1、AECMA STANDARD NORME AECMA AECMA NORM prEN 91 11 Edition P 2 December 2003 ICs: Descriptors: Supersedes edition P 1 March 2001 ENGLISH VERSION Aerospace series Quality management systems Assessment applicable to maintenance organizations (based on IS0 9001 :2000) Srie arospatiale Systmes de manageme
2、nt de la qualit valuation applicable aux organismes dentretien (bas sur IS0 9001:2000) Luft- und Raumfahrt Qualittsmanagementsysteme Audit fr Wartungsfirmen (basiert auf IS0 9001 :2000) This “Aerospace Series“ frestandard has been drawn up under the responsibility of AECMA-STAN (The European Associa
3、tion of Aerospace Industries - 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 comments. Subsequent to the publication of this frestandard, the technical content shall not be
4、changed to an extent that interchangeabilify is affected, physically or functionally, without re-identification of the standard. After examination and review by users and formal agreement of AECMA-STAN, it will be submitted as a draft European Standard (prEN) to CEN (European Committee for Standardi
5、zation) 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 withdrawing any national standards conflicting with the EN. NOTE This standard is technically
6、equivalent to SAE AS91 11 Edition approved for publication I Comments should be sent within six months I 31 December 2003 after the date of publication to AECMA-STAN Quality Domain Copytight 2003 O by AECMA-STA1 Copyright Association Europeene des Constructeurs de Materiel Aerospatial Provided by IH
7、S under license with AECMANot for ResaleNo reproduction or networking permitted without license from IHS-,-,-Page 2 prEN 91 11 :2003 Foreword In December 1998, the Aerospace Industry has established the International Aerospace Quality Group (IAQG) with the purpose of achieving significant improvemen
8、ts in quality and reductions in cost throughout the value stream. This organization, with representation from Aerospace companies in Americas, Asia and Europe and sponsored by SAE, SJAC and AECMA has agreed to take responsibility for the technical contents of this standard . This standard was review
9、ed by the Domain Technical Coordinator of AECMA-STANS Quality Domain. After inquiries and votes carried out in accordance with the rules of AECMA-STAN defined in AECMA- STANS General Process Manual, this standard has received approval for Publication. Copyright Association Europeene des Constructeur
10、s de Materiel Aerospatial Provided by IHS under license with AECMANot for ResaleNo reproduction or networking permitted without license from IHS-,-,-Page 3 prEN 91 11 :2003 Contents QUALITY MANAGEMENT SYSTEMS -ASSESSMENT APPLICABLE TO MAINTENANCE ORGANIZATIONS (based on IS0 9001 :2000) 5 1 Purpose 6
11、 2 Quality system assessment report content 6 Appendix A Maintenance organizations quality system questionnaire 14 Bibliography 50 Copyright Association Europeene des Constructeurs de Materiel Aerospatial Provided by IHS under license with AECMANot for ResaleNo reproduction or networking permitted w
12、ithout license from IHS-,-,-Page 4 prEN 91 11 :2003 Blank page Copyright Association Europeene des Constructeurs de Materiel Aerospatial Provided by IHS under license with AECMANot for ResaleNo reproduction or networking permitted without license from IHS-,-,-Page 5 prEN 91 11 :2003 QUALITY MANAGEME
13、NT SYSTEMS ASSESSMENT APPLICABLE TO MAINTENANCE ORGANIZATIONS (based on IS0 9001 :2000) Copyright Association Europeene des Constructeurs de Materiel Aerospatial Provided by IHS under license with AECMANot for ResaleNo reproduction or networking permitted without license from IHS-,-,-Page 6 prEN 91
14、11 :2003 1 PURPOSE The purpose of this document is to define the content and the presentation of the Assessment Report of the EN 91 10 (based on IS0 9001:2000). 2 QUALITY SYSTEM ASSESSMENT REPORT CONTENT The Assessment Report is made up of: Page 7 (required) General Assessment Information Page 8 (re
15、quired) Assessment Conclusions Page 9 (opfional) General Organization Information Page 10 (required) Assessment Result Summary Page 11 (required) Quality System Scoring Page 12 Corrective Action Request (when required) Page 13 List of RecommendationslObservationslComments Appendix MAINTENANCE ORGANI
16、ZATIONS - Quality System Questionnaire associated to the International Quality Management System Standard EN 9110 (based on IS0 9001 :2000) Appendix Documents regarding the company: - Organization charts, - Copies of agreements and certifications . Copyright Association Europeene des Constructeurs d
17、e Materiel Aerospatial Provided by IHS under license with AECMANot for ResaleNo reproduction or networking permitted without license from IHS-,-,-Page 7 prEN 91 11 :2003 ASSESSMENT REPORT Standards 91 10/9111 Assessing company logo GENERAL ASSESSMENT INFORMATION Assessing Company 1 Maintenance Organ
18、ization graphics; summary tables; reports ;etc for items a) to h) Objective evidence assessed I Observations I Comments/ NIA explanation S : Satisfactory - CAR : Corrective action required - MA : Major corrective action - mi : Minor corrective action NIA : Not applicable - NIE: Not evaluated - P : P
19、roduct - M : Management Copyright Association Europeene des Constructeurs de Materiel Aerospatial Provided by IHS under license with AECMANot for ResaleNo reproduction or networking permitted without license from IHS-,-,-Page 26 prEN 91 11 :2003 ASSESSMENT QUESTIONS KEY S CAR N/A N/E Requirements Nu
20、mber Ma or mi 6 Resource management 6.1 Provision of resources O1 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 requi
21、rements? 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 (I)? 03 Are non-certificated personnel assessed on their ability to carry out maintenance operations prior to perform
22、ing the work? 6.2.2 Competence, awareness and training 04 Does the organization: a) determine the necessary 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)
23、 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 appropriate records of education, training, skills and experience (see 4.2.4) (3)? f) Ensure that personnel performing maintenanc
24、e release of aircraft and aircraft component are qualified and certified in accordance with Authority requirements (4)? g) Establish a continuation training program to ensure that personnel performing specific tasks remain current in terms of procedures, human factors and technical knowledge and? h)
