ASD-STAN PREN 9133-2016 Aerospace series Quality Management Systems Qualification Procedure for Aerospace Standard Products (Edition P 2).pdf

1、ASD-STAN STANDARD NORME ASD-STAN ASD-STAN NORMprEN 9133 Edition P 2 April 2016 PUBLISHED BY THE AEROSPACE AND DEFENCE INDUSTRIES ASSOCIATION OF EUROPE - STANDARDIZATION Rue Montoyer 10 - 1000 Brussels - Tel. 32 2 775 8126 - Fax. 32 2 775 8131 - www.asd-stan.org ICS: Supersedes edition P 1 of prEN 91

2、33:2004 Descriptors: Note Technically equivalent writings published in all IAQG sectors ENGLISH VERSION Aerospace series Quality Management Systems Qualification Procedure for Aerospace Standard Products Luft- und Raumfahrt Qualittsmanagementsystem Qualifikationsverfahren fr genormte Teile der Luft-

3、 und Raumfahrt Srie arospatiale Systmes de management de la qualit Procdure de qualification pour pices arospatiales normalises This “Aerospace Series“ Prestandard has been drawn up under the responsibility of ASD-STAN (The AeroSpace and Defence Industries Association of Europe - Standardization). I

4、t is published for the needs of the European Aerospace Industry. It has been technically approved by the experts of the concerned Domain following member comments. Subsequent to the publication of this Prestandard, the technical content shall not be changed to an extent that interchangeability is af

5、fected, physically or functionally, without re-identification of the standard. After examination and review by users and formal agreement of ASD-STAN, it will be submitted as a draft European Standard (prEN) to CEN (European Committee for Standardization) for formal vote and transformation to full E

6、uropean Standard (EN). The CEN national members have then to implement the EN at national level by giving the EN the status of a national standard and by withdrawing any national standards conflicting with the EN. ASD-STAN Technical Committee approves that: “This document is published by ASD-STAN fo

7、r the needs of the European Aerospace Industry. The use of this standard is entirely voluntary, and its applicability and suitability for any particular use, including any patent infringement arising therefrom, is the sole responsibility of the user.” ASD-STAN reviews each standard and technical rep

8、ort at least every five years at which time it may be revised, reaffirmed, stabilized or cancelled. ASD-STAN invites you to send your written comments or any suggestions that may arise. All rights reserved. No parts of this publication may be reproduced, stored in a retrieval system or transmitted,

9、in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without prior written permission of ASD-STAN. Order details: E-mail: salesasd-stan.org Web address: http:/www.asd-stan.org/ Edition approved for publication 1st April 2016 Comments should be sent within six m

10、onths after the date of publication to ASD-STAN Quality Domain Copyright 2016 ASD-STAN prEN 9133:2016 (E) 2 RATIONALE This standard has undergone full technical revision to reflect improvements introduced to the product qualification process and incorporate identified best practices since its initia

11、l release. This standard 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, carry

12、 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 indus

13、try 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 organizations

14、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 mu

15、ltiple 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 stre

16、am. 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 p

17、rocess. prEN 9133:2016 (E) 3 Contents Page 1 Scope 4 1.1 General 4 1.2 Application .4 2 Normative references 4 3 Terms and definitions 5 4 Qualification process 9 5 Mandated body representative registration 11 6 Qualification procedure . 11 7 Qualification activity report . 14 8 Qualification reques

18、ted by analogy . 14 9 Qualification requested by grandfather product status . 15 10 Certification procedure 15 11 Qualified products list. 16 12 Qualified product certification maintenance and renewal . 16 13 Manufacturing change request for a manufacturing sealed route . 17 14 Value added distribut

19、ors . 17 15 Quality failures, noncompliance, and customer complaints . 18 16 Notes 18 16.1 Revision indicator 18 Annex A (informative) Acronym log . 19 Annex B (informative) Mandated body Product Qualification Activity Report (QAR) Template example 20 Figure Figure 1 Qualification process flow chart

20、 . 10 prEN 9133:2016 (E) 4 1 Scope 1.1 General This standard defines a system for the qualification of standard products for aviation, space, and defence applications. It defines the principles that shall be adhered to when carrying out product qualification; applied in conjunction with the rules an

21、d 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 standard requir

22、es 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 this standard, sh

23、all 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 standard will be mandated either in the product standar

24、d 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 the CA, to ensur

25、e 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 requirements. Quali

26、fied 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, in whole or in part, are normatively referenced in this document and are indispensable for

27、its application. 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 9102, Aerospace series Qu

28、ality 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 each IAQG sector. ASD-CER

29、T Quality Manual (see www.asd-cert.org) ISO 9000, Quality management systems Fundamentals and vocabulary prEN 9133:2016 (E) 5 ISO 9001, Quality management systems Requirements ISO 10012, Measurement management systems Requirements for measurement processes and measuring equipment ISO/IEC 17025, Gene

