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1、BRITISH STANDARD BS 9000-7: 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/.8 Licensed Copy: London South Bank University, London South Bank Uni
2、versity, Fri Dec 08 04:15:26 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 9000-7:1989 This British Standard, having been prepared under the direction of the Electronic Components Standards Policy Committee, was published under the authority of the Board of BSI and comes into effect on 31 October 19
3、89 BSI 03-1999 The following BSI references relate to the work on this standard: Committee reference ECL/- Draft for comment 88/30358 DC ISBN 0 580 17708 4 Committees responsible for this British Standard This British Standard was prepared by the Electronic Components Standards Policy Committee (ECL
4、/-), upon which the following bodies were represented: BEAMA Ltd. British Standards Society British Telecommunications plc Department of Trade and Industry (Electronics Applications Division) Electronic Components Industry Federation Electronic Engineering Association Institution of Electrical Engin
5、eers Ministry of Defence National Supervising Inspectorate Society of British Aerospace Companies Limited Telecommunication Engineering and Manufacturing Association (TEMA) Amendments issued since publication Amd. No.Date of issueComments Licensed Copy: London South Bank University, London South Ban
6、k University, Fri Dec 08 04:15:26 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 9000-7:1989 BSI 03-1999i Contents Page Committees responsibleInside front cover Forewordii 1Scope1 2Acceptance sampling procedures1 3Formation of inspection lots2 4Release2 5Certified test records for qualification appro
7、val3 Appendix A Format for certificate of conformity for use by an approved manufacturer or an approved class A IC design house5 Appendix B Format for certificate of conformity for use by an approved distributor6 Appendix C Format for certificate of conformity for use by an approved independent asse
8、ssor of unencapsulated add-on components7 Appendix D Example of a certified test record8 Table 1 Designation of the term “responsible authority” for the purposes of implementing BS 6001-1:19721 Publications referred toInside back cover Licensed Copy: London South Bank University, London South Bank U
9、niversity, Fri Dec 08 04:15:26 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 9000-7:1989 ii BSI 03-1999 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 BS 9000-1:1981 and BS 9005:1985,
10、 both of which are now withdrawn. The revision comprises a vital and necessary restructuring of those standards coupled with the incorporation of text from BS 9000-2:1972 and from various circular letters from PD 9004. The restructuring has resulted in BS 9000-1:1981 and BS 9005:1985 being replaced
11、by the following publications. Part 1: Specification of general procedures; Part 4: Specification of procedures 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: Sp
12、ecification of lot formation, release procedures and certified test records; Part 8: Drafting requirements; Section 8.1: Generic, sectional and blank detail specifications produced under qualification approval; Section 8.2: Generic and sectional specifications produced under capability approval. NOT
13、EA cross-reference between BS 9000-1:1981 and this revision is given in Appendix A, Table 1 of BS 9000-1:1989. These publications describe, and specify, the BS 9000 system. They are not intended to apply to the United Kingdom implementation of either the CECC1) or IECQ2) systems. It has been decided
14、, after considering the implications of the intended completion of the Internal Market by December 1992, that a complete “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 s
15、ystem is also envisaged. BS 9000-2 and BS 9000-3 will be revised to implement these decisions. This revision of BS 9000-1:1981 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
16、and to all generic, sectional and blank detail specifications drafted after the date of its publication. The requirements contained in the revision will also apply to the revision of existing BS 9000 standards. BS 9000-4 specifies procedures for the approval of organizations. It is intended that the
17、 appropriate Part of BS 5750 be invoked in due course as a requirement for approval. It should be noted that BS 9000-4 contains requirements specific to the System3) not covered by BS 5750. A British Standard does not purport to include all the necessary provisions of a contract. Users of British St
18、andards are 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, pages i and ii, pages 1 to 8, an inside back cover and a back cover. Thi
19、s standard 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. 1) CENELEC Electronic Components Committee (System for Europe). 2) IEC Quality Assessment System for Electronic Components. 3) For defin
20、ition of “the System”, see 2.1.1 of BS 9000-1:1989. Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 04:15:26 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 9000-7:1989 BSI 03-19991 1 Scope This Part of BS 9000 specifies the procedures for the formation of lots, a
21、nd 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 specification, the statistical sampl
22、ing procedures and the tables to be used shall be those specified in BS 6001-1. 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 authority”, as used in BS 6000-1 shall be,
23、 for the purposes of implementing that standard in the System, as designated in Table 1. Table 1 Designation of the term “responsible authority” for the purposes of implementing BS 6000-1:1972 b) Unit of product. The electronic component defined and described in the detail specification. c) Lots. Th
24、e inspection lot as defined in 2.6.14 of BS 9000-1:1989. 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 been no design or process chan
25、ges of the electronic components that may affect qualification approval (see 3.7.1 of BS 9000-5:1989) or capability approval (see 5.1 of BS 9000-6:1989); 2) there has been no change in the approved location (see 3.7.2 of BS 9000-5:1989 and 5.2 of BS 9000-6:1989); 3) there has been no break in produc
26、tion 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 procedure for the release test
