1、ASD STANDARD NORME ASD ASD NORM prEN 9121 Edition P 4 August 2007 PUBLISHED BY THE AEROSPACE AND DEFENCE INDUSTRIES ASSOCIATION OF EUROPE - STANDARDIZATIONAvenue de Tervuren, 270 - B-1150 Brussels - Tel. + 32 2 775 8126 - Fax. + 32 2 763 3565 - www.asd-stan.orgICS: Supersedes edition P 3 of December
2、 2003and will supersede EN 9121:2005 Descriptors: ENGLISH VERSION Aerospace series Quality management systems Assessment applicable to stockist distributors (based on ISO 9001:2000) Srie arospatiale Systmes de management de la qualit valuation applicable aux distributeurs stockistes (bas sur ISO 900
3、1:2000) Luft- und Raumfahrt Qualittsmanagementsysteme Audit fr Hndler und Lagerhalter (basiert auf ISO 9001:2000) This “Aerospace Series“ Prestandard has been drawn up under the responsibility of ASD-STAN (The AeroSpace and Defence Industries Association of Europe - Standardization). It is published
4、 for the needs of the European Aerospace Industry. It has been technically approved by the experts of the concerned Domain following member comments. Subsequent to the publication of this Prestandard, the technical content shall not be changed to an extent that interchangeability is affected, physic
5、ally or functionally, without re-identification of the standard. After examination and review by users and formal agreement of ASD-STAN, it will be submitted as a draft European Standard (prEN) to CEN (European Committee for Standardization) for formal vote and transformation to full European Standa
6、rd (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 withdrawing any national standards conflicting with the EN. Edition approved for publication 31 August 2007 Comments should be sent within six months after the
7、date of publication to ASD-STAN Engineering Procedures Domain Copyright 2007 by ASD-STAN 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 9121:20072 Contents Page Fo
8、reword3 1 PURPOSE .4 2 QUALITY SYSTEM ASSESSMENT REPORT CONTENT.4 Annex A (normative) QUALITY MANAGEMENT SYSTEM QUESTIONNAIRE . 12 Annex B (normative) QUALITY MANAGEMENT SYSTEM AUDIT SCORING. 36 Bibliography. 39 Copyright European Association of Aerospace Industries Provided by IHS under license wit
9、h AECMA Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-prEN 9121:20073 Foreword This standard was reviewed by the Domain Technical Coordinator of ASD-STANs Quality Domain. After inquiries and votes carried out in accordance with the rules of ASD-STAN defined in AS
10、D-STANs General Process Manual, this standard has received approval for Publication. To assure customer satisfaction, aerospace industry organizations must produce, and continually improve, safe, reliable products that meet or exceed customer and regulatory authority requirements. The globalization
11、of the aerospace industry, and the resulting diversity of regional/national requirements and expectations, has complicated this objective. End product organizations face the challenge of assuring the quality of, and integrating, product purchased from suppliers throughout the world and at all levels
12、 within the supply chain. Aerospace suppliers and processors face the challenge of delivering product to multiple customers having varying quality expectations and requirements. The aerospace industry has established the International Aerospace Quality Group (IAQG) for the purpose of achieving signi
13、ficant improvements in quality and safety, and reductions in cost, throughout the value stream. This organization includes representatives from aerospace companies in the Americas, Asia/Pacific, and Europe. This international standard has been prepared by the IAQG. Copyright European Association of
14、Aerospace Industries Provided by IHS under license with AECMA Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-prEN 9121:20074 1 PURPOSE The purpose of this document is to define the content and the presentation of the Assessment Report of the section 1 of EN 9100 s
15、tandard (based on ISO 9001:2000). 2 QUALITY SYSTEM ASSESSMENT REPORT CONTENT The Assessment Report is made up of: Page 5 (required) General Assessment Information Page 6 (required) Assessment Conclusions Page 7 (optional) Specific Organization Information Page 8 (required) QMS Assessment Result Summ
16、ary Page 9 (required) QMS Assessment Scoring Page 10 Corrective Action Request (when required) Page 11 Observations / Comments Annex Quality Management System Questionnaire relative to EN 9120 (based on ISO 9001:2000) Annex Quality Management Systems Audit Scoring Copyright European Association of A
17、erospace Industries Provided by IHS under license with AECMA Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-prEN 9121:2007 5 Audit Report No.: ASSESSMENT REPORT Assessing company logo GENERAL ASSESSMENT INFORMATION 1 Distributor Organization graphics; summary tabl
18、es; reports; etc. 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 9121:2007QUALITY MANAGEMEN
19、T 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 21 6 RESOURCE MANAGEMENT 6.1 Provision of
20、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 customer requirements? 6.2 Human resources 6.2.1 General 02 Are per
21、sonnel 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 competence for personnel performing work affecting product quality (2)?
