Reference number ISO 9004:2000(E) Quality management systems Guidelines for performance improvements Systmes de management de la qualit Lignes directrices pour lamlioration des performances EN ISO 9004:2000 Licensed C
31、opy: sheffieldun sheffieldun, na, Wed Nov 15 10:48:36 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii EN ISO 9004:2000 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 10:48:36 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iii ContentsPage 1Scope .1 2Normative reference .1 3Terms and definitions 1
32、4Quality management system 2 4.1Managing systems and processes 2 4.2Documentation 3 4.3Use of quality management principles 4 5Management responsibility .5 5.1General guidance 5 5.2Needs and expectations of interested parties .7 5.3Quality policy .9 5.4Planning .10 5.5Responsibility, authority and c
33、ommunication .11 5.6Management review 12 6Resource management 14 6.1General guidance 14 6.2People 15 6.3Infrastructure .17 6.4Work environment 18 6.5Information .18 6.6Suppliers and partnerships 19 6.7Natural resources 19 6.8Financial resources .19 7Product realization 20 7.1General guidance 20 7.2P
34、rocesses related to interested parties .23 7.3Design and development .24 7.4Purchasing .29 7.5Production and service operations 31 7.6Control of measuring and monitoring devices .33 8Measurement, analysis and improvement 34 8.1General guidance 34 8.2Measurement and monitoring 35 8.3Control of noncon
35、formity .40 8.4Analysis of data .41 8.5Improvement 42 EN ISO 9004:2000 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 10:48:36 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iv Annexes AGuidelines for self-assessment.46 BProcess for continual improvement.53 Bibliography.55 EN ISO 9004:2000 Licen
36、sed Copy: sheffieldun sheffieldun, na, Wed Nov 15 10:48:36 GMT+00:00 2006, Uncontrolled Copy, (c) BSI v 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 norma
37、lly 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 th
38、e 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 technic
39、al 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 r
40、ights. ISO shall not be held responsible for identifying any or all such patent rights. International Standard ISO 9004 was prepared by Technical Committee ISO/TC 176,Quality management and quality assurance, Subcommittee SC 2,Quality systems. This second edition of ISO 9004 cancels and replaces ISO
41、 9004-1:1994, which has been technically revised. The title has been modified to reflect the comprehensiveness of the quality management system. Many of the existing International Standards within the ISO 9000 family will be reviewed for withdrawal, or for re-issue as Technical Reports, as many of t
42、heir provisions are incorporated into this International Standard. In comparison to previous editions, ISO 9001 and ISO 9004 now form a consistent pair of standards on quality management. ISO 9001 aims to give quality assurance of product and to enhance customer satisfaction, while ISO 9004 uses a b
43、roader perspective of quality management to give guidance for performance improvement. Annexes A and B of this International Standard are for information only. EN ISO 9004:2000 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 10:48:36 GMT+00:00 2006, Uncontrolled Copy, (c) BSI vi Introduction
44、0.1General The adoption of a quality management system should be a strategic decision by the top management of an organization. The design and implementation of an organizations quality management system is influenced by varying needs, particular objectives, the products provided, the processes empl
45、oyed and the size and structure of the organization. This International Standard is based on eight quality management principles. However, it is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation. The purpos
46、e of an organization is to identify and meet the needs and expectations of its customers and other interested parties (people in the organization, suppliers, owners, society), to achieve competitive advantage, and to do this in an effective and efficient manner, and to achieve, maintain, and improve
47、 overall organizational performance and capabilities. The application of quality management principles not only provides direct benefits but also makes an important contribution to managing costs and risks. Benefit, cost and risk management considerations are important for the organization, its cust
48、omers and other interested parties. These considerations on overall performance of the organization may impact customer loyalty, repeat business and referral, operational results such as revenue and market share, flexible and fast responses to market opportunities, costs and cycle times through effe
49、ctive and efficient use of resources, alignment of processes which will best achieve desired results, competitive advantage through improved organizational capabilities, understanding and motivation of people towards the organizations goals and objectives, as well as participation in continual improvement, confidence of interested parties in the effectiveness and efficiency of the organization, as demonstrated by the financial and social benefits from the organizations performance, product life cycle, and reputation, ability