ASD-STAN PREN 9101-2014 Quality Management Systems Audit Requirements for Aviation Space and Defence Organizations (Edition P 7).pdf

1、 ASD-STAN STANDARD NORME ASD-STAN ASD-STAN NORM prEN 9101:2014 Edition P7 2014-03 CORRIGENDUM - ISSUE 2: 2014-09-01 PUBLISHED BY THE AEROSPACE AND DEFENCE INDUSTRIES ASSOCIATION OF EUROPE - STANDARDIZATION Rue Montoyer 10 - 1000 Brussels - Tel. 32 2 775 8126 - Fax. 32 2 775 8131 - www.asd-stan.org I

2、CS: 03.120.10; 49.020 Supersedes edition P 6 of December 2009 and will supersede EN 9101:2011 Descriptors: ENGLISH VERSION Quality Management Systems Audit Requirements for Aviation, Space, and Defence Organisations Qualittsmanagementsysteme Audit-Anforderungen fr Organisationen der Luftfahrt, Raumf

3、ahrt und Verteidigung Systmes de management de la Qualit Exigences dAudits pour les Organisations de lAronautique, lEspace et la Dfense This “Aerospace Series“ Prestandard has been drawn up under the responsibility of ASD-STAN (The Aerospace and Defence Industries Association of Europe- Standardizat

4、ion). It is published on green paper for the needs of the European Aerospace and Defence Industry. It has been technically approved by the experts of the concerned Domain following member comments. Subsequent to the publication of this Prestandard, the technical content shall not be changed to an ex

5、tent that interchangeability is affected, physically or functionally, without re-identification of the standard. After examination and review by users and formal agreement of ASD-STAN it will be submitted as a draft European Standard to CEN (European Committee for Standardization) for formal vote. E

6、dition approved for publication Comments should be sent within six months after the date of publication to ASD-STAN prEN 9101:2014 (E) 2 Contents Page Foreword 3 RATIONALE . 4 FOREWORD . 4 Introduction . 5 0.1 General 5 0.2 Auditing approach . 5 0.3 Audit records and reports . 5 REQUIREMENTS . 6 1 S

7、cope 6 1.1 General 6 1.2 Application . 6 2 Normative references 6 3 Terms and definitions . 7 3.1 Containment . 7 3.2 Key Performance Indicator (KPI) . 7 3.3 Major nonconformity . 7 3.4 Minor nonconformity . 8 3.5 Nonconformity Report (NCR) . 8 3.6 Online Aerospace Supplier Information System (OASIS

8、) . 8 3.7 Planned activities 8 3.8 Planned results 8 3.9 Process Effectiveness Assessment Report (PEAR) 8 4 Auditing and reporting 8 4.1 General 9 4.1.1 Audit process . 9 4.1.2 Audit approaches 11 4.1.2.1 Customer focus . 11 4.1.2.2 Organisational leadership. 11 4.1.2.3 Quality management system per

9、formance and effectiveness 11 4.1.2.4 Process management 12 4.1.2.5 Special processes . 12 4.1.2.6 Continual improvement . 13 4.1.3 Reporting 13 4.2 Common audit activities . 14 4.2.1 Audit planning 15 4.2.2 Conducting on-site audits 16 4.2.2.1 General 16 4.2.2.2 Conducting the opening meeting 16 4.

10、2.2.3 Site tour 16 4.2.2.4 Audit conduct . 17 4.2.2.5 Identifying and recording of audit findings 17 4.2.2.5.1 Process results 17 4.2.2.5.2 Process realisation 18 4.2.2.5.3 Process effectiveness . 18 4.2.2.6 Preparing audit conclusions 18 4.2.2.7 Conducting the closing meeting 19 4.2.3 Audit report

11、19 4.2.4 Nonconformity management 20 4.3 Audit phase specific requirements 21 prEN 9101:2014 (E) 3 4.3.1 Pre-audit activities . 21 4.3.1.1 Application . 21 4.3.1.2 Application Review 21 4.3.1.2.1 Requirements for the Certification Body. 21 4.3.1.2.2 Requirements for the audit team leader 22 4.3.2 St

