BS EN 9133-2004 en 2878 Aerospace series - Quality management systems - Qualification procedure for aerospace standard parts《航空航天系列 质量管理体系 航空航天标准部件的质量鉴定程序》.pdf

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1、BRITISH STANDARD AEROSPACE SERIESBS EN 9133:2004Aerospace series Quality management systems Qualification procedure for aerospace standard partsThe European Standard EN 9133:2004 has the status of a British StandardICS 03.120.10; 49.020g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g

2、3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58BS EN 9133:2004Incorporating corrigendum January 2015BS EN 9133:2004ISBN 978 0 580 89216 5Amendments/corrigenda issued since publicationDate Comments31 January 2015

3、 Correction to supersession details in national forewordThis British Standard was published under the authority of the Standards Policy and Strategy Committee on 2 December 2004 The British Standards Institution 2015. Published by BSI Standards Limited 2015National forewordThis British Standard is t

4、he official English language version of EN 9133:2004. It supersedes BS EN 3042:1992 which is withdrawn. Together with BS EN 9100:2009 it supersedes BS EN 2000:1992 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee ACE/1, International and European Aerosp

5、ace Policy and Processes.A list of organizations represented on this committee can be obtained on request to its secretary.The publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.Compliance with a British Standard cann

6、ot confer immunity from legal obligations.EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 9133 November 2004 ICS 49.020; 03.120.10 Supersedes EN 3042:1991 English version Aerospace series - Quality management systems - Qualification procedure for aerospace standard parts Srie arospatiale - Syst

7、mes de management de la qualit - Procdure de qualification pour pices arospatiales normalises Luft- und Raumfahrt - Qualittsmanagementsystem - Qualifikationsverfahren fr genormte Teile der Luft- und Raumfahrt This European Standard was approved by CEN on 4 June 2004. CEN members are bound to comply

8、with the CEN/CENELEC Internal Regulations which 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 Secret

9、ariat or to any CEN member. This European Standard 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 offici

10、al versions. CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden

11、, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2004 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members.

12、Ref. No. EN 9133:2004: EEN 9133:2004 (E) 2 Contents Page Foreword3 1 Scope 4 2 Normative references 4 3 Terms, definitions and abbreviated terms 4 4 Application process 5 5 Qualification procedure 5 6 Certification procedure .6 7 Maintenance .7 BS EN 9133:2004EN 9133:2004 (E)EN 9133:2004 (E) 3 Forew

13、ord This document (EN 9133:2004) has been prepared by the European Association of Aerospace Manufacturers Standardization (AECMA-STAN). 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 May 2005, an

14、d conflicting national standards shall be withdrawn at the latest by May 2005. This document supersedes EN 3042:1991. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cy

15、prus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. In December 1998, the Aerospace Industry has est

16、ablished the International Aerospace Quality Group (IAQG) with the purpose of achieving significant improvements in quality and reductions in cost throughout the value stream. This organization, with representation from Aerospace companies in Americas, Asia and Europe and sponsored by SAE, SJAC and

17、AECMA has agreed to take responsibility for the technical contents of this standard. This standard was reviewed by the Domain Technical Coordinator of AECMA-STANs Process Domain. After enquiries and votes carried out in accordance with the rules of this Association, this Standard has received the ap

18、proval of the National Associations and the Official Services of the member countries of AECMA, prior to its presentation to CEN. BS EN 9133:2004EN 9133:2004 (E)EN 9133:2004 (E) 4 1 Scope This document provides a basic uniform method for ensuring that aerospace standard parts (products) conform with

19、 the requirements of technical specifications referring to qualified parts and for a manufacturer of such parts to have a qualified management system at least equivalent to EN 9100. EN 9100 and EN 9103 apply when called out in the aerospace standard part standard. 2 Normative references The followin

20、g referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 9000, Quality management systems Fundamentals and vocabul

21、ary. EN 9100, Quality management systems Requirements (based on ISO 9001:2000) and Quality systems Model for quality assurance in design, development, production, installation and servicing (based on ISO 9001:1994).1)EN 9103, Aerospace series Quality management systems Variation management of key ch

22、aracteristics.1)3 Terms, definitions and abbreviated terms For the purpose of this standard, the terms, definitions and abbreviations given in ISO 9000 and the following definitions apply: 3.1 mandated body organization or person, approved by the relevant authority, tasked with assessing whether the

23、 manufacturers products comply with the relevant standards and whether the manufacturers quality system complies with EN 9100. For complex products/processes, EN 9103 could be used, if so decided by the mandated body. In this case the key characteristics are identified in the technical specification

24、 for the qualified parts 3.2 product standard part, standard part manufacturing process and standard part material (possibility of building a family of products must be laid down in the relevant technical specification) 3.3 relevant authority an authority that runs a qualified products registration

25、system for qualified products, issues product qualification certificates and maintains a list of qualified products and their manufacturers (e.g. AECMA-CERT, PRI-QPL). This list shall indicate the following minimum information: the serial number, issue and granting date of the certificate, and the p

