SAE AS 9104A-2005 Requirements for Aerospace Quality Management System Certification Registrations Programs《航空航天质量管理体系认证 登记计划要求》.pdf

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5、-11 Superseding AS9104 Requirements for Aerospace Quality Management System Certification/Registrations Programs RATIONALEAS9104A has been reaffirmed to comply with the SAE five-year review policy. FOREWORDIn December 1998, the Aerospace Industry established the International Aerospace Quality Group

6、 (IAQG) with the purpose of achieving significant improvements in quality and reductions in cost throughout the value stream. The IAQG has developed specific requirements for quality systems that are to be implemented and maintained throughout the supply chain in the design, manufacture and maintena

7、nce of products used in aviation and space applications. These requirements are published simultaneously as AS/EN/JISQ 9100-series by SAE in the Americas, AECMA in Europe and JISQ in Asia/Pacific. Other countries will follow with technically identical national standards. In this document, these stan

8、dards are indicated as Aerospace Quality Management Systems (AQMS) Standards.A further initiative of the IAQG was the development of a truly global scheme for the use of assessment results performed by Certification/Registration Bodies (CRBs), based on the 9100-series standards and taking into accou

9、nt the schemes already in use or under development in the various IAQG sectors. All these schemes have two major elements in common: - Use of a voluntary certification/registration scheme with specific aerospace elements and requirements, under the supervision and control of the aerospace industry.-

10、 A harmonized approach to the CRBs with the purpose to improve the quality level and control throughout the whole supply chain. Copyright SAE International Provided by IHS under license with SAENot for ResaleNo reproduction or networking permitted without license from IHS-,-,-This document provides

11、requirements for sectorial/regional schemes for the controlled use of assessment results of CRBs, based on three fundamentals: - Use of accredited CRBs. - Use of qualified and approved aerospace auditors. - Use of international aerospace standards for quality management systems in aerospace industry

12、.This document addresses the following issues: a. Qualification and accreditation of CRBs. b. Assessment of quality systems by accredited CRBs. c. The principles for determining the content and duration of assessments. d. Reporting and control of nonconformities. e. The form of registration recommen

13、dations. f. Minimum standards of qualification and experience for aerospace auditors employed by CRBs.g. Authentication of auditors by CRBs, Accreditation Bodies (ABs) and the IAQG sectors. h. Oversight of ABs by applicable Sector Management Structure (SMS). i. Oversight of CRBs by applicable SMS an

14、d IAQG Original Equipment Manufacturers (OEM).j. Operation of the IAQG oversight function. This document introduces certification/registration to the 9110 (maintenance organizations) and 9120 (stockist/distributors) standards, use of ISO 19011, mandatory use of the scoring process, as well as a numb

15、er of clarifications and detail improvements resulting from the initial operation of the scheme. The requirements of this document are effective upon publication.SAE INTERNATIONAL AS9104A Page 2 of 30_Copyright SAE International Provided by IHS under license with SAENot for ResaleNo reproduction or

16、networking permitted without license from IHS-,-,-TABLE OF CONTENTS 1. SCOPE 5 1.1 Purpose5 2. REFERENCES.53. DEFINITIONS 7 4. GENERAL9 5. REQUIREMENTS FOR ACCREDITATION BODIES.9 6. REQUIREMENTS FOR CERTIFICATION/REGISTRATION BODIES.10 7. REQUIREMENTS FOR AUDITORS 12 7.1 Auditors127.2 Aerospace Expe

17、rience Auditors for 9100.127.3 Aerospace Experience Auditors for 9120 (distributors/stockists).147.4 Aerospace Experience Auditors for 9110 (maintenance).167.5 Continuing Qualification and Education .18 7.6 Summary of the Requirements for Aerospace Industry Auditors .18 8. REQUIREMENTS FOR ASSESSMEN

18、T AND REPORTING .18 8.1 Aerospace Assessment Teams .188.2 Duration of Assessment.198.3 Nonconformity208.4 Audit Team Conclusions and Reporting.218.5 Surveillance and Re-certification Assessments .218.6 Registration/Issue of Certificates .228.7 Loss of Certification/Registration .22 9. AUTHENTICATION