12、age 1 Audit 22 4.3.2.1 General . 22 4.3.2.2 Collection of information 22 4.3.2.3 Review of the organisation . 23 4.3.2.4 Stage 1 conclusions 24 4.3.3 Stage 2 audit 25 4.3.4 Surveillance audit 25 4.3.5 Recertification audit 26 4.3.6 Special audit 26 5 Notes . 26 Appendices Appendix A ACRONYM LOG 27 A

13、ppendix B FORMS . 28 Figures and Tables Figure 1 OVERVIEW OF AUDIT PROCESS FLOW 10 Table 1 CERTIFICATION STRUCTURE REPORTING MATRIX . 14 Table 2 RELATIONSHIP BETWEEN COMMON ACTIVITIES AND AUDIT PHASES 15 Table 3 PROCESS EVALUATION MATRIX. 19 Foreword This standard was reviewed by the Domain Technica

14、l Coordinator of ASD-STANs Quality Domain. After inquiries and votes carried out in accordance with the rules of ASD-STAN defined in ASD-STANs General Process Manual, this standard has received approval for publication. prEN 9101:2014 (E) 4 RATIONALE This standard has been revised to incorporate the

15、 requirements for accredited Certification Bodies (CBs) introduced by International Organisation for Standardisation (ISO) / International Electrotechnical Commission (IEC) 17021:2011, 9104/1:2012, and inputs received from industry stakeholders associated to process-based auditing methods and the ev

16、aluation of process effectiveness. FOREWORD To assure customer satisfaction, aviation, space, and defence organisations must produce and continually improve safe reliable products that meet or exceed customer and applicable statutory/regulatory requirements. The globalisation of the industry and the

17、 resulting diversity of regional and national requirements and expectations have complicated this objective. Organisations have the challenge of purchasing products from suppliers, at all levels of the supply chain, throughout the world. Suppliers have the challenge of delivering products to multipl

18、e customers having varying quality requirements and expectations. Industry established the International Aerospace Quality Group (IAQG), with representatives from companies in the Americas, Asia/Pacific, and Europe, to implement initiatives that make significant improvements in quality and reduction

19、s in cost throughout the value stream. This document has been prepared by the IAQG and standardises the requirements for conducting 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.

20、It provides requirements for an audit and reporting process, based on: the process and continual improvement approach defined in 9100-series standards; the specific aviation, space, and defence additions in 9100-series standards; the use of common audit tools; and the uniform, transparent, and stand

21、ardised reporting of audit results. In this standard, the word “shall” indicates a requirement and the word “should” 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 unders

22、tanding or clarifying the associated requirement. prEN 9101:2014 (E) 5 Introduction 0.1 General Auditing is a basic tool to assess effective implementation of and conformity to QMS requirements. In addition to the determination of conformity, this standard focuses on the evaluation of effectiveness

23、(see ISO 9000 subclause 3.2.14) of the QMS and its associated processes. An organisation is not only required to be in conformity with QMS requirements, but to be effective in meeting customer expectations and delivering products that meet those expectations. Additionally, this standard takes into a

24、ccount the new requirements presented in the 2009 revisions of the 9100-series standards e.g., critical items, special requirements, On-time Delivery (OTD) performance, risk management, project management. 0.2 Auditing approach This standard supports the engagement and evaluation of an organisations

25、 QMS process approach, as required by the 9100-series standards. When evaluating an organisations 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 adequate

26、ly implemented and 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 quality (as delivered), customer satisfaction, and QMS effectiveness can be cons

27、idered 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 organisation and its customers wi

28、th objective evidence on the conformity and effectiveness of the QMS (including process effectiveness), and reporting the audit results in a standard format/structure. prEN 9101:2014 (E) 6 prEN 9101:2014(E) REQUIREMENTS 1 Scope 1.1 General This standard defines requirements for the preparation and e

