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 Page 2 prEN 91 11 :2003 Foreword In December 1998, the Aerospace Industry has establishe
7、d the International Aerospace Quality Group (IAQG) with the purpose of achieving significant improvements 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 h
8、as agreed to take responsibility for the technical contents of this standard . This standard was reviewed 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
9、, this standard has received approval for Publication. Page 3 prEN 91 11 :2003 Contents QUALITY MANAGEMENT SYSTEMS -ASSESSMENT APPLICABLE TO MAINTENANCE ORGANIZATIONS (based on IS0 9001 :2000) 5 1 Purpose 6 2 Quality system assessment report content 6 Appendix A Maintenance organizations quality sys
10、tem questionnaire 14 Bibliography 50 Page 4 prEN 91 11 :2003 Blank page Page 5 prEN 91 11 :2003 QUALITY MANAGEMENT SYSTEMS ASSESSMENT APPLICABLE TO MAINTENANCE ORGANIZATIONS (based on IS0 9001 :2000) Page 6 prEN 91 11 :2003 1 PURPOSE The purpose of this document is to define the content and the pres
11、entation 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 (required) Assessment Conclusions Page 9 (opfional) General Organization Information Pag
12、e 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 ORGANIZATIONS - Quality System Questionnaire associated to the International Quality Manage
13、ment System Standard EN 9110 (based on IS0 9001 :2000) Appendix Documents regarding the company: - Organization charts, - Copies of agreements and certifications . Page 7 prEN 91 11 :2003 ASSESSMENT REPORT Standards 91 10/9111 Assessing company logo GENERAL ASSESSMENT INFORMATION Assessing Company 1
14、 Maintenance Organization 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
15、 evaluated - P : Product - M : Management Page 26 prEN 91 11 :2003 ASSESSMENT QUESTIONS KEY S CAR N/A N/E Requirements Number 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 manag
16、ement 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 personnel performing work affecting product quality competent on the basis of appropriate education, training, skills and experie
17、nce (I)? 03 Are non-certificated personnel assessed on their ability to carry out maintenance operations prior to performing 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)?
18、 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
19、ate records of education, training, skills and experience (see 4.2.4) (3)? f) Ensure that personnel performing maintenance 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
20、 personnel performing specific tasks remain current in terms of procedures, human factors and technical knowledge and? h) Ensure that continuation training is provided that covers changes in relevant regulatory requirements, the organizations procedures, and the maintenance standards of the products
21、 being maintained? P Guidance Note 1) 2) 3) 4) Review training Records and Plan (status of the current year and of the previous year) Give examples of methods used to determine competence (e.g.: competence matrix, multiskill .) Review training certificates for the certified personnel and training re
22、cords (internal and external training courses, OJT) Refer to the actions included in the continuation training and verify changes due to evolution in: regulatory requirement, organizations procedures Objective evidence assessed I Observations I Comments/ NIA explanation S : Satisfactory - CAR : Corr
23、ective action required - MA : Major corrective action - mi : Minor corrective action NIA : Not applicable - NIE: Not evaluated - P : Product - M : Management Page 27 prEN 91 11 :2003 ASSESSMENT QUESTIONS I QUALITY SYSTEM QUESTIONNAIRE I KEY S CAR N/A N/E Requirements Number MR or mi 06 Does the orga
24、nization 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, protection from electrostatic discharge, etc. 6.3 Infrastructure P 05 Does
25、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) process equipment (both hardware and software)? and c) supporting services (such
26、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) Give the most significant action in relation with different maintenance proces
27、ses ( 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 - mi : Minor corrective action NIA : Not applicable - NIE: Not evaluated - P
28、 : Product - M : Management 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 produ
29、ct 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 the product? b) the need to establish proce
30、sses, 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 realization processes and resulting product
31、 meet requirements (see 4.2.4)? 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 (
32、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 realization processes. 7.2 Customer-relate
33、d processes 7.2.1 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 (I)? b) requirements not stated by the customer but necessary for specified or i
34、ntended use, where known? c) 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 mai
35、ntenance contract - approved 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
36、 approved or not - a provision 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 -
37、mi : Minor corrective action NIA : Not applicable - NIE: Not evaluated - P : Product - M : Management Page 29 prEN 91 11 :2003 ASSESSMENT 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
38、 review the requirements related to the product? 07 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
39、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., new technology, short delivery time scale) have been evaluated? and e) that maintenance contracts
40、include the scope of work, define the data and delivery requirements, and define the requirements regarding subcontracting of the 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 o
41、f 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 changed requirements? 11 Do contract amendment p
42、rocesses include provisions for disposition of out-of scope defects discovered during maintenance? 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
43、. 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 or order handling, including amendments? and c) customer feedback, including customer complaints
44、? Guidance Note 1) 2) Give examples 3) Check that all affected functions are involved in the review Refer to examples of customer communication with relevant functions in the maintenance organization Objective evidence assessed I Observations I Comments/ NIA explanation S : Satisfactory - CAR : Corr
45、ective action required - MA : Major corrective action - mi : Minor corrective action NIA : Not applicable - NIE: Not evaluated - P : Product - M : Management Page 30 prEN 91 11 :2003 ASSESSMENT QUESTIONS I QUALITY SYSTEM QUESTIONNAIRE I KEY S CAR N/A N/E Requirements Number Ma or mi 17 Is Planning o
46、utput updated. as appropriate. as the design and development progresses? 7.3 Design and development This clause applies onlv to orcianizations responsible for the desicin of modifications. 7.3.1 Design and development planning I II III 13 Does the organization plan and control the design and develop
47、ment of product? 14 During the design and development planning, does the organization determine (1): a) the design and development stages? - in respect of organization, task sequence, mandatory steps, significant stages and method of configuration control, b) the review, verification and validation
48、that are appropriate to each design and development stage? and c) the responsibilities and authorities for design and development? 15 Where appropriate, due to complexity, does the organization give consideration to the following activities: - structuring the design effort into significant elements?
49、 - 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, planning constraints, and performance conditions. Is the input data specific to each element reviewed to ensure consistency with requirements? M 16 Does the organization manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibilitv? II 18 Are the different design and development tasks to be carried o
