EN 9101-2015 en Quality Management Systems - Audit Requirements for Aviation Space and Defence Organizations《质量管理体系 航空 航天和国防组织的审计要求》.pdf

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1、BSI Standards PublicationBS EN 9101:2015Quality Management Systems Audit Requirements forAviation, Space, and DefenceOrganisationsBS EN 9101:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN 9101:2015. Itsupersedes BS EN 9101:2011 which is withdrawn.The UK pa

2、rticipation in its preparation was entrusted to TechnicalCommittee ACE/1, International and European Aerospace Policy andProcesses.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions

3、 of a contract. Users are responsible for its correctapplication. The British Standards Institution 2015. Published by BSI StandardsLimited 2015ISBN 978 0 580 82126 4ICS 03.120.10; 49.020Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was publish

4、ed under the authority of theStandards Policy and Strategy Committee on 30 September 2015.Amendments issued since publicationDate Text affectedBS EN 9101:2015EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 9101 September 2015 ICS 03.120.10; 49.020 Supersedes EN 9101:2011English Version Quality

5、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 fr Organisationen der Luftfahrt, Raumfahrt und Ve

6、rteidigung This European Standard was approved by CEN on 20 March 2015. 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 any alteration. Up-to-date lists and bibliograp

7、hical 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 language made by translation under the responsibili

8、ty 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, Denmark, Estonia, Finland, Former Yugoslav Republic o

9、f Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATI

10、ON EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 9101:2015 EBS EN 9101:2015EN 9101:2015 (E) 2 Contents Page European foreword 4

11、0 Introduction . 5 0.1 General . 5 0.2 Auditing approach . 6 0.3 Audit records and reports 6 1 Scope . 7 1.1 General . 7 1.2 Application . 7 2 Normative references . 7 3 Terms and definitions 8 4 Auditing and reporting 10 4.1 General . 10 4.1.1 Audit process . 10 4.1.2 Audit approaches . 12 4.1.2.1

12、Customer focus 12 4.1.2.2 Organisational leadership . 12 4.1.2.3 Quality management system performance and effectiveness 12 4.1.2.4 Process management . 13 4.1.2.5 Special processes 14 4.1.2.6 Continual improvement . 14 4.1.3 Reporting 14 4.2 Common audit activities 15 4.2.1 Audit planning . 16 4.2.

13、2 Conducting on-site audits . 17 4.2.2.1 General . 17 4.2.2.2 Conducting the opening meeting 17 4.2.2.3 Site tour 17 4.2.2.4 Audit conduct . 18 4.2.2.5 Identifying and recording of audit findings 18 4.2.2.5.1 Process results . 18 4.2.2.5.2 Process realization . 19 4.2.2.5.3 Process effectiveness . 1

14、9 4.2.2.6 Preparing audit conclusions . 19 BS EN 9101:2015EN 9101:2015 (E) 3 4.2.2.7 Conducting the closing meeting 20 4.2.3 Audit report . 20 4.2.4 Nonconformity management . 21 4.3 Audit phase specific requirements 22 4.3.1 Pre-audit activities 22 4.3.1.1 Application 22 4.3.1.2 Application Review

15、22 4.3.1.2.1 Requirements for the Certification Body . 22 4.3.1.2.2 Requirements for the audit team leader 23 4.3.2 Stage 1 Audit 23 4.3.2.1 General . 23 4.3.2.2 Collection of information . 23 4.3.2.3 Review of the organization . 24 4.3.2.4 Stage 1 conclusions 26 4.3.3 Stage 2 audit. 26 4.3.4 Survei

16、llance audit 26 4.3.5 Recertification audit . 27 4.3.6 Special audit. 27 5 Notes . 27 Appendices Appendix A (informative) ACRONYM LOG 28 Appendix B (normative) FORMS . 29 Figures and Tables Figure 1 Overview of audit process flow . 11 Table 1 CERTIFICATION STRUCTURE REPORTING MATRIX 15 Table 2 RELAT

17、IONSHIP BETWEEN COMMON ACTIVITIES AND AUDIT PHASES 16 Table 3 PROCESS EVALUATION MATRIX . 20 BS EN 9101:2015EN 9101:2015 (E) 4 European foreword This document (EN 9101:2015) has been prepared by the Aerospace and Defence Industries Association of Europe - Standardization (ASD-STAN). After enquiries

18、and votes carried out in accordance with the rules of this Association, this European Standard has received the approval of the National Associations and the Official Services of the member countries of ASD, prior to its presentation to CEN. This European Standard shall be given the status of a nati

19、onal standard, either by publication of an identical text or by endorsement, at the latest by March 2016, and conflicting national standards shall be withdrawn at the latest by March 2016. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent r

20、ights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN 9101:2011. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standa

21、rd: 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, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spai

22、n, Sweden, Switzerland, Turkey and the United Kingdom. BS EN 9101:2015EN 9101:2015 (E) 5 RATIONALE This European standard has been revised to incorporate the requirements for accredited Certification Bodies (CBs) introduced by International Organization for Standardization (ISO) / International Elec

23、trotechnical Commission (IEC) ISO/IEC 17021:2011, EN 9104/1:2012, and inputs received from industry stakeholders associated to process-based auditing methods and the evaluation of process effectiveness. FOREWORD To assure customer satisfaction, aviation, space, and defence organisations must produce

24、 and continually improve safe reliable products that meet or exceed customer and applicable statutory/regulatory requirements. The globalization of the industry and the resulting diversity of regional and national requirements and expectations have complicated this objective. Organisations have the

