1、ASD STANDARD NORME ASD ASD NORM prEN 9101 Edition P 5 February 2007 PUBLISHED BY THE AEROSPACE AND DEFENCE INDUSTRIES ASSOCIATION OF EUROPE - STANDARDIZATIONGulledelle 94 - B-1200 Brussels - Tel. + 32 2 775 8126 - Fax. + 32 2 763 3565 - www.asd-stan.orgICS: Supersedes edition P 4 December 2003 Descr
2、iptors: ENGLISH VERSION Aerospace series Quality management systems Assessment (based on ISO 9001:2000) Srie arospatiale Systmes de management de la qualit valuation (bas sur ISO 9001:2000) Luft- und Raumfahrt Qualittsmanagementsysteme Audit (basiert auf ISO 9001:2000) This “Aerospace Series“ Presta
3、ndard has been drawn up under the responsibility of ASD-STAN (The AeroSpace and Defence Industries Association of Europe - Standardization). It is published for the needs of the European Aerospace Industry. It has been technically approved by the experts of the concerned Domain following member comm
4、ents. Subsequent to the publication of this Prestandard, the technical content shall not be changed to an extent that interchangeability is affected, physically or functionally, without re-identification of the standard. After examination and review by users and formal agreement of ASD-STAN, it will
5、 be submitted as a draft European Standard (prEN) to CEN (European Committee for Standardization) for formal vote and transformation to full European Standard (EN). The CEN national members have then to implement the EN at national level by giving the EN the status of a national standard and by with
6、drawing any national standards conflicting with the EN. Edition approved for publication 28 February 2007 Comments should be sent within six months after the date of publication to ASD-STAN Quality Domain Copyright 2007 by ASD-STAN Copyright European Association of Aerospace Industries Provided by I
7、HS under license with AECMA Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-prEN 9101:20072 Contents Page Foreword3 1 PURPOSE .5 2 QUALITY MANAGEMENT SYSTEM ASSESSMENT REPORT CONTENT5 Annex A (normative) QUALITY MANAGEMENT SYSTEM QUESTIONNAIRE. 13 Annex B (normativ
8、e) QUALITY MANAGEMENT SYSTEM AUDIT SCORING 45 Bibliography. 48 Copyright European Association of Aerospace Industries Provided by IHS under license with AECMA Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-prEN 9101:20073 Foreword This standard was reviewed by the
9、 Domain Technical Coordinator of ASD-STANs Quality Domain. After inquiries and votes carried out in accordance with the rules of ASD-STAN defined in ASD-STANs General Process Manual, this standard has received approval for Publication. To assure customer satisfaction, aerospace industry organization
10、s must produce, and continually improve, safe, reliable products that meet or exceed customer and regulatory authority requirements. The globalization of the aerospace industry, and the resulting diversity of regional/national requirements and expectations, has complicated this objective. End-produc
11、t organizations face the challenge of assuring the quality of, and integrating, product purchased from suppliers throughout the world and at all levels within the supply chain. Aerospace suppliers and processors face the challenge of delivering product to multiple customers having varying quality ex
12、pectations and requirements. The aerospace industry has established the International Aerospace Quality Group (IAQG) for the purpose of achieving significant improvements in quality and safety, and reductions in cost, throughout the value stream. This organization includes representatives from aeros
13、pace companies in the Americas, Asia/Pacific, and Europe. This international standard has been prepared by the IAQG. Copyright European Association of Aerospace Industries Provided by IHS under license with AECMA Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-prEN
14、 9101:20074 Page intentionally left blank Copyright European Association of Aerospace Industries Provided by IHS under license with AECMA Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-prEN 9101:20075 1 PURPOSE The purpose of this document is to define the content
15、 and the presentation of the Assessment Report for the EN 9100 standard. 2 QUALITY MANAGEMENT SYSTEM ASSESSMENT REPORT CONTENT The Assessment Report is made up of: Page 6 (required) General Assessment Information Page 7 (required) Assessment Conclusions Page 8 (optional) Specific Organization Inform
16、ation Page 9 (required) QMS Assessment Result Summary Page 10 (required) QMS Assessment Scoring Page 11 (required when nonconformities are identified during assessment) Corrective Action Request Page 12 (required when observations/comments are identified during assessment) Observations/Comments Anne
