1、ASD STANDARD NORME ASD ASD NORM prEN 9120 Edition P 4 June 2009 PUBLISHED BY THE AEROSPACE AND DEFENCE INDUSTRIES ASSOCIATION OF EUROPE - STANDARDIZATIONAvenue de Tervuren, 270 - B-1150 Brussels - Tel. + 32 2 775 8126 - Fax. + 32 2 775 8131 - www.asd-stan.orgICS: Supersedes edition P 3 of December 2
2、003 and will supersede EN 9120:2005 Descriptors: ENGLISH VERSION Quality Management Systems Requirements 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
3、 und Lagerhalter der Luftfahrt, Raumfahrt und Verteidigung 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 European Aerospace Industry. It h
4、as 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, without re-identification of the
5、standard. After examination and review by users and formal agreement of ASD-STAN, it 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 CEN national members have then to implemen
6、t 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. NOTE This standard is technically equivalent to AS9120 Edition approved for publication 30 June 2009 Comments should be sent within six months after the da
7、te of publication to ASD-STAN Quality Domain Copyright 2009 by ASD-STAN prEN 9120:2009 (E) 2 Contents Page FOREWORD.4 REVISION SUMMARY/RATIONALE.4 0 Introduction5 0.1 General .5 0.2 Process approach .5 Quality management systems Requirements 7 1 Scope7 1.1 General .7 1.2 Application .7 2 Normative r
8、eferences8 3 Terms and definitions .8 3.1 Airworthiness certificate 8 3.2 Certificate of conformity.8 3.3 Counterfeit part9 3.4 Distributor 9 3.5 Risk .9 3.6 Splitting 9 3.7 Suspected unapproved part.9 3.8 Test report9 4 QUALITY MANAGEMENT SYSTEM9 4.1 General requirements .9 4.2 Documentation Requir
9、ements 10 4.2.1 General 10 4.2.2 Quality Manual 11 4.2.3 Control of Documents 11 4.2.4 Control of Records. 11 5 MANAGEMENT RESPONSIBILITY 12 5.1 Management Commitment 12 5.2 Customer Focus . 12 5.3 Quality Policy 12 5.4 Planning 13 5.4.1 Quality Objectives 13 5.4.2 Quality Management System Planning
10、 13 5.5 Responsibility, Authority and Communication . 13 5.5.1 Responsibility and Authority 13 5.5.2 Management Representative. 13 5.5.3 Internal Communication 13 5.6 Management Review 14 5.6.1 General 14 5.6.2 Review Input . 14 5.6.3 Review Output 14 6 RESOURCE MANAGEMENT 14 6.1 Provision of Resour
11、ces . 14 6.2 Human Resources 15 6.2.1 General 15 6.2.2 Competence, Training and Awareness 15 6.3 Infrastructure 15 prEN 9120:2009 (E) 3 6.4 Work Environment 15 7 PRODUCT REALIZATION .15 7.1 Planning of Product Realization15 7.1.1 Configuration Management16 7.1.2 Control of work transfers .16 7.2 Cus
12、tomer related processes16 7.2.1 Determination of requirements related to the product .16 7.2.2 Review of Requirements Related to the Product.17 7.2.3 Customer Communication .17 7.3 Design and Development .17 7.4 Purchasing.18 7.4.1 Purchasing Process18 7.4.2 Purchasing Information18 7.4.3 Verificati
13、on of Purchased Product 19 7.5 Production and Service Provision 19 7.5.1 Control of Production and Service Provision 19 7.5.2 Validation of Processes for Production and Service Provision.20 7.5.4 Customer Property21 7.5.5 Preservation of Product .21 7.6 Control of Monitoring and Measuring Equipment
14、.21 8 MEASUREMENT, ANALYSIS AND IMPROVEMENT.22 8.1 General.22 8.2 Monitoring and Measurement23 8.2.1 Customer Satisfaction23 8.2.2 Internal Audit .23 8.2.3 Monitoring and Measurement of Processes 23 8.2.4 Monitoring and Measurement of Product.24 8.2.5 Evidence of conformity 24 8.3 Control of Nonconf
15、orming Product 25 8.4 Analysis of Data 26 8.5 Improvement26 8.5.1 Continual Improvement26 8.5.2 Corrective Action 26 8.5.3 Preventive Action27 BIBLIOGRAPHY 28 prEN 9120:2009 (E) 4 FOREWORD To assure customer satisfaction, aviation and defense organizations must produce, maintain, repair and continua
16、lly improve, safe, reliable products 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 challen
17、ge of purchasing products from suppliers 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 (IAQ
18、G), 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 standard has been prepared by the IAQG. This document standardizes quality management syst
19、em requirements to the greatest extent 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 g
20、ood practice. While primarily developed 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.
