1、AECMA STANDARD NORME AECMA AECMA NORM Withdrawal approved prEN 9000-1 Edition P 3 January 2000 Comments should be sent within six months after the date of publication to QC Chairman CO B Chairman PUBLISHED BY THE EUROPEAN ASSOCIATION OF AEROSPACE INDUSTRIES (AECMA) Gulledelle 94 - 6-1200 BRUXELLES -
2、 Tel. (+32) 2 775 81 10 - Fax. (+32) 2 775 81 11 Mr Fehrenbach ICs: Descriptors: Mr Zagonel ENGLISH VERSION Aerospace series Aerospace industry quality system Part I : Requirements applicable to suppliers Supersedes edition P 2 February 1999 Srie arospatiale Luft- und Raumfahrt Systme qualit du sect
3、eur aronautique et spatial Partie 1 : Exigences applicables aux fournisseurs Qualittsmanagementsystem fr die Luft- und Raumfahrt Teil i: Anforderungen an die Lieferanten This “Aerospace Series“ Prestandard has bee European Association of Aerospace Industries). It is publis Members. It has been techn
4、ically approved by the expe following comment by the Member countries. shall not be changed to an thout re-identification of the of the Official Standardization) for formal vote. Replace page 1 of the previous edition by this page 2000-01-31 AECMA Gulledelle 94 6-1 200 BRUXELLES I I I aecrna 2( O 1
5、2 3 3.1 3.2 3.3 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 4.2.5 4.3 4.3.1 4.3.2 4.3.3 4.3.4 4.4 4.4.1 4.4.2 4.4.2. 1 4.4.2.2 4.4.2.3 4.4.3 4.4.4 4.4.5 4.4.6 4.4.7 4.4.8 4.4.8.1 4.4.8.2 4.4.9 4.4.9.1 4.4.9.2 4.5 4.5.1 4.5.2 4.5.3 4.6 4.6.1 4.6.2 Contents Page Introdu
6、ction Scope Normative references Definitions . Product Tender Contract Quality system requirements . Management responsibility . Quality policy Organization Responsibility and authority . Resources Management representative Management review . Quality system General Quality system procedures Quality
7、 planning . Risk control Configuration management Contract review . General . Review . Amendment to a contract . Records Design control General Design and development planning Work breakdown structure ( WBS ) Design and development management planning . Reliability, availabilify, maintainability, sa
8、fety Organizational and technical interfaces . Design input . Design output Design review . Design verification . Design validation Testing Justificatron of efrnrtron Design changes Configura tion control . Design change approval Document and data control General Document and data approval and issue
9、 . Document and data changes Purchasing . General . Evaluation of subcontractors . . . . . 5 5 5 6 6 6 6 6 6 6 7 7 7 7 7 7 7 8 8 8 9 9 9 9 9 9 10 10 10 10 10 10 10 10 11 11 Il 11 12 12 12 12 12 12 12 13 13 13 13 13 Previous page is blank STD*AECMA PREN 9000-L-ENGL 1999 LOL231iI OOLbObb 5bT E Page 4
10、prEN 9000-1: 1999 4.6.3 4.6.4 4.6.4.1 4.6.4.2 4.7 4.8 4.9 4.9.1 4.9.1.1 4.9.1.2 4.9.1.3 4.9.1.4 4.9.1.5 4.9.2 4.1 O 4.10.1 4.70.7.7 4.70.1.2 4.10.2 4.10.3 4.10.4 4.10.5 4.10.6 4.1 1 4.11.1 4.11.2 4.1 2 4.12.1 4.12.2 4.13 4.13.1 4.13.2 4.14 4.14.1 4.14.2 4.14.3 4.1 5 4.15.1 4.15.2 4.15.3 4.15.4 4.15.