19、 AND OVERSIGHT OF ACCREDITATION BODIES 23 10. AUTHENTICATION AND OVERSIGHT OF CERTIFICATION/ REGISTRATION BODIES23 11. AUTHENTICATION AND OVERSIGHT OF AUDITORS .24 12. RECORDS .25 13. FEE 25 SAE INTERNATIONAL AS9104A Page 3 of 30_Copyright SAE International Provided by IHS under license with SAENot

20、for ResaleNo reproduction or networking permitted without license from IHS-,-,-14. RESPONSIBILITIES 25 14.1 Procedure.2514.2 Responsibility of the IAQG OT .2514.3 Composition of the IAQG OT .2614.4 IAQG Oversight Activities.26 15 SECTOR MANAGEMENT STRUCTURE (SMS) .26 15.1 Responsibilities of the SMS

21、 2615.2 Composition of SMS .2615.3 Reporting of Essential Data .2715.4 Sector Resolutions.27 15.5 SMS Authority 27APPENDIX A INFORMATION TO BE PROVIDED INTO THE IAQG-OASIS DATABASE.28 APPENDIX B IAQG OVERSIGHT TEAM (OT) ACTIVITIES 29SAE INTERNATIONAL AS9104A Page 4 of 30_Copyright SAE International

22、Provided by IHS under license with SAENot for ResaleNo reproduction or networking permitted without license from IHS-,-,-1. SCOPE: These requirements are applicable to IAQG sector schemes when making use of ABs, CRBs and their auditors, for the assessment and certification/registration of supplier q

23、uality systems in accordance with the requirements of this document. The quality management system standard used by the CRB shall be 9100/9110/9120, as appropriate to the suppliers activities. It shall be applied to the suppliers complete Quality System that covers aerospace products. Sectors may us

24、e these requirements for other standards.IAQG members have committed to recognize the equivalence of certification/registration of a suppliers quality management system to either of the AS, EN or JISQ/SJAC standards. 1.1 Purpose: The purpose of this document is to give requirements on the process fo

25、r providing aerospace companies and their suppliers with assessment and certification/registration of their quality systems, by accredited CRBs.2. REFERENCES: Assessments shall be based on the latest versions of the following quality systems standards and guidelines, as appropriate. AS/EN/JISQ 9100

26、Quality Management Systems - Aerospace - Requirements AS/EN 9110 Quality Management Systems - Aerospace - Requirements for Maintenance Organizations AS/EN 9120 Quality Management Systems - Aerospace - Requirements for Stockist / Distributors NOTE: The above standards are referred throughout this doc

27、ument as AQMS Standards. SAE INTERNATIONAL AS9104A Page 5 of 30_Copyright SAE International Provided by IHS under license with SAENot for ResaleNo reproduction or networking permitted without license from IHS-,-,-2. (Continued): AS/EN/SJAC 9101 Quality Management Systems Assessment AS/EN 9111 Qualit

28、y Management System Assessment applicable to Maintenance Organizations AS/EN 9121 Quality System Assessment Applicable to Stockist Distributors NOTE: The above standards are referred throughout this document as the Aerospace Assessment Report and Questionnaires. AS/EN/SJAC 9102 Aerospace First Artic

29、le Inspection Requirement AS/EN/SJAC 9103 Variation Management of Key Characteristics ISO 9000 Quality Management Systems - Fundamentals and Vocabulary ISO 9001 Quality Management Systems - RequirementsISO 9004 Quality Management Systems - Guidelines for Performance ImprovementsISO 19011 Guidelines

30、for Quality and/or Environmental Management Systems AuditingISO/IEC Guide 61 General Requirements for Assessment and Accreditation of Certification/Registration Bodies ISO/IEC Guide 62 General Requirements for Bodies Operating Assessment and Certification/Registration of Quality SystemsIAF Guidance

31、on the Application of ISO/IEC Guide 61 IAF Guidance on the Application of ISO/IEC Guide 62 SAE INTERNATIONAL AS9104A Page 6 of 30_Copyright SAE International Provided by IHS under license with SAENot for ResaleNo reproduction or networking permitted without license from IHS-,-,-3. DEFINITIONS: For t