27、s provided that the conditions detailed in 2.3.2 are met. This supplementary procedure applies only to group B tests (for qualification approval as described in Appendix E of BS 9000-8.1:1989) and to those release tests of a similar nature used for capability approval. 2.3.2 A reduced inspection pro
28、cedure is permitted provided that: a) the requirements for the change from normal to reduced inspection as given in 8.3.3 of BS 6001-1:1972 have been met and in addition that the limit number given in Table VIII of BS 6001-1:1972 is greater than zero; b) there have been zero failures in the samples
29、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 of 3 months instead of on a lot-by-lot basis. 2.3.3 A single failed inspection lot in this 3-monthly sample (see note t
30、o 2.3.2) shall cause reversion to the lot-by-lot inspection until such time as the conditions for reduced inspection (see 2.3.2) have again been satisfied. In the event of such a failure, the lot-by-lot inspection may continue under reduced inspection as defined in BS 6001-1 provided that the condit
31、ions given in 8.3.3 and Table VIII of BS 6001-1:1972 are still satisfied, otherwise reversion to normal inspection as specified in 8.3.4 of BS 6001-1:1972 shall apply. Clause in BS 6001-1:1972 Designation for use in the BS 9000 system 1.1BS 9000-1, BS 9000-4 to BS 9000-7 and BS 9000-8.1 and BS 9000-
32、8.2 4.5Detail specification 5.4Manufacturers approved person 6.2Manufacturers approved person 6.4Manufacturers approved person 8.1BS 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 8.4National Supervising Inspectorate 9.2Detail specification
33、 9.4Manufacturers approved person Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 04:15:26 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 9000-7:1989 2 BSI 03-1999 3 Formation of inspection lots It is permitted for an inspection lot to be formed by the aggregatio
34、n of several production lots of structurally- similar components, provided that: a) the production lots are manufactured under essentially the same conditions (materials, processes, machines, personnel); b) the control exercised during production indicates for each production lot that the quality of
35、 materials and processing has been maintained within the limits necessary for the production of components which will meet the 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 excee
36、d 1 month unless permitted by the relevant generic or sectional specification. The period shall be declared in the approved manufacturers quality manual. 4 Release 4.1 General 4.1.1 Requirements prior to release. A valid qualification approval certificate (see 3.5 of BS 9000-5:1989) or capability ap
37、proval certificate (see 3.10 of BS 9000-6:1989) is required prior to component release except as given in 4.1.3. Components for release under the System shall have passed the lot-by-lot quality conformance inspection tests given in the relevant detail specification, or valid customer detail specific
38、ation. The periodic tests or capability qualifying component maintenance tests applicable to these components shall also have been passed. 4.1.2 Release following receipt of the approval certificate. The released delivery lots shall be unambiguously identified by a certificate of conformity. NOTEThe
39、 issue of a certificate of conformity is under the surveillance of the National Supervising Inspectorate. The authority to issue the certificate of conformity will be suspended or withdrawn by BSI on the recommendation of the National Supervising Inspectorate if there is persistent non-conformity wi
40、th the specification (see 3.8 and 3.9 of BS 9000-5:1989 or 7.1 and 7.2 of BS 9000-6:1989) or the requirements of the System. 4.1.3 Release prior to the issue of an approval certificate. An approved manufacturer is permitted to release approved components prior to the issue of a qualification approva
41、l certificate, a capability approval certificate or an extended capability approval certificate provided that: either a) the qualification approval test report for the component(s) has been countersigned by the National Supervising Inspectorate; or b) the capability approval test report for the capa
42、bility qualifying components has been countersigned by the National Supervising Inspectorate; and c) a draft approval certificate has been accepted by the National Supervising Inspectorate, and the approved manufacturer has submitted to BSI a written statement announcing his intention to release app
43、roved components together with a copy of this draft approval certificate. This statement shall be countersigned by the National Supervising Inspectorate. In releasing approved components, the approved manufacturer shall: 1) annotate the certificate of conformity with the text “Released in accordance
44、 with 4.1.3 of BS 9000-7:1989”; 2) be responsible for any corrective action which may be required of him by BSI if for any reason qualification or capability approval is subsequently withheld or the content of the approval certificate is significantly different from the original draft agreed by the
45、National Supervising Inspectorate. 4.1.4 Conditions of release for an approved distributor. In all cases of release by an approved distributor the certificate of conformity shall be that of the approved distributor selling the goods. All cases of investigation of returned approved components shall b
46、e handled in the first instance by the releasing approved distributor. The approved distributor, using his traceability records, shall then take whatever action is necessary with his supplying approved organization and, where appropriate, with all customers who have been supplied approved components
47、 from the same delivery lot. Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 04:15:26 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 9000-7:1989 BSI 03-19993 4.2 Date code Date codes used under the System shall be in accordance with ISO 2015 wherein the first day
48、 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 be marked with a co
49、de 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 more 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 d
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