BS EN 9104-002-2016 Aerospace series Quality management systems Requirements for Oversight of Aerospace Quality Management System Registration Certification Programs《航空航天系列 质量管理体系 .pdf

1、BS EN 9104-002:2016Aerospace series Qualitymanagement systemsPart 002: Requirements for Oversight ofAerospace Quality Management SystemRegistration/Certification ProgramsBSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS EN 9104-002:2016 BRITISH STANDARDNational fore

2、wordThis British Standard is the UK implementation of EN 9104-002:2016. It supersedes BS EN 9104-002:2008 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee ACE/1, International and European Aerospace Policy and Processes.A list of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 represent

3、ed 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 2016.Published by BSI Standards Limited 2016ISBN 978 0 580 83

4、013 6 ICS 03.120.10; 49.020 Compliance 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 2016.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e

5、 dBS EN 9104-002:2016EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 9104-002 June 2016 ICS 03.120.10; 49.020 Supersedes EN 9104-002:2008English Version Aerospace series - Quality management systems - Part 002: Requirements for Oversight of Aerospace Quality Management System Registration/Certi

6、fication ProgramsSrie arospatiale - Systmes de management de la qualit - Partie 002: Exigences relatives la supervision des processus de certification des Systmes de Management de la qualit dans le domaine arospatial Luft- und Raumfahrt - Qualittsmanagementsysteme - Teil 002: Anforderungen an berwac

7、hung/Kontrolle von Zertifizierungsverfahren fr Qualittsmanagementsysteme der Luft- und RaumfahrtThis European Standard was approved by CEN on 17 December 2015. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard t

8、he 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 Centre or to any CEN member. This European Standard exists in three official versions (English, Fre

9、nch, 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 the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria

10、, 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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey

11、 andUnited Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2016 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref.

12、 No. EN 9104-002:2016 EBS EN 9104-002:2016EN 9104-002:2016 (E) 2 Contents Page European foreword . 3 1 Scope 6 2 Normative references 6 3 Terms and definitions . 7 4 General 9 5 Requirements for oversight and assessment personnel . 10 6 Responsibilities 12 7 Requirements for oversight assessments .

13、16 8 Annual review of oversight assessment results 24 9 Complaint resolution process 25 10 Records 26 11 Notes . 27 Appendices Page Appendix A EN 9104-002 FORMS . 28 Appendix B ACRONYM LOG 91 Appendix C INDUSTRY CONTROLLED OTHER PARTY (ICOP) PROCESS MODEL . 93 Tables Page Table 1 Oversight assessmen

14、t frequency summary . 17 Table 2 Complaint resolution escalation examples 26 BS EN 9104-002:2016EN 9104-002:2016 (E) 3 European foreword This document (EN 9104-002:2016) has been prepared by the Aerospace and Defence Industries Association of Europe - Standardization (ASD-STAN). After enquiries and

15、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 a national standard

16、, either by publication of an identical text or by endorsement, at the latest by December 2016, and conflicting national standards shall be withdrawn at the latest by December 2016. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights.

17、CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN 9104-002:2008. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard:

18、 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, Slovakia, Slovenia, Spain,

19、Sweden, Switzerland, Turkey and the United Kingdom. BS EN 9104-002:2016EN 9104-002:2016 (E) 4 RATIONALE After the initial publication of International Aerospace Quality Group (IAQG) standard EN 9104 in 2004, it became evident that a single standard containing all aspects of the Industry Controlled O

20、ther 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 Aerospac

21、e Quality Management System Registration/Certification Programs; and EN 9104-003 Requirements for Aerospace Auditor Competency and Training Courses. This document is written to define a robust shared oversight process to ensure conformance to established aviation, space, and defence industry EN 9100

22、-series accreditation/certification requirements. The purpose of this revision is to align with the respective EN 9104-001 and EN 9104-003 standards and incorporate lessons learned from past oversight activities. BS EN 9104-002:2016EN 9104-002:2016 (E) 5 FOREWORD In December 1998, the aviation, spac

23、e, and defence industry established the IAQG with the goal of achieving significant improvements in quality and reductions in cost throughout the value stream. This document details the operating processes of the IAQG Other Party Management Team (OPMT) that monitors and reviews the Aerospace Supplie

24、r Quality System Accreditation/Certification Programs of each Sector Management Structure (SMS). This document provides requirements for a shared oversight process based on the: establishment of oversight committees at the international and global sector levels; use of joint team assessments; use of

25、 qualified and approved IAQG member Other Party (OP) assessors; use of common assessment tools; and reporting of oversight results. This document addresses the following activities: a) Establishment of standard oversight processes in all three global sectors (i.e., Europe, Asia Pacific, and the Amer

26、icas). The management of these global sector schemes is referred to as SMS. b) Oversight of SMS, Certification Body Management Committees (CBMCs), Accreditation Bodies (ABs), Certification Bodies (CBs), Auditor Authentication Bodies (AABs), Training Provider Approval Bodies (TPABs), and training cla

27、sses. BS EN 9104-002:2016EN 9104-002:2016 (E) 6 1 Scope The requirements established in this document are applicable to the IAQG and associated sectors for managing oversight to established requirements contained in EN 9104-series standards (i.e., EN 9104-001, EN 9104-002, EN 9104-003). The requirem

28、ents are applicable to IAQG working groups for oversight. NOTE All required forms are depicted in Appendix A. These form exhibits are provided for reference only; the current versions of these forms are available on the IAQG website. 1.1 Purpose The purpose of this standard is to document the ICOP o

