BS 9000-7-1989 General requirements for a system for electronic components of assessed quality - Specification of lot formation release procedures and certified test records《电子元器件质.pdf

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1、BRITISH STANDARD BS9000-7: 1989 General requirements for a system for electronic components of assessed quality Part 7: Specification of lot formation, release procedures and certified test records UDC 621.37/.39:658.562.64:006.3/.8BS 9000-7:1989 This British Standard, havingbeen prepared under the

2、direction of the Electronic Components StandardsPolicy Committee, was published under the authority of the Board of BSI and comes into effect on 31 October 1989 BSI 03-1999 The following BSI references relate to the work on this standard: Committee reference ECL/- Draft for comment 88/30358 DC ISBN

3、0 580 17708 4 Committees responsible for this British Standard This British Standard was prepared by the Electronic Components Standards Policy Committee (ECL/-), upon which the following bodies were represented: BEAMA Ltd. British Standards Society British Telecommunications plc Department of Trade

4、 and Industry (Electronics Applications Division) Electronic Components Industry Federation Electronic Engineering Association Institution of Electrical Engineers Ministry of Defence National Supervising Inspectorate Society of British Aerospace Companies Limited Telecommunication Engineering and Ma

5、nufacturing Association (TEMA) Amendments issued since publication Amd. No. Date of issue CommentsBS9000-7:1989 BSI03-1999 i Contents Page Committees responsible Inside front cover Foreword ii 1 Scope 1 2 Acceptance sampling procedures 1 3 Formation of inspection lots 2 4 Release 2 5 Certified test

6、records for qualification approval 3 Appendix A Format for certificate of conformity for use by an approved manufacturer or an approved class A IC design house 5 Appendix B Format for certificate of conformity for use by an approved distributor 6 Appendix C Format for certificate of conformity for u

7、se by an approved independent assessor of unencapsulated add-on components 7 Appendix D Example of a certified test record 8 Table 1 Designation of the term “responsible authority” for the purposesofimplementing BS 6001-1:1972 1 Publications referred to Inside back coverBS 9000-7:1989 ii BSI 03-1999

8、 Foreword This Part of BS 9000 has been prepared under the direction of the Electronic Components Standards Policy Committee (ECL/-). It forms part of a revision of BS9000-1:1981 and BS9005:1985, both of which are now withdrawn. The revision comprises a vital and necessary restructuring of those sta

9、ndards coupled with the incorporation of text from BS9000-2:1972 and from various circular letters from PD9004. The restructuring has resulted in BS9000-1:1981 and BS9005:1985 being replaced by the following publications. Part 1: Specification of general procedures; Part 4: Specification of procedur

10、es for the approval of an organization; Part 5: Specification of qualification approval and conformance testing procedures; Part 6: Specification of capability approval procedures; Part 7: Specification of lot formation, release procedures and certified test records; Part 8: Drafting requirements; S

11、ection 8.1: Generic, sectional and blank detail specifications produced under qualification approval; Section 8.2: Generic and sectional specifications produced under capability approval. NOTEA cross-reference between BS9000-1:1981 and this revision is given in Appendix A, Table1 of BS9000-1:1989. T

12、hese publications describe, and specify, the BS9000 system. They are not intended to apply to the United Kingdom implementation of either the CECC 1)or IECQ 2)systems. It has been decided, after considering the implications of the intended completion of the Internal Market by December 1992, that a c

13、omplete “stand alone” publication describing and specifying the UK implementation of the CECC system is needed. A similar “stand alone” publication for the UK implementation of the IECQ system is also envisaged. BS9000-2 and BS9000-3 will be revised to implement these decisions. This revision of BS9

14、000-1:1981 gives a more complete description of the requirements for capability approval and for the drafting of specifications. The revision will be applied to all approval exercises and to all generic, sectional and blank detail specifications drafted after the date of its publication. The require

15、ments contained in the revision will also apply to the revision of existing BS9000 standards. BS9000-4 specifies procedures for the approval of organizations. It is intended that the appropriate Part of BS5750 be invoked in due course as a requirement for approval. It should be noted that BS9000-4 c

16、ontains requirements specific to the System 3)not covered by BS5750. 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 immun

