EN 9101-2018 en Quality Management Systems - Audit Requirements for Aviation Space and Defence Organisations.pdf

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1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Quality Management Systems - Audit Requirements for Aviation, Space, and Defence OrganisationsBS EN 9101:2018EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 9101 May 2018 ICS 03.100.70; 03.120.10; 03.120.20; 49.020

2、 Supersedes EN 9101:2015English Version Quality Management Systems - Audit Requirements for Aviation, Space, and Defence Organisations Systmes de Management de la Qualit - Exigences dAudits pour les Organisations de lAronautique, lEspace et la Dfense Qualittsmanagementsysteme - Audit-Anforderungen f

3、r Organisationen der Luftfahrt, Raumfahrt und Verteidigung This European Standard was approved by CEN on 10 March 2017. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without

4、 any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other lan

5、guage made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denma

6、rk, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN CO

7、MMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels 2018 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 9101:2018 ENational

8、 forewordThis British Standard is the UK implementation of EN 9101:2018. It supersedes BS EN 9101:2015, which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee ACE/1, International and European Aerospace Policy and Processes.A list of organizations represented

9、 on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2018 Published by BSI Standards Limited 2018ISBN 978 0 580 9307

10、7 5ICS 03.120.10; 49.020; 03.120.20; 03.100.70Compliance with a British Standard cannot confer immunity from legal obligations. This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 May 2018.Amendments/corrigenda issued since publicationDate Tex

11、t affectedBRITISH STANDARDBS EN 9101:2018EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 9101 May 2018 ICS 03.100.70; 03.120.10; 03.120.20; 49.020 Supersedes EN 9101:2015English Version Quality Management Systems - Audit Requirements for Aviation, Space, and Defence Organisations Systmes de Man

12、agement de la Qualit - Exigences dAudits pour les Organisations de lAronautique, lEspace et la Dfense Qualittsmanagementsysteme - Audit-Anforderungen fr Organisationen der Luftfahrt, Raumfahrt und Verteidigung This European Standard was approved by CEN on 10 March 2017. CEN members are bound to comp

13、ly with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC

14、 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 translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the sa

15、me status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg

16、, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Rue de la Science 23, B-1040

17、 Brussels 2018 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 9101:2018 EBS EN 9101:2018EN 9101:2018 (E) 2 Contents Page European foreword . 3 Rationale . 4 Foreword 4 0 Introduction 5 0.1 General 5 0.2 Auditing approach 5 0.3 Aud

18、it records and reports 5 1 Scope 6 1.1 General 6 1.2 Application 6 2 Normative references 6 3 Terms and definitions . 7 4 Auditing and reporting 9 4.1 General 9 4.1.1 Audit process 9 4.1.2 Reporting 10 4.2 Common audit activities 10 4.2.1 Audit planning . 11 4.2.2 Conducting on-site audits 12 4.2.3

19、Audit report 16 4.2.4 Nonconformity management . 17 4.3 Audit phase specific requirements 18 4.3.1 Pre-audit activities 18 4.3.2 Stage 1 audit . 19 4.3.3 Stage 2 audit . 21 4.3.4 Surveillance audit 22 4.3.5 Recertification audit . 22 4.3.6 Special audit . 23 Annex A (informative) Acronym log . 24 An

20、nex B (informative) Forms . 25 B.1 EN 9101 Form 1: Stage 1 Audit Report . 25 B.2 EN 9101 Form 2: QMS Process Matrix Report 27 B.3 EN 9101 Form 3: Process Effectiveness Assessment Report 28 B.4 EN 9101 Form 4: Nonconformity Report (NCR) 28 B.5 EN 9101 Form 5: Audit Report 29 B.6 EN 9101 Form 6: Suppl

21、emental Audit Report 30 Tables Table 1 Audit reporting matrix 10 Table 2 Relationship between common activities and audit phases . 11 Table 3 Process evaluation matrix . 16 BS EN 9101:2018EN 9101:2018 (E) 3 European foreword This document (EN 9101:2018) has been prepared by the Aerospace and Defence

22、 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

23、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 November 2018, and conflicting national standards shall be withdrawn at the latest by November 2018. Attention is drawn to the possibil

24、ity 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 9101:2015. According to the CEN-CENELEC Internal Regulations, the national standards organis

25、ations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Ma

26、lta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. BS EN 9101:2018EN 9101:2018 (E) 4 Rationale This standard has been revised to incorporate the requirements for accredited Certification Bodies (CBs) introduced

27、by International Organization for Standardization (ISO) / International Electrotechnical Commission EN ISO/IEC 17021-1:2015, the 2016 changes to International Aerospace Quality Group EN 9100-series standards Quality Management System (QMS) requirements, and inputs received from interested parties re

28、lating to process-based auditing methods and the evaluation of process effectiveness. Foreword To assure customer satisfaction, aviation, space, and defence organizations must provide and continually improve safe and reliable products and services that meet or exceed customer and applicable statutor

29、y and regulatory requirements. The globalization of the industry and the resulting diversity of regional and national requirements and expectations have complicated this objective. Organizations have the challenge of purchasing products and services from suppliers, throughout the world, at all level