25、 Ensure that continuation training is provided that covers changes in relevant regulatory requirements, the organizations procedures, and the maintenance standards of the products being maintained? P Guidance Note 1) 2) 3) 4) Review training Records and Plan (status of the current year and of the pr
26、evious year) Give examples of methods used to determine competence (e.g.: competence matrix, multiskill .) Review training certificates for the certified personnel and training records (internal and external training courses, OJT) Refer to the actions included in the continuation training and verify
27、 changes due to evolution in: regulatory requirement, organizations procedures Objective evidence assessed I Observations I Comments/ NIA explanation S : Satisfactory - CAR : Corrective action required - MA : Major corrective action - mi : Minor corrective action NIA : Not applicable - NIE: Not eval
28、uated - P : Product - M : Management Copyright Association Europeene des Constructeurs de Materiel Aerospatial Provided by IHS under license with AECMANot for ResaleNo reproduction or networking permitted without license from IHS-,-,-Page 27 prEN 91 11 :2003 ASSESSMENT QUESTIONS I QUALITY SYSTEM QUE
29、STIONNAIRE I KEY S CAR N/A N/E Requirements Number MR or mi 06 Does the organization determine and manage the work environment needed to achieve conformity to product requirements (2)? - Note: Factors that may affect the conformity of the product include temperature, humidity, lighting, cleanliness,
30、 protection from electrostatic discharge, etc. 6.3 Infrastructure P 05 Does the organization determine, provide and maintain the infrastructure needed to achieve conformity to product requirements (I)? Infrastructure includes, as applicable: a) buildings, workspace and associated utilities? b) proce
31、ss equipment (both hardware and software)? and c) supporting services (such as transport or communication)? 6.4 Work environment I Guidance Note 1) Give organization objectives and status of their implementation for new workplace, new process equipment to improve the maintenance infrastructure 2) Gi
32、ve the most significant action in relation with different maintenance processes ( painting, surface treatment, heat treatment, clean room, ESD .) Objective evidence assessed I Observations I Comments/ NIA explanation S : Satisfactory - CAR : Corrective action required - MA : Major corrective action
33、- mi : Minor corrective action NIA : Not applicable - NIE: Not evaluated - P : Product - M : Management Copyright Association Europeene des Constructeurs de Materiel Aerospatial Provided by IHS under license with AECMANot for ResaleNo reproduction or networking permitted without license from IHS-,-,
34、-Page 28 prEN 91 11 :2003 ASSESSMENT QUESTIONS KEY S CAR N/A N/E Requirements Number Ma or mi 7 Product realization 7.1 Planning of product realization O1 Does the organization plan and develop the processes needed for product realization (see 4.1)? 02 Is planning of product realization consistent w
35、ith 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 the product? b) the need to establish processes, documents, and provid
36、e 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 realization processes and resulting product meet requirements (see 4.2
37、.4)? e) the identification of resources to support operation and maintenance of the product? 04 Is the output of this planning in a form suitable for the organizations method of operations? P P I NOTE 1 A document specifying the processes of the quality management system (including the product reali
38、zation 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 realization processes. 7.2 Customer-related processes 7.2.1 Determina
39、tion 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 (I)? b) requirements not stated by the customer but necessary for specified or intended use, where known? c
40、) statutory and regulatory requirements related to the product? and d) any additional requirements determined by the organization? M Guidance Note 1) Verify the following requirements for different maintenance customer orders and contract - scope of work subject to the maintenance contract - approve
41、d maintenance data to be used for carrying out the maintenance -the kind of delivery documentation to be provided -the record keeping system and the retention times -the conditions under which the organization may subcontract tasks to a sub-tier party whether this party is approved or not - a provis
42、ion allowing the customer, and if applicable, the regulatory authority to perform surveillance over the organization. Objective evidence assessed I Observations I Comment/ NIA explanation S : Satisfactory - CAR : Corrective action required - MA : Major corrective action - mi : Minor corrective actio
43、n NIA : Not applicable - NIE: Not evaluated - P : Product - M : Management Copyright Association Europeene des Constructeurs de Materiel Aerospatial Provided by IHS under license with AECMANot for ResaleNo reproduction or networking permitted without license from IHS-,-,-Page 29 prEN 91 11 :2003 ASS
44、ESSMENT QUESTIONS QUALITY SYSTEM QUESTIONNAIRE KEY S CAR N/A N/E Requirements Number MR or mi 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 organizations commitment to supply a prod
45、uct 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? c) the organiz
46、ation has the ability to meet the defined requirements? d) risks (e.g., new technology, short delivery time scale) have been evaluated? and e) that maintenance contracts include the scope of work, define the data and delivery requirements, and define the requirements regarding subcontracting of the
47、work? 08 Are records of the results of the review and actions arising from the review maintained (see 4.2.4) (2)? O9 Where the customer provides no documented statement of requirement, are the customer requirements confirmed by the organization before acceptance? 10 Where product requirements are ch
48、anged, does the organization ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements? 11 Do contract amendment processes include provisions for disposition of out-of scope defects discovered during maintenance? Note: In some situations, such
49、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 12 Does the organization determine and implement effective arrangements for communicating with customers in relation to (3): a) product information? b) enquiries, contracts o
