1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN ISO 9004:2000 The European Standard E
2、N 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 performance improvementsThis British Standard, having been prepared under the direction of the Management Systems Sector
3、 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 Amendments issued since publication Amd. No. Date Comments National foreword This British Standard is the official English language ve
4、rsion 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 It supersedes BS EN ISO 9004-1:1994 which is withdrawn.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 standards, including Frequently Asked Questions, Transition Planning Guidance and Guidance on the Documentation Requirements
5、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 9000:2000 series revision programme; www.tc176
6、.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 quality assurance procedures, to Subcommitte
7、e 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 UK interests informed; monitor related intern
8、ational 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 include an annex which lists normative refere
9、nces 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 Standards Correspondence Index”, or by using the
10、 “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 does not of itself confer immunity from
11、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 viii, pages 1 to 56, the annex ZA page and a back cover. The BSI copyright notice displayed in this document indicates wh
12、en the document was last issued.EUROPEANSTANDARD NORMEEUROPENNE EUROPISCHENORM ENISO9004 December2000 ICS00.012.10 SupersedesENISO90041:1994 Englishversion QualitymanagementsystemsGuidelinesforperformance improvements(ISO9004:2000) SystmesdemanagementdelaqualitLignesdirectrices pourlamliorationdespe
13、rformances(ISO9004:2000) QualittsmanagementsystemeLeitfadenzur Leistungsverbesserung(ISO9004:2000) ThisEuropeanStandardwasapprovedbyCENon15December2000. CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEurope an Standardthestatusofanationalstanda
14、rdwithoutanyalteration.Uptodatelistsandb bliographicalreferencesconcernings uchnational standardsmaybeobtainedonapplicationtotheManagementCentreortoanyCENmember. ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).Aversioninanyotherlanguagemadebytra nslation undertheresponsibili
15、tyofaCENmemberintoitsownlanguageandnotifiedtotheManagementCentrehasthesamestatusasthe official versions. CENmembersarethenationalstandardsbodiesofAustria,Belgium,CzechRepublic,Denmark,Finland,France,Germany,Greece, Iceland,Ireland,Italy,Luxembourg,Netherlands,Norway,Portugal,Spain,Sweden,Switzerland
16、andUnitedKingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeStassart,36B1050Brussels 2000CEN Allrightsofexploitationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.ENISO9004:2000EForeword ThetextoftheIntern
17、ationalStandardISO9004:2000hasbeenpreparedbyTechnical CommitteeISO/TC176“Qualitymanagementandqualityassurance“,Subcommittee2, “Qualitysystems”,incollaborationwiththeCENManagementCentre(CMC). ThisEuropeanStandardsupersedesENISO90041:1994. ThisEuropeanStandardshallbegiventhestatusofanationalstandard,e
18、itherbypublication ofanidenticaltextorbyendorsement,atthelatestbyJune2001,andconflictingnational standardsshallbewithdrawnatthelatestbyJune2001. AccordingtotheCEN/CENELECInternalRegulations,thenationalstandardsorganizationsof thefollowingcountriesareboundtoimplementthisEuropeanStandard:Austria,Belgi
19、um, CzechRepublic,Denmark,Finland,France,Germany,Greece,Iceland,Ireland,Italy, Luxembourg,Netherlands,Norway,Portugal,Spain,Sweden,SwitzerlandandtheUnited Kingdom. Endorsementnotice ThetextoftheInternationalStandardISO9004:2000hasbeenapprovedbyCENasa EuropeanStandardwithoutanymodifications. NOTE:Nor
20、mativereferencestoInternationalStandardsarelistedinannexZA(normative). (ISO)(theInternationalOrganizationforStandardization)isaworldwidefederationofnational standardsbodies(ISOmemberbodies).TheworkofpreparingInternationalStandardsis normallycarriedoutthroughISOtechnicalcommittees.Eachmemberbodyinter
21、estedina subjectforwhichatechnicalcommitteehasbeenestablishedhastherighttoberepresented onthatcommittee.Internationalorganizations,governmentalandnongovernmental,in liaisonwithISO,alsotakepartinthework.ISOcollaboratescloselywiththeInternational ElectronicalCommission(IEC)onallmattersofelectrotechnic
22、alstandardization. InternationalStandardsaredraftedinaccordancewiththerulesgivenintheISO/IEC Directives,Part3. DraftInternationalStandardsadoptedbythetechnicalcommitteesarecirculatedtothe memberbodiesforvoting.PublicationasanInternationalStandardrequiresapprovalbyat least75%ofthememberbodiescastinga