30、ral requirements for the competence of testing and calibration laboratories AC7101/11), Nadcap Audit Criteria for Materials Testing Laboratories General Requirements for all Laboratories AC71021), Nadcap Audit Criteria for Heat Treating AC71081), Nadcap Audit Criteria for Chemical Processing AC71141

31、), 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 Terms and definitions For the purpose

32、 of this standard, the terms and definitions provided in ISO 9000 and the following apply. Furthermore, an acronym log for this standard is presented in Annex A. 3.1 Analogy the act of granting product qualification certification approval based on testing that has been carried out on similar qualifi

33、ed product; where the new standard products manufacturing method is substantially the same as the manufacturing method of the existing qualified product 3.2 Certification Authority CA an authority that administers a certification system for qualification of standard products (e.g. ASD-CERT, SAE-PRI)

34、; acknowledged by the aviation, space, and 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 an organization purchasing aviation, space, and defence q

35、ualified standard products. Could be an OEM, OCM, and/or government agency purchasing standard products to be utilized within an assembly, part, or finished product 3.4 First Article Inspection FAI a planned, complete, independent, and documented inspection and verification process to ensure that pr

36、escribed production processes have produced an item conforming to engineering drawings, Digital 1) Documents published by Performance Review Institute (PRI) and available from www.eAuditN prEN 9133:2016 (E) 6 Product Definition (DPD), planning, purchase order, engineering specifications, and/or othe

37、r applicable design documents as defined by the EN 9102 standard 3.5 First Article Inspection Report FAIR the forms and package of documentation for a part number, sub-assembly, or assembly, including associated FAI results as defined by the EN 9102 standard 3.6 Grandfather Qualified Product Status

38、the act of an OCM requesting qualified product approval from a CA based on them having existing and current approval for the product standard listed on a Qualified Products List (QPL) with another OEM, government, or military organization 3.7 Mandated Body MB an OEM who benefits from the qualificati

39、on of standard products and use of qualified products; nominates the Mandated Body Representatives (MBRs) 3.8 Mandated Body Representative MBR an individual accepted by the CA, based on their knowledge and experience as an industry Subject Matter Expert (SME), to act as agent on behalf of the CA; ta

40、sked with assessing if an OCMs products comply with applicable controlling product standards and technical specifications 3.9 Manufacturing Change Request MCR a process employed by the qualified OCM to request a change to a manufacturing sealed route for qualified product from the CA 3.10 Manufactur

41、ing Sealed Route a list of the manufacturing drawings, significant manufacturing operations, manufacturing flowchart, raw materials, components, subcontracted and/or VAD activities, and processes identified by name and controlling document number that are used to manufacture the product being qualif

42、ied 3.11 Memorandum of Understanding MOU a written agreement between two organizations to work together in support of a common goal or deliverable 3.12 Original Component Manufacturer OCM company or organization manufacturing standard products (see 3.23) requiring qualification approval from a CA pr

43、EN 9133:2016 (E) 7 3.13 Original Equipment Manufacturer OEM a manufacturer of an end user item, system, or subsystem e.g. an airframe, power system (engine), auxiliary power unit 3.14 Product Qualification Certificate PQC a serialized document that certifies an OCM of standard product has been grant

44、ed qualification approval by a CA, according to the relevant product standard and technical specifications. It defines the qualified product part numbers, applicable technical specifications, the approved OCM and applicable manufacturing site(s), period of approval, and the certificate renewal date

45、(i.e. expiry date) 3.15 Product Qualification Review the act of confirming compliance to an OCMs Qualification Test Program (QTP) for product being qualified to applicable product standards and technical specifications; activity overseen by either a MBR or carried out by an independent Nadcap approv

46、ed test laboratory (e.g. AC7101/1) culminating in a Qualification Activity Report (QAR) being submitted to the CA for review and approval 3.16 Product Standard a standard defined and approved by consensus agreement of industry SMEs; issued by a Standards Development Organization (SDO) 3.17 Qualifica

47、tion Activity Report QAR a report submitted by the MBR with the relevant supporting data and their recommendation to the CA (see Clause 7 and Annex B) 3.18 Qualification Test Program QTP a program defined by the product manufacturer (i.e. OCM) or OCM designated VAD to confirm compliance of their sta

48、ndard product to the requirements of applicable product standards and associated technical specifications. Standard product qualification may be a combination of tests, analysis, or other supporting documentation or declarations of compliance 3.19 Qualification Test Report QTR a report compiled by t

49、he OCM or OCM designated VAD that contains the associated test results in accordance with the QTP and EN 9102 standard FAIR requirements 3.20 Qualified Product an aerospace standard product that has been confirmed by witness assessment and approval by a CA as complying with applicable key characteristics and defined product standard and technical specification(s) requirements prEN 9133:2016 (E) 8 3.21 Qualified Products List QPL a directory of qualified products and their OCMs (e.g. ASD-Cert qualified products directory is available at w