22、 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 the achievement of the quality objectives? e) maintain appropri
23、ate 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. Infrastructure includes, as applicable: a) buildings, workspace and associ
24、ated utilities? b) process equipment (both hardware and software)? and 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 conformity to product requirements (4)? P Note: Factors that m
25、ay 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) 2) Give examples of methods used to determine competenc
26、e (e.g.: competence matrix, multiskill, ) 3) Review training certificates for the certified personnel and training records (internal and external training courses) 4) Explain management methods of work environment adapted to stored and distributed products Objective evidence assessed / Observations
27、/ 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 9121:2007QUALITY MANAGEMENT SYSTEM QUESTIONNAIRE ASSESSMENT QUESTIONS KEY Requirements
28、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 22 7 PRODUCT REALIZATION 7.1 Planning of product realization Note: This section not required for compli
29、ance to this standard 7.2 Customer-related processes 7.2.1 Determination of requirements related to the product 01 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 custo
30、mer but necessary for specified or intended use, where known? c) statutory and regulatory requirements related to the product? d) and any additional requirements determined by the organization? M 7.2.2 Review of requirements related to the product 02 Does the organization review the requirements rel
31、ated to the product? 03 Is the review conducted prior to the organizations 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)
32、 contract or order requirements differing from those previously 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 04 Are records of the results of the review and actions aris
33、ing from the review maintained (see 4.2.4) (2)? 05 Where the customer provides no documented statement of requirement, are the customer requirements confirmed by the organization before acceptance? 06 Where product requirements are changed, does the organization ensure that relevant documents are am
34、ended and that relevant personnel are made aware of the changed 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 co
35、mmunication 07 Does the organization determine and implement effective arrangements for communicating with customers in relation to: a) product information? b) enquiries, contracts or order handling, including amendments? and c) customer feedback, including customer complaints? Guidance Notes 1) Che
36、ck that all affected functions are involved in the review 2) Give examples 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 wit
37、hout license from IHS-,-,-prEN 9121:2007QUALITY 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: Product
38、 M: Management 23 7.3 Design and development Note: This section not required for compliance to this standard 7.4 Purchasing 7.4.1 Purchasing process 08 Does the organization ensure that purchased product conforms to specified purchase requirements? P 09 Is the type and extent of control applied to t
39、he Supplier and the purchased product dependent upon the effect of the purchased product on subsequent product realization or the final product? 10 Does the organization evaluate and select Suppliers based on their ability to supply product in accordance with the organizations requirements? 11 Are c
40、riteria for selection, evaluation and re-evaluation established? 12 Are records of the results of evaluations and any necessary actions arising from the evaluation maintained (see 4.2.4)? 13 Does the organization: a) maintain a register of approved Suppliers that includes the scope of the approval (
41、1)? b) periodically review Suppliers performance and use the records of these reviews as a basis for establishing the level of controls to be implemented (2)? c) define the necessary actions to take when dealing with suppliers that do not meet requirements (3)? d) prevent the purchase of counterfeit
42、 / suspect unapproved products? M Guidance Notes 1) Review current list of approved Suppliers 2) Review suppliers performance / measurement system (e.g.: supplier rating, etc.) 3) Describe the rules applied Objective evidence assessed / Observations / Comments / N/A explanation Copyright European As
43、sociation of Aerospace Industries Provided by IHS under license with AECMA Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-prEN 9121:2007QUALITY MANAGEMENT SYSTEM QUESTIONNAIRE ASSESSMENT QUESTIONS KEY Requirements S CAR Number Ma or mi N/A N/E S: Satisfactory CAR:
44、 Corrective action request Ma: Major corrective action mi: Minor corrective action N/A: Not applicable N/E: Not evaluated P: Product M: Management 24 7.4 Purchasing (continued) 7.4.2 Purchasing information 14 Does purchasing information describe the product to be purchased, including where appropria
45、te (1) (2): a) requirements for approval of product, procedures, processes and equipment? b) requirements for qualification of personnel? c) quality management system requirements? d) the name/product description or other positive identification, and other relevant technical data (e.g., revision lev
46、el), e) requirements relative to supplier notification to organization of nonconforming product f) requirements for the supplier to notify the organization of changes in product definition, g) right of access by the organization, their customer, and regulatory authorities to all facilities involved
47、in the order and to all applicable records, and h) requirements for a certificate of conformity or airworthiness approval from the approved manufacturer or approved repair station. P 15 Does the organization ensure the adequacy of specified purchase requirements prior to their communication to the s
48、upplier? Guidance Notes 1) Examine purchase orders that apply to several types of procurement. 2) Note the purchase order numbers and the text of requirements, applicable issue for specifications, drawings, and product conformity requirements 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 9121:2007QUALITY MANAGEMENT SYSTEM
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