1、AECMA Technical Report Rapport Technique AECMA AECMA Fachbericht TR 9135 Edition 1 March 2005 PUBLISHED BY THE EUROPEAN ASSOCIATION OF AEROSPACE INDUSTRIES - STANDARDIZATION Gulledelle 94 - B-1200 Brussels - Tel. + 32 2 775 8110 - Fax. + 32 2 775 8111 - www.aecma-stan.orgICS: Descriptors: ENGLISH VE
2、RSION Aerospace series Quality systems Specific quality requirements for NATO suppliers Srie arospatiale Systmes qualit Exigences qualit spcifiques pour les fournisseurs OTAN Luft- und Raumfahrt Qualittsmanagement Besondere Qualittsanforderungen an NATO zulieferer This Technical Report was drawn up
3、by the Quality Domain of AECMA-STAN. The reason which led to the publication of the document as a Technical Report is explained in the foreword. Edition approved for publication 31 March 2005 Quality Domain Copyright 2005 by AECMA-STAN Page 2 TR 9135:03-2005Foreword The main task of AECMA-STAN is to
4、 prepare EN standards. In exceptional circumstances, however, the publication of a Technical Report of one of the following types may be proposed : - type 1, the subject is still under technical development requiring wider exposure ; - type 2, a Technical Committee has collected data of a different
5、kind from that which is normally published as a European Standard. The Quality Domain decided to publish this document in the form of a Technical Report of type 2 in order to facilitate the updating of this document. Page 3 TR 9135:03-2005Contents Page 1 General 4 1.1 Introduction. 4 1.2 Purpose 4 1
6、.3 Applicability 4 2 Compliance with this technical report 4 2.1 Organizational compliance 4 2.2 Contractual compliance 4 3 Composition of requirements in TR 9135 . 5 3.1 Composition 5 3.2 References 5 3.3 Terms and definitions 6 4 Quality management system. 7 4.1 General requirements 7 4.2 Document
7、ation requirements. 7 4.3 Configuration management 7 5 Management responsibility. 8 5.1 Management commitment 8 5.2 Customer focus. 8 5.3 Quality Policy 8 5.4 Planning. 8 5.5 Responsibility, authority and communication. 8 5.6 Management review . 9 6 Resource management 9 6.1 Provision of resources .
8、 9 6.2 Human resources 9 6.3 Infrastructure. 9 6.4 Work environment 10 7 Product realization 10 7.1 Planning of product realization. 10 7.2 Customer-related processes . 10 7.3 Design and development . 10 7.4 Purchasing . 11 7.5 Production and service provision 11 7.6 Control of monitoring and measur
9、ing devices . 12 7.7 Reliability and Maintainability (R ii) A link to other Standards. 3.2 References 3.2.1 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, th
10、e latest edition of the referenced document (including any amendments) applies. EN 9100, Aerospace series Quality management systems Requirements (based on ISO 9001:2000) and Quality systems Model for quality assurance in design, development, production, installation and servicing (based on ISO 9001
11、:1994). ISO 9000:2000, Quality management systems Fundamentals and vocabulary. ISO 10012, Measurement management systems Requirements for measurement processes and measuring equipment. AQAP 2110, NATO Quality Assurance Requirements for Design, Development and Production. 3.2.2 Informative references
12、 ISO 9001:2000, Quality management systems Requirements. STANAG 4159, NATO Materiel Configuration Management Policy and procedure for multinational joint projects. STANAG 4174, Allied Reliability and Maintainability Publications. STANAG 4427, Introduction of Allied Configuration Management Publicati
13、ons (ACMPs). AQAP 2000, NATO policy on an Integrated Systems Approach to Quality through the Life Cycle. AQAP 2009, NATO Guidance on the use of the AQAP 2000 series. AQAP 2070, NATO Mutual Government Quality Assurance(GQA) process. Page 6 TR 9135:03-2005AQAP 2105, NATO requirements for Deliverable Q
14、uality Plans. ACMP, Allied Configuration Management Publications. ARMP, Allied Reliability and Maintainability Publications. 3.3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 9000:2000 and the following apply. For contracts requiring the application
15、of EN 9100 and NATO Quality Assurance Requirements, the term “Government Quality Assurance Representative (GQAR)” will be equivalent to the term “Authority”, and the term “Acquirer” will be equivalent to the term “Customer”. 3.3.1 acquirer governmental and/or NATO Organizations, that enter into a co
16、ntractual relationship with a supplier, defining the product and quality requirements 3.3.2 certificate of conformity a document, signed by the supplier, which states that the product conforms with contractual requirements 3.3.3 government quality assurance Government Quality Assurance is the proces
17、s by which the appropriate National Authorities establish confidence that the contractual requirements relating to quality are met 3.3.4 GQAR and/or Acquirer the term “GQAR and/or Acquirer” has been used in this document to enable the acquirer to be the default in situations in which there is either
18、 no GQAR associated with the contract or where the appointed GQAR has not been delegated the authority to conduct particular activities 3.3.5 product result of activities, processes and tasks A product may include service, hardware, processed materials, software or a combination thereof. A product c
