ASD-STAN PREN 9104-001-2012 Aerospace series Quality management systems Part 001 Requirements for Aviation Space and Defence Quality Management System Certification Programs (Editi.pdf

1、ASD-STAN STANDARD NORME ASD-STAN ASD-STAN NORM prEN 9104-001 Edition P 1 January 2012 PUBLISHED BY THE AEROSPACE AND DEFENCE INDUSTRIES ASSOCIATION OF EUROPE - STANDARDIZATIONAvenue de Tervuren, 270 - B-1150 Brussels - Tel. + 32 2 775 8126 - Fax. + 32 2 775 8131 - www.asd-stan.orgICS: Descriptors: E

2、NGLISH VERSION Aerospace series Quality management systems 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 man

3、agement de la qualit dans le domaine aronautique, spatial et de dfenseLuft- und Raumfahrt Qualittsmanagementsysteme Teil 001: Anforderungen an Zertifizierungsprogramme fr Qualittsmanagementsysteme in der Luftfahrt, Raumfahrt und Verteidigung This “Aerospace Series“ Prestandard has been drawn up unde

4、r the responsibility of ASD-STAN (The AeroSpace and Defence Industries Association of Europe - Standardization). It 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 publ

5、ication of this Prestandard, the technical content shall not be changed to an extent that interchangeability is affected, 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 Eur

6、opean Standard (prEN) to CEN (European Committee for Standardization) for formal vote and transformation to full European 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 standar

7、ds conflicting with the EN. Edition approved for publication 1 January 2012 Comments should be sent within six months after the date of publication to ASD-STAN Quality Domain Copyright 2010 by ASD-STAN prEN 9104-001:2012 (E) 2 Contents Page Introduction 4 Rationale . 4 Foreword . 4 1 Scope . 5 2 Nor

8、mative References 6 3 Terms and Definitions 7 4 Requirements of the Sector Management Structure . 10 5 Requirements for Accreditation Bodies . 12 5.1 General . 12 5.2 Organizational Requirements for Accreditation Bodies . 12 5.3 Quality Management System Requirements for Accreditation Bodies . 12 5.

9、4 Accreditation Body Personnel Requirements . 18 6 Requirements for Certification Bodies . 18 7 Requirements for Aerospace Quality Management System Auditors 21 8 Requirements for Audits and Reporting 21 8.1 Certification Structure Requirements . 21 8.2 Minimum Audit Duration 24 8.3 Aerospace Audit

10、Teams . 29 8.4 Nonconformities . 30 8.5 Audit Team Conclusions and Reporting 30 8.6 Issuance of Certificates 31 8.7 Loss of Certification . 32 8.8 Transfer of Certificates . 32 8.9 Advanced Surveillance and Recertification Procedures 33 8.10 Computer Assisted Auditing Techniques 33 9 Requirements fo

11、r Oversight Process . 33 10 Requirements for Auditor Authentication Bodies . 34 10.1 General . 34 10.2 Organizational Requirements for Auditor Authentication Bodies . 34 10.3 Quality Management System Requirements for Auditor Authentication Bodies . 34 10.4 Aerospace Quality Management System Audito

12、r Competency . 35 10.5 Use of Auditor Authentication Bodies Marks and Logos . 35 10.6 Maintenance, Suspension, Extension, and Withdrawal of Aerospace Quality Management System Auditor Authentication . 35 10.7 Aerospace Quality Management System Auditor Authentication Record Retention 36 10.8 Aerospa

13、ce Quality Management System Auditor Authentication Recognition . 36 11 Requirements for Training Provider Approval Bodies . 36 11.1 General . 36 11.2 Organizational Requirements for Training Provider Approval Bodies . 36 11.3 Quality Management System Requirements for Training Provider Approval Bod

14、ies . 36 12 Online Aerospace Supplier Information System Database 37 13 Requirements of the Other Party Management Team . 38 13.1 Procedure 38 13.2 Responsibilities of the Other Party Management Team . 38 prEN 9104-001:2012 (E) 3 13.3 Composition of the Other Party Management Team 39 13.4 Internatio

15、nal Aerospace Quality Group Oversight Activities . 39 13.5 Certification Structure Oversight Subcommittee . 39 14 Online Aerospace Supplier Information System Database Feedback Process 39 14.1 Online Aerospace Supplier Information System Database . 39 14.2 Feedback Loop A (from Customer to Supplier)

16、 . 39 14.3 Feedback Loop B (from Customer to Certification Body) . 40 14.4 Feedback Loop C (Audit Activity to Customer) 40 14.5 Feedback to Accreditation Bodies . 40 15 Sector Management Structure . 41 15.1 Organization of the Sector Management Structure . 41 15.2 Composition of the Sector Managemen

17、t Structure . 41 15.3 Authority of the Sector Management Structure . 41 15.4 Sector Management Structure Representation to the International Aerospace Quality Group Other Party Management Team 41 16 Cross Frontier Policy for 9104-002 Oversight Activity 42 17 Records 43 18 Requirements for Certified

18、Organizations 43 19 Confidentiality and Conflicts of Interest . 44 20 Fees and Financials. 44 21 Notes . 44 Appendix Page Appendix A Acronym Log 45 Appendix B Industry Controlled Other Party Scheme Certification Structures Matrix for 9100/9110/9120:2009 Certification Audits . 46 Appendix C Informati