17、x A Quality Management System Questionnaire Copyright European Association of Aerospace Industries Provided by IHS under license with AECMA Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-prEN 9101:20076 Audit Report No.: ASSESSMENT REPORT Assessing company logo GE
18、NERAL ASSESSMENT INFORMATION 1 Organization graphics; summary tables; reports). Objective evidence assessed / Observations / Comments / N/A explanation Copyright European Association of Aerospace Industries Provided by IHS under license with AECMA Not for ResaleNo reproduction or networking permitte
19、d without license from IHS-,-,-prEN 9101:2007QUALITY MANAGEMENT SYSTEM QUESTIONNAIRE ASSESSMENT QUESTIONS KEY Requirements S CAR Number Ma or mi N/A N/E S: Satisfactory CAR: Corrective action request Ma: Major corrective action mi: Minor corrective action N/A: Not applicable N/E: Not evaluated P: Pr
20、oduct M: Management 22 6 RESOURCE MANAGEMENT 6.1 Provision of resources 01 Has the organization determined and provided the resources needed: a) to implement and maintain the quality management system and continually improve its effectiveness? and b) to enhance customer satisfaction by meeting custo
21、mer requirements? 6.2 Human resources 6.2.1 General 02 Are personnel performing work affecting product quality competent on the basis of appropriate education, training, skills and experience? (1) 6.2.2 Competence, awareness and training 03 Does the organization: a) determine the necessary competenc
22、e for personnel performing work affecting product quality? (2) b) provide training or take other actions to satisfy these needs? c) evaluate the effectiveness of the actions taken? d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to t
23、he achievement of the quality objectives? e) maintain appropriate records of education, training, skills and experience (see 4.2.4)? (3) P 6.3 Infrastructure 04 Does the organization determine, provide and maintain the infrastructure needed to achieve conformity to product requirements? Infrastructu
24、re includes, as applicable: a) buildings, workspace and associated utilities? b) process equipment (both hardware and software)? c) supporting services (such as transport or communication)? 6.4 Work environment 05 Does the organization determine and manage the work environment needed to achieve conf
25、ormity to product requirements? P Note: Factors that may affect the conformity of the product include temperature, humidity, lighting, cleanliness, protection from electrostatic discharge, etc. Guidance Notes 1) Review training records and plan (status of the current year and of the previous year).
26、2) Give examples of methods used to determine competence (e.g.: competence matrix, multi-skill). 3) Review training certificates for the certified personnel and training records (internal and external training courses). Objective evidence assessed / Observations / Comments / N/A explanation Copyrigh
27、t European Association of Aerospace Industries Provided by IHS under license with AECMA Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-prEN 9101:2007QUALITY MANAGEMENT SYSTEM QUESTIONNAIRE ASSESSMENT QUESTIONS KEY Requirements S CAR Number Ma or mi N/A N/E S: Sati
28、sfactory CAR: Corrective action request Ma: Major corrective action mi: Minor corrective action N/A: Not applicable N/E: Not evaluated P: Product M: Management 23 7 PRODUCT REALIZATION 7.1 Planning of product realization 01 Does the organization plan and develop the processes needed for product real
29、ization (see 4.1)? 02 Is planning of product realization consistent with the requirements of the other processes of the quality management system (see 4.1)? 03 In planning product realization, does the organization determine the following, as appropriate: a) quality objectives and requirements for t
30、he product? b) the need to establish processes, documents, and provide resources specific to the product? c) required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance? d) records needed to provide evidence that the r
31、ealization processes and resulting product meet requirements (see 4.2.4)? e) the identification of resources to support operation and maintenance of the product? P 04 Is the output of this planning in a form suitable for the organizations method of operations? Note 1: A document specifying the proce
32、sses of the quality management system (including the product realization processes) and the resources to be applied to a specific product, project or contract, can be referred to as a quality plan. Note 2: The organization may also apply the requirements given in 7.3 to the development of product re
33、alization processes. Objective evidence assessed / Observations / Comments / N/A explanation Copyright European Association of Aerospace Industries Provided by IHS under license with AECMA Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-prEN 9101:2007QUALITY MANAGE
