BS EN ISO 9000-1-1994 Quality management and quality assurance standards - Guidelines for selection and use《质量管理和质量保证标准 选择和使用导则》.pdf

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1、BRITISH STANDARD BS EN ISO 9000-1:1994 Quality management and quality assurance standards Part 1: Guidelines for selection and use Formerly BS 5750-0.1 The European Standard EN ISO 9000-1:1994 has the status of a British Standard ICS 03.120.10BSEN ISO 9000-1:1994 This British Standard, having been p

2、repared under the direction of the Quality, Management and Statistics Standards Policy Committee, was published under the authority of the Standards Board and comes into effect on 1 July 1994 BSI 10-1998 The following BSI references relate to the work on this standard: Committee reference QMS/22 Dra

3、ft for comment 93/408100 DC ISBN 0 580 23438 X Committees responsible for this British Standard The preparation of this British Standard was entrusted by the Quality, Management and Statistics Standards Policy Committee (QMS/-) to Technical Committee QMS/22, upon which the following bodies were repr

4、esented: Associated Offices Technical Committee Electricity Association Association of British Certification Bodies Electronic Components Industry Federation Association of British Health-care Industries Energy Industries Council Association of British Mining Equipment Engineering Equipment and Mate

5、rials Users Companies Association Association of Consulting Engineers Federation of Small Businesses Association of Consulting Scientists GAMBICA (BEAMA Ltd.) Association of Field Service Managers Guildford County College of Technology International (UK) Southern Health and Safety Executive BEAMA Lt

6、d. Information Systems Quality Association Bristol Quality Centre Institute of Chartered Accountants British Approvals Service for Cables Institute of Management British Gas plc Institute of Quality Assurance British Marine Industries Federation Institute of Trading Standards Administration British

7、Maritime Technology Institution of Chemical Engineers British Nuclear Fuels plc Institution of Electrical Engineers British Paper and Board Industry Federation Institution of Mechanical Engineers British Photographic Association International Atomic Energy Agency British Quality Foundation Mercury C

8、ommunications Limited British Railways Board Ministry of Defence British Steel Industry National Accreditation Council of Certification British Surgical Trades Association Bodies British Telecommunications plc National Association of Plumbing, Heating and British Welded Steel Tube Association Mechan

9、ical Services Contractors Centre for Advanced Maritime Studies National House-building Council Ceramic Industry Certification Scheme Ltd. National Quality Development Support Chemical Industries Association Network Computing Services Association Peratec Limited Confederation of British Industry Powe

10、r Generation Contractors Association Consumer Policy Committee of BSI (PGCA) (BEAMA Ltd.) Consumers Association Royal Institution of Chartered Surveyors Defence Manufacturers Association Society of British Aerospace Companies Department of the Environment (Quality Limited Competition and Attestation

11、 Branch) Society of Engineers Incorporated Department of Trade and Industry Society of Motor Manufacturers and Traders (Namas Executive) Limited EEA (the Association of the Electronics, University of Salford Telecommunications and Business Water Services Association of England and Equipment Industri

12、es) Wales West Midlands Enterprise Board Amendments issued since publication Amd. No. Date CommentsBSENISO9000-1:1994 BSI 10-1998 i Contents Page Committees responsible Inside front cover National foreword ii Foreword 2 Introduction 3 1 Scope 3 2 Normative reference 3 3 Definitions 3 4 Principal con

13、cepts 4 5 Roles of documentation 9 6 Quality system situations 9 7 Selection and use of International Standards on quality 10 8 Selection and use of International Standards for external quality assurance 13 Annex A (normative) Terms and definitions taken from ISO 8402:1994 15 Annex B (informative) P

14、roduct and process factors 16 Annex C (informative) Proliferation of standards 16 Annex D (informative) Cross-reference list of clause numbers for corresponding topics 18 Annex E (informative) Bibliography 19 Figure 1 All work is accomplished by a process 7 Figure 2 Supply-chain relationship of proc

15、esses, with product-related and information-related flow 8 Figure C.1 Activity matrix for quality assurance standards 17 Table 1 Relationships of organizations in the supply chain 4 List of references Inside back coverBSEN ISO 9000-1:1994 ii BSI 10-1998 National foreword This Part of BS EN ISO 9000

