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 prEN 9121:20072 Contents Page Foreword3 1 PURPOSE .4 2 QUALITY SYSTEM ASSESSMENT REPORT CONTENT.4 Annex A (normative) QUALITY MANAGEMENT SYSTEM QUESTIONNAIRE . 12 Annex B (normative) QUALITY MANAGEMENT SYSTEM AU
8、DIT SCORING. 36 Bibliography. 39 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 ASD-STANs General Process Manual, this standard has received
9、 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 of the aerospace industry, and the resulting diversity of
10、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 within the supply chain. Aerospace suppliers and processo
11、rs 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 significant improvements in quality and safety, and reductions
12、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. prEN 9121:20074 1 PURPOSE The purpose of this document is to define the content and the pres
13、entation of the Assessment Report of the section 1 of EN 9100 standard (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 Organi
14、zation Information Page 8 (required) QMS Assessment Result Summary 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 Manag
15、ement Systems Audit Scoring prEN 9121:2007 5 Audit Report No.: ASSESSMENT REPORT Assessing company logo GENERAL ASSESSMENT INFORMATION 1 Distributor Organization graphics; summary tables; reports; etc. Objective evidence assessed / Observations / Comments / N/A explanation prEN 9121:2007QUALITY MANA
16、GEMENT 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 Provisio
17、n 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 customer requirements? 6.2 Human resources 6.2.1 General 02 Ar
18、e 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 competence for personnel performing work affecting product quality
19、 (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 the achievement of the quality objectives? e) maintain app
20、ropriate 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 a
21、ssociated 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 t
22、hat 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) 2) Give examples of methods used to determine comp
23、etence (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 / Observat
24、ions / Comments / N/A explanation 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:
25、 Product M: Management 22 7 PRODUCT REALIZATION 7.1 Planning of product realization Note: This section not required for compliance 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
26、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 known? c) statutory and regulatory requirements related to the product? d) and any additional requirements determined b
27、y the organization? M 7.2.2 Review of requirements related to the product 02 Does the organization review the requirements related 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
28、 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 previously expressed are resolved? c) the organization has the ability to meet the defined requirements? d) risks (e.g.,
29、new technology, short delivery time scale) have been evaluated? P 04 Are records of the results of the review and actions arising 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 organiza
30、tion before acceptance? 06 Where product requirements are changed, does the organization ensure that relevant documents are amended 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 orde
31、r. Instead the review can cover the relevant product information such as catalogues or advertising material. 7.2.3 Customer communication 07 Does the organization determine and implement effective arrangements for communicating with customers in relation to: a) product information? b) enquiries, con
32、tracts or order handling, including amendments? and c) customer feedback, including customer complaints? Guidance Notes 1) Check that all affected functions are involved in the review 2) Give examples Objective evidence assessed / Observations / Comments / N/A explanation prEN 9121:2007QUALITY MANAG
33、EMENT 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 23 7.3 Design and development Note: Th
34、is 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 the Supplier and the purchased product dependent upon
35、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 criteria for selection, evaluation and re-evaluation e
36、stablished? 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 (1)? b) periodically review Suppliers performance and
37、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 / suspect unapproved products? M Guidance Notes 1) R
38、eview 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 prEN 9121:2007QUALITY MANAGEMENT SYSTEM QUESTIONNAIRE ASSESSMENT QUESTIONS
39、 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 7.4 Purchasing (continued) 7.4.2 Purchasing information 14 Does purchasing informa
40、tion describe the product to be purchased, including where appropriate (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 i
41、dentification, and other relevant technical data (e.g., revision level), 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, th
42、eir customer, and regulatory authorities to all facilities involved 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 s
43、pecified purchase requirements prior to their communication to the supplier? 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 re
44、quirements Objective evidence assessed / Observations / Comments / N/A explanation 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
45、 action N/A: Not applicable N/E: Not evaluated P: Product M: Management 25 7.4 Purchasing (continued) 7.4.3 Verification of purchased product 16 Does the organization establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase req
46、uirements, they may include (1): a) obtaining objective evidence of the quality of the product from suppliers and verifying the authenticity of the accompanying documentation, e.g. certificate of conformity from the manufacturer, airworthiness certificate, test reports, statistical records, process
47、control; b) review of the required documentation; c) inspection of products upon receipt. P 17 Where the organization or its customer intends to perform verification at the suppliers premises, does the organization state the intended verification arrangements and method of product release in the pur
48、chasing information? 18 Where specified in the contract, is the customer or the customers representative afforded the right to verify at the suppliers premises and the organizations premises that subcontracted product conforms to specified requirements? 19 It is ensured that verification by the cust
49、omer is not used by the organization as evidence of effective control of quality by the supplier (it does not absolve the organization of the responsibility to provide acceptable product, nor shall it preclude subsequent rejection by the customer)? 7.5 Production and service provision 7.5.1 Control of production and service provision 20 Does the organization plan and carry out production and service provision under controlled conditions (2). Do these controlled conditions i
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