21、 REVISION SUMMARY/RATIONALE This standard 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. prEN
22、9120:2009 (E) 5 0 Introduction 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 t
23、he risks associated with 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 International Standard to imply uniformity in the structure of quality manag
24、ement systems or uniformity of documentation. The quality management system requirements specified in this International Standard are complementary to requirements for products. Information marked “NOTE” is for guidance in understanding or clarifying the associated requirement. This International St
25、andard can be used by internal and external 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
26、 ISO 9004 have been taken into consideration during the development of this International Standard. 0.2 Process approach This International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance cu
27、stomer satisfaction by meeting customer requirements. 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
28、as a process. Often the output from one process 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
29、“process approach”. An advantage of the process 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 emphasi
30、zes the importance of a) understanding and meeting requirements, b) the need to consider processes in terms of added value, prEN 9120:2009 (E) 6 c) obtaining results of process performance and effectiveness, and d) continual improvement of processes based on objective measurement. The model of a pro
31、cess-based quality management system 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
32、to customer perception as to whether the organization has met the customer requirements. The model shown in Figure 1 covers all the requirements of this International Standard, but does not show processes at a detailed level. NOTE In addition, the methodology known as “Plan-Do-Check-Act” (PDCA) can
33、be applied to all processes. PDCA can 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 agai
34、nst policies, objectives and requirements 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 Customers Satisfaction Resource
35、 management Managementresponsibility Measurement,analysis and improvementRequirements Input Product OutputProduct realization Key Value-adding activities Information flow prEN 9120:2009 (E) 7 Quality management systems Requirements 1 Scope 1.1 General This standard includes ISO 9001:20081)quality ma
36、nagement system requirements 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
37、and regulatory requirements. Should there be a conflict between the requirements of this standard and applicable statutory or regulatory requirements, the latter shall take precedence. This International Standard specifies requirements for a quality management system where an organization a) needs t
38、o demonstrate its ability to 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 assura
39、nce of conformity to customer and applicable statutory and regulatory requirements. NOTE 1 In this International 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
40、 and regulatory requirements can be expressed as legal requirements. 1.2 Application All requirements of this International 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 International Stand
41、ard 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 International Standard are not acceptable unless these exclusions are limited to requirements within Clause 7, and such exclusions
42、 do not affect the organizations ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements. 1) With the permission of the International Organization for Standardization (ISO). The complete standard may be obtained from any ISO member or f
43、rom the ISO Central Secretariat: 1, ch. de la Voie-Creuse, Case postale 56, CH-1211 Geneva 20, SWITZERLAND. Copyright remains with ISO. prEN 9120:2009 (E) 8 This standard is for use by organizations that procure parts, materials and assemblies and resells these products to a customer in the aviation
44、, space and defense industries. This includes organizations that procure products and split them into smaller quantities including those that coordinate a customer controlled service on the product. This standard is not intended for organizations that maintain or repair products. Organizations that
45、perform work that affect or could affect product characteristics or conformity should use the IAQG-developed 9100 or 9110 standards, as appropriate (see Bibliography). Requirements for the aviation, space and defence industries are specified in this standard. Compliance to this standard means the ex
46、pected exclusions for distributors are already taken for the ISO 9001:2008 standard unless otherwise specified by the organization. The following ISO 9001:2008 clauses are excluded in their entirety for purposes of this standard: 7.3 Design and development 7.5.2 Validation of processes for productio
47、n and service provision 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. IS
48、O 9000:2005, Quality management systems Fundamentals and vocabulary. 3 Terms and definitions For the purposes of this International Standard, the terms and definitions given in ISO 9000 apply. Throughout the text of this International Standard, wherever the term “product” occurs, it can also mean “s
49、ervice”. For the purpose of this standard, the term manufacturer is intentionally used to clearly delineate the relationship between the product creator and the organization. The terms supplier, manufacturer and product creator may be synonymous. supplier organization customer (manufacturer /product creator) 3.1 Airworthiness certificate A document issued by the cognizant civil aviation authority (e.g., EASA Form 1, FAA Form 8130-3) that certifies that the part conforms to the applicable regulatory requirements. 3.2 Certificate of conformity A document that cert
