ASD-STAN PREN 9104-002-2014 Aerospace series Quality management systems Part 002 Requirements for Oversight of Aerospace Quality Management System Certification Registrations Progr.pdf

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1、ASD-STAN STANDARD NORME ASD-STAN ASD-STAN NORM CORRIGENDUM - ISSUE 2: 2014-10-23 prEN 9104-002 Edition P 2 September 2014 PUBLISHED BY THE AEROSPACE AND DEFENCE INDUSTRIES ASSOCIATION OF EUROPE - STANDARDIZATIONRue Montoyer 10 - 1000 Brussels - Tel. 32 2 775 8126 - Fax. 32 2 775 8131 - www.asd-stan.

2、orgICS: Supersedes edition P 1 of February 2007 and will supersede EN 9104-002:2008 Descriptors: Note Technically equivalent writings published in all IAQG sectors ENGLISH VERSION Aerospace series Quality management systems Part 002: Requirements for Oversight of Aerospace Quality Management System

3、Registration/Certification Programs Srie 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: Anforderung

4、en an berwachung/Kontrolle von Zertifizierungsverfahren fr Qualittsmanagementsysteme der Luft- und Raumfahrt This “Aerospace Series“ Prestandard has been drawn up under the responsibility of ASD-STAN (The AeroSpace and Defence Industries Association of Europe - Standardization). It is published for

5、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 affected, physically

6、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 European Standard (E

7、N). 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. Edition approved for publication 1stSeptember 2014 Comments should be sent within six months after the da

8、te of publication to ASD-STAN Quality Domain Copyright 2014 by ASD-STAN prEN 9104-002:2014 (E) 2 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 Controlle

9、d 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 Aeros

10、pace 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 9

11、100-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. prEN 9104-002:2014 (E) 3 FOREWORD In December 1998, the aviation, space, and defence

12、 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 Supplier Quality Syst

13、em 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 qualified and

14、 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 Americas). The man

15、agement 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 classes. prEN 910

16、4-002:2014 (E) 4 Contents Page Foreword 5 1 Scope 6 1.1 Purpose .6 2 Normative references 6 3 Terms and definitions .7 4 General 9 5 Requirements for oversight and assessment personnel 9 5.1 General 9 5.2 Other party assessor .9 5.3 Confidentiality and conflicts of interest 10 6 Responsibilities .11

17、 6.1 General 11 6.2 Oversight assessment team leader .11 6.3 Other party assessor .12 6.4 International aerospace quality group other party management team 12 6.5 Sector management structure or certification body management committee .13 6.6 Sector management structure or certification body manageme

18、nt committee oversight chair .14 6.7 International aerospace quality group member company 14 7 Requirements for oversight assessments 14 7.1 Oversight frequency 14 7.2 Sector management structure risk-based oversight .15 7.3 Shared oversight program management 16 7.4 Shared oversight scheduling .16

19、7.5 Shared oversight assessment planning 17 7.6 Oversight of the online aerospace supplier information system database 17 7.7 Oversight of sector management structures and certification body management committees .17 7.8 Oversight of auditor authentication bodies 18 7.9 Oversight of training provide

20、r approval bodies .18 7.10 Oversight of a training class 18 7.11 Oversight of accreditation bodies 19 7.12 Oversight of certification bodies 19 7.13 International aerospace quality group member company supplemental oversight .20 7.14 Reporting of oversight assessments.21 7.15 Oversight assessment no

21、nconformities .21 8 Annual review of oversight assessment results 22 8.1 General 22 8.2 Sector management structure review or certification body management committee review .22 8.3 Accreditation body review 22 9 Complaint resolution process 23 10 Records .23 11 Notes .24 prEN 9104-002:2014 (E) 5 App

22、endices Page Appendix A EN 9104-002 FORMS 25 Appendix B ACRONYM LOG 88 Appendix C INDUSTRY CONTROLLED OTHER PARTY (ICOP) PROCESS MODEL . 90 Tables Page Table 1 Oversight assessment frequency summary 15 Table 2 Complaint resolution escalation examples . 23 Foreword This standard was reviewed by the D

