1、Draft for Public Comment Kv;, I. “:Fdki all comments will be given consideration prior to publication. See overleaf for information on commenting. No copying is allowed, in any form, without prior written permission from BSI except as permitted under the Copyright, Designs and Patent Act 1988 or for
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4、 Cross-references The British Standards which implement international or European publications referred to in this draft may be found by referring to the British Standards Online Service on the BSI website under the International Relationship information. This information is also available within th
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6、/05/01 Direct tel: 020 8996 7266 Version 4 4 March 2000 Commenting on drafts Introduction This draft standard is based on European discussions in which the UK took an active part. Your comments on this draft are welcome and will assist in the preparation of the consequent British Standard. If no com
7、ments are received to the contrary, then the UK will approve this draft and implement it as a British Standard. Comment is particularly welcome on national legislative or similar deviations that may be necessary. Even if this draft standard is not approved by the UK, if it receives the necessary sup
8、port in Europe, the UK will be obliged to publish the official English Language text unchanged as a British Standard and to withdraw any conflicting standard. UK vote Please indicate whether you consider the UK should submit a negative (with reasons) or positive vote on this draft. Format The guidan
9、ce given below is intended to ensure that all comments receive efficient and appropriate attention by the responsible BSI committee. Annotated drafts are not acceptable and will be rejected. Each comment shall make one point only, be clearly separated from the others and be structured as follows in
10、clause order: e clause/sub-clause; paragraphhablebigure number; type of comment (general, technical or editorial); comment (with rationale); proposed change. Submission Insert here name, address and contact details of delegated secretariat: preferably electronically via e- mail or on diskette (MS-DO
11、S compatible, 1.44 megabytes). Comments should be compatible with Version 6.0 or Version 97 of MicrosofNB Word for WindowsTM, if possible; otherwise comments in ASCII text format are acceptable. Any comments not submitted electronically should still adhere to the formaf requirements given above. No
12、acknowledgement will normally be sent. Microsoft and MS-DOS are registered trademarks, and Windows is a trademark of Microsoft Corporation. Q, Q, c .- E E 8 - O c Q) Q) c - o“ U C N prEN not yet allocated Edition: 1 Study no: 8.6013 Draft no: Date: May 2001 Step no: Ref.: 8.6013.006 ENGLISH VERSION
13、Aerospace series Qualification Procedure for Aerospace Products Srie arospatiale Luft- und Raumfahrt Warning This document is NOT an AECMA Standard. It is distributed for review and comment. It is subject to change without notice and may NOT be referred to as an AECMA Standard. Recipients of this do
14、cument are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to provide supporting documentation. Author: Dr Shrader, EADS Airbus Germany E-mail: THE EUROPEAN ASSOCIATION OF AEROSPACE INDUSTRIES - STANDARDIZATION Gulledelle 96, B - 1200 Br
15、uxelles Tel. : (32) 2 775 81 10 Fax.: (32) 2 775 81 11 Page 3 prEN -: 2001 1. Scope This document provides a basic uniform method for ensuring products conform with the requirements of technical specifications referring to qualified parts and for a manufacturer of such parts to have a qualified mana
16、gement system at least equivalent to EN 91 OO. 2. Normative References This European Standard incorporates by dated or undated reference, provisions from other publications. These normative references are cited at the appropriate places in the text and the publications are listed hereafter. For date
17、d references, subsequent amendments to or revisions of any of these publications apply to this European Standard only when incorporated in it by amendment or revision. For undated references the latest edition of the publication referred to applies (including amendments). EN 9100 Quality systems - M
18、odel for quality assurance in design, development, production, installation and servicing ) EN 9103 Variation Management of Key characteristics *) 3. Terms, definitions and abbreviations mandated body Organisation or person tasked with assessing whether the manufacturers products comply with the rel
19、evant standards and whether the manufacturers quality system complies with AS EN 91 OO. product Part, process, or material. product qualification certificate A Serialised Document that certifies that a product has been qualified according to the relevant standards. relevant authority An authority th
20、at runs a qualified products system, issues product qualification certificates and maintains a list of qualified products and their manufacturers (A list of such Authorities for this document is shown in Annex A). user An organisation purchasing specific aerospace qualified products. manufacturer Co
21、mpany or organisation manufacturing the products to be qualified and having a quality management system meeting the requirements of EN 91 OO. 1) Published as AECMA Prestandard at the date of publication of this standard 2) In preparation at the date of publication of this standard Page 4 prEN -: 200
