ASD-STAN PREN 9000-2-2000 Aerospace Series Aeroapace Industry Quality System Part 2 Requirements Applicable to Maintenance Organizations (Edition P2)《航空航天系列 航空航天工业质量系统 第2部分 适用于维护机构.pdf

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1、STD-AECMA PREN 9000-2-ENGL 2000 LO123LL OOLBb22 508 W AECMA STANDARD prEN 9000-2 NORME AECMA Edition P 2 April 2000 AECMA NORM I I aecrna 2000 PUBLISHED BY THE EUROPEAN ASSOCIATION OF AEROSPACE INDUSTRIES - STANDARDIZATION Gulledelle 96 - B-I 200 BRUXELLES - Tel. (+32) 2 775 81 23 - Fax. (+32) 2 763

2、 3565 Supersedes edition P I January 1999 ICs: Descriptors: l ENGLISH VERSION Comments should be sent within six months after the date of publication to Gulledelle 96 AECMA-STAN B-1200 BRUXELLES Aerospace series Aerospace industry quality system Part 2: Requirements applicable to maintenance organiz

3、ations QC Chairman CO B Chairman Mr Fehrenbach Mr Zagonel Srie arospatiale Systme qualit du secteur aronautique et spatiale Partie 2 : Exigences applicables aux organismes dentretien Luft- und Raumfahrt Qualittsmanagementsysteme fr die Luft- und Raumfahrt Teil 2: Anforderungen an die Wartungsfirmen

4、This “Aerospace Series Prestandard has been dra European Association of Aerospace Industries. It is pu Members. If has been technically approved by the experts following comment by the Member countries. chnical Committee shall not be changed to an thout re-identification of the After examinat of the

5、 Oficial Standardization) for formal vote. I Replace page 1 of the previous edition by this page I Nota - Extra copies can be supplied by B.N.A.E. - Technopolis 54 - 199. rue Jean-Jacques Rousseau - 92138 ISSY-LES-MOUCINEAUX CEDEX Withdrawal approved 2000-04-30 STD-AECMA PREN 9000-2-ENGL 1999 101231

6、1 0015918 058 E Page 3 prEN 9000-2: 1999 Contents O I 2 3 3.1 3.2 3.3 3.4 4 4.1 4.1.1 4.1.2 4.1.2.1 4.1.2.2 4.1.2.3 4.1.3 4.2 4.2.1 4.2.2 4.2.3 4.2.4 4.3 4.3.1 4.3.2 4.3.3 4.3.4 4.4 4.4.1 4.4.2 4.4.3 4.4.4 4.4.5 4.4.6 4.4.7 4.4.8 4.4.9 4.4. IO 4.5 4.5.1 4.5.2 4.5.3 4.6 4.6.1 4.6.2 4.6.3 4.6.4 4.6.4.

7、1 4.6.4.2 Introduction Scope Normative references Definitions Product Tender Contract Additional definitions Quality system requirements Management responsibility Quality policy Organization Responsibility and authority Resources Management representative Management review Quality system General Qua

8、lity system procedures Quality planning Risk control Contract review General Review Amendment to a contract Records Design control General Design and development planning Organizational and technical interfaces Design input Design output Design review Design verification Design validation Design cha

9、nges Modifica tion and repar technical data approval Document and data control General Document and data approval and issue Document and data changes Purchasing General Evaluation of subcontractors Purchasing data Verification of purchased product Supplier verification at subcontractor?s premises Cu

10、stomer verification of subcontracted product 5 5 5 5 5 5 6 6 6 6 6 7 7 7 7 8 8 8 8 9 9 9 9 9 10 10 10 10 10 11 11 11 11 11 11 11 12 12 12 12 12 12 12 13 13 14 14 14 Previous page is blank STD=AECMA PREN 9000-2-ENGL 3999 B LOL23LL 00L59b9 T94 Page 4 prEN 9000-2: 1999 4.7 4.8 4.9 4.9. I 4.9.1.1 4.9.1.

11、2 4.9.1.3 4.9.1.4 4.9.1.5 4.9.2 4.1 O 4.10.1 4 . IO . I . I 4.10.1.2 4.10.2 4.10.3 4.10.4 4.10.5 4.1 1 4.11.1 4.1 1.2 4.12 4.12.1 4.12.2 4.13 4.13.1 4.1 3.2 4.14 4.14.1 4.14.2 4.14.3 4.1 5 4.15.1 4.1 5.2 4.15.3 4.15.4 4.15.5 4.15.6 4.16 4.17 4.18 4.18. I 4.18.2 4.19 4.20 4.20.1 4.20.2 Control of cus

12、tomer-supplied product Product identification and traceability . Process control General . Maintenance documentation Maintenance control Control of maintenance process Chang . C of maintenance equipment, tools and N . C . machine programs U supplies and workplace environment . Special processes . In

