AECMA PREN 9104-002-2007 Aerospace series Quality management systems Part 002 Requirements for Oversight of Aerospace Quality Management System Certification Registrations Programs.pdf

1、ASD STANDARD NORME ASD ASD NORM prEN 9104-002 Edition P 1 February 2007 PUBLISHED BY THE AEROSPACE AND DEFENCE INDUSTRIES ASSOCIATION OF EUROPE - STANDARDIZATIONGulledelle 94 - B-1200 Brussels - Tel. + 32 2 775 8126 - Fax. + 32 2 763 3565 - www.asd-stan.orgICS: Descriptors: ENGLISH VERSION Aerospace

2、 series Quality management systems Part 002: Requirements for Oversight of Aerospace Quality Management System Certification/Registrations Programs Srie arospatiale Systmes de management de la qualit Partie 002 : Exigences relatives la supervision des processus de certification des Systmes de Manage

3、ment de la qualit dans le domaine arospatial Luft- und Raumfahrt Qualittsmanagementsysteme Teil 002 : Anforderungen an berwachung/Kontrolle von Zertifizierungsverfahren fr Qualittsmanagementsysteme der Luft- und Raumfahrt This “Aerospace Series“ Prestandard has been drawn up under the responsibility

4、 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 publication of this Pres

5、tandard, 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 European Standard (prEN

6、) 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 standards conflicting with

7、the EN. Edition approved for publication 28 February 2007 Comments should be sent within six months after the date of publication to ASD-STAN Quality Domain Copyright 2007 by ASD-STAN Copyright European Association of Aerospace Industries Provided by IHS under license with AECMA Not for ResaleNo rep

8、roduction or networking permitted without license from IHS-,-,-prEN 9104-002:20072 Contents Page Foreword3 1 Scope 4 2 Normative references 4 3 Terms and definitions .5 4 General7 5 Requirements for participating international aerospace quality group member companies8 6 Requirements for internationa

9、l aerospace quality group other party management team.9 7 Requirements for the sector management structure 12 8 Requirements for international aerospace quality group member shared oversight . 14 9 Roles and responsibilities . 16 10 Confidentiality and conflict of interest . 18 11 Complaint resoluti

10、on process. 19 12 Records 19 13 Notes 19 Annex A (normative) International aerospace quality group (IAQG) industry controlled other party (ICOP) sector management structure diagram and process model 20 Annex B (normative) On-line aerospace supplier information system (OASIS) management assessment ch

11、eck sheet 22 Annex C (normative) Sector management structure (SMS) assessment check sheet. 24 Annex D (normative) Certification body management committee (CBMC) assessment check sheet. 26 Annex E (normative) Accreditation body (AB) office assessment check sheet 29 Annex F (normative) Certification b

12、ody (CB) office assessment check sheet 31 Annex G (normative) Accreditation body (AB) / certification body (CB) witness assessment check sheet . 34 Annex H (normative) Auditor authentication body (AAB) / training provider approval body (TPAB) office assessment check sheet. 37 Annex I (normative) Ind

13、ustry Controlled Other Party (ICOP) declaration form for other party (OP) assessors conducting EN 9104 oversight . 39 Annex J (normative) Oversight nonconformity record 40 Annex K (normative) Oversight assessment summary report 42 Bibliography. 43 Copyright European Association of Aerospace Industri

14、es Provided by IHS under license with AECMA Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-prEN 9104-002:20073 Foreword This standard was reviewed by the Domain Technical Coordinator of ASD-STANs Quality Domain. After inquiries and votes carried out in accordance

15、with the rules of ASD-STAN defined in ASD-STANs General Process Manual, this standard has received approval for Publication. This document is written to define a robust shared oversight process to ensure conformance to established aerospace industry 9100-series accreditation/certification requiremen

16、ts. In December 1998, the Aerospace Industry established the International Aerospace Quality Group (IAQG) with the purpose 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 Manage