19、an be tangible (e.g. assemblies or processes materials) or intangible (e.g. knowledge or concepts), or a combination thereof. A product can be either intended (e.g. offering to customers) or unintended (e.g. pollutant or unwanted effects). 3.3.6 government quality assurance representative government
20、 quality assurance representatives are the personnel with responsibility for Government Quality Assurance (GQA), acting on behalf of the acquirer 3.3.7 quality plan a Quality Plan is a suppliers document that specifies which procedures and associated resources shall be applied by whom and when to a
21、specific project, product, process or contract requirement 3.3.8 supplier organization that acts in a contract as the provider of products to the acquirer 3.3.9 sub-supplier provider of products to the supplier Page 7 TR 9135:03-20054 Quality management system 4.1 General requirements NATO specific
22、requirement: Add: The Acquirer and/or Government Quality Assurance Representative (GQAR) reserves the right to reject this system as it applies to the contract. Objective evidence, which may include documentation from first, second and/or third party assessment/certification processes that this syst
23、em is compliant with the AQAP 2110 (using this Technical report) and is effective shall be readily available to the GQAR and/or Acquirer. 4.2 Documentation requirements 4.2.1 General No NATO specific requirements. 4.2.2 Quality manual NATO specific requirement: Delete: Last part of the sentence a):
24、“including details of and justification for any exclusions (see 1.2)” 4.2.3 Control of documents No NATO specific requirements. 4.2.4 Control of records No NATO specific requirements. 4.3 Configuration management NATO specific requirement: Add: 4.3.1 Configuration Management (CM) requirements As a m
25、inimum, the supplier shall describe and document the CM procedures for: Configuration Identification; Configuration Control; Configuration Status Accounting; Configuration Audit. 4.3.2 Configuration Management Plan (CMP) The supplier shall prepare a CMP, which describes the application of CM to the
26、contract. NOTE 1 The CMP may form part of another plan if appropriate. NATO Configuration Management Policy is established in STANAG 4159 while detailed contractual requirements for CM are contained within STANAG 4427 and associated Allied Configuration Management Publications (ACMP). NOTE 2 For low
27、 risk Products or Services the GQAR and/or Acquirer could not require to the supplier to develop a specific Configuration Management Plan (CMP). Page 8 TR 9135:03-20055 Management responsibility 5.1 Management commitment No NATO specific requirements. 5.2 Customer focus No NATO specific requirements
28、. 5.3 Quality Policy No NATO specific requirements. 5.4 Planning NATO specific requirement: Add: The supplier shall submit a Quality Plan (QP) which addresses the contractual requirements to the GQAR and/or the Acquirer prior to the start of the activities. The QP shall be a clearly identified discr
29、ete document or part of another document that is prepared under the contract. The QP shall play two complementary roles: 1) Describe and document the quality management system requirements “contract-specific“ necessary to satisfy the contract requirements (making reference, where applicable, to the
30、“company-wide“ quality management system); 2) Describe and document the planning of the product realization, in terms of quality requirements for the product, needed resources, required control activities (verification, validation, monitoring, inspection, testing), and acceptance criteria. The Suppl
31、ier and sub-supplier shall provide objective evidence, that risks are considered during planning, including but not limited to Risk Identification, Risk analysis, Risk Control and Risk Mitigation. The planning shall start with risk identification during contract review and updated thereafter in a ti
32、mely manner. The acquirer and/or GQAR reserve the right to reject QPs, Risk Plans and their revisions. NOTE 1 The QP requirements for role 1 relate to Clause 5.4, while the QP requirements for role 2 relate to Clause 7.1. NOTE 2 For low risk Products or Services the GQAR and/or Acquirer could not re
33、quire to the supplier the submission of a Quality Plan (QP) and/or a Risk Plan 5.4.1 Quality objectives No NATO specific requirements. 5.4.2 Quality Management system planning No NATO specific requirements. 5.5 Responsibility, authority and communication 5.5.1 Responsibility and authority No NATO sp
34、ecific requirements. Page 9 TR 9135:03-20055.5.2 Management representative No NATO specific requirements. 5.5.3 Internal communication No NATO specific requirements. 5.6 Management review 5.6.1 General No NATO specific requirements. 5.6.2 Review input No NATO specific requirements. 5.6.3 Review outp
35、ut NATO specific requirement: Add: Records of the review output, related to the contract, shall be available to the GQAR and/or Acquirer. The Supplier shall notify the GQAR and/or Acquirer prior to making significant changes to its organization that affect product quality or the Quality Management S
36、ystem. The Supplier shall notify the GQAR and/or Acquirer of proposed action, resulting from Review Output that will affect compliance with contractual requirements. Review output shall, where action item(s) are identified, specify the responsible person/function and due date of the action item(s).