23、vote. AttentionisdrawntothepossibilitythatsomeoftheelementsofthisInternationalStandard maybethesubjectofpatentrights.ISOshallnotbeheldresponsibleforidentifyinganyorall suchpatentrights. InternationalStandardISO9004waspreparedbyTechnicalCommitteeISO/TC176, Quality managementandqualityassurance ,Subco
24、mmitteeSC2, Qualitysystems. ThissecondeditionofISO9004cancelsandreplacesISO90041:1994,whichhasbeen technicallyrevised.Thetitlehasbeenmodifiedtoreflectthecomprehensivenessofthe qualitymanagementsystem.ManyoftheexistingInternationalStandardswithintheISO9000 familywillbereviewedforwithdrawal,orforreiss
25、ueasTechnicalReports,asmanyoftheir provisionsareincorporatedintothisInternationalStandard. Incomparisontopreviouseditions,ISO9001andISO9004nowformaconsistentpairof standardsonqualitymanagement.ISO9001aimstogivequalityassuranceofproductandto enhancecustomersatisfaction,whileISO9004usesabroaderperspec
26、tiveofquality managementtogiveguidanceforperformanceimprovement. AnnexesAandBofthisInternationalStandardareforinformationonly. ENISO9004:2000INTERNATIONAL STANDARD ISO 9004 Second edition 2000-12-15 Reference number ISO 9004:2000(E) Quality management systems Guidelines for performance improvements
27、Systmes de management de la qualit Lignes directrices pour lamlioration des performances ENISO9004:2000ii ENISO9004:2000iii Contents Page 1 Scope . 1 2 Normative reference . 1 3 Terms and definitions 1 4 Quality management system 2 4.1 Managing systems and processes 2 4.2 Documentation 3 4.3 Use of
28、quality management principles 4 5 Management responsibility . 5 5.1 General guidance 5 5.2 Needs and expectations of interested parties . 7 5.3 Quality policy . 9 5.4 Planning . 10 5.5 Responsibility, authority and communication . 11 5.6 Management review 12 6 Resource management 14 6.1 General guid
29、ance 14 6.2 People 15 6.3 Infrastructure . 17 6.4 Work environment 18 6.5 Information . 18 6.6 Suppliers and partnerships 19 6.7 Natural resources 19 6.8 Financial resources . 19 7 Product realization 20 7.1 General guidance 20 7.2 Processes related to interested parties . 23 7.3 Design and developm
30、ent . 24 7.4 Purchasing . 29 7.5 Production and service operations 31 7.6 Control of measuring and monitoring devices . 33 8 Measurement, analysis and improvement 34 8.1 General guidance 34 8.2 Measurement and monitoring 35 8.3 Control of nonconformity . 40 8.4 Analysis of data . 41 8.5 Improvement
31、42 ENISO9004:2000iv Annexes A Guidelines for self-assessment . 46 B Process for continual improvement. 53 Bibliography. 55 ENISO9004:2000v Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of prepari
32、ng 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 lia
33、ison 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 Internation
34、al 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 Stan
35、dard 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,S ub co m mi tte eSC2,Quality systems. This second editi
36、on 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-i
37、ssue 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 custome
38、r 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. ENISO9004:2000vi Introduction 0.1 General The adoption of a quality management system should be a str
39、ategic 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 employed and the size and structure of the organization. This Internationa
40、l 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 purpose of an organization is to identify and meet the needs and expectation
41、s 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 overall organizational performance and capabilities. The application
42、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 customers and other interested parties. These considerations on overall pe
43、rformance 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 effective and efficient use of resources, alignment of processes which wil
44、l 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 effi
45、ciency of the organization, as demonstrated by the financial and social benefits from the organizations performance, product life cycle, and reputation, ability to create value for both the organization and its suppliers by optimization of costs and resources as well as flexibility and speed of join
46、t responses to changing markets. 0.2 Process approach This International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness and efficiency of a quality management system to enhance interested party satisfaction by meeting interested par
47、ty requirements. For an organization to function effectively and efficiently, 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, is 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 and managing of the