13、spection and testing Inspection documentation . Delegation . In-process inspection and testing . Final inspection and testing . Inspection and test records . General . . Receiving inspection and testing . . Control of inspection, measuring and test equipment . General Control procedure . inspection

14、and test status Authorized signatories . Inspection stamps Control of nonconforming product . General Review and disposition of nonconforming product Corrective and preventive action General . Corrective action . Preventive action . Handling, storage, packaging, preservation and delivery General Han

15、dling Storage Packaging Preservation Delivery . Control of quality records Internal quality audits Training . Assessment of competence Continuation training . Servicing Statistical techniques . Identification of need . Procedures Annex A . Bibliography . 14 15 15 15 15 16 16 16 16 16 17 17 17 17 18

16、18 18 18 19 19 19 20 20 20 20 20 20 21 21 21 21 22 22 22 22 22 22 22 23 23 23 23 23 24 24 24 24 25 STD*AECMA PREN 9000-2-ENGL L999 10423111 00L59Z0 706 Page 5 prEN 9000-2: 1999 r O Introduction The aim of this series of standards is to harmonize the quality system requirements for the suppliers to E

17、uropean aerospace industry and consequently reduce the amount of multiple assessments against various other company and regulatory body standards based on similar principles and basic rules. Taking into account IS0 9001/ISO 9002 models, additional requirements represent, to the greatest possible ext

18、ent, common specific requirements to the aerospace industry, including, when applicable, requirements of civil and military authorities (e.g. JARS and AQAPs). EN 9000-1 is applicable to all suppliers to the European aerospace industry except maintenance organizations and stockists-distributors for w

19、hich there are specific quality system standards (respectively EN 9000-2 and EN 9000-3). I Scope This standard includes IS0 9001/ISO 9002 quality system requirements and specifies additional ones for the quality system of aerospace industry suppliers involved in maintenance activities. For those sup

20、pliers not involved in design activities (IS0 9002), 4.4 is not applicable. It is emphasized that the quality system requirements specified in this standard are complementary (not alternative) to the contractual and applicable law and regulatory requirements. 2 Normative references This European Sta

21、ndard incorporates provisions from other publications. These normative references are cited at the appropriate places in the text and the publications are listed hereafter. For dated references, subsequent amendments to or revisions of any of these publications apply to this European Standard only w

22、hen incorporated in it by amendment or revision. For undated references the latest edition of the publication referred to applies. IS0 8402: 1994 Quality management and quality assurance - Vocabulary IS0 9001 : 1994 Quality systems - Model for quality assurance in design, development, production, in

23、stallation and servicing Quality systems - Model for quality assurance in production, installation and servicing IS0 9002: 1994 NOTE 1 : For information references, see annex A. 3 Defini tio ns For the purposes of this standard, the definitions given in IS0 8402 and the following definitions apply:

24、3.1 Product Result of activities or processes NOTE 2: A product may include service, hardware, processed materials, software or a combination thereof. NOTE 3: A product can be tangible (e.g. assemblies or processed materials) or intangible (e.g. knowledge or concepts), or a combination thereof. NOTE

25、 4: For the purposes of this document, the term “ product ” applies to the intended product offering only and not to unintended I by-products ” affecting the environment. This differs from the definition given in IS0 8402. 3.2 Tender Offer made by a supplier in response to an invitation to satisfy a

26、 contract awarded to provide product. STD.AECMA PREN 9000-2-ENGL 3999 E LOL2311 OOL592L b42 .I Page 6 prEN 9000-2: 1999 3.3 Contract Agreed requirements between a supplier and customer transmitted by any means. 3.4 Additional definitions 3.4.1 Supplier An organisation performing maintenance of aircr

27、aft or aircraft components in accordance with contractual requirements. If required it shall hold an approval certificate issued under the regulation applicable in the particular case. 3.4.2 Subcontractor An organisation that perfoms specific maintenance functions under the suppliers control 3.4.3 M

28、aintenance Means any one or combination of overhaul, repair, inspection, replacement, modification or defect rectification of an aircraft or an aircraft component 3.4.4 Authority Means the National Aviation Authority, applying in the particular case, having legal jurisdiction over the manufacturer,

29、aircraft owner and operator, maintenance organizations; it could be civilian or military 3.4.5 Technical approved data Means any information necessary to ensure that an aircraft or an aircraft component is maintained in a condition approved by the Authority 3.4.6 Accountable manager Means the manage

30、r who has corporate authority for ensuring that all maintenance required by the aircraft operator can be financed and carried out to the standard required by the authority 3.4.7 Release certificate Is the certification issued on completion of any maintenance, which certifies conformance of the activ