22、1 4. Application Process A manufacturer seeking to have a product qualified shall apply to the relevant authority specifying: P the description of the product to be qualified, identifying their applicable specifications and identify the relevant qualification standard to be used. P an overview of th
23、e company (organisation, products manufactured, Manpower, facilities, etc.). k a list of approvals and/or qualifications already granted and, if any, information on results of evaluations already performed. This shall be accompanied by a certificate showing compliance to EN 9100 carried out by a bod
24、y acceptable to the relevant authorities plus any other required certifications/accreditations from relevant organisations. After examination of the above information the relevant authorities shall forward it to the mandated body. 5. Qualification Procedure The mandated body shall: 8 8 8 8 8 8 8 8 8
25、 request the manufacturer to implement a Qualification Test Programme and to specify the place and facilities proposed to achieve this programme evaluate the Qualification Test Programme (QTP) establish a schedule for completion of the QTP ensure that the QTP is correctly achieved ensure that a repo
26、rt documenting the results of the QTP is prepared have access during all stages of the production and test program of relevant manufacturing data and inspection data for the product ensure all tools and test equipment used in the qualification are in calibration and being used correctly ensure the p
27、roduct to be evaluated has been manufactured and inspected as applicable to production parts reserve the right to proceed to verification test and have counter test performed when it is deemed necessary ensure that the significant manufacturing operations and parameters are identified, that these op
28、erations and parameters are recorded, design and manufacturing drawings are recorded and all signed by representatives of both the mandated body and the manufacturer (signed and sealed). The manufacturer shall certify not to change anything without the express written approval of the Appropriate Aut
29、horities. For all significant manufacturing operations and parameters that are identified, ensure that EN 91 03 (Variation Management of Key Characteristics) is applied as appropriate for purpose of establishing a predictably consistent supply of conforming product. After examination of the test res
30、ults the mandated body shall write a qualification test report (QTR) and forward a copy to the relevant authority and the manufacturer. This report shall contain at least the following: Page 5 prEN -: 2001 . . a list of all the tests carried out in accordance with the QTP reference number of the agr
31、eed and frozen manufacturing and inspection file a recommendation of the acceptance or otherwise of the qualification any required corrective action and its compliance a full list of quantitative test results and summary sheet giving the results of tests as pass/fail 6. Certification Procedure After
32、 consideration of the test report, the relevant authority shall decide (after taking into account the recommendations from the mandated body) whether or not to grant the manufacturer a product qualification certificate for the product concerned. The certificate shall contain the following minimum in
33、formation: 0 name of the manufacturer of the product 0 where the product was manufactured part number of the Product Qualified and reference number of technical specification the part was qualified to 0 the Qualification Test Report number o a serial number, issue and granting date of the certificat
34、e a validity period (of e. g. 3 years) o reference to the approved quality management system. 7. Maintenance In due time before the end of the validity period the relevant authority shall have a mandated body perform an audit on the manufacturer to verify that the manufacturing process is still vali
35、d and then make a recommendation to the relevant authority whether or not the qualification can be continued. A user may conduct or have conducted on his behalf, complimentary evaluations which he judges are necessary. In case of dispute, appeal can be made to the relevant authority appeal committee
36、. The manufacturer shall inform the relevant authority when . any change is made in his quality system that might affect the granted approval any evolutions occur in the company situation (merger, take-over, winding up, change of name, change of premises, etc.) . modifications are proposed in manufa
37、cturing (significant operations and/or parameters, place change of manufacture, change of sub suppliers, etc.) The relevant Authority will examine each case and give a considered verdict. This may include a request to the mandated body for additional assessment. Page 6 prEN -: 2001 Any information g
38、iven to the relevant Authority shall be treated with the confidentiality requirements of its organisation. Users of qualified aerospace products shall report to the relevant Authority any failure or problems relative to the qualified aerospace products of the authorities given in Annex A. In the cas
39、e of complaint from the users to the relevant Authority on the performance of a qualified aerospace product provided with a qualification certificate, the relevant Authority may request a mandated body to perform an audit at the place of manufacture. After consideration of the audit report the relevant Authority shall notify the manufacturer of the decision taken.