34、MENT SYSTEM QUESTIONNAIRE ASSESSMENT QUESTIONS KEY Requirements S CAR Number Ma or mi N/A N/E S: Satisfactory CAR: Corrective action request Ma: Major corrective action mi: Minor corrective action N/A: Not applicable N/E: Not evaluated P: Product M: Management 24 7.2 Customer-related processes 7.2.1
35、 Determination of requirements related to the product 05 Does the organization determine: a) requirements specified by the customer, including the requirements for delivery and post-delivery activities? b) requirements not stated by the customer but necessary for specified or intended use, where kno
36、wn? c) statutory and regulatory requirements related to the product? d) any additional requirements determined by the organization? M 7.2.2 Review of requirements related to the product 06 Does the organization review the requirements related to the product? 07 Is the review conducted prior to the o
37、rganizations commitment to supply a product to the customer (e.g., submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and does it ensure that (1): a) product requirements are defined? b) contract or order requirements differing from those previous
38、ly expressed are resolved? c) the organization has the ability to meet the defined requirements? d) risks (e.g., new technology, short delivery time scale) have been evaluated? P 08 Are records of the results of the review and actions arising from the review maintained (see 4.2.4)? (2) 09 Where the
39、customer provides no documented statement of requirement, are the customer requirements confirmed by the organization before acceptance? 10 Where product requirements are changed, does the organization ensure that relevant documents are amended and that relevant personnel are made aware of the chang
40、ed requirements? P Note: In some situations, such as internet sales, a formal review is impractical for each order. Instead the review can cover the relevant product information such as catalogues or advertising material. 7.2.3 Customer communication 11 Does the organization determine and implement
41、effective arrangements for communicating with customers in relation to: a) product information? b) enquiries, contracts or order handling, including amendments? c) customer feedback, including customer complaints? Guidance Notes 1) Check that all affected functions are involved in the review. 2) Giv
42、e examples of records reviewed. Objective evidence assessed / Observations / Comments / N/A explanation Copyright European Association of Aerospace Industries Provided by IHS under license with AECMA Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-prEN 9101:2007QUA
43、LITY MANAGEMENT SYSTEM QUESTIONNAIRE ASSESSMENT QUESTIONS KEY Requirements S CAR Number Ma or mi N/A N/E S: Satisfactory CAR: Corrective action request Ma: Major corrective action mi: Minor corrective action N/A: Not applicable N/E: Not evaluated P: Product M: Management 25 7.3 Design and developmen
44、t 7.3.1 Design and development planning 12 Does the organization plan and control the design and development of product? 13 During the design and development planning, does the organization determine: a) the design and development stages? (1) - in respect of organization, task sequence, mandatory st
45、eps, significant stages and method of configuration control, b) the review, verification and validation that are appropriate to each design and development stage? c) the responsibilities and authorities for design and development? M 14 Where appropriate, due to complexity, does the organization give
46、 consideration to the following activities: - structuring the design effort into significant elements? - for each element, analyzing the tasks and the necessary resources for its design and development. Does this analysis consider an identified responsible person, design content, input data, plannin
47、g constraints, and performance conditions. Is the input data specific to each clause reviewed to ensure consistency with requirements? 15 Does the organization manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of
48、responsibility? 16 Is planning output updated, as appropriate, as the design and development progresses? 17 Are the different design and development tasks to be carried out defined according to specified safety or functional objectives of the product in accordance with customer and/or regulatory authority requirements? (2) P 7.3.2 Design and development inputs 18 Are inputs relating to product requirements determined and are records maintained (see 4.2.4)? (3) Do these inputs include: a) functional and performance requirements? b) app
