1、 ASD STANDARD NORME ASD ASD NORM ASD-STAN prEN 9101:2016 Edition 2016-10 PUBLISHED BY THE AEROSPACE AND DEFENCE INDUSTRIES ASSOCIATION OF EUROPE - STANDARDIZATION Rue Montoyer, 10/5 - B-1000 Brussels, Belgium - Tel +32 2 775 81 26 - Fax +32 2 775 81 31 - www.asd-stan.org ICS: Descriptors: Note Techn
2、ically equivalent writings published in all IAQG sectors ENGLISH VERSION Quality Management Systems Audit Requirements for Aviation, Space, and Defence Organizations Qualittsmanagementsysteme Audit-Anforderungen fr Organisationen der Luftfahrt, Raumfahrt und Verteidigung Systmes de management de la
3、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 - Standardization). It is published for the needs of the Europe
4、an Aerospace 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 extent that interchangeability is affected, physically or functionally, withou
5、t re-identification of the standard. After examination and review by users and formal agreement of ASD-STAN, the ASD-STAN prEN will be submitted as a draft European Standard (prEN) to CEN (European Committee for Standardization) for formal vote and transformation to full European Standard (EN). The
6、CEN national members have then to implement the EN at national level by giving the EN the status of a national standard and by withdrawing any national standards conflicting with the EN. ASD-STAN Technical Committee approves that: “This document is published by ASD-STAN for the needs of the European
7、 Aerospace Industry. The use of this standard is entirely voluntary, and its applicability and suitability for any particular use, including any patent infringement arising therefrom, is the sole responsibility of the user.” ASD-STAN reviews each standard and technical report at least every five yea
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10、-STAN Quality domain prEN 9101:2016 (E) 2 Contents Page Rationale . 3 Foreword 3 0 Introduction 4 0.1 General 4 0.2 Auditing approach 4 0.3 Audit records and reports 4 1 Scope 5 1.1 General 5 1.2 Application 5 2 Normative references 5 3 Terms and definitions . 6 4 Auditing and reporting 8 4.1 Genera
11、l 8 4.1.1 Audit process 8 4.1.2 Reporting . 9 4.2 Common audit activities . 9 4.2.1 Audit planning . 10 4.2.2 Conducting on-site audits 11 4.2.3 Audit report 15 4.2.4 Nonconformity management . 16 4.3 Audit phase specific requirements 17 4.3.1 Pre-audit activities 17 4.3.2 Stage 1 audit . 18 4.3.3 S
12、tage 2 audit . 20 4.3.4 Surveillance audit 21 4.3.5 Recertification audit . 21 4.3.6 Special audit . 22 Annex A (informative) Acronym log . 23 Annex B (informative) Forms . 24 B.1 EN 9101 Form 1: Stage 1 Audit Report . 24 B.2 EN 9101 Form 2: QMS Process Matrix Report 26 B.3 EN 9101 Form 3: Process E
13、ffectiveness Assessment Report 27 B.4 EN 9101 Form 4: Nonconformity Report (NCR) 27 B.5 EN 9101 Form 5: Audit Report 28 B.6 EN 9101 Form 6: Supplemental Audit Report 29 Tables Table 1 Audit reporting matrix . 9 Table 2 Relationship between common activities and audit phases . 10 Table 3 Process eval
14、uation matrix . 15 prEN 9101:2016 (E) 3 Rationale This standard has been revised to incorporate the requirements for accredited Certification Bodies (CBs) introduced by International Organization for Standardization (ISO) / International Electrotechnical Commission EN ISO/IEC 17021-1:2015, the 2016
15、changes to International Aerospace Quality Group EN 9100-series standards Quality Management System (QMS) requirements, and inputs received from interested parties relating to process-based auditing methods and the evaluation of process effectiveness. Foreword To assure customer satisfaction, aviati
16、on, space, and defence organizations must provide and continually improve safe and reliable products and services that meet or exceed customer and applicable statutory and regulatory requirements. The globalization of the industry and the resulting diversity of regional and national requirements and
17、 expectations have complicated this objective. Organizations have the challenge of purchasing products and services from suppliers, throughout the world, at all levels of the supply chain. Suppliers have the challenge of delivering products and services to multiple customers having varying quality r
18、equirements and expectations. Industry established the IAQG, with representatives from aviation, space, and defence 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 doc
19、ument 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 organizations around the world. It provides requirements for an audit and reporting process, based on the: process and continual impro
20、vement approach defined in EN 9100-series standards; specific aviation, space, and defence additions in EN 9100-series standards; use of common audit tools; and uniform, transparent, and standardized reporting of audit results. In this standard, the following terms are used: “shall” indicates a requ
21、irement; “should” indicates a recommendation; “may” indicates a permission; and “can” indicates a possibility or capability. Words “typical”, “example”, or “e. g.” indicate suggestions given for guidance. Information marked “NOTE” is for guidance in understanding or clarifying the associated require
22、ment. prEN 9101:2016 (E) 4 0 Introduction 0.1 General Auditing is a basic tool to assess effective implementation of and conformity to QMS requirements. 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 as
23、sociated processes. An organization is not only required to be in conformity with QMS requirements, but to be effective in meeting customer expectations and delivering products and services that meet those expectations. Additionally, this standard takes into account the requirements presented in the
24、 2016 revisions of the EN 9100-series standards. 0.2 Auditing approach This standard supports the engagement and evaluation of an organizations QMS process approach, as required by the EN 9100-series standards. When evaluating an organizations QMS, there are basic questions that should be asked of e
25、very process, for example: a) Is the process appropriately determined? b) Are responsibilities assigned? c) Are the processes adequately implemented and maintained? d) Is the process effective in achieving the desired results? The collective answers to these and other associated questions will contr
26、ibute to the evaluation results. In addition, product and service quality (as delivered), customer satisfaction, and QMS effectiveness can be considered as interrelated. This relationship should be reflected in the audit process and associated results. 0.3 Audit records and reports This standard def