17、ity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, pages1 to 8, an inside back cover and a back cover. This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in the a

18、mendment table on theinside front cover. 1) CENELEC Electronic Components Committee (System for Europe). 2) IEC Quality Assessment System for Electronic Components. 3) For definition of “the System”, see 2.1.1 of BS9000-1:1989.BS 9000-7:1989 BSI03-1999 1 1 Scope This Part of BS9000 specifies the pro

19、cedures for the formation of lots, and their release under the System. NOTEThe titles of the publications referred to in this standard are listed on the inside back cover. 2 Acceptance sampling procedures 2.1 Acceptance sampling for inspection by attributes Unless otherwise specified in the generic

20、specification, the statistical sampling procedures and the tables to be used shall be those specified inBS6001-1. 2.2 Implementation of BS 6001-1 For the purpose of implementing BS 6001-1 the following designations and definitions shall apply. a) Responsible authority. The term “responsible authorit

21、y”, as used in BS6000-1 shall be, for the purposes of implementing that standard in the System, as designated inTable 1. Table 1 Designation of the term “responsible authority” for the purposes of implementingBS6000-1:1972 b) Unit of product. The electronic component defined and described in the det

22、ail specification. c) Lots. The inspection lot as defined in 2.6.14 of BS9000-1:1989. d) Consecutive lots. Production lots following in an uninterrupted succession submitted for acceptance, when obtained from continuous production. e) Continuous production. The circumstances in which: 1) there has b

23、een no design or process changes of the electronic components that may affectqualification approval (see 3.7.1 of BS9000-5:1989) or capability approval (see5.1 of BS9000-6:1989); 2) there has been no change in the approved location (see 3.7.2 of BS9000-5:1989 and5.2 of BS9000-6:1989); 3) there has b

24、een no break in production exceeding six months or, exceptionally, a longer period as agreed with the National Supervising Inspectorate. 2.3 Supplementary procedure for reduced inspection 2.3.1 Unless otherwise stated in the generic specification, it is permitted to use a reduced inspection procedur

25、e for the release tests provided that the conditions detailed in2.3.2 are met. This supplementary procedure applies only to group B tests (for qualification approval as described in Appendix E of BS9000-8.1:1989) and to those release tests of a similar nature used for capability approval. 2.3.2 A re

26、duced inspection procedure is permitted provided that: a) the requirements for the change from normal to reduced inspection as given in8.3.3 of BS6001-1:1972 have been met and in addition that the limit number given in Table VIII of BS6001-1:1972 is greater than zero; b) there have been zero failure

27、s in the samples from ten successive inspection lots submitted to testing. NOTEThis supplementary procedure allows a manufacturer to carry out the appropriate test at normal inspection at intervals of3 months instead of on a lot-by-lot basis. 2.3.3 A single failed inspection lot in this 3-monthly sa

28、mple (see note to2.3.2) shall cause reversion to the lot-by-lot inspection until such time as the conditions for reduced inspection (see2.3.2) have again been satisfied. In the event of such a failure, the lot-by-lot inspection may continue under reduced inspection as defined in BS6001-1 provided th

29、at the conditions given in 8.3.3 and Table VIII of BS6001-1:1972 are still satisfied, otherwise reversion to normal inspection as specified in8.3.4 of BS6001-1:1972 shall apply. Clause in BS6001-1:1972 Designation for use in the BS 9000 system 1.1 BS9000-1, BS9000-4 to BS9000-7 and BS9000-8.1 and BS

30、9000-8.2 4.5 Detail specification 5.4 Manufacturers approved person 6.2 Manufacturers approved person 6.4 Manufacturers approved person 8.1 BS 9000-1, BS 9000-4 to BS 9000-7 and BS 9000-8.1 and BS 9000-8.2 8.3.3 item 4) Manufacturers approved person 8.4 National Supervising Inspectorate 9.2 Detail s

31、pecification 9.4 Manufacturers approved personBS 9000-7:1989 2 BSI 03-1999 3 Formation of inspection lots It is permitted for an inspection lot to be formed by the aggregation of several production lots of structurally- similar components, provided that: a) the production lots are manufactured under

32、 essentially the same conditions (materials, processes, machines, personnel); b) the control exercised during production indicates for each production lot that the quality of materials and processing has been maintained within the limits necessary for the production of components which will meet the