31、ities carried out with the suppliers approved procedures and with the applicable regulatory authority requirements 4 Quality system requirements This clause reproduces 1) (placed in frames) clause 4 of IS0 9001. Additional aerospace industry requirements are shown in italics. 4. I Management respons

32、ibility 4.1.1 Quality policy The suppliers management with executive responsibility shall define and document its policy for quality, including objectives for quality and its commitment to quality. The quality policy shall be relevant to the suppliers organizational goals and the expectations and ne

33、eds of its customers. The supplier shall ensure that this policy is understood, implemented and maintained at all levels of the organization. 1) With the permission of the International Organization for Standardization (ISO). The complete standard may be obtained from any IS0 member or from the IS0

34、Central Secretariat, Case Postale 56, 1211 Geneva 20, SWITZERLAND. Copyright remains with ISO. Page 7 prEN 9000-2: 1999 STD.AECMA PREN 4000-2-ENGL 1999 1012311 0015922 5/37 4.1.2 Organization 4.1.2.1 Responsibility and authority The responsibility, authority and the interrelation of personnel who ma

35、nage, perform and verify work affecting quality shall be defined and documented, particularly for personnel who need the organizational freedom and authority to: a) initiate action to prevent the occurrence of any nonconformities relating to the product, process and quality system: b) identify and r

36、ecord any problems relating to the product, process and quality system; c) initiate, recommend or provide solutions through designated channels; d) verify the implementation of solutions; e) control further processing, delivery or installation of nonconforming product until the deficiency or unsatis

37、factory condition has been corrected. r) report to the competent Authority any maintenance findings that could require Airworthiness Directive actions; g) certify that all maintenance performed has been properly carried out in accordance with the suppliers quality procedures. 4.1.2.2 Resources The s

38、upplier shall identify resource requirements and provide adequate resources, including the assignment of trained personnel (see 4.1 8), for management, performance of work and verification activities including internal quality audits. 4.1.2.3 Management representative The suppliers management with e

39、xecutive responsibility shall appoint a member of the suppliers own management who, irrespective of other responsibilities, shall have defined authority for a) ensuring that a quality system is established, implemented and maintained in accordance with this International Standard, and b) reporting o

40、n the performance of the quality system to the suppliers management for review and as a basis for improvement of the quality system. NOTE 5: The responsibility of a management representative may also include liaison with external parties on matters relating to the suppliers quality system. c) reques

41、ting corrective actions as necessary by any other departmental manager as appropriate. The management representative shall have the necessary authority and organizational freedom to resolve matters pertaining to quality. Suppliers having a quality assurance activity performed by an individual proces

42、s owner (e.g., operator, buyer, planner) shall have procedures that define the specific tasks and responsibilities that are authorized and the corresponding requirements and training necessary to perform those tasks. 4.1.2.3.1 Accountable manager The supplier shall appoint a manager with corporate a

43、uthority to ensure that all contracted maintenance can be financed and carried out to the required applicable standards. The manager specified shall be responsible to ensure that the necessary resources are available to accomplish all contracted maintenance to the quality standards required. In diff

44、erent organizations covered by a single approval, the accountable manager may delegate his duties, in writing, to another person, providing that the terms of such delegations are clearly defined. STD-AECIA PREN 9000-2-ENGL 1999 LOL23L1 0035923 415 Page 8 prEN 9000-2: 1999 4.7.2.3.2 Maintenance manag

45、er The supplier shall appoint a manager to ensure that all maintenance required is carried out to the standards and company procedures specified and is also responsible for any corrective action resulting from the quality compliance monitor. 4.1.3 Management review The suppliers management with exec

46、utive responsibility shall review the quality system at defined intervals sufficient to ensure its continuing suitability and effectiveness in satisfying the requirements of this International Standard and the suppliers stated quality policy and objectives (see 4.1 .I). Records of such reviews shall

47、 be maintained (see 4.16). 4.2 Quality system _ 4.2.1 General The supplier shall establish, document and maintain a quality system as a means of ensuring that product conforms to specified requirements. The supplier shall prepare a quality manual covering the requirements of this International Stand

48、ard. The quality manual shall include or make reference to the quality system procedures and outline the structure of the documentation used in the quality system. NOTE 6: Guidance on quality manuals is given in IS0 10013. Other requirements of the regulatory Authority concerned shall be included or

49、 referenced in the quality system documentation. The supplier shall ensure that quality system procedures are kept current and are readily available to personnel who are responsible for compliance to requirements, and to customer and/or regulatory Authority representa tives. Specific guidance on maintenance exposition is given in regulatory Authority documentation. 4.2.2 Quality system procedures The supplier shall a) prepare documented procedures consistent with the requirements of this International Standard and the suppliers stated quality policy, and b) ef

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