16、has been prepared under the direction of the Quality, Management and Statistics Standards Policy Committee. It has been developed in the interests of international harmonization and international trade and is identical with ISO 9000-1:1994 Quality management and quality assurance standards Part 1: G

17、uidelines for selection and use, published by the International Organization for Standardization (ISO). It supersedes BS 5750-0.1:1987 which is withdrawn. This standard has been revised in the light of user experiences with BS 5750-0.1:1987 in the UK and ISO 9000-1:1987 internationally. During the r

18、evision process, account was taken of the Vision 2000 1)strategy for the longer term development of the ISO 9000 family of quality standards which was adopted by ISO Technical Committee ISO/TC 176, Quality management and quality assurance, in 1990. In 1994 the European Committee for Standardization

19、(CEN) accepted ISO 9000-1:1994 as European Standard EN ISO 9000-1. Cross-references International standard Corresponding British Standard Normative reference ISO 8402:1994 BS 4778 Quality vocabulary Part 1:1987 International terms (Identical) 2) Informative references BS 5750 Quality systems ISO 900

20、0-3:1991 Part 13:1991 Guide to the application of BS 5750-1 to the development, supply and maintenance of software (Identical) ISO 9000-4:1993 Part 14:1993 Guide to dependability programme management (Identical) ISO 9001:1994 BS EN ISO 9001:1994 Quality systems Specification for design, development,

21、 production, installation and servicing (Identical) ISO 9002:1994 BS EN ISO 9002:1994 Quality systems Specification for production, installation and servicing (Identical) ISO 9003:1994 BS EN ISO 9003:1994 Quality systems Specification for final inspection and test (Identical) ISO 9004-1:1994 BS EN I

22、SO 9004-1 Quality management and quality system elements Part 1:1994 Guidelines (Identical) ISO 9004-2:1991 BS 5750 Quality systems Part 8:1994 Guide to quality management and quality systems elements for services (Identical) 1) Available from BSI as PD 6538:1993 Vision 2000. A strategy for internat

23、ional standards implementation in the quality arena during the 1990s. 2) BS 4778-1:1987 is identical with ISO 8402:1986. ISO 8402:1994 is under consideration for implementation as a revisions to BS 4778-1.BSENISO9000-1:1994 BSI 10-1998 iii ISO 9004-4:1993 BS 7850 Total quality management Part 2:1992

24、 Guidelines for quality improvement (Identical) BS 7229 Quality systems auditing ISO 10011-1:1991 Part 1:1991 Auditing (Identical) ISO 10011-2:1991 Part 2:1991 Qualification criteria for auditors (Identical) ISO 10011-3:1991 Part 3:1991 Management of audit programmes (Identical) ISO 10012-1:1992 BS

25、5781 Quality assurance requirements for measuring equipment Part 1:1992 Metrological confirmation system for measuring equipment (Identical) A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct applica

26、tion. 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, pages i to iv, theENtitle page, pages 2 to 20, an inside back cover and a back cover. This standard has been updated (see

27、 copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on theinside front cover.iv blankEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 9000-1 July 1994 ICS 03.120.10 Supersedes EN 29000:1987 Descriptors: Quality management, quality assuranc

28、e, quality audit, quality systems, general conditions English version Quality management and quality assurance standards Part 1: Guidelines for selection and use (ISO 9000-1:1994) Normes pour la gestion de la qualit et lassurance de la qualit Partie 1: Lignes directrices pour la slection et lutilisa

29、tion (ISO 9000-1:1994) Normen zur Qualittsmanagement und zur Darlegung von Qualittsmanagementsystemen Teil 1: Leitfaden zur Auswahl und Anwendung (ISO 9000-1:1994) This European Standard was approved by CEN on 1994-06-20. CEN members are bound to comply with the CEN/CENELEC Internal Regulations whic

30、h 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 Central Secretariat or to any CEN member. This European Stan

31、dard 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 Central Secretariat has the same status as the official versions. CEN members are the national stan

