EN 9104-001-2013 en Aerospace series - Quality management systems - Part 001 Requirements for Aviation Space and Defence Quality Management System Certification Programs《航空航天系列 质量管.pdf

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1、BSI Standards PublicationBS EN 9104-001:2013Aerospace series Qualitymanagement systemsPart 001: Requirements for Aviation, Space,and Defence Quality Management SystemCertification ProgramsBS EN 9104-001:2013Incorporating corrigendum August 2013BS EN 9104-001:2013 BRITISH STANDARDNational forewordThi

2、s British Standard is the UK implementation of EN 9104-001:2013. It supersedes BS EN 9104:2006, which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee ACE/1, International and European Aerospace Policy and Processes.A list of organizations represented on this

3、 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 2013. Published by BSI Standards Limited 2013ISBN 978 0 580 83173 7ICS

4、03.120.10; 49.020Compliance 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 31 March 2013.Amendments/corrigenda issued since publicationDate Text affected31 August 2013 Imp

5、lementation of CEN correction notice 8 May 2013: Supersession statement added to the national foreword and CEN forewordEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 9104-001 March 2013 ICS 03.120.10; 49.020 Supersedes EN 9104:2006English Version Aerospace series - Quality management systems -

6、 Part 001: Requirements for Aviation, Space, and Defence Quality Management System Certification Programs Srie arospatiale - Systmes de management de la qualit - Partie 001: Exigences applicables aux processus de certification des systmes de management de la qualit dans le domaine aronautique, spati

7、al et de dfense Luft- und Raumfahrt - Qualittsmanagementsysteme - Teil 001: Anforderungen an Zertifizierungsprogramme fr Qualittsmanagementsysteme in der Luftfahrt, Raumfahrt und Verteidigung This European Standard was approved by CEN on 10 November 2012. CEN members are bound to comply with the CEN

8、/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 CEN-CENELEC Management Cen

9、tre 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 Centre has the same status as th

10、e 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, Lithuania, Luxembourg, Malta, Nether

11、lands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2013 CEN All rights of exploi

12、tation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 9104-001:2013: EEN 9104-001:2013 (E) 2 Contents Page Foreword . 4 Introduction 5 Rationale . 6 1 Scope 8 2 Normative references . 8 3 Terms and definitions 9 4 Requirements of the sector management structure

13、 . 12 5 Requirements for accreditation bodies . 14 6 Requirements for certification bodies . 20 7 For aerospace requirements quality management system auditors . 23 8 Requirements for audits and reporting . 23 9 Requirements for oversight process. 36 10 Requirements for auditor authentication bodies

14、 36 11 Requirements for training provider approval bodies . 38 12 Online aerospace supplier information system database 40 13 Requirements of the other party management team 41 14 Online aerospace supplier information system database feedback process . 42 15 Sector management structure . 43 16 Cross

15、 frontier policy for EN 9104/2 oversight activity 45 17 Records 45 18 Requirements for certified organizations . 46 19 Confidentiality and conflicts of interest 46 20 Fees and financials 47 21 NOTES 47 Appendix A ACRONYM LOG . 48 Appendix B Industry controlled other party scheme certification struct

16、ures matrix for 9100/9110/9120:2009 certification audits 49 Appendix C Information to be uploaded into the online aerospace supplier information system database . 51 BS EN 9104-001:2013EN 9104-001:2013 (E)EN 9104-001:2013 (E) 3 Figures and Tables Page Table 1 Accreditation body assessment requiremen

17、ts of certification bodies . 17 Table 2 Audit duration requirements . 25 Table 3 Multiple site organization audit frequency . 27 Table 4 Permissible reductions for reduced SCOPE / complexity for several site organizations 28 Table 5 Online aerospace supplier information system database data responsi

18、bility . 40 Figure 1 Illustration of the customer Supplier Certification body feedback loops within the online aerospace supplier information system database 43 Figure 2 Sector management structure diagram 44 BS EN 9104-001:2013EN 9104-001:2013 (E)EN 9104-001:2013 (E) 4 Foreword This document (EN 91

19、04-001:2013) has been prepared by the Aerospace and Defence Industries Association of Europe - Standardization (ASD-STAN). 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 Ser

20、vices of the member countries of ASD, prior to its presentation to CEN. 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 September 2013, and conflicting national standards shall be withdrawn at the

21、 latest by September 2013. This document supersedes EN 9104:2006. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. According to the CEN

22、-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungar

23、y, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. BS EN 9104-001:2013EN 9104-001:2013 (E)EN 9104-001:2013 (E) 5 Introduction In December 1998, the aviation,

24、space, and defence industry established the IAQG with the goal of achieving significant improvements in quality and reductions in cost throughout the value stream. The IAQG developed specific requirements for aviation, space, and defence (interchangeably referred to as aerospace) quality management

25、systems that are to be implemented and maintained throughout the supply chain for the design, manufacture, and maintenance of products used in aviation, space, and defence applications. These requirements are published simultaneously as the EN 9100-series standards (i.e., EN 9100, EN 9110, EN 9120)

26、by SAE International in the Americas, AeroSpace and Defence Industries Association of Europe - Standardization (ASD-STAN) in Europe, and Japanese Standards Association (JSA) and Society of Japanese Aerospace Companies (SJAC) in Asia/Pacific. Another initiative of the IAQG was the development of a gl

27、obal scheme for the acceptance and recognition of audits performed by Certification Bodies (CBs), using the EN 9100-series standards, and taking into account the schemes already in use or under development in the various IAQG sectors. All these schemes have two major elements in common: the use of a

28、 3rd party audit certification scheme with specific aviation, space, and defence elements and requirements, under the guidance and oversight of the aviation, space, and defence industry; and the use of a harmonized approach with the CBs for the purpose of improving the quality and process control th