11、5 4.15.6 4.1 6 4.1 7 4.1 8 4.19 4.20 4.20.1 4.20.2 Purchasing data . Verification of purchased product Supplier verification at subcontractors premises Customer verification of subcontracted product . Control of customer-supplied product Product identification and traceability Process control Genera
12、l . Production documentation . Production control Control of production process changes . Control of production equipment, tools and N . C . machine programs Utilities, supplies and workplace environment Special processes Inspection and testing Delegation . Receiving inspection and testing Final ins
13、pection and testing . Inspection and test records First atticle inspection General . Inspection documentation. . In-process inspection and testing Control of inspection, measuring and test equipment General . . Control procedure . Inspection and test status Authorized signatories Inspection stamps .
14、 Control of nonconforming product . General Review and disposition of nonconforming product Corrective and preventive action General . Corrective action Preventive action Handling, storage, packaging, pres n and delivery General Handling Storage . Packaging Preservation Delivery Control of quality r
15、ecords Internal quality audits Training Servicing . Statistical techniques . Identification of need . Procedu res . Annex A . Bibliography 14 14 15 15 15 15 16 16 16 16 16 16 17 17 17 17 18 18 18 18 18 19 19 19 19 20 20 20 20 21 21 21 21 21 22 22 22 22 23 23 23 23 23 23 24 24 24 24 24 24 26 Page 5 p
16、rEN 9000-1 : 1999 STDmAECMA PREN 9000-1-ENGL I999 9 1012311 0016067 4Tb D O Introduction The aim of this series of standards is to harmonize the quality system requirements for the suppliers to European aerospace industry and consequently reduce the amount of multiple assessments against various oth
17、er company and regulatory body standards based on similar principles and basic rules. Taking into account IS0 9001/ IS0 9002 models, additional requirements represent, to the greatest possible extent, common specific requirements to the aerospace industry, including, when applicable, requirements of
18、 civil and military regulatory authorities (e.g. JAR 21 and AQAPs). EN 9000-1 is applicable to all suppliers to the European aerospace industry except maintenance organizations and stockists-distributors for which there are specific quality system standards (respectively EN 9000-2 and EN 9000-3). I
19、Scope This standard includes IS0 900111SO 9002 quality system requirements and specifies additional ones for the quality system of aerospace industry suppliers 1). For those suppliers not involved in design activities (IS0 9002), 4.4 is not applicable. It is emphasized that the quality system requir
20、ements specified in this standard are complementary (not alternative) to the contractual and applicable law and regulatory requirements. 2 Normative references This European Standard incorporates provisions from other publications. These normative references are cited at the appropriate places in th
21、e 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 when incorporated in it by amendment or revision. For undated references the latest edition of the publication referred to a
22、pplies. IS0 8402: 1994 IS0 9001: 1994 Quality management and quality assurance - Vocabulary Quality systems - Model for quality assurance in design, development, production, installation and servicing IS0 9002: 1994 Quality systems - Model for quality assurance in production, installation and servic
23、ing NOTE 1 : For information references, see annex A. 1) Except stockists-distributors and maintenance organizations. Page 6 STD*AECMA PREN 7000-1-ENGL 1999 W 101231L 001bOb8 332 prEN 9000-1 : 1999 3 Definitions For the purposes of this standard, the definitions given in IS0 8402 and the following d
24、efinitions apply: 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 combina
25、tion thereof. NOTE 4: For the purposes of this standard, the term a product n applies to the intended product offering only and not to unintended c by-products n affecting the environment. This differs from the definition given in IS0 8402. 3.2 Tender Offer made by a supplier in response to an invit
26、ation to satisfy a contract awarded to provide product. 3.3 Contract Agreed requirements between a supplier and customer transmitted by any means. 4 Quality system requirements This clause reproduces 2) (placed in frames) clause 4 of IS0 9001. Additional aerospace industry requirements are shown in
27、italics. 4. I Management responsibility 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 g
28、oals and the expectations and needs of its customers. The supplier shall ensure that this policy is understood, implemented and maintained at all levels of the organization. 2) With the permission of the International Organization for Standardization (ISO). The complete standard may be obtained from
29、 any IS0 member or from the IS0 Central Secretariat, Case Postale 56, 1211 Geneva 20, SWITZERLAND. Copyright remains with EO. STD.AECMA PREN SODO-1-ENGL 1999 1012343 00LbOb9 279 H Page 7 prEN 9000-1: 1999 4.1.2 Organization 4.1.2.1 Responsibility and authority The responsibility, authority and the i