23、omain Technical Coordinator of ASD-STANs Quality Domain. After inquiries and votes carried out in accordance with the rules of ASD-STAN defined in ASD-STANs General Process Manual, this standard has received approval for Publication. prEN 9104-002:2014 (E) 6 1 Scope The requirements established in t

24、his 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 requirements are applicable to IAQG working groups for oversight. NOTE All required forms are dep

25、icted 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 oversight process and define a robust shared oversight process which provides objective ev

26、idence 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 documents, in whole or in part, are normatively referenced in this document and are indispe

27、nsable 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 Management Systems Requirements for Aviation, Space and Defence Organizations EN 9101 1), Qu

28、ality 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 Quality Management System Certification Programs EN 9104-003 1), Aerospace series Quality man

29、agement 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 EN 9120 1), Quality Management Systems Requirements for Aviation Space and Defence Distr

30、ibutors 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/IEC 17011:2004, Conformity assessment General requirements for accreditation bodies accre

31、diting conformity assessment bodies ISO/IEC 17021:2011, Conformity assessment Requirements for bodies 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 Org

32、anizations 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 International, European Committee for Standardization (CEN), Japanese Standards Association (JSA)/Society of Japanese

33、Aerospace Companies (SJAC), Brazilian Association for Technical Norms (ABNT). prEN 9104-002:2014 (E) 7 IAF MD 1:2007, IAF Mandatory Document for the Certification of Multiple Sites Based on Sampling IAF MD 2:2007, IAF Mandatory Document for the Transfer of Accredited Certification of Management Syst

34、ems 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 (“CAAT”) for Accredited Certification of Management Systems IAF MD 5:2009, IAF Mandatory Document for Duration

35、 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 Document for the Application of ISO/IEC 17021 for Audits of Integrated Management Systems 3 Terms and defini

36、tions 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 document is presented in Appendix B. For the purpose of this standard, the following definitions apply: 3.

37、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 allied businesses, including vehicle maintenance and parts distribution operations 3.2 appeal request by

38、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). An appeal can be lodged by any entity within the ICOP scheme. 3.3 assessment a systematic process to ass

39、ess 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 process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit cr

40、iteria are fulfilled 3.5 complaint expression of dissatisfaction, other than appeal, by any person or organization to a conformity assessment body or AB, 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 lodge

41、d against any entity within the ICOP scheme. 3.6 containment action to control and mitigate the impact of a nonconformity and protect the customers operation (stop the problem from getting worse); includes correction, immediate corrective action, immediate communication, and verification that the no

42、nconforming situation does not further degrade prEN 9104-002:2014 (E) 8 3.7 Industry Controlled Other Party (ICOP) the AQMS standard certification scheme, under IAQG and industry management, for the assessment and certification of organization quality management systems by other parties, in accordan

43、ce 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 by a team of representatives, which may be comprised of AB assessors, OP assessors, and observers 3.9 nonconformity (also

44、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 nonconformities) 3.10 office assessment an on-site evaluation of an AB, AAB, or TPAB management office or CB lead office to the

45、 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 or retired staff member) from either an IAQG member company or from an National Aerospace Industry Association (NAIA) member

46、 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

47、IAQG member company oversight activity in accordance with this standard 3.12 shared oversight the IAQG OPMT managed process that assures conformance and global harmonisation of the ICOP scheme across all IAQG sectors. Shared oversight includes assessments of approved, accredited, and authenticated s

48、takeholders, as defined in the EN 9104-001 standard. Shared oversight prevents duplication of effort and allows IAQG member companies to share results. 3.13 supplemental oversight additional oversight conducted by IAQG member companies in accordance with this standard, using qualified OP assessors.

49、Supplemental oversight activity does not duplicate SMS or CBMC shared oversight activities. Supplemental oversight may be used to increase IAQG member company confidence in the ICOP scheme effectiveness. Supplemental oversight can also be used to address supply chain risk. 3.14 suspension temporary invalidation of the statement of conformity for all or part of the specified scope of attestation (see ISO/IEC 17000) 3.15 witness asse