AECMA PREN 9104-2004 Aerospace series Quality management systems Requirements for Aerospace Quality Management System Certification Registrations Programs Edition P 1《航空航天系列.质量系统要求.pdf

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1、AECMA STANDARD NORME AECMA AECMA NORM Edition approved for publication 31 December 2004 prEN 9104 Edition P 1 December 2004 Comments should be sent within six months after the date of publication to AECMA-STAN PUBLISHED BY THE EUROPEAN ASSOCIATION OF AEROSPACE INDUSTRIES - STANDARDIZATION d%k? or c)

2、 If less than 4 (four) years aerospace industry experience in the last 10 (or more than 6 (six) consecutive years since last industry work experience from date the of application), the completion of an in-depth Aerospace Industry Competency course developed by the CRB or an independent organization

3、is required. Both the course and the training organization shall be approved by the SMS. The course shall include the following topics as a minimum: Aerospace industry quality perspective. CAA requirements. Principles of military aerospace requirements and regulations. First Article Inspection (EN 9

4、102). Airworthiness and safety requirements. Design, development, verification and validation. Aerospace ma te ri al tracea bi I i ty requirements . Aerospace subcontractor approval and control requirements. Variation management of key characteristics (EN 91 03). Flow down of Quality requirements. F

5、oreign Object Damage (FOD) prevention program requirements. Use of Customer supplied products. Calibration controls and positive recall system. Acceptance authority media. Nonconforming material, system requirements and operation. Sampling inspection requirements and limitations. Special processes.

6、Configuration managementhequirements control. and Copyright Association Europeene des Constructeurs de Materiel Aerospatial Provided by IHS under license with AECMANot for ResaleNo reproduction or networking permitted without license from IHS-,-,-Page 11 prEN 9104:2004 d) In addition to 7.2.c), the

7、auditor shall have participated in at least 2 (two) full EN 9100 aerospace industry audits within the past 3 (three) years and have been witnessed by a currently qualified Aerospace Experienced Auditor or the AB, who themselves have not become qualified via training as per 7.2.c). The audits shall c

8、over all elements of the standard and shall have been conducted at organizations that are predominately aerospace oriented. The auditor candidate shall receive a positive and documented recommendation for qualification on all audits. NOTE relevant Aerospace knowledge and experience as per 7.2.a) and

9、 7.2.c). Exceptions to these requirements will be considered providing candidates can demonstrate adequate and 7.3 Aerospace Experience Auditors for EN 9120 (distributors/stockists) Auditors that are to be considered, as Aerospace Experience Auditors for EN 9120 shall have 4 (four) years aerospace i

10、ndustry experience, within the prior 10 calendar years, meet the requirements of 7.1 above and the following: Training in the EN 9120 Requirements: This may be self-taught, but with a formal test to demonstrate knowledge of the specification. Work Experience: Four years full time in the aerospace in

11、dustry directly involved in Engineering, Design, Manufacturing, Quality or Process Control for a major airframe manufacturer, prime supplier, auxiliary equipment supplier and/or appropriate oficial civil, military or space organization, such as NAA, ESANASA, MOD. The work experience should have incl

12、uded direct involvement or knowledge of the elements as defined in 7.3.c); or If less than 4 (four) years aerospace industry experience in the last 10 or more than 6 (six) consecutive years since last industry work experience from date the of application, the completion an of an in-depth Aerospace I

13、ndustry Competency course developed by the CRB or an independent organization is required. Both the course and the training organization shall be approved by the SMS. The course shall include the following topics as a minimum: Aerospace industry quality perspective. CAA requirements. Principles of m

14、ilitary aerospace requirements and regulations. Airworthiness and safety requirements. Aerospace material traceability requirements. Flow down of Quality requirements. FOD prevention program requirements. Use of Customer supplied products. Calibration controls and positive recall system. Acceptance

15、authority media. Nonconforming material, system requirements and operation. Sampling inspection requirements and limitations. Configuration managementrequirements control. and Copyright Association Europeene des Constructeurs de Materiel Aerospatial Provided by IHS under license with AECMANot for Re

16、saleNo reproduction or networking permitted without license from IHS-,-,-Page 12 prEN 9104:2004 d) In addition to 7.3.c), the auditor shall have participated in at least 2 (two) full EN 91 O0 or EN 91 10 aerospace industry audits within the past 3 (three) years and have been witnessed by a currently