25、challenge of purchasing products from suppliers, at all levels of the supply chain, throughout the world. Suppliers have the challenge of delivering products to multiple customers having varying quality requirements and expectations. Industry established the International Aerospace Quality Group (IA

26、QG), with representatives from companies in the Americas, Asia/Pacific, and Europe, 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 standardises the requirements for conducting

27、and reporting of Quality Management System (QMS) audits. It can be used by aviation, space, and defence organisations at all levels throughout the global supply chain. It provides requirements for an audit and reporting process, based on: the process and continual improvement approach defined in EN

28、9100-series standards; the specific aviation, space, and defence additions in EN 9100-series standards; the use of common audit tools; and the uniform, transparent, and standardised reporting of audit results. In this European Standard, the word “shall” indicates a requirement and the word “should”

29、a recommendation to meet the intent of the standard. Words “typical”, “example”, or “e.g.” indicate suggestions given for guidance. Information marked “NOTE” is for guidance in understanding or clarifying the associated requirement. 0 Introduction 0.1 General Auditing is a basic tool to assess effec

30、tive implementation of and conformity to QMS requirements. In addition to the determination of conformity, this European Standard focuses on the evaluation of effectiveness (see ISO 9000, subclause 3.2.14) of the QMS and its associated processes. An organization is not only required to be in conform

31、ity with QMS requirements, but to be effective in meeting customer expectations and delivering products that meet those expectations. Additionally, this European Standard takes into account the new requirements presented in the 2009 revisions of the EN 9100-series standards e.g. critical items, spec

32、ial requirements, On-time Delivery (OTD) performance, risk management, project management. BS EN 9101:2015EN 9101:2015 (E) 6 0.2 Auditing approach This European Standard supports the engagement and evaluation of an organizations QMS process approach, as required by the EN 9100-series standards. When

33、 evaluating an organizations QMS, there are basic questions that should be asked of every process, for example: a) Is the process identified and appropriately defined? b) Are responsibilities assigned? c) Are the processes adequately implemented and maintained? d) Is the process effective in achievi

34、ng the desired results? The collective answers to these and other associated questions will contribute to the evaluation results. In addition, product quality (as delivered), customer satisfaction, and QMS effectiveness can be considered as interrelated. This relationship should be reflected in the

35、audit process and associated results. 0.3 Audit records and reports This European 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 objective evidence on the conformity and effectiveness of

36、 the QMS (including process effectiveness), and reporting the audit results in a standard format/structure. BS EN 9101:2015EN 9101:2015 (E) 7 1 Scope 1.1 General This European Standard defines requirements for the preparation and execution of the audit process. In addition, it defines the content an

37、d 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 European Standard are additions or represent changes to the requirements an

38、d guidelines in the standards for conformity assessment, auditing, and certification as published by ISO/IEC (i.e. ISO/IEC 17000, ISO/IEC 17021). When there is conflict with these standards, the requirements of the EN 9101 standard shall take precedence. NOTE 1 In this European Standard, the term “E

39、N 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 European Standard, the IAQG publishes deployment support material

40、 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 European Standard shall be used for audits of EN 9100-series standards by CBs for certification of organisations, under the auspices of the aviation, space, and

41、defence industry certification scheme also known as Industry Controlled Other Party (ICOP) scheme. The ICOP scheme requirements are defined in the EN 9104-series standards (i.e. EN 9104/1, EN 9104/2, EN 9104/3). NOTE Relevant parts of this European Standard can be used by an organization in support

42、of internal audits (1st party) and external audits at suppliers (2nd party). 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated r

43、eferences, the latest edition of the referenced document (including any amendments) applies. EN 91001), Quality Management Systems Requirements for Aviation, Space and Defence Organisations EN 91021), Aerospace series Quality systems First article inspection EN 9104-0011), Aerospace series Quality m

44、anagement 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 Certification/Registrations Programs EN 91

45、04-0031), Aerospace series Quality management systems Part 003: Requirements for Aerospace Quality Management System (AQMS) Auditor Training and Qualification 1)As developed under the auspice of the IAQG and published by various standards bodies e.g., SAE International, European Committee for Standa

46、rdisation (CEN), Japanese Standards Association/Society of Japanese Aerospace Companies (JSA/SJAC), Brazilian Association for Technical Norms (ABNT). BS EN 9101:2015EN 9101:2015 (E) 8 EN 91101), Quality Management Systems Requirements for Aviation Maintenance Organisations EN 91151), Quality Managem

47、ent Systems Requirements for Aviation, Space and Defence Organisations Deliverable Software (Supplement to EN 9100) EN 91201), Quality Management Systems Requirements for Aviation Space and Defence Distributors EN 91311), Aerospace series Quality Management Systems Nonconformance Data Definition and

48、 Documentation IAF MD 2:2007, IAF Mandatory Document for the Transfer of Accredited Certification of Management Systems IAF MD 3:2008, IAF Mandatory Document for Advanced Surveillance and Recertification Procedures IAF MD 4:2008, IAF Mandatory Document for the Use of Computer Assisted Auditing Techn

49、iques (“CAAT”) for Accredited Certification of Management Systems IAQG Procedure 119, Forms Management ISO 9000:2005, Quality management systems Fundamentals and vocabulary ISO/IEC 17000:2004, Conformity assessment Vocabulary and general principles ISO/IEC 17021:2011, Conformity assessment Requirements for bodies providing audit and certification of management systems 3 Terms and definitions For the purpose of this European Standard, the terms and definitions provided in ISO 9000, ISO/IEC 17000, EN 9100-serie