1、BS EN 9120:2010ICS 03.120.10; 49.020; 95.020NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDQuality ManagementSystems Requirements forAviation, Space andDefence DistributorsThis British Standardwas published under theauthority of the StandardsPolicy and Strategy
2、Committee on 31 July 2010 BSI 2010ISBN 978 0 580 69904 7Amendments/corrigenda issued since publicationDate CommentsBS EN 9120:2010National forewordThis British Standard is the UK implementation of EN 9120:2010. Itsupersedes BS EN 9120:2005 which is withdrawn.The UK participation in its preparation w
3、as entrusted to TechnicalCommittee ACE/1, International and European Aerospace Policy andProcesses.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisionsof a contract. Users are respon
4、sible for its correct application.Compliance with a British Standard cannot confer immunityfrom legal obligations.BS EN 9120:2010EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 9120 June 2010 ICS 03.120.10; 49.020; 95.020 Supersedes EN 9120:2005English Version Quality Management Systems - Requi
5、rements for Aviation, Space and Defence Distributors Systmes de management de la Qualit - Exigences pour les distributeurs en aronautique, spatial et dfense Qualittsmanagementsysteme - Anforderungen fr Hndler und Lagerhalter der Luftfahrt, Raumfahrt und VerteidigungThis European Standard was approve
6、d by CEN on 11 March 2010. 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 bibliographical references concerning such national sta
7、ndards may be obtained on application to the CEN 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
8、 to the CEN 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembour
9、g, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2010 CEN All rights o
10、f exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 9120:2010: EBS EN 9120:2010EN 9120:2010 (E) 2 Contents Page Foreword 4FOREWORD .5REVISION SUMMARY/RATIONALE .50 Introduction 60.1 General .60.2 Process approach .6Quality management systems Requireme
11、nts .81 Scope 81.1 General .81.2 Application .82 Normative references 93 Terms and definitions .93.1 Airworthiness certificate 93.2 Certificate of conformity .93.3 Counterfeit part 93.4 Distributor 93.5 Risk .93.6 Splitting . 103.7 Suspected unapproved part 103.8 Test report . 104 QUALITY MANAGEMENT
12、 SYSTEM. 104.1 General requirements 104.2 Documentation Requirements 114.2.1 General 114.2.2 Quality Manual 114.2.3 Control of Documents 124.2.4 Control of Records . 125 MANAGEMENT RESPONSIBILITY 135.1 Management Commitment 135.2 Customer Focus . 135.3 Quality Policy 135.4 Planning 135.4.1 Quality O
13、bjectives 135.4.2 Quality Management System Planning 135.5 Responsibility, Authority and Communication . 145.5.1 Responsibility and Authority 145.5.2 Management Representative . 145.5.3 Internal Communication 145.6 Management Review 145.6.1 General 145.6.2 Review Input . 145.6.3 Review Output 156 RE
14、SOURCE MANAGEMENT 156.1 Provision of Resources . 156.2 Human Resources 156.2.1 General 156.2.2 Competence, Training and Awareness 15BS EN 9120:2010EN 9120:2010 (E) 3 6.3 Infrastructure . 166.4 Work Environment 167 PRODUCT REALIZATION . 167.1 Planning of Product Realization 167.1.1 Configuration Mana
15、gement 167.1.2 Control of work transfers . 177.2 Customer related processes 177.2.1 Determination of requirements related to the product . 177.2.2 Review of Requirements Related to the Product . 177.2.3 Customer Communication . 187.3 Design and Development . 187.4 Purchasing . 187.4.1 Purchasing Pro
16、cess 187.4.2 Purchasing Information 197.4.3 Verification of Purchased Product 197.5 Production and Service Provision 207.5.1 Control of Production and Service Provision 207.5.2 Validation of Processes for Production and Service Provision . 207.5.4 Customer Property 217.5.5 Preservation of Product .
