1、BRITISH STANDARD AEROSPACE SERIESBS EN 9111:2005Quality management systems Assessment applicable to maintenance organizationsThe European Standard EN 9111:2005 has the status of a British StandardICS 03.120.10; 49.020g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54
2、g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58BS EN 9111:2005This British Standard was published under the authority of the Standards Policy and Strategy Committee on 17 January 2006 BSI 17 January 2006ISBN 0 580 47557 3National
3、forewordThis British Standard is the official English language version of EN 9111:2005.The UK participation in its preparation was entrusted to Technical Committee ACE/1, International and European aerospace policy and processes, which has the responsibility to: A list of organizations represented o
4、n this committee can be obtained on request to its secretary.Cross-referencesThe British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by us
5、ing the “Search” facility of the BSI Electronic Catalogue or of British Standards Online.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity f
6、rom legal obligations. aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep UK interests informed; monitor related international and European developments and promulgate them in the UK
7、.Summary of pagesThis document comprises a front cover, an inside front cover, the EN title page, pages 2 to 50, an inside back cover and a back cover.The BSI copyright notice displayed in this document indicates when the document was last issued.Amendments issued since publicationAmd. No. Date Comm
8、entsEUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN 9111December 2005ICS 03.120.10; 49.020English VersionAerospace series - Quality management systems - Assessmentapplicable to maintenance organizations (based on ISO9001:2000)Srie arospatiale - Systmes de management de laqualit - valuation applica
9、ble aux organismes dentretien(bas sur ISO 9001:2000)Luft- und Raumfahrt - Qualittsmanagementsystems -Audit fr Wartungsfirmen (basiert auf ISO 9001:2000)This European Standard was approved by CEN on 28 October 2005.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipul
10、ate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the Central Secretariat or to any CEN member.This European Standard exists
11、 in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the officialversions.CEN members are the national standards bodies o
12、f Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDA
13、RDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 2005 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 9111:2005: E2 Contents Page Foreword 3 1 Purpose .4 2 Qu
14、ality System Assessment Report content4 Annex A (normative) Maintenance Organizations Quality System Questionnaire12 Annex B (normative) Systems audit scoring .47 Bibliography.50 EN 9111:20053 Foreword This European Standard (EN 9111:2005) has been prepared by the European Association of Aerospace M
15、anufacturers - Standardization (AECMA-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 AECMA, prior to its presentation to CEN. This
16、 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 June 2006, and conflicting national standards shall be withdrawn at the latest by June 2006. Attention is drawn to the possibility that some of the elem
17、ents 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. In December 1998, the Aerospace Industry established the International Aerospace Quality Group (IAQG) with the purpose of achieving significant i
18、mprovements 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 wa
19、s reviewed by the Domain Technical Coordinator of AECMA-STANs Quality Domain. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia,
20、Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. EN 9111:20054 1 Purpose The purpose of this standard is to define the content and th
21、e presentation of the Assessment Report of the EN 9110 (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) General Organization Informatio
22、n Page 8 (required) Assessment Result Summary Page 9 (required) Quality System Scoring Page 10 Corrective Action Request (when required) Page 11 List of Recommendations/Observations/Comments Annex MAINTENANCE ORGANIZATIONS Quality System Questionnaire associated to the International Quality Manageme
23、nt System Standard EN 9110 (based on ISO 9001:2000) Annex Documents regarding the company: - Organization charts, - Copies of agreements and certifications . EN 9111:20055 ASSESSMENT REPORT Standards 9110/9111 Assessing company logo GENERAL ASSESSMENT INFORMATION 1 Maintenance Organization graphics;
24、 summary tables; reports ;etc for items a) to h) Objective evidence assessed / Observations / Comments/ N/A explanation EN 9111:2005QUALITY SYSTEM QUESTIONNAIRE ASSESSMENT QUESTIONS KEY Requirements S CAR Number Ma or mi N/A N/E S: Satisfactory - CAR: Corrective action required Ma: Major corrective
25、action mi: Minor corrective action N /A: Not applicable - N/E: Not evaluated - P: Product - M: Management 23 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 continual
26、ly 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 experience (1)? 03 Are non-certif
27、icated 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)? b) provide training or ta
28、ke 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 appropriate records of education,
29、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 personnel performing spec
30、ific 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 being maintained? P Guida
31、nce Note 1) Review training Records and Plan (status of the current year and of 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 tr
32、aining courses, OJT) 4) Refer to the actions included in the continuation training and verify changes due to evolution in: regulatory requirement, organizations procedures Objective evidence assessed / Observations / Comments/ N/A explanation EN 9111:2005QUALITY SYSTEM QUESTIONNAIRE ASSESSMENT QUEST
33、IONS KEY Requirements S CAR Number Ma or mi N/A N/E S: Satisfactory - CAR: Corrective action required Ma: Major corrective action mi: Minor corrective action N /A: Not applicable - N/E: Not evaluated - P: Product - M: Management 24 6.3 Infrastructure 05 Does the organization determine, provide and m
34、aintain the infrastructure needed to achieve conformity to product requirements (1)? 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
35、environment 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, protection from electrostatic discharge, etc. P G
36、uidance 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 processes ( painting, surface treatment, heat treatment, clean
37、 room, ESD) Objective evidence assessed / Observations / Comments/ N/A explanation EN 9111:2005QUALITY SYSTEM QUESTIONNAIRE ASSESSMENT QUESTIONS KEY Requirements S CAR Number Ma or mi N/A N/E S: Satisfactory - CAR: Corrective action required Ma: Major corrective action mi: Minor corrective action N
38、/A: Not applicable - N/E: Not evaluated - P: Product - M: Management 25 7 Product realization 7.1 Planning of product realization 01 Does the organization plan and develop the processes needed for product realization (see 4.1)? P 02 Is planning of product realization consistent with the requirements
39、 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 provide resources specific
40、 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 4.2.4)? e) the identifi
41、cation of resources to support operation and maintenance of the product? P 04 Is the output of this planning in a form suitable for the organizations method of operations? NOTE 1 A document specifying the processes of the quality management system (including the product realization processes) and th
42、e 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 Determination of requirements rel
43、ated to the product 05 Does the organization determine: a) requirements specified by the customer, including the requirements for delivery and post-delivery activities (1)? b) requirements not stated by the customer but necessary for specified or intended use, where known? c) statutory and regulator
44、y 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 - approved maintenance data to be
45、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 provision allowing the custo
46、mer, and if applicable, the regulatory authority to perform surveillance over the organization. Objective evidence assessed / Observations / Comment/ N/A explanation EN 9111:2005QUALITY SYSTEM QUESTIONNAIRE ASSESSMENT QUESTIONS KEY Requirements S CAR Number Ma or mi N/A N/E S: Satisfactory - CAR: Co
47、rrective action required Ma: Major corrective action mi: Minor corrective action N /A: Not applicable - N/E: Not evaluated - P: Product - M: Management 26 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 con
48、ducted 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) contract or order requirements differing
49、 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 include the scope of work, define the data and delivery requirements, and define the requirements regarding subcontracting of the work? P 08 Are records of the results of the review and actions arising from the review maintained (see 4.2.4) (2)? 09 Where the customer provides no documented
