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1、BRITISH STANDARD BS EN ISO 8402:1995 Quality management and quality assurance Vocabulary Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 05:34:47 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 8402:1995 This British Standard, having been prepared under the direction of the Management Sy
2、stems Sector Board, was published under the authority of the Standards Board and comes into effect on 15 July 1995 BSI 12-1998 The following BSI references relate to the work on this standard: Committee reference QMS/21 Draft for comment 92/89011 DC ISBN 0 580 24500 4 Committees responsible for this
3、 British Standard The preparation of this British Standard was entrusted to Technical Committee QMS/21, Quality terminology, upon which the following bodies were represented: Associated Offices Technical Committee British Gas plc British Standards Society British Telecommunications plc Chemical Indu
4、stries Association Council of Independent Inspecting Authorities Electricity Association Federation of Small Businesses Institute of Quality Assurance Institution of Electrical Engineers University of Leeds Amendments issued since publication Amd. No.DateComments Licensed Copy: sheffieldun sheffield
5、un, na, Wed Nov 15 05:34:47 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 8402:1995 BSI 12-1998i Contents Page Committees responsibleInside front cover National forewordii Text of EN ISO 84022 List of referencesInside back cover Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 05:34:47
6、GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 8402:1995 ii BSI 12-1998 National foreword This British Standard has been prepared by Technical Committee QMS/21 and is the English language version of EN ISO 8402:1995 Quality management and quality assurance Vocabulary published by the European
7、Committee for Standardization (CEN). It has been developed in the interests of international harmonization and international trade and is identical with ISO 8402:1994, published by the International Organization for Standardization (ISO). It supersedes BS 4778-1:1987 which was identical to ISO 8402:
8、1986 which is withdrawn. The role of BS 4778-2 is being reviewed. This standard has been revised and considerably extended, in line with the development of the ISO 9000 family of standards, by Technical Committee ISO/TC 176, Quality management and quality assurance. The UK has contributed to the dev
9、elopment of this standard but, in the interests of international harmonization and adherence to already existing Directives, continue to express, at international level, some reservations concerning specific terms defined in the standard which conflict with EN 45020:1993 (ISO/IEC Guide 2:1991) and I
10、EC 50(191):1990. The principal concern is the use of the term “entity” throughout the standard. In this respect, users may prefer to adopt the convention of BS EN 45020:1993 General terms and their definitions concerning standardization and related activities which considers the proper subject of st
11、andardization to be “product, process or service” not “entity”. The term “entity”, in its all embracing sense, can give rise to ambiguity in definitions, for example, when applied to a “person” or “body”. NOTEIt should be noted that ISO/IEC Directives: Part 3 recommend adherence to the terminology o
12、f existing basic International Standards, of which ISO/IEC Guide 2:1991 is one. Cross-references Informative references Publication referred toCorresponding British Standard BS ISO 3534 Statistics Vocabulary and symbols ISO 3534-1:1993Part 1:1993 Probability and general statistical terms ISO 3534-2:
13、1993Part 2:1993 Statistical quality control ISO 3534-3:1985Part 3:1985 Glossary of terms relating to the design of experiments ISO/IEC Guide 2:1991BS EN 45020:1993 Glossary of terms for standardization and related activities BS 4778 Quality vocabulary Part 3 Availability, reliability and maintainabi
14、lity terms IEC 50(191):1990Section 3.2:1991 Glossary of international terms ISO 9000-1:1994BS EN ISO 9000 Quality management and quality assurance standards Part 1:1994 Guidelines for selection and use (Formerly BS 5750-0.1) BS 5750 Quality systems ISO 9000-2:1993Part 4:1994 Guide to the use of BS E
15、N ISO 9001 “Model for quality assurance in design, development, production, installation and servicing (Formerly BS 5750-1)”, BS EN ISO 9002 “Model for quality assurance in production, installation and servicing (Formerly BS 5750-2)” and BS EN ISO 9003 “Model for quality assurance in final inspectio