37、6 Resource management 6.1 Provision of resources No NATO specific requirements. 6.2 Human resources 6.2.1 General No NATO specific requirements. 6.2.2 Competence, awareness and training No NATO specific requirements. 6.3 Infrastructure No NATO specific requirements. Page 10 TR 9135:03-20056.4 Work e
38、nvironment No NATO specific requirements. 7 Product realization 7.1 Planning of product realization NATO specific requirement: Add: For details, see this technical report Clause 5.4. 7.2 Customer-related processes 7.2.1 Determination of requirements related to the product No NATO specific requiremen
39、ts. 7.2.2 Review of requirements related to the product No NATO specific requirements. 7.2.3 Customer communication No NATO specific requirements. 7.3 Design and development 7.3.1 Design and development planning No NATO specific requirements. 7.3.2 Design and development inputs No NATO specific requ
40、irements. 7.3.3 Design and development outputs No NATO specific requirements. 7.3.4 Design and development review No NATO specific requirements. 7.3.5 Design and development verification No NATO specific requirements. 7.3.6 Design and development validation No NATO specific requirements. Page 11 TR
41、9135:03-20057.3.7 Control of design and development changes No NATO specific requirements. 7.4 Purchasing 7.4.1 Purchasing process NATO specific requirement: Add: The supplier shall on request provide the GQAR and/or Acquirer with a copy of any subcontracts or orders for product related to the contr
42、act. The supplier shall notify the GQAR and/or Acquirer if a subcontract or order has been identified as constituting or involving risk. This shall be documented in accordance with 5.4 of this technical report. 7.4.2 Purchasing information NATO specific requirement: Add: The supplier shall flow down
43、 the applicable contractual requirements to sub-suppliers by referencing the stated contractual requirements, including relevant AQAP(s). The supplier shall insert the following in all purchasing documents: “All requirements of this contract may be subject to GQA. You will be notified of any GQA act
44、ivity to be performed.” Only the supplier placing the purchasing documents with a sub-supplier will issue consequential instructions to that sub-supplier. It is the suppliers responsibility to ensure that the procedures and processes required to fulfil contract requirements are fully implemented at
45、the sub-suppliers facilities. GQA activities at sub-supplier facilities do not relieve the Supplier from any contractual quality responsibilities. NOTE Conduct of GQA and associated GQAR and/or Acquirer access rights, at sub-suppliers facilities can only be requested by the GQAR and/or Acquirer. 7.4
46、.3 Verification of purchased product NATO specific requirement: Add: Suppliers shall notify the GQAR and/or Acquirer if a sub-supplied product is rejected or repaired which has been identified as involving risk or supplied by a sub-supplier whose selection or subsequent performance has been identifi
47、ed as involving risk. 7.5 Production and service provision 7.5.1 Control of production and service provision No NATO specific requirements. 7.5.2 Validation of processes for production and service provision No NATO specific requirements. 7.5.3 Identification and traceability No NATO specific require
48、ments. Page 12 TR 9135:03-20057.5.4 Customer property No NATO specific requirements. 7.5.5 Preservation of product No NATO specific requirements. 7.6 Control of monitoring and measuring devices NATO specific requirement: Add: The measurement and calibration system applied to this contract shall be i
49、n accordance with the requirement of ISO 10012. When an item of measuring equipment is found to fail re-calibration or is not in calibration, and when there are affected products, the GQAR and/or Acquirer is to be informed and presented with details of affected products, including products already delivered. 7.7 Reliability and Maintainability (R&M) No EN 9100 requirement available NATO specific requirement: Add: If stated in the contract, the suppliers R&M system, appropriate to the design of the product, shall ensure that R&M issues and related documents, i