32、he purpose of this document the following definitions are used: 3.1 Accreditation Body (AB): A body recognized by an IAQG sector that has the primary responsibility for the accreditation of CRBs to issue certifications/registrations to AQMS standards. 3.2 Aerospace: The business of design, manufactu

33、re, maintenance, distribution and support of aviation vehicles and engines, accessories and component parts, all ancillary and allied businesses including aerospace vehicle operations. 3.3 Aerospace Experience Auditor1:An auditor that has met the requirements set forth in 7.2, 7.3 or 7.4 of this doc

34、ument. 3.4 Aerospace Product: An aircraft, rotorcraft, guided weapon, launcher, spacecraft or other product designed to travel through the air, inside or outside the ground effect, or to travel outside the influence of the earths atmosphere or major components of these products such as engines or ma

35、jor sub-systems or parts, appliances, equipment and materials as contained in these. 3.5 Auditor2:A person that has met the requirements set forth in 7.1 of this document.3.6 Certification/Registration Body (CRB): A party that audits and certifies/registers the quality management system of organizat

36、ions with respect to published quality management system standards and any supplementary documentation required under the system. 3.7 International Aerospace Quality Group (IAQG): A body of prime aerospace OEMs. This group is chartered to develop common requirements for use by the aerospace industry

37、 for quality improvement.1, 2NOTE: Sectors may use other names for Auditor, Aerospace Auditor and Aerospace Experienced Auditor as long as the requirements of this documents are applied. SAE INTERNATIONAL AS9104A Page 7 of 30_Copyright SAE International Provided by IHS under license with SAENot for

38、ResaleNo reproduction or networking permitted without license from IHS-,-,-3.8 International Aerospace Quality Group (IAQG) Sector or Sector: A sub-structure of the IAQG, consisting of the members in a specific area, such as Americas, Europe and Asia/Pacific. 3.9 Nonconformity: The absence of, or th

39、e failure to implement and maintain, one or more quality management system requirements, or a situation that would, on the basis of available objective evidence, raise significant doubt as to the quality of what the organization is supplying.Major: The absence of, or total breakdown of a quality man

40、agement system element specified in the AQMS standard or any non-conformities where the effect is judged to be detrimental to the integrity of the product, processes or service. Minor: A single system failure or lapse in conformance with a procedure relating to the AQMS standard. NOTE: A number of m

41、inor non-conformities against one requirement can represent a total breakdown of the system and this can be considered as a major nonconformity.Any finding (e.g., comments, observations) that equates to the above definition shall be documented as a nonconformity, categorized as major or minor, and d

42、ealt with in accordance with 8.3. 3.10 On Line Aerospace Supplier Information System (OASIS): The web-based IAQG database containing information on participating National Aerospace Industry Associations, ABs, accredited CRBs, authenticated Aerospace Experience Auditors, Certified Suppliers and Asses

43、sments 3.11 Sector Management Structure (SMS): The organization established in a sector that manages the application of the sector scheme based on this document. Each sector may use a different name for this organization (e.g., Registrar Management Committee in the Americas and Asia/Pacific, Certifi

44、cation Body Management Committee in Europe within AECMA). SAE INTERNATIONAL AS9104A Page 8 of 30_Copyright SAE International Provided by IHS under license with SAENot for ResaleNo reproduction or networking permitted without license from IHS-,-,-4. GENERAL: 4.1 The requirements stated herein shall b

45、e based on the latest versions of the documents listed in Section 2.4.2 Aerospace additional requirements are identified in the AQMS Standards as bold italic items. These elements are in addition to ISO 9001 elements and should also be applied in the organizations quality system.4.3 Data, in the for

46、m of checklists, approvals or other company specific information, generated in the application of this document shall be handled as “confidential, proprietary and sensitive” between the parties generating, collecting, or using the data. Companies using this data shall keep its usage confidential both internally and externally, unless otherwise agreed in writing by the consenting parties. Data resident at the ABs and CRBs on OEMs sh