29、roughout the entire supply chain. BS EN 9104-001:2013EN 9104-001:2013 (E)EN 9104-001:2013 (E) 6 Rationale After the initial publication of International Aerospace Quality Group (IAQG) EN 9104 standard in 2004, it became evident that a single standard containing all aspects of the Industry Controlled

30、 Other Party (ICOP) Aerospace Quality Management System (AQMS) was too complex. It was decided that the standard be broken into three sections: EN 9104-001 Requirements for Aviation, Space, and Defence Quality Management System Certification Programs; EN 9104-002 Requirements for Oversight of Aerosp

31、ace Quality Management System Registration/ Certification Programs; and EN 9104-003 Requirements for Aerospace Auditor Competency and Training Courses. The requirements for oversight and AQMS auditor qualification information (EN 9104-002 and EN 9104-003 respectively) were removed from the original

32、EN 9104 text. This effort necessitated the total rewrite of the initial standard, now re-designated as EN 9104-001, which is the keystone document of the EN 9104-series trilogy. This standard defines the basic requirements for managing the AQMS certification scheme (commonly referred to as the ICOP

33、scheme). Two other standards in this series (i.e., EN 9104-002, EN 9104-003) provide specific requirements for defining the oversight process, and the AQMS auditor qualification and training requirements, respectively. These three standards together are commonly referred to as the ICOP certification

34、 management system Trilogy. This standard establishes provisions for the individual IAQG sector schemes controlled use of audit results provided by CBs, based on three primary criteria: the use of accredited CBs; the CBs use of qualified and authenticated AQMS auditors; and the use of international

35、aviation, space, and defence standards for quality management systems. This standard addresses the following elements necessary for the ICOP scheme: a) the approval of Accreditation Bodies (ABs), Auditor Authentication Bodies (AABs), and Training Provider Approval Bodies (TPABs); b) the qualificatio

36、n, accreditation, and recognition of CBs; c) the audits of quality management systems by accredited CBs; d) the criteria for determining the certification structure, content, and duration of audits; e) the recording and disposition of nonconformities generated by the audits; f) the posting of audit

37、results, findings, and certification; g) the entry of data into the Online Aerospace Supplier Information System (OASIS) database; and h) the use of International Accreditation Forum (IAF) guidance and mandatory documents for established processes (e.g. audit duration calculations, multiple site cer

38、tifications). BS EN 9104-001:2013EN 9104-001:2013 (E)EN 9104-001:2013 (E) 7 Additionally, this standard references the other standards in the EN 9104-series (i.e., EN 9104-002, EN 9104-003) that specify: i) the minimum standards of qualification and experience for AQMS auditors; j) the authenticatio

39、n of AQMS auditors by AABs and recognition by IAQG sectors; k) the oversight of ABs, CBs, TPABs, AABs, and AQMS auditors by applicable Sector Management Structure (SMS) and IAQG Original Equipment Manufacturers (OEMs), and other organizations and their representatives who participate in the manageme

40、nt of the ICOP scheme; and l) the operation of the IAQG oversight function. This standard also provides guidance for the use of the required audit process reporting tools (see EN 9101), and provides clarifications and process improvements resulting from the lessons learned during the initial operati

41、on of the ICOP scheme. BS EN 9104-001:2013EN 9104-001:2013 (E)EN 9104-001:2013 (E) 8 1 Scope This European Standard defines the requirements and industry-accepted practices for managing the ICOP scheme, which provides confidence to aviation, space, and defence customers and organizations that their

42、suppliers with certification of their quality management systems, issued by accredited CBs, meet the applicable AQMS standard requirements. The requirements established in this standard are applicable to the IAQG and its three sectors for managing AQMS certification and associated activities. The re

43、quirements are applicable to IAQG working groups e.g. SMS, Other Party Management Team (OPMT), IAQG member companies, ABs, CBs, Certification Body Management Committees (CBMCs), AABs, TPABs, Training Providers (TPs), and organizations seeking/obtaining AQMS standard certification. The AQMS standard

44、adopted by the organization should be EN 9100, EN 9110, and/or EN 9120, as appropriate to the organizations activities; these standards are referred to throughout this writing as AQMS standards. IAQG member companies have committed to recognize the certification of a suppliers quality management sys

45、tem to all equivalent AQMS standards (e.g. AS, EN, JISQ, NBR). IAQG sectors may expand the application of the requirements defined in this standard for other standards approved by the IAQG and its three sectors i.e., Americas Aerospace Quality Group (AAQG), European Aerospace Quality Group (EAQG), A

46、sia/Pacific Aerospace Quality Group (APAQG). 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of

47、 the referenced document (including any amendments) applies. EN 9100, Quality management systems Requirements for aviation, space and defence organizations EN 9101, Quality management systems Audit requirements for aviation, space, and defence organizations EN 9104-002, Aerospace series Quality mana

48、gement systems Part 002: Requirements for oversight of aerospace quality management system certification/registrations programs EN 9104-003, Aerospace series Quality management systems Part 003: Requirements for Aerospace Quality Management System (AQMS) Auditor Training and Qualification EN 9110, Q

49、uality management systems Requirements for aviation maintenance organizations EN 9120, Quality management systems Requirements for aviation space and defence distributors NOTE Equivalent versions (e.g. AS, EN, JISQ, SJAC, NBR) of the IAQG standards listed above are published internationally in each IAQG sector. EN ISO 9000, Quality management systems Fundamentals and vocabulary (ISO 9000) EN ISO 9001, Quality management systems Requirements (ISO 9001) EN ISO/IEC 17011:2004, Conformity assessmen