16、n and test (Formerly BS 5750-3)” Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 05:34:47 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 8402:1995 BSI 12-1998iii NOTEAll British Standards are identical or technically equivalent to the international standard except for BS 5750-4:1994 aga
17、inst ISO 9000-2:1993. 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 legal obligations. ISO 9000-3:1991Part
18、 13:1991 Guide to the application of BS 5750-1 to the development, supply and maintenance of software ISO 9000-4:1993Part 14:1993 Guide to dependability programme management ISO 9001:1994BS EN ISO 9001:1994 Quality systems Model for quality assurance in design, development, production, installation
19、and servicing (Formerly BS 5750-1) ISO 9002:1994BS EN ISO 9002:1994 Quality systems Model for quality assurance in production, installation and servicing (Formerly BS 5750-2) ISO 9003:1994BS EN ISO 9003:1994 Quality systems Model for quality assurance in final inspection and test (Formerly BS 5750-3
20、) BS EN ISO 9004 Quality management and quality system elements ISO 9004-1:1994Part 1:1994 Guidelines (Formerly BS 5750-0.2) BS 5750 Quality systems ISO 9004-2:1991Part 8:1991Guide to quality management and quality systems elements for services BS 7850 Total quality management ISO 9004-4:1993Part 2:
21、1994 Guidelines for quality improvement BS EN 30011 Guidelines for auditing quality systems ISO 10011-1:1990Part 1:1993 Auditing ISO 10011-2:1991Part 2:1993 Qualification criteria for quality systems auditors ISO 10011-3:1991Part 3:1993 Management of audit programmes BS EN 30012 Quality assurance re
22、quirements for measuring equipment ISO 10012-1:1992Part 1:1994 Metrological confirmation system for measuring equipment Summary of pages This document comprises a front cover, an inside front cover, pages i to iv, the EN title page, pages 2 to 50, an inside back cover and a back cover. This standard
23、 has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 05:34:47 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iv blank Licensed Copy: sheffieldun she
24、ffieldun, na, Wed Nov 15 05:34:47 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 8402 March 1995 ICS 03.120.10Supersedes EN 28402:1991 Descriptors: Quality, quality assurance, vocabulary English version Quality management and quality assurance Voc
25、abulary (ISO 8402:1994) Management de la qualit et assurance de la qualit Vocabulaire (ISO 8402:1994) Qualittsmanagement Begriffe (ISO 8402:1994) This European Standard was approved by CEN on 1995-01-11. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the co
26、nditions 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 Standard exists in thr
27、ee 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 standards bodies of Au
28、stria, 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 Central Secretariat:
29、rue de Stassart 36, B-1050 Brussels 1995 All rights of reproduction and communication in any form and by any means reserved in all countries to CEN and its members Ref. No. EN ISO 8402:1995 E Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 05:34:47 GMT+00:00 2006, Uncontrolled Copy, (c) BSI E
30、N ISO 8402:1995 BSI 12-1998 2 Foreword This European Standard was taken over by CEN from the work of ISO/TC 176, Quality management and quality assurance, subcommittee SC1, Concepts and terminology, of the International Standards Organization (ISO). This second edition of EN ISO 8402 replaces the fi
31、rst edition EN 28402:1991. 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 September 1995, and conflicting national standards shall be withdrawn at the latest by September 1995. According to the C
32、EN/CENELEC Internal Regulations, the following countries are bound to implement this European Standard: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom. Contents Page Foreword2
33、 Introduction3 Scope11 Terms and definitions11 Section 1: General terms12 1.1entity12 1.2process12 1.3procedure12 1.4product13 1.5service13 1.6service delivery14 1.7organization14 1.8organizational structure14 1.9customer14 1.10 supplier15 1.11 purchaser15 1.12 contractor15 1.13 subcontractor15 Sect
34、ion 2: Terms related to quality16 2.1quality16 2.2grade17 2.3requirements for quality18 2.4requirements of society18 2.5dependability19 2.6compatibility19 2.7interchangeability20 2.8safety20 2.9conformity20 2.10 nonconformity20 2.11 defect21 2.12 product liability21 2.13 qualification process21 2.14
35、 qualified21 2.15 inspection22 2.16 self-inspection22 2.17 verification22 2.18 validation23 2.19 objective evidence23 Section 3: Terms related to the quality system24 3.1quality policy24 3.2quality management24 3.3quality planning25 3.4quality control25 3.5quality assurance25 Licensed Copy: sheffiel
