1、BS EN 9121:2009ICS 03.120.10; 49.020NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDAerospace series Quality managementsystems Assessmentapplicable to stockistdistributors (based onISO 9001:2000)This British Standardwas published under theauthority of the Standa
2、rdsPolicy and StrategyCommittee on 30 April2009 BSI 2009ISBN 978 0 580 57179 4Amendments/corrigenda issued since publicationDate CommentsBS EN 9121:2009National forewordThis British Standard is the UK implementation of EN 9121:2009. Itsupersedes BS EN 9121:2005 which is withdrawn.The UK participatio
3、n in its preparation was entrusted to TechnicalCommittee ACE/1, International and European aerospace policy andprocesses.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisionsof a cont
4、ract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunityfrom legal obligations.BS EN 9121:2009EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN 9121March 2009ICS 03.120.10; 49.020 Supersedes EN 9121:2005 English VersionAerospace series - Quali
5、ty management systems - Assessmentapplicable to stockist distributors (based on ISO 9001:2000)Srie arospatiale - Systmes de management de laqualit - valuation applicable aux distributeurs stockistes(bas sur ISO 9001:2000)Luft- und Raumfahrt - Qualittsmanagementsysteme -Audit fr Hndler und Lagerhalte
6、r (basiert auf ISO9001:2000)This European Standard was approved by CEN on 11 July 2008.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists
7、and bibliographical references concerning such nationalstandards may be obtained on application to the CEN Management Centre or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsib
8、ility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Greece, Hungary, Iceland,
9、Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: Avenue Marnix 17
10、, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 9121:2009: EBS EN 9121:2009EN 9121:2009 (E) 2 Contents Page Foreword 3 1 Scope 4 2 QUALITY SYSTEM ASSESSMENT REPORT CONTENT .4 Annex A (normative) QUALITY MANAGEM
11、ENT SYSTEM QUESTIONNAIRE . 12 1 PURPOSE 12 2 USE OF THE QUESTIONNAIRE . 12 3 USE OF THE ASESSMENT SCORING CHART . 13 Annex B (normative) QUALITY MANAGEMENT SYSTEM AUDIT SCORING . 36 BS EN 9121:2009EN 9121:2009 (E) 3 Foreword This document (EN 9121:2009) has been prepared by the Aerospace and Defence
12、 Industries Association of Europe - Standardization (ASD-STAN). After enquiries and votes carried out in accordance with the rules of this Association, this Standard has received the approval of the National Associations and the Official Services of the member countries of ASD, prior to its presenta
13、tion to CEN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by September 2009, and conflicting national standards shall be withdrawn at the latest by September 2009. Attention is drawn to the possib
14、ility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN 9121:2005. This standard was reviewed by the Domain Technical Coordinator of ASD-STANs Qua
15、lity 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 organizations must produce, and continually improve, safe,
16、 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 product organizations face the challenge of assuring
17、 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 expectations and requirements. The aerospace ind
18、ustry 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 aerospace companies in the Americas, Asia/Pacific,
19、and Europe. This international standard has been prepared by the IAQG. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estoni
20、a, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. BS EN 9121:2009EN 9121:2009 (E) 4 1 Scope The scope of this document is
21、to define the content and the presentation 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
22、 Page 7 (optional) Specific Organization 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
23、ISO 9001:2000) Annex Quality Management Systems Audit Scoring BS EN 9121:2009EN 9121:2009 (E) 5 Audit Report No.: ASSESSMENT REPORT Assessing company logo GENERAL ASSESSMENT INFORMATION 1 Distributor Organization graphics; summary tables; reports; etc. Objective evidence assessed / Observations / Co
24、mments / N/A explanation BS EN 9121:2009EN 9121:2009 (E) QUALITY 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 eva
25、luated P: Product M: Management 21 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 m
26、eeting customer 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 necessa
27、ry competence 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 con
28、tribute to the 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.
29、Infrastructure includes, as applicable: a) buildings, workspace and associated 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
30、 to achieve conformity to product requirements (4)? 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
31、the previous year) 2) Give examples of methods used to determine competence (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 s
32、tored and distributed products Objective evidence assessed / Observations / Comments / N/A explanation BS EN 9121:2009EN 9121:2009 (E) QUALITY 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
33、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 compliance to this standard 7.2 Customer-related processes 7.2.1 Determination of requirement
34、s 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 customer but necessary for specified or intended use, where known? c) statutory and regulato
35、ry 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 related to the product? 03 Is the review conducted prior to the organizations commitment t
36、o 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 previously expressed are resolved?
37、 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 arising from the review maintained (see 4.2.4) (2)? 05 Where the customer provides no docum
38、ented 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 amended and that relevant personnel are made aware of the changed requirements? P Note: I
39、n 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 07 Does the organization determine and implement effective arrangements for
40、 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) Check that all affected functions are involved in the review 2) Give examples Objective ev
41、idence assessed / Observations / Comments / N/A explanation BS EN 9121:2009EN 9121:2009 (E) QUALITY 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 acti
42、on N/A: Not applicable N/E: Not evaluated P: Product 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?
43、 P 09 Is the type and extent of control applied to the 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 acco
44、rdance with the organizations requirements? 11 Are criteria 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
45、 Suppliers that includes the scope of the approval (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 requ
46、irements (3)? d) prevent the purchase of counterfeit / 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 / Observation
47、s / Comments / N/A explanation BS EN 9121:2009EN 9121:2009 (E) QUALITY 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: N
48、ot 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 appropriate (1) (2): a) requirements for approval of product, procedures, processes and equipment? b) requirements for
49、 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 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, their customer, and regulatory authorities to all facilit
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