EN 9133-2018 en Aerospace series - Quality Management Systems - Qualification Procedure for Aerospace Standard Products.pdf

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1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Aerospace series - Quality Management Systems - Qualification Procedure for Aerospace Standard ProductsBS EN 9133:2018EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 9133 June 2018 ICS 03.100.70; 03.120.10; 49.020

2、Supersedes EN 9133:2004English Version Aerospace series - Quality Management Systems - Qualification Procedure for Aerospace Standard ProductsSrie arospatiale - Systmes de management de la qualit - Procdure de qualification pour pices arospatiales normalises Luft- und Raumfahrt - Qualittsmanagements

3、ystem - Qualifikationsverfahren fr genormte Teile der Luft- und Raumfahrt This European Standard was approved by CEN on 18 September 2017. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a nation

4、al standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A versi

5、on in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Cz

6、ech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United K

7、ingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels 2018 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN

8、9133:2018 ENational forewordThis British Standard is the UK implementation of EN 9133:2018. It supersedes BS EN 9133:2004, which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee ACE/1, International and European Aerospace Policy and Processes.A list of organi

9、zations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2018 Published by BSI Standards Limited 2018

10、ISBN 978 0 580 86171 0ICS 49.020; 03.100.70; 03.120.10Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 June 2018.Amendments/corrigenda issued since publication

11、Date Text affectedBRITISH STANDARDBS EN 9133:2018EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 9133 June 2018 ICS 03.100.70; 03.120.10; 49.020 Supersedes EN 9133:2004English Version Aerospace series - Quality Management Systems - Qualification Procedure for Aerospace Standard ProductsSrie aro

12、spatiale - Systmes 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 18 September 2017. CEN members

13、 are bound to comply 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

14、to the CEN-CENELEC Management Centre 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 CEN-CENELEC Management

15、 Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lit

16、huania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Rue de la

17、Science 23, B-1040 Brussels 2018 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 9133:2018 EBS EN 9133:2018EN 9133:2018 (E) 2 Contents Page European foreword . 3 Rationale . 4 Foreword 4 1 Scope 5 1.1 General 5 1.2 Application 5 2

18、Normative references 5 3 Terms and definitions . 6 4 Qualification process 10 5 Mandated body representative registration 12 6 Qualification procedure . 12 7 Qualification activity report . 14 8 Qualification requested by analogy . 15 9 Qualification requested by grandfather product status 16 10 Cer

19、tification procedure 16 11 Qualified products list 17 12 Qualified product certification maintenance and renewal . 17 13 Manufacturing change request for a manufacturing sealed route . 18 14 Value added distributors . 18 15 Quality failures, noncompliance, and customer complaints 19 (informative) Ac

20、ronym log . 20 (informative) Mandated Body Product Qualification Activity Report (QAR) Template example . 21 BS EN 9133:2018EN 9133:2018 (E) 3 European foreword This document (EN 9133:2018) has been prepared by the Aerospace and Defence Industries Association of Europe - Standardization (ASD-STAN).

21、After enquiries and votes carried out in accordance with the rules of this Association, this Standard has received the approval of the National Associations and the Official Services of the member countries of ASD, prior to its presentation to CEN. This European Standard shall be given the status of

22、 a national standard, either by publication of an identical text or by endorsement, at the latest by December 2018, and conflicting national standards shall be withdrawn at the latest by December 2018. Attention is drawn to the possibility that some of the elements of this document may be the subjec

23、t of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN 9133:2004. According to the CEN-CENELEC Internal Regulations, the national standards organisations of the following countries are bound to implement this Eu

24、ropean Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slo

25、vakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. BS EN 9133:2018EN 9133:2018 (E) 4 Rationale This document has undergone full technical revision to reflect improvements introduced to the product qualification process and incorporate identified best practices since its init

26、ial release. This document defines the process by which a manufacturer wishing to manufacture aviation, space, and defence standard products may obtain qualification approval from the controlling Certification Authority (CA). It defines the procedures to be followed by a manufacturer to request, car

27、ry out, obtain, and maintain certification approval by confirming the manufactured products meet the minimum technical and performance requirements defined by the product standard and controlling technical specifications. Foreword To assure customer satisfaction, the aviation, space, and defence ind

28、ustry organizations must produce and continually improve safe, reliable products that meet or exceed customer and regulatory authority requirements. The globalization of the industry and the complexity of resulting organizations supply chains have complicated this objective. End-product organization

29、s face the challenge of assuring the quality of, and integrating, product purchased from suppliers throughout the world and at all levels within the supply chain. Furthermore, the aviation, space, and defence suppliers and processors, within the industry, face the challenge of delivering product to

30、multiple customers having varying quality expectations and requirements. The aviation, space, and defence industry established the International Aerospace Quality Group (IAQG) for the purpose of achieving significant improvements in quality and safety, and reductions in cost, throughout the value st