36、dun sheffieldun, na, Wed Nov 15 05:34:47 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 8402:1995 BSI 12-19983 Page 3.6quality system26 3.7total quality management27 3.8quality improvement28 3.9management review28 3.10 contract review28 3.11 design review29 3.12 quality manual29 3.13 quality plan
37、30 3.14 specification30 3.15 record31 3.16 traceability31 Section 4: Terms related to tools and techniques 33 4.1quality loop33 4.2quality-related costs33 4.3quality losses33 4.4model for quality assurance34 4.5degree of demonstration34 4.6quality evaluation34 4.7quality surveillance35 4.8hold point
38、36 4.9quality audit36 4.10 quality audit observation37 4.11 quality auditor37 4.12 auditee37 4.13 preventive action37 4.14 corrective action38 4.15 disposition of nonconformity38 4.16 production permit deviation permit39 4.17 waiver39 4.18 repair39 4.19 rework40 Annex A (informative) Bibliography41
39、Alphabetical index44 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 05:34:47 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 4 blank Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 05:34:47 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 8402:1995 BSI 12-19985 Introduction Many ordinary
40、words, in everyday use, are used in the quality field in a specific or restricted manner compared with the full range of dictionary definitions, due to such reasons as: the adoption of quality terminology by different sectors of business and industry to suit their specific perceived needs, the intro
41、duction of a multiplicity of terms by quality professionals in different industrial and economic sectors. The intent of this International Standard is to clarify and standardize the quality terms as they apply to the field of quality management. These terms and definitions are discussed and grouped
42、together in the text according to logical topics. They are also regrouped in an alphabetical index at the end for convenience. The word quality (2.1) in popular usage often means different things to different people. In this International Standard quality is defined as the totality of characteristic
43、s of an entity that bear on its ability to satisfy stated and implied needs. There are many different usages of the word quality. These different usages create considerable confusion and misunderstanding. Two such usages are “conformance to requirements” and “degree of excellence”. “Conformance to r
44、equirements” leads people to argue that “quality costs less”, which in some cases it does. Conversely, “degree of excellence” implies that “quality costs more”, which in some cases it does. In order to resolve some of the confusion in the usage of the word quality, another term grade (2.2) can be us
45、ed to describe the degree of excellence. The term grade is used, when needed, to describe the sense of technical excellence. Grade reflects a planned or recognized difference in the requirements for quality. Although the different categories of grade do not necessarily stand in rank order relationsh
46、ip to each other, grade indicators can readily be used in a rank order sense to describe the sense of technical excellence. An example of this usage is that it costs more to provide and run a five-star hotel than a boarding house. The term product (1.4) is used throughout this International Standard
47、. It is the result of activities or processes and can be tangible or intangible, or a combination thereof. In current ISO quality management standardization, products are classified in four generic product categories: hardware (e.g. parts, components, assemblies), software (e.g. computer programs, p
48、rocedures, information, data, records), processed materials (e.g. raw materials, liquids, solids, gases, sheets, wires), services (e.g. insurance, banking, transport). It is recognized that products generally involve combinations of these generic product categories. The terms and concepts presented
49、in this International Standard are intended to be applicable to any product. In this International Standard, the term entity (1.1) includes the term product, but extends further to cover, for example, activity, process (1.2), organization (1.7) or person. Confusion has arisen in understanding the terms quality control (3.4), quality assurance (3.5), quality management (3.2) and total quality management (3.7). This International Standard is intended to clarify these concepts. In simplified terms, quality control concerns the operational mea
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