17、 qualified Aerospace Experienced Auditor or the AB, who themselves have not become qualified via training as per 7.3.c). The audits shall cover all elements of the standard and shall have been conducted at organizations that are predominately aerospace oriented. The auditor candidate shall receive a

18、 positive and documented recommendation for qualification on all audits. NOTE relevant Aerospace knowledge and experience as per 7.3.b) and 7.3.c). Exceptions to these requirements will be considered providing candidates can demonstrate adequate and 7.4 Aerospace Experience Auditors for EN 91 10 (ma

19、intenance) Auditors that are to be considered, as Aerospace Experience Auditors for EN 91 10 shall have 4 (four) years aerospace industry experience, within the prior 10 calendar years, meet the requirements of 7.1 and the following: a) Training in the EN 91 10 requirements and tested; b) Work Exper

20、ience: 4 (four) years full time in the aerospace industry directly involved in Engineering, Design, Manufacturing, Quality or Process Control for a major airframe manufacturer, prime supplier, auxiliary equipment supplier and/or appropriate official civil, military or space organization, such as NAA

21、, ESA/NASA, MOD . In addition they shall have had specific training in Repair/Overhaul or demonstrated 2 (two) years full time experience in the last 4 (four) years. The work experience should have included direct involvement or knowledge of the elements as defined in 7.4.c); or c) If less than 4 (f

22、our) years aerospace experience in the last 10 or more than 6 (six) consecutive years since last industry work experience from date the of application, the completion of an in-depth Aerospace Industry Competency course developed by the CRB or an independent organization is required. Both the course

23、and the training organization shall be approved by the SMS. The course shall include the following topics as a minimum: Aerospace industry quality perspective. CAA requirements. Principles of military aerospace requirements and regulations. First Article Inspection (EN 9102). Airworthiness and safet

24、y requirements. Design, development, verification and validation. Aerospace ma te ri al tracea bi I i ty requirements . Aerospace subcontractor approval and control requirements. Variation management of key characteristics (EN 91 03). Quality requirements flow downs. FOD prevention program requireme

25、nts. Use of Customer supplied products. Calibration controls and positive recall system. Acceptance authority media. Nonconforming material, system requirements and operation. Sampling inspection requirements and limitations. Special processes. Copyright Association Europeene des Constructeurs de Ma

26、teriel Aerospatial Provided by IHS under license with AECMANot for ResaleNo reproduction or networking permitted without license from IHS-,-,-Page 13 prEN 91 04:2004 JAR/FAR 145/136 (EASA IR M). Tool control. “Return to service” process. Flight test. Functional check flight. Weight and balance. Wing

27、 walking or aircraft marshalling techniques. Configuration managementrequirements control. and d) In addition to 7.4.c) the auditor shall have participated in at least 2 (two) full aerospace industry audits within the past 3 (three) years and have been witnessed by a currently qualified Aerospace Ex

28、perienced Auditor or the AB, who themselves have not become qualified via training as per 7.4.c). The audits shall cover all elements of the standard and shall have been conducted at organizations that are predominately aerospace oriented. The auditor candidate shall receive a positive and documente

29、d recommendation for qualification on all audits. NOTE relevant Aerospace knowledge and experience as per 7.4.b) and 7.4.c). Exceptions to these requirements will be considered providing candidates can demonstrate adequate and 7.5 Continuing qualification and education To maintain qualification all

30、auditors and aerospace experience auditors shall participate in at least 4 (four) aerospace audits in 3 (three) years and participate in continuing education in accordance with sectorial training requirements that requires review of the changes to the aerospace industry standards, auditing methods a

31、nd IS0 requirements at a minimum of 15 hours total within 3 (three) years. 7.6 Summary of the requirements for aerospace industry auditors Table 1 Auditor 17.11 Aerospace experienced auditor includes 7.1 & 7.2/7.3/7.4 Auditors are to be trained and approved-for IS0 9001 auditing per IS0 1901 1 Gener

32、al knowledge of Aerospace Quality Management Systems Standards Auditor training in industry standards and current aerospace industry requirements 6.4.b) or 4 years of aerospace work experience in the last 1 O years 7.2.a) & 7.3.b) & 7.4.b)l or ndustry experience less than 4 years & training on aeros

33、pace industry requirements and 2 witness audits 7.2.c)/7.2.d) & 7.3.c)/7.3.d) & 7.4.c)/7.4.d) All auditors & Aerospace experienced auditors 15 hours of continuing education for auditors within every 3 years & 4 audits within 3 years V.51 NOTE Numbers in refer to paragraph numbers in this document Co