30、nterrelation of personnel who manage, 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 q
31、uality system; b) identify and record 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
32、 until the deficiency or unsatisfactory condition has been corrected. 4.1.2.2 Resources The supplier shall identify resource requirements and provide adequate resources, including the assignment of trained personnel (see 4.18), for management, performance of work and verification activities includin
33、g internal quality audits. 4.1.2.3 Management representative The suppliers management with executive 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, i
34、mplemented and maintained in accordance with this International Standard, and b) reporting on 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
35、liaison with external parties on matters relating to the suppliers quality system. The Management representative shall have the necessary authority and organizational freedom to resolve matters pertaining to quality. I I 4.1.3 Management review The suppliers management with executive responsibility
36、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 4.1.1). Records of such reviews shall be maintained (see 4.
37、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 Standard. The quality manual
38、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. STDgAECMA PREN 9000-1-ENGL 1997 LOI2311 00bb070 T90 Page 8 prEN 9000-1: 1999 Other requirements of th
39、e National Aviation Authority concerned shall be included or referenced in the Quality System 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, an
40、d b) effectively implement the quality system and its documented procedures. For the purposes of this International Standard, the range and detail of the procedures that form part of the quality system shall be dependent upon the complexity of the work, the methods used, and the skills and training
41、needed by personnel involved in carrying out the activity. NOTE 7: Documented procedures may make reference to work instructions that define how an activity is performed. 4.2.3 Quality planning The supplier shall define and document how the requirements for quality will be met. Quality planning shal
42、l be consistent with all other requirements of a suppliers quality system and shall be documented in a format to suit the suppliers method of operation. The supplier shall give consideration to the following activities, as appropriate, in meeting the specified requirements for products, projects or
43、contracts: a) the preparation of quality plans; b) the identification and acquisition of any controls, processes, equipment (including inspection and test equipment), fixtures, resources and skills that may be needed to achieve the required quality; c) ensuring the compatibility of the design, produ
44、ction process, installation, servicing, inspection and test procedures and the applicable documentation; d) the updating, as necessary, of quality control, inspection and testing techniques, including the development of new instrumentation; e) the identification of any measurement requirement involv
45、ing capability that exceeds the known state of the art, in sufficient time for the needed capability to be developed; 9 the identification of suitable verification at appropriate stages in the realization of product; g) the clarification of standards of acceptability for all features and requirement
46、s, including those which contain a subjective element; h) the identification and preparation of quality records (see 4.16). NOTE 8: The quality plans referred to see 4.2.3a)l may be in the form of a reference to the appropriate documented procedures that form an integral part of the suppliers qualit
47、y system. I 4.2.4 Risk control A system shall be implemented for the continuing identification and evaluation of risk to the achievement of contract requirements. The evaluation shall include the assessment of - The potential seriousness of the outcome resulting from the occurrence of the identifed
48、risk event. - The probability of the occurrence of the risk event. The supplier shall review the risks identified and take action appropriate to the significance of the risk to minimise the effect and/or reduce the probability of occurrence. Page 9 - 4.3.3 Amendment to a contract The supplier shall
49、identify how an amendment to a contract is made and correctly transferred to the functions concerned within the suppliers organization. prEN 9000-1 : 1999 4.2.5 Configuration management The supplier shall establish, document and maintain a configuration management system appropriate to the product, from concept through to design, development, procurement, production, installation, operation and maintenance and to the disposal of products. Guidance on configuration management is given in IS0 10007. 4.3 Contract review 4.3.1 General The supplier shall establish an
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