29、versight process and define a robust shared oversight process which provides objective evidence of conformance to established aerospace industry EN 9100-series standards (i.e., EN 9100, EN 9110, EN 9120) requirements and associated accreditation/certification. 2 Normative references The following do

30、cuments, 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 the referenced document (including any amendments) applies. EN 9100 1), Quality Man

31、agement Systems Requirements for Aviation, Space and Defence Organizations EN 9101 1), Quality Management Systems Audit Requirements for Aviation, Space, and Defence Organizations EN 9104-001 1), Aerospace series Quality management systems Part 001: Requirements for Aviation, Space, and Defence Qual

32、ity Management System Certification Programs EN 9104-003 1), Aerospace series Quality management systems Part 003: Requirements for Aerospace Quality Management System (AQMS) Auditor Training and Qualification EN 9110 1), Quality Management Systems Requirements for Aviation Maintenance Organizations

33、 EN 9120 1), Quality Management Systems Requirements for Aviation Space and Defence Distributors IAQG Operating Procedure 119, “IAQG Forms Management”ISO 9000:2005, Quality management systems Fundamentals and vocabulary ISO/IEC 17000:2004, Conformity assessment Vocabulary and general principles ISO/

34、IEC 17011:2004, Conformity assessment General requirements for accreditation bodies accrediting conformity assessment bodies 1) As developed under the auspice of the IAQG and published by various standards bodies e.g., AeroSpace and Defence Industries Association Standardization (ASD-STAN), SAE Inte

35、rnational, European Committee for Standardization (CEN), Japanese Standards Association (JSA)/Society of Japanese Aerospace Companies (SJAC), Brazilian Association for Technical Norms (ABNT). BS EN 9104-002:2016EN 9104-002:2016 (E) 7 ISO/IEC 17021:2011, Conformity assessment Requirements for bodies

36、providing audit and certification of management systems ISO 19011:2011, Guidelines for auditing management systems IAF ID 4:2012, IAF Informative Document Market Surveillance Visits to Certified Organizations IAF MD 1:2007, IAF Mandatory Document for the Certification of Multiple Sites Based on Samp

37、ling IAF MD 2:2007, IAF Mandatory Document for the Transfer of Accredited Certification of Management Systems IAF MD 3:2008, IAF Mandatory Document for Advanced Surveillance and Recertification Procedures IAF MD 4:2008, IAF Mandatory Document for the Use of Computer Assisted Auditing Techniques (“CA

38、AT”) for Accredited Certification of Management Systems IAF MD 5:2009, IAF Mandatory Document for Duration of QMS and EMS Audits IAF MD 10:2013, IAF Mandatory Document for Assessment of Certification Body Management of Competence in Accordance with ISO/IEC 17021:2011 IAF MD 11:2013, IAF Mandatory Do

39、cument for the Application of ISO/IEC 17021 for Audits of Integrated Management Systems 3 Terms and definitions Definitions for general terms can be found in ISO 9000, ISO/IEC 17000, ISO 19011, EN 9104-001, and the IAQG International Dictionary (located on the IAQG website). An acronym log for this

40、document is presented in Appendix B. For the purpose of this standard, the following definitions apply: 3.1 aerospace the business of design, manufacture, maintenance, distribution, or support of aviation, space, and defence vehicles or engines, accessories, or component parts; and all ancillary and

41、 allied businesses, including vehicle maintenance and parts distribution operations 3.2 appeal request by the provider of the object of conformity assessment to the conformity assessment body or AB for reconsideration by that body of a decision it has made relating to that object (see ISO/IEC 17000)

42、. An appeal can be lodged by any entity within the ICOP scheme. 3.3 assessment a systematic process to assess the competence of an AB or a conformity assessment body (e.g., AB, CB, AAB, TPAB), based on the assessment criteria (see ISO/IEC 17011) 3.4 audit a systematic, independent, and documented pr

43、ocess for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled BS EN 9104-002:2016EN 9104-002:2016 (E) 8 3.5 complaint expression of dissatisfaction, other than appeal, by any person or organization to a conformity assessment body or AB

44、, relating to the activities of that body, where a response is expected (see ISO/IEC 17000 and section 9 of this standard). A complaint can be lodged against any entity within the ICOP scheme. 3.6 containment action to control and mitigate the impact of a nonconformity and protect the customers oper

45、ation (stop the problem from getting worse); includes correction, immediate corrective action, immediate communication, and verification that the nonconforming situation does not further degrade 3.7 Industry Controlled Other Party (ICOP) the AQMS standard certification scheme, under IAQG and industr

46、y management, for the assessment and certification of organization quality management systems by other parties, in accordance with the requirements defined in the EN 9104-series standards 3.8 joint team assessment an oversight assessment conducted in accordance with the requirements of this standard

47、 by a team of representatives, which may be comprised of AB assessors, OP assessors, and observers 3.9 nonconformity (also referred to as nonconformance) the non-fulfilment of a requirement that is stated, generally implied, or obligatory (see EN 9101 standard for definitions of major and minor nonc

48、onformities) 3.10 office assessment an on-site evaluation of an AB, AAB, or TPAB management office or CB lead office to the applicable requirements using the evaluation tools and methods contained in the EN 9104-series standards 3.11 Other Party (OP) assessor a full-time employee (not a contractor o

49、r retired staff member) from either an IAQG member company or from an National Aerospace Industry Association (NAIA) member company i.e., Aviation, Space, or Defence Original Equipment Manufacturer (OEM) or direct supplier to an OEM that is actively participating in the ICOP oversight process, who has been qualified and approved in accordance with this standard, and conducts shared oversight assessment or supplementary IAQG member company oversight activity in accordance with this standard 3.12 shared ov