ASD-STAN 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.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 Page 11 prEN 9104:2004 d) In addition to 7.2.c), the 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 Aud

7、itor or the AB, who themselves have not become qualified via training as per 7.2.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 documented recommendat

8、ion for qualification on all audits. NOTE relevant Aerospace knowledge and experience as per 7.2.a) and 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 a

9、re to be considered, as Aerospace Experience Auditors for EN 9120 shall have 4 (four) years aerospace industry 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 t

10、o demonstrate knowledge of the specification. Work Experience: 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 oficial

11、 civil, military or space organization, such as NAA, ESANASA, MOD. The work experience should have included 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 l

12、ast industry work experience from date the of application, the completion an of an in-depth Aerospace Industry 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 f

13、ollowing topics as a minimum: Aerospace industry quality perspective. CAA requirements. Principles of military aerospace requirements and regulations. Airworthiness and safety requirements. Aerospace material traceability requirements. Flow down of Quality requirements. FOD prevention program requir

14、ements. 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. Configuration managementrequirements control. and Page 12 prEN 9104:200

15、4 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 qualified Aerospace Experienced Auditor or the AB, who themselves have not become qualified v

16、ia 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 positive and documented recommendation for qualification on all audits. NOTE relevant Aerospa

17、ce 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 (maintenance) Auditors that are to be considered, as Aerospace Experience Auditors for EN 91 10 s

18、hall 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 Experience: 4 (four) years full time in the aerospace industry directly involved in Engineering, De

19、sign, 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, ESA/NASA, MOD . In addition they shall have had specific training in Repair/Overhaul or demo

20、nstrated 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 (four) years aerospace experience in the last 10 or more than 6 (six) consecutive years since la

21、st 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 and the training organization shall be approved by the SMS. The course shall include the follo

22、wing topics as a minimum: Aerospace industry quality perspective. CAA requirements. Principles of military aerospace requirements and regulations. First Article Inspection (EN 9102). Airworthiness and safety requirements. Design, development, verification and validation. Aerospace ma te ri al tracea

23、 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 requirements. Use of Customer supplied products. Calibration controls and positive recall system. Accep

24、tance authority media. Nonconforming material, system requirements and operation. Sampling inspection requirements and limitations. Special processes. 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 bala

25、nce. Wing 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 Aer

26、ospace Experienced 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

27、documented 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 qualifica

28、tion all 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

29、methods and 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 190

30、1 1 General 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

31、 on aerospace 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 do

32、cument Page 14 prEN 9104:2004 8 Requirements for assessment and reporting 8.1 Aerospace Assessment Teams 8.1.1 The 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 A

33、QMS standard concerned (EN 9100: 7.2, EN 9110: 7.4, EN 9120: 7.3). 8.1.2 The team may include other auditors according 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 t

34、eam shall have a general understanding and background in each technological and industrial sector in which it operates. 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 br

35、iefing, specific training or experts in attendance. The CRB may attach non-auditor experts to their assessment teams. 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 CR

36、B may rely on outside help (.e., from industry or professional institutions). 8.1.4 The team leader shall ensure 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

37、 provide guidance to the assessment team throughout the assessment on the interpretation of aerospace requirements 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

38、as observers of the assessment process at any time. When Customer or Government representatives are participating 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 Requirem

39、ents are to be established for minimum auditor-person days, for initial assessment, surveillance and re-certification 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

40、 system and the number and variety of activities, but the guidance in Annex 2 of the IAF Guidance on the Application 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

41、 the organization involved. The duration of an assessment shall be as agreed between the organization being assessed 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 acco

42、rding to the following table (Table 2), also depending on organization size and the specific scope of the AQMS being assessed: Page 15 prEN 9104:2004 Additional Auditor-days Initial Assessment 91 O0 Annual Surveillance Initial Assessment Annual Surveillance Initial Assessment 9110 Table 2 Total Numb

43、er 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 multiple sites for a single Registration/Certificate shall be conducted by assessing each si

44、te 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/IEC Guide 62 and shall be limited to sites located in the same country. Surveillance

45、/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 individual sites engage in a subset of the overall processes of the total organization an

46、d 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 cer

47、tificate and are upgrading to the aerospace standard. 8.2.5 Existing and valid EN 9100 Registration/Certificate may be extended to other AQMS standards 91 1 O or 91 20 during surveillance assessments, by assessing the requirements of the other standard that are not covered by the existing certificat

48、e. 8.3 Nonconformity The assessment team shall record all nonconformities identified during an assessment. The team shall assign a nonconformity to the aerospace categories of “Major“ or “Minor“. See Definitions 3.9. No certificates or approvals to AQMS Standards or any combination of AQMS Standards

49、 with IS0 9001 shall be issued unless all major and minor nonconformities have been satisfactorily corrected with the root cause analysis and corrective action verified by the CRB. 8.4 Audit Team Conclusions and Reporting The Assessment Team leader shall present the audit report to the organization using the items listed in Aerospace Assessment Report and Questionnaires as a minimum, stating its conclusions on conformance and effectiveness of the quality system to the AQMS standards requirements. The AQMS audits shall be documented on the Aerospace Assessment Report and

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