27、ines 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 the QMS (including process effectiveness), and reporting the audit results in a standard form
28、at/structure. prEN 9101:2016 (E) 5 Quality management systems audit requirements 1 Scope 1.1 General This standard defines requirements for the preparation and execution of the audit process. In addition, it defines the content and composition for the audit reporting of conformity and process effect
29、iveness to the EN 9100-series standards, the organizations QMS documentation, and customer and statutory/regulatory requirements. The requirements in this standard are additions or represent changes to the requirements and guidelines in the standards for conformity assessment, auditing, and certific
30、ation 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. NOTE 1 In this standard, the term “EN 9100-series standards” comprises the following Aerospace Quality Management
31、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 deployment support material on the IAQG website (see http:/www.sae.org/iaqg/) that can be used by audit teams, whe
32、n executing the audit process. 1.2 Application This standard shall be used for audits of EN 9100-series standards by CBs for certification of organizations, under the auspices of the aviation, space, and defence industry certification scheme also known as the Industry Controlled Other Party (ICOP) s
33、cheme. 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 an organization in support of internal audits (1stparty) and external audits at suppliers (2nd party). 2 Normative
34、references The following referenced documents are indispensable for the application of this standard. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN 9100*, Quality Management Systems R
35、equirements for Aviation, Space and Defence Organizations EN 9102*, Aerospace First Article Inspection Requirement EN 9104-001*, Aerospace series Quality management systems Part 001: Requirements for Aviation, Space, and Defence Quality Management System Certification Programs EN 9104-002*, Aerospac
36、e series Quality management systems Part 002: Requirements for Oversight of Aerospace Quality Management System Registration/Certification Programs * As developed under the auspice of the IAQG and published by various standards bodies e. g., SAE International, European Committee for Standardization
37、(CEN), Japanese Standards Association/Society of Japanese Aerospace Companies (JSA/SJAC), Brazilian Association for Technical Norms (ABNT). prEN 9101:2016 (E) 6 EN 9104-003*, Aerospace series Quality management systems Part 003: Requirements for Aerospace Quality Management System (AQMS) Auditor Tra
38、ining and Qualification EN 9110*, Quality Management Systems Requirements for Aviation Maintenance Organizations EN 9115*, Quality Management Systems Requirements for Aviation, Space and Defence Organizations Deliverable Software (Supplement to EN 9100:2016) EN 9120*, Quality Management Systems Requ
39、irements for Aviation, Space and Defence Distributors EN 9131*, Aerospace series Quality Management Systems Nonconformance Data Definition and Documentation EN ISO 9000:2015, Quality management systems Fundamentals and vocabulary EN ISO/IEC 17000, Conformity assessment Vocabulary and general princip
40、les (ISO/IEC 17000:2004) EN ISO/IEC 17021-1, Conformity assessment Requirements for bodies providing audit and certification of management systems Part 1: Requirements (ISO/IEC 17021-1:2015) IAQG Procedure 105.6, IAQG Forms Management IAF MD 3:2008, IAF Mandatory Document for Advanced Surveillance a
41、nd Recertification Procedures IAF MD 4:2008, IAF Mandatory Document for the Use of Computer Assisted Auditing Techniques (“CAAT”) for Accredited Certification of Management Systems 3 Terms and definitions For the purpose of this standard, the terms and definitions provided in EN ISO 9000, EN ISO/IEC
42、 17000, EN 9100-series standards, EN 9104-001 standard, and the following apply. Furthermore, an acronym log for this standard is presented in Annex A. 3.1 containment action to control and mitigate the impact of a nonconformity and protect the customers operation (stop the problem from getting wors
43、e); includes correction, immediate corrective action, immediate communication, and verification that the nonconforming situation does not further degrade 3.2 Key Performance Indicator KPI measures associated with goals or targets showing how well an organization is achieving its objectives or critic
44、al success factors for a particular project. KPIs are used to objectively define a quantifiable and measurable indication of the organizations progress towards achieving its goals Note 1 to entry: KPIs relating to an organizations financial performance are not in the scope of the EN 9101 standard; h
45、owever, economic measures (e. g., sales quotas, scrap value reduction) can be considered acceptable measures for process improvement. 3.3 major nonconformity The requirements of EN ISO/IEC 17021-1 clause 3.12 apply. prEN 9101:2016 (E) 7 In addition, a major nonconformity can be one or more of the fo
46、llowing situations: a nonconformity where 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 EN 9100-series standard requirement, a customer QMS requirement, or documented information defined by the organization;
47、 any nonconformity that can result in the probable delivery of nonconforming product or service; and a condition that can result in the failure or reduce the usability of the product or service and its intended purpose. 3.4 minor nonconformity The requirements of EN ISO/IEC 17021-1 clause 3.13 apply
48、. In addition a minor nonconformity can be a single system failure or lapse in conformity to meet a EN 9100-series standard requirement, customer QMS requirement, or documented information defined by the organization. 3.5 Nonconformity Report NCR a document stating results and providing objective ev
49、idence of nonconformity against audit criteria, including the following information: containment, correction, root cause, corrective action implementation, and closure 3.6 Online Aerospace Supplier Information System OASIS web-based IAQG database containing information on participating IAQG member companies, National Aerospace Industry Associations (NAIA), National Accreditation Bodies (NAB), accredited CBs, authenticated Aerospace Experience Auditors (AEAs), Aerospace Auditors (AAs) certified supplie