17、ment Team (OPMT) that monitors and reviews the Aerospace Supplier Quality System Accreditation/Certification Schemes 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

18、and global sector levels; use of joint team assessments; the use of qualified and approved IAQG member Other Party (OP) assessors; the use of common assessment tools; the reporting of oversight results. This document addresses the following issues: a) Establishment of standard oversight processes in

19、 all three global sectors (Europe, Asia Pacific and the Americas). 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),

20、 Training Provider Approval Bodies (TPABs) and training providers. Copyright European Association of Aerospace Industries Provided by IHS under license with AECMA Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-prEN 9104-002:20074 1 Scope 1.1 General These requirem

21、ents are applicable to IAQG global sectors when utilizing Aerospace Industry Controlled Other Party (ICOP) schemes for the assessment and certification of supplier quality systems in accordance with the requirements contained in EN 9104. IAQG member companies have committed to perform sufficient ove

22、rsight of the Aerospace accreditation/ certification assessment processes in order to ensure conformance to established requirements contained in EN 9104. NOTE The IAQG OPMT oversight structure is depicted graphically in Annex A. 1.2 Purpose The purpose of this standard is to document the process fo

23、r oversight of the 9100-series certification of Aerospace Quality Management Systems (AQMS) program. This process shall be implemented by participating IAQG member companies, ABs, CBs, AABs, TPABs and training providers to ensure consistent conformance with the requirements of EN 9104. 2 Normative r

24、eferences The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN 9100, Aerospace series Quality manag

25、ement systems Requirements (based on ISO 9001:2000) and Quality systems Model for quality assurance in design, development, production, installation and servicing (based on ISO 9001:1994). 1)EN 9104, Aerospace series Quality management systems Requirements for Aerospace Quality Management System Cer

26、tification/Registrations Programs. 1)EN 9104-003, Aerospace series Quality management systems Part 003:Requirements for Aerospace Auditor Authentication. 1)2)EN 9110, Aerospace series Quality systems Model for quality assurance applicable to maintenance organizations. 1)EN 9120, Aerospace series Qua

27、lity management systems Requirements for stockist distributors (based on ISO 9001:2000). 1)ISO 9000, Quality management systems Fundamentals and vocabulary. ISO 9001, Quality management systems Requirements. ISO/IEC 17011, Conformity assessment General requirements for accreditation bodies accrediti

28、ng conformity assessment bodies. 1) Or the corresponding AAQG standards (e.g. AS, ARP, etc.) or APAQG (e.g. JISQ, SJAC, HB, etc.) 2) In preparation at the date of publication of this standard. Copyright European Association of Aerospace Industries Provided by IHS under license with AECMA Not for Res

29、aleNo reproduction or networking permitted without license from IHS-,-,-prEN 9104-002:20075 ISO/IEC 17021, Conformity assessment Requirements for bodies providing audit and certification of management systems. ISO/IEC 17024, Conformity assessment General requirements for bodies operating certificati

30、on of persons. ISO 19011, Guidelines for quality and/or environmental management systems auditing. IAF, Guidance on the Application of ISO/IEC Guide 61:1996. IAF, Guidance on the Application of ISO/IEC Guide 62:1996. 3 Terms and definitions For the purposes of this document, the following terms and

31、definitions apply. 3.1 accreditation body (AB) body recognized by an IAQG sector that has the primary responsibility for the accreditation of CBs to issue certifications/registrations to AQMS standards 3.2 aerospace business of design, manufacture, maintenance, distribution, and support of aviation

32、vehicles and engines, accessories and component parts, all ancillary and allied businesses including aerospace vehicle operations This also includes Space and Defence. 3.3 aerospace experience auditor (AEA) 3)auditor that has met the requirements set forth in EN 9104 and EN 9104-003 3.4 auditor auth

33、entication body (AAB) body recognized by an IAQG sector that has the primary responsibility for certifying or approving persons (e.g., auditors) against specific requirements 3.5 other party (OP) assessor IAQG member representative that has been qualified and approved in accordance with this standar