19、on to be uploaded into the Online Aerospace Supplier Information System Database . 48 Figures and Tables Page Table 1 Accreditation Body Assessment Requirements of Certification Bodies . 15 Table 2 Audit Duration Requirements 23 Table 3 Multiple Site Organization Audit Frequency 25 Table 4 Permissib

20、le Reductions for Reduced Scope / Complexity for Several Site Organizations 26 Table 5 Online Aerospace Supplier Information System Database Data Responsibility . 37 Figure 1 Illustration of the Customer Supplier Certification Body Feedback Loops within the Online Aerospace Supplier Information Syst

21、em Database 40 Figure 2 Sector Management Structure Diagram . 42 prEN 9104-001:2012 (E) 4 Introduction This standard was reviewed by the Domain 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 Gener

22、al Process Manual, this standard has received approval for Publication. Rationale After the initial publication of International Aerospace Quality Group (IAQG) 9104 standard in 2004, it became evident that a single standard containing all aspects of the Industry Controlled Other Party (ICOP) Aerospa

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

24、istration/ Certification Programs; and 9104-003 Requirements for Aerospace Auditor Competency and Training Courses. The requirements for oversight and AQMS auditor qualification information (9104-002 and 9104-003 respectively) were removed from the original 9104 text. This effort necessitated the to

25、tal rewrite of the initial standard, now re-designated as 9104-001, which is the keystone document of the 9104-series trilogy. Foreword In December 1998, the aviation, space, and defence industry established the IAQG with the goal of achieving significant improvements in quality and reductions in co

26、st throughout the value stream. The IAQG developed specific requirements for aviation, space, and defence (interchangeably referred to as aerospace) quality management systems that are to be implemented and maintained throughout the supply chain for the design, manufacture, and maintenance of produc

27、ts used in aviation, space, and defence applications. These requirements are published simultaneously as the 9100-series standards (i.e., 9100, 9110, 9120) by SAE International in the Americas, AeroSpace and Defence Industries Association of Europe - Standardization (ASD-STAN) in Europe, and Japanes

28、e Standards Association (JSA) and Society of Japanese Aerospace Companies (SJAC) in Asia/Pacific. Another initiative of the IAQG was the development of a global scheme for the acceptance and recognition of audits performed by Certification Bodies (CBs), using the 9100-series standards, and taking in

29、to 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 3rd party audit certification scheme with specific aviation, space, and defence elements and requirements, under the guidance and oversight of the

30、 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 throughout the entire supply chain. This standard defines the basic requirements for managing the AQMS certification scheme (commonly referred to as

31、the ICOP scheme). Two other standards in this series (i.e., 9104-002, 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 certificat

32、ion management system Trilogy. prEN 9104-001:2012 (E) 5 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; a

33、nd the use of international 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

34、(TPABs); b) the qualification, 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 audi

35、ts; f) the posting of audit 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 ca

36、lculations, multiple site certifications). Additionally, this standard references the other standards in the 9104-series (i.e., 9104-002, 9104-003) that specify: i) the minimum standards of qualification and experience for AQMS auditors; j) the authentication of AQMS auditors by AABs and recognition

37、 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 management of the ICOP scheme; and l) the operatio

38、n of the IAQG oversight function. This standard also provides guidance for the use of the required audit process reporting tools (see 9101), and provides clarifications and process improvements resulting from the lessons learned during the initial operation of the ICOP scheme. 1 Scope The purpose of

39、 this standard is to define the requirements and industry-accepted practices for managing the ICOP scheme, which provides confidence to aviation, space, and defence customers and organizations that their suppliers with certification of their quality management systems, issued by accredited CBs, meet

40、 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 requirements are applicable to IAQG working groups e.g., SMS, Other Party Management Team (OPMT),

41、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 adopted by the organization shall be 9100, 9110, and/or 9120, as appropriate to the organizatio

42、ns 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 system to all equivalent AQMS standards (e.g., AS, EN, JISQ, NBR). IAQG sectors may expand the application o

43、f the prEN 9104-001:2012 (E) 6 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), Asia/Pacific Aerospace Quality Group (APAQG). 2 Normative References Audits and

44、assessments shall be based on the latest published versions of the following quality management systems standards, and guidance and mandatory documents, as applicable. For dated references, only the edition cited applies. When a conflict in requirements between this standard and the referenced stand

45、ards and documents exist, the requirements of this standard shall take precedence. 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, Aerospa

46、ce series Quality management 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 Qu

47、alification EN 9110, Quality 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 i

48、nternationally in each IAQG sector. ISO 9000, Quality management systems Fundamentals and vocabulary ISO 9001, Quality management systems Requirements ISO/IEC 17011:2004, Conformity assessment General requirements for accreditation bodies accrediting conformity assessment bodies ISO/IEC 17021:2011,

49、Conformity assessment Requirements for bodies providing audit and certification of management systems ISO/IEC 17024:2003, Conformity assessment General requirements for bodies operating certification of persons ISO 19011:2011, Guidelines for auditing management systems IAF GD 3:2003, IAF Guidance on Cross Frontier Accreditation 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 Certificat