29、xecution of the audit process. In addition, it defines the content and composition for the audit reporting of conformity and process effectiveness to the 9100-series standards, the organisations QMS documentation, and customer and statutory/regulatory requirements. The requirements in this standard

30、are additions or represent changes to the requirements and 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 9101 standard shall take pr

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

32、ployment 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 standard shall be used for audits of 9100-series standards by CBs for certification of organisations, under the auspices of the aviation

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

34、rnal 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 referenc

35、es, the latest edition of the referenced document (including any amendments) applies. EN 9100*, Quality Management Systems Requirements for Aviation, Space and Defence Organisations EN 9102*, Aerospace series Quality systems First article inspection EN 9104-001*, Aerospace series Quality management

36、systems Part 001: Requirements for Aviation, Space, and Defence Quality Management System Certification Programs EN 9104-002*, Aerospace series Quality management systems Part 002: Requirements for Oversight of Aerospace Quality Management System Certification/Registrations Programs EN 9104-003*, Ae

37、rospace series Quality management systems Part 003: Requirements for Aerospace Quality Management System (AQMS) Auditor Training and Qualification * As developed under the auspice of the IAQG and published by various standards bodies e.g., SAE International, European Committee for Standardisation (C

38、EN), Japanese Standards Association/Society of Japanese Aerospace Companies (JSA/SJAC), Brazilian Association for Technical Norms (ABNT). prEN 9101:2014 (E) 7 EN 9110*, Quality Management Systems Requirements for Aviation Maintenance Organisations EN 9115*, Quality Management Systems Requirements fo

39、r Aviation, Space and Defence Organisations Deliverable Software (Supplement to EN 9100) EN 9120*, Quality Management Systems Requirements for Aviation Space and Defence Distributors EN 9131*, Aerospace series Quality Management Systems Nonconformance Data Definition and Documentation IAF MD 2:2007,

40、 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 Techniques (“CAAT”) for Accredited

41、 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 audi

42、t and certification of management systems 3 Terms and definitions For the purpose of this standard, the terms and definitions provided in ISO 9000, ISO/IEC 17000, 9100-series standards, 9104/1 standard, and the following apply. Furthermore, an acronym log for this standard is presented in Appendix A

43、. 3.1 Containment Action to control and mitigate the impact of a nonconformity and protect the customers operation (stop the problem from getting worse); includes correction, immediate corrective action, immediate communication, and verification that the nonconforming situation does not further degr

44、ade. 3.2 Key Performance Indicator (KPI) Measures associated with goals or targets showing how well an organisation is achieving its objectives or critical success factors for a particular project. KPIs are used to objectively define a quantifiable and measurable indication of the organisations prog

45、ress towards achieving its goals. 3.3 Major nonconformity A non-fulfilment of a requirement which is likely to result in the failure of the QMS or reduce its ability to assure controlled processes or compliant products/services; it can be one or more of the following situations: a nonconformity wher

46、e the effect is judged to be detrimental to the integrity of the product or service; the absence of or total breakdown of a system to meet a 9100-series standard requirement, an organisation procedure, or customer QMS requirement; any nonconformity that would result in the probable shipment of nonco

47、nforming product; and a condition that could result in the failure or reduce the usability of the product or service and its intended purpose. prEN 9101:2014 (E) 8 prEN 9101:2014(E) 3.4 Minor nonconformity A non-fulfilment of a requirement which is not likely to result in the failure of the QMS or r

48、educe its ability to assure controlled processes or compliant products/services; it can be a single system failure or lapse in conformance with one of the following conditions: a 9100-series standard requirement; a customer QMS requirement; or a procedure associated to the organisations QMS. NOTE A

49、number of minor nonconformities against one requirement (e.g., similar nonconformities associated to different sites or different departments/functions/processes within a single site) can represent a total breakdown of the system and thus be considered a major nonconformity. 3.5 Nonconformity Report (NCR) A document stating results and providing objective evidence of nonconformity against audit criteria, including the following information: containment, correction, root cause, corrective