34、d, and supports a joint team assessment or conducts supplementary IAQG member oversight activity in accordance with this standard 3.6 certification body (CB) body that audits and certifies/registers the conformity of the quality management system of organizations with respect to published AQMS stand

35、ards and any supplementary documentation required under the system Also, referred to as Certification Registration Body (CRB). 3) Sectors may use other names for Auditor, Aerospace Auditor and Aerospace Experienced Auditor (AEA) as long as the requirements of EN 9104 are applied. Copyright European

36、Association of Aerospace Industries Provided by IHS under license with AECMA Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-prEN 9104-002:20076 3.7 certification bodies management committee (CBMC) organization within an SMS that functions on a national level (e.g.

37、, Italy, France, Germany, Spain, UK, Austria); responsible for EN 9104 conformance in their respective countries They perform the same functions as the SMS under the control of their global SMS. 3.8 international aerospace quality group (IAQG) body of prime aerospace Original Equipment Manufacturers

38、 (OEMs) This group is chartered to develop and implement common requirements and guidelines for use by the space, aviation and defense industry for quality improvement. 3.9 international aerospace quality group (IAQG) sector or sector sub-structure of the IAQG, consisting of the members in a specifi

39、c area, such as Americas, Europe and Asia/Pacific 3.10 joint team assessment 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 3.11 nonconformity non-fulfillment of a r

40、equirement (see ISO 9000) major: the absence of, or the failure to implement and maintain, one or more requirements which would, on the basis of available objective evidence raise significant doubt as to the credibility of conformance; or a number of minor nonconformities against one or more require

41、ments, which when combined, can represent a breakdown of the system or process minor: an observed lapse in conformance to a requirement 3.12 office assessment on-site evaluation of an AB, CB, AAB or TPAB, at the management office, to the applicable aerospace requirements, using the evaluation tools

42、and methods contained in this standard 3.13 sector management structure (SMS) organization established in a sector that manages the application of the sector scheme based on EN 9104 Each sector may use a different name for this organization, (e.g., Registration Management Committee in the Americas a

43、nd Asia Pacific, OPMT in Europe within the AeroSpace EAQG European Aerospace Quality Group; AAQG Americas Aerospace Quality Group, APAQG Asia Pacific Aerospace Quality Group; SMS Sector Management Structure; AB Accreditation Body; CB Certification Body; AAB Auditor Authentication Body; OASIS On-line

44、 Aerospace Supplier Information System; IAQG International Aerospace Quality Group; ICOP Industry Controlled Other Party Figure A.2 Copyright European Association of Aerospace Industries Provided by IHS under license with AECMA Not for ResaleNo reproduction or networking permitted without license fr

45、om IHS-,-,-prEN 9104-002:200722 Annex B (normative) On-line aerospace supplier information system (OASIS) management assessment check sheet Name (Organization being audited) Address City, State, Country Contact Name Assessment Date(s) Day(s)/Month/Year OP Assessor(s) First Name, Last Name; Assessmen

46、t Team Role, Organization Name Submitted by Name Date Submitted Day/Month/Year Item Reference Assessment Results Assessment Evidence / Comments EN 9104 Section (Unless Otherwise Noted) A - Acceptable X - Issue Identified NA - Not Applicable NE - Not Evaluated Briefly note observed objective evidence

47、, including strengths and issues identified during the assessment. Ensure supporting documentation exists for all identified issues. OASIS Management System 1. Does SAE establish and maintain the operation procedure for OASIS database in accordance with the requirement or enhancement requirement dec

48、ided by IAQG? Review the operation procedure and the implementation status. 14.2 2. Does SAE ensure that necessary information shall be provided to applicable data base administrator of AB, CB and the registered organization? Review the record of the distribution. 3. Does SAE data base administrator

49、 keep the report of rejections of any input data? Review the applicable report. Copyright European Association of Aerospace Industries Provided by IHS under license with AECMA Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-prEN 9104-002:200723 Item Reference Assessment Resul