32、dards bodies of Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CEN European Committee for Standardization Comit Europen de Normalisation Europisches Komitee fr Normung Cen

33、tral Secretariat: rue de Stassart 36, B-1050 Brussels 1994 Copyright reserved to CEN members Ref. No. EN ISO 9000-1:1994 EENISO 9000-1:1994 BSI 10-1998 2 Foreword This European Standard has been prepared by ISO/TC 176 “Quality management and quality assurance” of the International Organization for S

34、tandardization (ISO) and was adopted by ISO and CEN following a parallel voting procedure. This European Standard replaces EN 29000:1987. 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 January 19

35、95, and conflicting national standards shall be withdrawn at the latest by January 1995. In accordance with the CEN/CENELEC Internal Regulations, the following countries are bound to implement this European Standard: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Ital

36、y, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.ENISO9000-1:1994 BSI 10-1998 3 Introduction Organizations industrial, commercial or governmental supply products intended to satisfy customers needs and/or requirements. Increased global competition has led t

37、o increasingly more stringent customer expectations with regard to quality. To be competitive and to maintain good economic performance, organizations/suppliers need to employ increasingly effective and efficient systems. Such systems should result in continual improvements in quality and increased

38、satisfaction of the organizations customers and other stakeholders (employees, owners, subsuppliers, society). Customer requirements often are incorporated in “specifications”. However, specifications may not in themselves guarantee that a customers requirements will be met consistently, if there ar

39、e any deficiencies in the organizational system to supply and support the product. Consequently, these concerns have led to the development of quality system standards and guidelines that complement relevant product requirements given in the technical specifications. The International Standards in t

40、he ISO 9000 family are intended to provide a generic core of quality system standards applicable to a broad range of industry and economic sectors (clause 7). The management system of an organization is influenced by the objectives of the organization, by its products and by the practices specific t

41、o the organization and, therefore, quality systems also vary from one organization to another. A major purpose of quality management is to improve the systems and processes so that continual improvement of quality can be achieved. This Part of ISO 9000, which has the role of road map for the ISO 900

42、0 family, has been expanded substantially. In particular, it contains guidance concepts not included in the 1987 version. These additional concepts: are needed for effective understanding and current application of the ISO 9000 family; and are planned for complete integration into the architecture a

43、nd content of future revisions of the ISO 9000 family. In revision of the ISO 9000 family, there are no major changes in the architectures of ISO 9001, ISO9002, ISO 9003 and ISO 9004. (However, ISO9003 does contain additional clauses compared to the 1987 version.) Each of these International Standar

44、ds has had small-scale changes. These changes move toward future revisions to meet better the needs of users. This Part of ISO 9000 and all other International Standards in the ISO 9000 family are independent of any specific industry or economic sector. Collectively they provide guidance for quality

45、 management and general requirements for quality assurance. The International Standards in the ISO 9000 family describe what elements quality systems should encompass but not how a specific organization implements these elements. It is not the purpose of these International Standards to enforce unif

46、ormity of quality systems. Needs of organizations vary. The design and implementation of a quality system must necessarily be influenced by the particular objectives, products and processes, and specific practices of the organization. This Part of ISO 9000 clarifies the principal quality-related con

47、cepts contained within the quality management and quality assurance International Standards generated by ISO/TC 176 and provides guidance on their selection and use. 1 Scope This Part of ISO 9000: a) clarifies principal quality-related concepts and the distinctions and interrelationships among them;

48、 b) provides guidance for the selection and use of the ISO 9000 family of International Standards on quality management and quality assurance. 2 Normative reference The following standard contains provisions which, through reference in this text, constitute provisions of this Part of ISO 9000. At th

49、e time of publication, the edition indicated was valid. All standards are subject to revision, and parties to agreements based on this Part of ISO 9000 are encouraged to investigate the possibility of applying the most recent edition of the standard indicated below. Members of IEC and ISO maintain registers of currently valid International Standards. ISO 8402:1994 Quality management and quality assurance Vocabulary. 3 Definitions This revision of ISO 9000, ISO 9001, ISO 9002, ISO9003 and ISO 9004 has improved the harmonizat