33、 specified acceptable quality level; c) the period over which production lots may be aggregated into an inspection lot normally shall not exceed one week, and shall not exceed1month unless permitted by the relevant generic or sectional specification. The period shall be declared in the approved manu

34、facturers quality manual. 4 Release 4.1 General 4.1.1 Requirements prior to release. Avalid qualification approval certificate (see 3.5 of BS9000-5:1989) or capability approval certificate (see3.10 of BS9000-6:1989) is required prior to component release except as given in4.1.3. Components for relea

35、se under the System shall have passed the lot-by-lot quality conformance inspection tests given in the relevant detail specification, or valid customer detail specification. The periodic tests or capability qualifying component maintenance tests applicable to these components shall also have been pa

36、ssed. 4.1.2 Release following receipt of the approval certificate. The released delivery lots shall be unambiguously identified by a certificate of conformity. NOTEThe issue of a certificate of conformity is under the surveillance of the National Supervising Inspectorate. The authority to issue the

37、certificate of conformity will be suspended or withdrawn by BSI on the recommendation of the National Supervising Inspectorate if there is persistent non-conformity with the specification (see3.8 and3.9 of BS9000-5:1989 or7.1 and7.2 of BS9000-6:1989) or the requirements of the System. 4.1.3 Release

38、prior to the issue of an approval certificate. An approved manufacturer is permitted to release approved components prior to the issue of a qualification approval certificate, a capability approval certificate or an extended capability approval certificate provided that: either a) the qualification

39、approval test report for the component(s) has been countersigned by the National Supervising Inspectorate; or b) the capability approval test report for the capability qualifying components has been countersigned by the National Supervising Inspectorate; and c) a draft approval certificate has been

40、accepted by the National Supervising Inspectorate, and the approved manufacturer has submitted to BSI a written statement announcing his intention to release approved components together with a copy of this draft approval certificate. This statement shall be countersigned by the National Supervising

41、 Inspectorate. In releasing approved components, the approved manufacturer shall: 1) annotate the certificate of conformity with the text “Released in accordance with4.1.3 of BS9000-7:1989”; 2) be responsible for any corrective action which may be required of him by BSI if for any reason qualificati

42、on or capability approval is subsequently withheld or the content of the approval certificate is significantly different from the original draft agreed by the National Supervising Inspectorate. 4.1.4 Conditions of release for an approved distributor. In all cases of release by an approved distributo

43、r the certificate of conformity shall be that of the approved distributor selling the goods. All cases of investigation of returned approved components shall be handled in the first instance by the releasing approved distributor. The approved distributor, using his traceability records, shall then t

44、ake whatever action is necessary with his supplying approved organization and, where appropriate, with all customers who have been supplied approved components from the same delivery lot.BS 9000-7:1989 BSI03-1999 3 4.2 Date code Date codes used under the System shall be in accordance with ISO2015 wh

45、erein the first day of the week is taken as Monday and week 01 is the week containing the first Thursday in January. Reading from left to right or from top to bottom, the code shall designate the year and the week in that order. Where required by the generic specification, approved components shall

46、be marked with a code indicating the date of manufacture. (Alternatively, when the date of acceptance is within six months of the date of manufacture or within such shorter period from that date as prescribed in the generic specification, then it is permitted to use the date of acceptance.) Where mo

47、re than one inspection lot of identical components has the same date code, traceability to a particular inspection lot shall be provided by the use of a capital letter as a subscript to the date code. The capital letter used shall not cause confusion with other markings. The date code (and capital l

48、etter) shall normally be marked on the components. Where this is impracticable it shall be marked on the primary package containing a delivery lot. 4.3 Certificate of conformity 4.3.1 General. The certificate of conformity certifies that the approved components have been released in accordance with

49、the relevant specification. It shall allow reference to be made to the test documents against which the inspection lots have been released. 4.3.2 Certificate for use by approved manufacturers. All approved components released shall have a certificate of conformity. This certificate shall include all the information detailed in Appendix A. NOTE 1The form and layout of the certificate is optional. NOTE 2A certificate not containing lot identity is permitted following agreement with the customer. 4.3.3 Certificate for use by approved distributors. All approv