26、eriod of validity 3.4 user an organization purchasing specific aerospace qualified products 1) Published as AECMA Prestandard at the date of publication of this standard BS EN 9133:2004EN 9133:2004 (E)EN 9133:2004 (E) 5 3.5 manufacturer company or organization manufacturing the products to be qualif

27、ied and having a quality management system meeting the requirements of EN 9100. A manufacturer is assumed to be located in the place where the product is made 3.6 Qualification Test Program (QTP) a program to demonstrate that the tests (may be combinations of tests, analysis or other documentation)

28、meet the requirements of the technical specifications 3.7 Qualification Test Report (QTR) report contains the test results according to the QTP 3.8 Product Qualification Test Report (PQTR) validation of the QTR by mandated body 3.9 Product Qualification Certificate (PQC) a Serialized Document that c

29、ertifies that a product has been qualified according to the relevant standards, established by an appropriate organization (relevant Authority) 4 Application process A manufacturer seeking to have a product qualified shall apply to the relevant authority or to the mandated body specifying: the descr

30、iption of the product to be qualified, identifying the applicable specifications and the relevant qualification standard to be used; an overview of the company (organization, share holders and parent companies, products manufactured, manpower, facilities, etc); a list of approvals and/or qualificati

31、ons already granted and, if any, information on results of evaluations already performed. This shall be accompanied by a certificate showing compliance of the manufacturer with EN 9100 issued by a body acceptable to the relevant Authorities plus any other required certifications/accreditations from

32、relevant organizations. The above information shall be forwarded to the mandated body for examination. 5 Qualification procedure The mandated body shall: request the manufacturer to implement a QTP and to specify the place, facilities and manufacturing line proposed to achieve this program NOTE The

33、QTP can include all the tests required by the technical specifications, or only an appropriate selection of these tests or demonstration by analysis / similarity. To evaluate the qualification program, the mandated body can take into account tests already performed on similar products or results of

34、existing applications for the products used in similar conditions to those defined in the technical specifications. BS EN 9133:2004EN 9133:2004 (E)EN 9133:2004 (E) 6 evaluate the QTP (including test procedures) establish a schedule for completion of the QTP ensure that the QTP is correctly achieved

35、ensure that a QTR documenting the results of the QTP is prepared ensure that the QTR prepared by the manufacturer shall contain the following: a list of all the tests carried out in accordance with the QTP, including issue date of all relevant reference standards and documents; reference number of t

36、he agreed and frozen (issue date, index, .) manufacturing and inspection file; a full list of quantitative test results and a summary sheet giving the results of tests not as pass/fail, but with values. have access during all stages of the production and test program to relevant manufacturing and in

37、spection data for the product ensure all tools and test equipment used in the qualification are in calibration and being used correctly ensure the product to be evaluated has been manufactured and inspected in the same way as applicable to production parts reserve the right to proceed to verificatio

38、n test and have counter test performed when this is deemed necessary ensure that the significant manufacturing operations and parameters are identified, that these operations and parameters are recorded, design and manufacturing drawings are recorded and all signed by representatives of both the man

39、dated body and the manufacturer (signed and sealed). The manufacturer shall certify not to change anything (manufacturer identity, manufacturing/inspection process parameters or manufacturing location) without the express written approval of the relevant authorities. After examination of the test re

40、sults, the mandated body shall write a PQTR and forward a copy to the relevant authority and the manufacturer. This report shall contain at least the following: a recommendation of the acceptance or otherwise of the qualification any required corrective action and its compliance 6 Certification proc

41、edure The relevant authority shall accept the recommendations from the mandated body and issue a product qualification certificate which shall contain the following minimum information: name of the manufacturer of the product where the product was manufactured the product designation based on the pr

42、oduct standard, part number of the product qualified, reference number of technical specification the part was qualified to. the QTR number a serial number, issue and granting date of the certificate a validity period (of e.g. 3 years) BS EN 9133:2004EN 9133:2004 (E)EN 9133:2004 (E) 7 reference to t

43、he approved quality management system. 7 Maintenance In due time before the end of the validity period the relevant Authority shall inform the mandated body to perform a re-assessment (e.g. audit) on the manufacturer to verify that the manufacturing process is still valid and then make a recommendat

44、ion to the relevant Authority whether or not the qualification can be continued. A user may conduct or have conducted on his behalf, complementary evaluations which he judges are necessary. In case of dispute, appeal can be made to the relevant Authority appeal committee. The manufacturer shall info

45、rm 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 manufacturing or inspection (signifi

46、cant operations and/or parameters, process changes, place change of manufacture, change of sub suppliers, etc.); re-start of production is planned after break of more than 18 months. The relevant Authority will examine each case and give a considered verdict. This may include a request to the mandat

47、ed body for additional assessment. Any information given to the relevant Authority shall be treated with the confidentiality requirements of its organization, but any other applicant has the right to examine the QTP and QTR. Users of qualified aerospace products shall report to the relevant Authorit

48、y any failure or problems relative to the qualified aerospace products of the Authorities. In the case 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 bo

49、dy 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. BS EN 9133:2004EN 9133:2004 (E)BSI is the national body responsible for preparing British Standards and other standards-related publications, information and services.BSI is incorporated by Royal Charter. British Standards and other standardization products are published by BSI Standards Limited.British Standards Institutio

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