30、s of the supply chain. Suppliers have the challenge of delivering products and services to multiple customers having varying quality requirements and expectations. Industry established the IAQG, with representatives from aviation, space, and defence companies in the Americas, Asia/Pacific, and Europ

31、e, to implement initiatives that make significant improvements in quality and reductions in cost throughout the value stream. This document has been prepared by the IAQG and standardizes the requirements for conducting and reporting of QMS audits. It can be used at all levels of the supply chain by

32、organizations around the world. It provides requirements for an audit and reporting process, based on the: process and continual improvement approach defined in EN 9100-series standards; specific aviation, space, and defence additions in EN 9100-series standards; use of common audit tools; and unifo

33、rm, transparent, and standardized reporting of audit results. In this standard, the following terms are used: “shall” indicates a requirement; “should” indicates a recommendation; “may” indicates a permission; and “can” indicates a possibility or capability. Words “typical”, “example”, or “e. g.” in

34、dicate suggestions given for guidance. Information marked “NOTE” is for guidance in understanding or clarifying the associated requirement. BS EN 9101:2018EN 9101:2018 (E) 5 0 Introduction 0.1 General Auditing is a basic tool to assess effective implementation of and conformity to QMS requirements.

35、In addition to assessing conformity, this standard focuses on the evaluation of effectiveness (see EN ISO 9000 clause 3.7.11) of the QMS and its associated processes. An organization is not only required to be in conformity with QMS requirements, but to be effective in meeting customer expectations

36、and delivering products and services that meet those expectations. Additionally, this standard takes into account the requirements presented in the 2016 revisions of the EN 9100-series standards. 0.2 Auditing approach This standard supports the engagement and evaluation of an organizations QMS proce

37、ss approach, as required by the EN 9100-series standards. When evaluating an organizations QMS, there are basic questions that should be asked of every process, for example: a) Is the process appropriately determined? b) Are responsibilities assigned? c) Are the processes adequately implemented and

38、maintained? d) Is the process effective in achieving the desired results? The collective answers to these and other associated questions will contribute to the evaluation results. In addition, product and service quality (as delivered), customer satisfaction, and QMS effectiveness can be considered

39、as interrelated. This relationship should be reflected in the audit process and associated results. 0.3 Audit records and reports This standard defines the audit records and reports to be generated, during the audit process. They are critical in providing the organization and its customers with obje

40、ctive evidence on the conformity and effectiveness of the QMS (including process effectiveness), and reporting the audit results in a standard format/structure. BS EN 9101:2018EN 9101:2018 (E) 6 1 Scope 1.1 General This document defines requirements for the preparation and execution of the audit pro

41、cess. In addition, it defines the content and composition for the audit reporting of conformity and process effectiveness to the EN 9100-series standards, the organizations QMS documentation, and customer and statutory/regulatory requirements. The requirements in this document are additions or repre

42、sent changes to the requirements and guidelines in the standards for conformity assessment, auditing, and certification as published by ISO/IEC (i. e., EN ISO/IEC 17000, EN ISO/IEC 17021-1). When there is conflict with these standards, the requirements of the EN 9101 standard shall take precedence.

43、NOTE 1 In this standard, the term “EN 9100-series standards” comprises the following Aerospace Quality Management System (AQMS) standards: EN 9100, EN 9110, and EN 9120; developed by the IAQG and published by various national standards bodies. NOTE 2 In addition to this standard, the IAQG publishes

44、deployment support material on the IAQG website (see http:/www.sae.org/iaqg/) that can be used by audit teams, when executing the audit process. 1.2 Application This document shall be used for audits of EN 9100-series standards by CBs for certification of organizations, under the auspices of the avi

45、ation, space, and defence industry certification scheme also known as the Industry Controlled Other Party (ICOP) scheme. The ICOP scheme requirements are defined in the EN 9104-series standards (i. e., EN 9104-001, EN 9104-002, EN 9104-003). NOTE Relevant parts of this standard can also be used by a

46、n organization in support of internal audits (1stparty) and external audits at suppliers (2ndparty). 2 Normative references The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the ed

47、ition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN 91001, Quality Management Systems Requirements for Aviation, Space and Defence Organizations EN 91021, Aerospace First Article Inspection Requirement EN 9104-0011, Aerosp

48、ace series Quality management systems Part 001: Requirements for Aviation, Space, and Defence Quality Management System Certification Programs EN 9104-0021 , Aerospace series Quality management systems Part 002: Requirements for Oversight of Aerospace Quality Management System Registration/Certifica

49、tion Programs EN 9104-0031, Aerospace series Quality management systems Part 003: Requirements for Aerospace Quality Management System (AQMS) Auditor Training and Qualification 1As developed under the auspice of the IAQG and published by various standards bodies e. g., SAE International, European Committee for Standardization (CEN), Japanese Standards Association/Society of Japanese Aerospace Companies (JSA/SJAC), Brazilian Association for Technical Norms (ABNT). BS EN 9101:2018EN 9101:2018 (E) 7 EN 91101, Quali