34、pyright Association Europeene des Constructeurs de Materiel Aerospatial Provided by IHS under license with AECMANot for ResaleNo reproduction or networking permitted without license from IHS-,-,-Page 14 prEN 9104:2004 8 Requirements for assessment and reporting 8.1 Aerospace Assessment Teams 8.1.1 T

35、he Assessment Team Leader, shall be a qualified auditor per IS0 19011, as identified in the CRBs accredited system, and “Aerospace Experience Auditor” qualified and authenticated for the AQMS standard concerned (EN 9100: 7.2, EN 9110: 7.4, EN 9120: 7.3). 8.1.2 The team may include other auditors acc

36、ording to 7.1, as required. 8.1.3 The assessment team needs a background to ensure that the members understand the requirements relating to the system they are assessing. Each assessment team shall have a general understanding and background in each technological and industrial sector in which it op

37、erates. In certain instances, particularly where there are critical requirements and special procedures the background knowledge of the audit team may be supplemented by an organization briefing, specific training or experts in attendance. The CRB may attach non-auditor experts to their assessment t

38、eams. If a CRB does use technical experts, its system shall include details of how technical experts are selected and how their technical knowledge is assured on a continuing basis. The CRB may rely on outside help (.e., from industry or professional institutions). 8.1.4 The team leader shall ensure

39、 that all members of the team are aware of the requirements of this document as it may affect the scope of their assessment activity. Additionally the Aerospace Experience Auditor(s) shall provide guidance to the assessment team throughout the assessment on the interpretation of aerospace requiremen

40、ts and, when requested, the significance of any issues identified. 8.1.5 The ABS, IAQG OEM members, Regulatory Agency or Customer representatives or OEMs may accompany the assessment team as observers of the assessment process at any time. When Customer or Government representatives are participatin

41、g in the audit, the Team Leader shall have the option of including in the assessment report any findings brought forward by these representatives. 8.2 Duration of Assessment 8.2.1 Requirements are to be established for minimum auditor-person days, for initial assessment, surveillance and re-certific

42、ation assessment, appropriate to the size of the organization being assessed. For aerospace organizations these requirements may be vaned to take into account the complexity of the quality system and the number and variety of activities, but the guidance in Annex 2 of the IAF Guidance on the Applica

43、tion of ISO/IEC Guide 62 is to be used as minimum. 8.2.2 It is anticipated that the requirements of the AQMS Standards shall add on-site assessment time, depending on size and commodity of the organization involved. The duration of an assessment shall be as agreed between the organization being asse

44、ssed and the CRB, using ISO/IEC Guide 62 and IAF Guidance on the Application of ISO/IEC Guide 62 as a minimum. In addition the on-site assessment time for the applicable AQMS shall be according to the following table (Table 2), also depending on organization size and the specific scope of the AQMS b

45、eing assessed: Copyright Association Europeene des Constructeurs de Materiel Aerospatial Provided by IHS under license with AECMANot for ResaleNo reproduction or networking permitted without license from IHS-,-,-Page 15 prEN 9104:2004 Additional Auditor-days Initial Assessment 91 O0 Annual Surveilla

46、nce Initial Assessment Annual Surveillance Initial Assessment 9110 Table 2 Total Number of employees in the organization 5-1 O0 1 o1 -1 O00 Over 1000 +I .5 +2.0 +3.0 +I .o +I .5 +2.0 +I .o +2.0 +3.0 +O5 +I .o +I .5 +O5 +I .o +I .5 91 20 Annual Surveillance +O5 +O5 +O5 8.2.3 The assessment of multipl

47、e sites for a single Registration/Certificate shall be conducted by assessing each site to the complete and applicable AQMS requirements prior to Certificate issuance. For AQMS 9120 only, sampling of multiple sites shall comply with the guidance provided in the IAF Guidance on the Application of ISO

48、/IEC Guide 62 and shall be limited to sites located in the same country. Surveillance/Re-certification assessment shall assure that each site under a single Registration/Certificate is assessed during the period of validity of the Registration/Certificate. Some multi-site organizations may have indi

49、vidual sites engage in a subset of the overall processes of the total organization and the assessment for a specific site can be limited to the processes performed at each site. 8.2.4 A full assessment of all AQMS Standard requirements (IS0 9001 and Aerospace) using the whole questionnaire is required when assessing suppliers who have an existing “basic“ IS0 9001 :I 994 or :2000 certificate and are upgrading to the aerospace standard. 8.2.5 Existing and valid EN

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