17、217.6 Control of Monitoring and Measuring Equipment . 228 MEASUREMENT, ANALYSIS AND IMPROVEMENT . 228.1 General . 228.2 Monitoring and Measurement 238.2.1 Customer Satisfaction 238.2.2 Internal Audit . 238.2.3 Monitoring and Measurement of Processes 238.2.4 Monitoring and Measurement of Product . 24
18、8.2.5 Evidence of conformity 248.3 Control of Nonconforming Product 258.4 Analysis of Data 268.5 Improvement 268.5.1 Continual Improvement 268.5.2 Corrective Action 268.5.3 Preventive Action 27BIBLIOGRAPHY 28BS EN 9120:2010EN 9120:2010 (E) 4 Foreword This document (EN 9120:2010) has been prepared by
19、 the Aerospace and Defence 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
20、ASD, 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 December 2010, and conflicting national standards shall be withdrawn at the latest by December 2010. Attentio
21、n is drawn 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. This document supersedes EN 9120:2005. According to the CEN/CENELEC Internal Regulations, the
22、national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherla
23、nds, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. BS EN 9120:2010EN 9120:2010 (E) 5 FOREWORD To assure customer satisfaction, aviation and defense organizations must produce, maintain, repair and continually improve, safe, reliable product
24、s 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 expectations have complicated this objective. Organizations have the challenge of purchasing products from supp
25、liers throughout the world and at all levels of the supply chain. Suppliers have the challenge of delivering products to multiple customers having varying quality requirements and expectations. Industry has established the International Aerospace Quality Group (IAQG), with representatives from compa
26、nies 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 standard has been prepared by the IAQG. This document standardizes quality management system requirements to the greatest ext
27、ent possible and can be used at all levels of the supply chain by organizations around the world. Its use should result in improved quality, schedule and cost performance by the reduction or elimination of organization-unique requirements and wider application of good practice. While primarily devel
28、oped for the aviation and defense industry, organizations providing maintenance, repair and overhaul services, this standard can also be used in other industry sectors where a quality management system with additional requirements over an ISO 9001 system is needed. REVISION SUMMARY/RATIONALE This st
29、andard has been revised to incorporate the requirements of ISO 9001:2008 and IAQG developed 9100:2009. In addition, industry requirements, definitions and notes have been revised and additional requirements have been included in response to stakeholder needs. BS EN 9120:2010EN 9120:2010 (E) 6 0 Intr
30、oduction 0.1 General The adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organizations quality management system is influenced by: a) its organizational environment, changes in that environment, and the risks associated w
31、ith that environment; b) its varying needs; c) its particular objectives; d) the products it provides; e) the processes it employs; f) its size and organizational structure. It is not the intent of this European Standard to imply uniformity in the structure of quality management systems or uniformit
32、y of documentation. The quality management system requirements specified in this European Standard are complementary to requirements for products. Information marked “NOTE“ is for guidance in understanding or clarifying the associated requirement. This European Standard can be used by internal and e
33、xternal parties, including certification bodies, to assess the organizations ability to meet customer, statutory and regulatory requirements applicable to the product, and the organizations own requirements. The quality management principles stated in ISO 9000 and ISO 9004 have been taken into consi
34、deration during the development of this European Standard. 0.2 Process approach This European Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requir
35、ements. For an organization to function effectively, it has to determine and manage numerous linked activities. An activity or set of activities using resources, and managed in order to enable the transformation of inputs into outputs, can be considered as a process. Often the output from one proces
36、s directly forms the input to the next. The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management to produce the desired outcome, can be referred to as the “process approach“. An advantage of the proces
37、s approach is the ongoing control that it provides over the linkage between the individual processes within the system of processes, as well as over their combination and interaction. When used within a quality management system, such an approach emphasizes the importance of: a) understanding and me
38、eting requirements; b) the need to consider processes in terms of added value; BS EN 9120:2010EN 9120:2010 (E) 7 c) obtaining results of process performance and effectiveness; and d) continual improvement of processes based on objective measurement. The model of a process-based quality management sy
39、stem shown in Figure 1 illustrates the process linkages presented in Clauses 4 to 8. This illustration shows that customers play a significant role in defining requirements as inputs. Monitoring of customer satisfaction requires the evaluation of information relating to customer perception as to whe
40、ther the organization has met the customer requirements. The model shown in Figure 1 covers all the requirements of this European Standard, but does not show processes at a detailed level. NOTE In addition, the methodology known as “Plan-Do-Check-Act“ (PDCA) can be applied to all processes. PDCA can
41、 be briefly described as follows. Plan: establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organizations policies. Do: implement the processes. Check: monitor and measure processes and product against policies, objectives and requirem
42、ents for the product and report the results. Act: take actions to continually improve process performance. Figure 1 Model of a process-based quality management system Continual improvement of the quality management system Customers CustomersSatisfaction Resource management Managementresponsibility M
43、easurement,analysis and improvementRequirements Input Product Output Product realization Key Value-adding activities Information flow BS EN 9120:2010EN 9120:2010 (E) 8 Quality management systems Requirements 1 Scope 1.1 General This standard includes ISO 9001:20081)quality management system requirem
44、ents and specifies additional aviation, space and defense industry requirements, definitions and notes as shown in bold, italic text. It is emphasized that the requirements specified in this standard are complementary (not alternative) to contractual and applicable statutory and regulatory requireme
45、nts. Should there be a conflict between the requirements of this standard and applicable statutory or regulatory requirements, the latter shall take precedence. This European Standard specifies requirements for a quality management system where an organization: a) needs to demonstrate its ability to
46、 consistently provide product that meets customer and applicable statutory and regulatory requirements; and b) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to custome
47、r and applicable statutory and regulatory requirements. NOTE 1 In this European Standard, the term “product“ only applies to: a) product intended for, or required by, a customer; b) any intended output resulting from the product realization processes. NOTE 2 Statutory and regulatory requirements can
48、 be expressed as legal requirements. 1.2 Application All requirements of this European Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided. Where any requirement(s) of this European Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion. Where exclusions are made, claims of conformity to this European Standard are not acceptable unless these exclusions are limited to requirements within Clause 7, and such exclus