31、ream. This organization includes representation from aviation, space, and defence companies in the Americas, Asia/Pacific, and Europe. This document defines the qualification of standard products and should result in improved quality and safety, and decreased cost, due to the standardization of this

32、 process. BS EN 9133:2018EN 9133:2018 (E) 5 1 Scope 1.1 General This document defines a system for the qualification of standard products for aviation, space, and defenc applications. It defines the principles that shall be adhered to when carrying out product qualification; applied in conjunction w

33、ith the rules and procedures of the CA. The system enables the CA to confirm compliance is achieved and maintained, in accordance with the requirements of its product definition and associated controlling technical specifications by an Original Component Manufacturer (OCM) of standard products. This

34、 document requires an OCM that has been granted product qualification approval to ensure applicable approvals are maintained and renewed in accordance with the CAs quality system for that qualified product. OCMs and OCM designated Value Added Distributors (VADs) requesting product qualification to t

35、his standard, shall as a prerequisite, maintain EN 9100 standard quality management system certification approval. This certification shall be visible in the Online Aerospace Supplier Information System (OASIS) database. 1.2 Application The application of this document will be mandated either in the

36、 product standard or its controlling technical specifications. When invoked, the OCM wanting to produce aerospace standard products will need to gain qualification approval from an aerospace CA. The processes defined herein will be performed impartially for the benefit of the aerospace industry, by

37、the CA, to ensure continued compliance of standard products to the requirements defined in their controlling technical specifications. OCMs will need to ensure they allow sufficient lead-time to complete this process to gain product approval from the CA to support/satisfy their customer delivery req

38、uirements. Qualified products using this process shall not be supplied or used without qualification approval and a valid Product Qualification Certificate (PQC) being granted. 2 Normative references The following documents are referred to in the text in such a way that some or all of their content

39、constitutes requirements 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. EN 9100, Quality Management Systems Requirements for Aviation, Space and Defence Organizations EN

40、 9102, Aerospace series Quality systems First article inspection requirements EN 9103, Aerospace series Quality management systems Variation management of key characteristics NOTE Equivalent versions (e.g. AS, EN, JISQ, SJAC, NBR) of the IAQG standards listed above are published internationally in e

41、ach IAQG sector. EN ISO 9000, Quality management systems Fundamentals and vocabulary EN ISO 9001, Quality management systems Requirements BS EN 9133:2018EN 9133:2018 (E) 6 ISO 10012, Measurement management systems Requirements for measurement processes and measuring equipment ISO/IEC 17025, General

42、requirements for the competence of testing and calibration laboratories ASD-CERT Quality Manual (see www.asd-cert.org) AC7101/11, Nadcap Audit Criteria for Materials Testing Laboratories General Requirements for all Laboratories AC71021, Nadcap Audit Criteria for Heat Treating AC71081, Nadcap Audit

43、Criteria for Chemical Processing AC71141, Nadcap Audit Criteria for Nondestructive Testing (NDT) Suppliers Accreditation Program PD20001, Governance and Administration of an Industry Managed Product Qualification Program PD20011, Manufacturer Request for Product Approval and Qualification Process 3

44、Terms and definitions For the purpose of this document, the terms and definitions provided in EN ISO 9000 and the following apply. Furthermore, an acronym log for this standard is presented in Annex A. ISO and IEC maintain terminological databases for use in standardization at the following addresse

45、s: IEC Electropedia: available at http:/www.electropedia.org/ ISO Online browsing platform: available at http:/www.iso.org/obp 3.1 analogy act of granting product qualification certification approval based on testing that has been carried out on similar qualified product; where the new standard prod

46、ucts manufacturing method is substantially the same as the manufacturing method of the existing qualified product 3.2 Certification Authority CA authority that administers a certification system for qualification of standard products (e.g. ASD-CERT, SAE-PRI); acknowledged by the aviation, space, and

47、 defence industry Original Equipment Manufacturers (OEMs) and associated regulatory agencies i.e. Federal Aviation Administration (FAA), European Aviation Safety Agency (EASA), or similar 3.3 end user organization purchasing aviation, space, and defence ualified standard products. Could be an OEM, O

48、CM, and/or government agency purchasing standard products to be utilized within an assembly, part, or finished product 1Documents published by Performance Review Institute (PRI) and available from www.eAuditN BS EN 9133:2018EN 9133:2018 (E) 7 3.4 First Article Inspection FAI planned, complete, indep

49、endent, and documented inspection and verification process to ensure that prescribed production processes have produced an item conforming to engineering drawings, Digital Product Definition (DPD), planning, purchase order, engineering specifications, and/or other applicable design documents as defined by the EN 9102 standard 3.5 First Article Inspection Report FAIR forms and package of documentation for a part number, sub-assembly, or assembly, including associated FAI results as defined by the EN 9102 standard 3.