BS EN 9111-2005 Aerospace series - Quality management systems - Assessment applicable to maintenance organizations《航空航天系列 质量管理体系 适用于维修机构的评估》.pdf

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、g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58Licensed Copy: Wang Bin, na, Fri Apr 14 07:43:35 BST 2006, Uncontrolled Copy, (c) BSIBS EN 9111:2005This British Standard was published under the authority of the Standards Policy and

3、 Strategy Committee on 17 January 2006 BSI 17 January 2006ISBN 0 580 47557 3National 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

4、and processes, which has the responsibility to: A list of organizations represented on 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 Catalogu

5、e under the section entitled “International Standards Correspondence Index”, or by using 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

6、 application. Compliance with a British Standard does not of itself confer immunity from 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;

7、monitor related international and European developments and promulgate them in the UK.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 wh

8、en the document was last issued.Amendments issued since publicationAmd. No. Date CommentsLicensed Copy: Wang Bin, na, Fri Apr 14 07:43:35 BST 2006, Uncontrolled Copy, (c) BSIEUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN 9111December 2005ICS 03.120.10; 49.020English VersionAerospace series - Qual

9、ity management systems - Assessmentapplicable to maintenance organizations (based on ISO9001:2000)Srie arospatiale - Systmes de management de laqualit - valuation applicable aux organismes dentretien(bas sur ISO 9001:2000)Luft- und Raumfahrt - Qualittsmanagementsystems -Audit fr Wartungsfirmen (basi

10、ert 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 stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and

11、 bibliographical references concerning such nationalstandards may be obtained on application to the Central Secretariat 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 responsibility

12、 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 of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,Germany, Greece, Hungary, Iceland, Ireland, Italy, L

13、atvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 2005 C

14、EN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 9111:2005: ELicensed Copy: Wang Bin, na, Fri Apr 14 07:43:35 BST 2006, Uncontrolled Copy, (c) BSI2 Contents Page Foreword 3 1 Purpose .4 2 Quality System Assessment Report content4 Annex

15、 A (normative) Maintenance Organizations Quality System Questionnaire12 Annex B (normative) Systems audit scoring .47 Bibliography.50 EN 9111:2005Licensed Copy: Wang Bin, na, Fri Apr 14 07:43:35 BST 2006, Uncontrolled Copy, (c) BSI3 Foreword This European Standard (EN 9111:2005) has been prepared by

16、 the European Association of Aerospace Manufacturers - 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

17、, prior to its presentation 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 June 2006, and conflicting national standards shall be withdrawn at the latest by June 2006. Attention is drawn

18、to the possibility 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. In December 1998, the Aerospace Industry established the International Aerospace Quality Group (IAQG) wit

19、h 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 has agreed to take responsibility for the technical con

20、tents of this standard. This standard was 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, Cy

21、prus, 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 the United Kingdom. EN 9111:2005Licensed Copy: Wang Bin, na, Fri

22、 Apr 14 07:43:35 BST 2006, Uncontrolled Copy, (c) BSI4 1 Purpose The purpose of this standard is to define the content and the 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 (requir

23、ed) General Assessment Information Page 6 (required) Assessment Conclusions Page 7 (optional) General Organization Information Page 8 (required) Assessment Result Summary Page 9 (required) Quality System Scoring Page 10 Corrective Action Request (when required) Page 11 List of Recommendations/Observ

24、ations/Comments Annex MAINTENANCE ORGANIZATIONS Quality System Questionnaire associated to the International Quality Management System Standard EN 9110 (based on ISO 9001:2000) Annex Documents regarding the company: - Organization charts, - Copies of agreements and certifications . EN 9111:2005Licen

25、sed Copy: Wang Bin, na, Fri Apr 14 07:43:35 BST 2006, Uncontrolled Copy, (c) BSI5 ASSESSMENT REPORT Standards 9110/9111 Assessing company logo GENERAL ASSESSMENT INFORMATION 1 Maintenance Organization graphics; summary tables; reports ;etc for items a) to h) Objective evidence assessed / Observation

26、s / Comments/ N/A explanation EN 9111:2005Licensed Copy: Wang Bin, na, Fri Apr 14 07:43:35 BST 2006, Uncontrolled Copy, (c) BSIQUALITY 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 actio

27、n 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 continually im

28、prove 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-certificate

29、d 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 take ot

30、her 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, train

31、ing, 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 specific

32、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 Guidance N

33、ote 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 trainin

34、g 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 9111:2005Licensed Copy: Wang Bin, na, Fri Apr 14 07:43:35 B

35、ST 2006, Uncontrolled Copy, (c) BSIQUALITY 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 /A: Not applicable - N/E: Not evaluated - P: Product - M: Ma

36、nagement 24 6.3 Infrastructure 05 Does the organization determine, provide and maintain 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 softw

37、are)? and c) supporting services (such as transport or communication)? 6.4 Work 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, hu

38、midity, lighting, cleanliness, protection from electrostatic discharge, etc. P 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 diff

39、erent maintenance processes ( painting, surface treatment, heat treatment, clean room, ESD) Objective evidence assessed / Observations / Comments/ N/A explanation EN 9111:2005Licensed Copy: Wang Bin, na, Fri Apr 14 07:43:35 BST 2006, Uncontrolled Copy, (c) BSIQUALITY SYSTEM QUESTIONNAIRE ASSESSMENT

40、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 /A: Not applicable - N/E: Not evaluated - P: Product - M: Management 25 7 Product realization 7.1 Planning of product realization 01 Do

41、es 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 of the other processes of the quality management system (see 4.1)? 03 In planning product realization, does the organization determine

42、 the following, as appropriate: a) quality objectives and requirements for the product? b) the need to establish processes, documents, and provide resources specific to the product? c) required verification, validation, monitoring, inspection and test activities specific to the product and the crite

43、ria for product acceptance? d) records needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.4)? e) the identification of resources to support operation and maintenance of the product? P 04 Is the output of this planning in a form suitable for the

44、 organizations method of operations? NOTE 1 A document specifying the processes of the quality management system (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

45、 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 related to the product 05 Does the organization determine: a) requirements specified by the customer, including the requirements for deliv

46、ery and post-delivery activities (1)? 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? and d) any additional requirements determined by the organization? M Guidance Note 1) Verify the

47、 following requirements for different maintenance customer orders and contract - scope of work subject to the maintenance 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

48、 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 customer, and if applicable, the regulatory authority to perform surveillance over the organization. Objective evidence assessed / Observati

49、ons / Comment/ N/A explanation EN 9111:2005Licensed Copy: Wang Bin, na, Fri Apr 14 07:43:35 BST 2006, Uncontrolled Copy, (c) BSIQUALITY 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 /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 produc