AS9100 C 中英文标准

1、Quality Management Systems Requirements for Aviation, Space and Defense Organizations航空, 航天和国防工业组织-质量管理体系要求AS9100 Rev C (2009)Foreword To assure customer satisfaction, aviation, space and defense organizations must produce, and continually improve, safe, reliable products that meet or exceed custome

2、r 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 suppliers throughout the world an

3、d 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 companies in the Americas, Asia/Pa

4、cific 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 extent possible and can be used

5、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 developed for the aviation, space

6、and defense industry, 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/RationaleThis standard has been revised to incorporate the requirements of ISO 9001:2008. In addition, indu

7、stry requirements, definitions and notes have been revised and additional requirements have been included in response to stakeholder needs. Introduction0.1General01总则The adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an org

8、anizations quality management system is influenced by 采用质量管理体系应当是组织的一项战略性决策。一个组织质量管理体系的设计和实施受下列因素的影响。a) its organizational environment, changes in that environment, and the risks associated with that environment, 组织的环境，环境上的变化，和与该环境有关的风险b) its varying needs, 组织不断变化的需求 c) its particular objectives, 组织

9、的具体目标d) the products it provides, 组织所提供的产品e) the processes it employs, 组织所采用的过程f) its size and organizational structure. 组织的规模和组织的结构It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation。统一质量管理体系的结构或文件不是本标

10、准的目的。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.本标准所规定的质量管理体系要求是对产品要求的补充。“注”是理解和说明有关要求的指南。This International St

11、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.本标准能用于内部和外部（包括认证机构）评定组织满足顾客、适用于产品的法令和法律法规要求，和组织自身要求的能力。Th

12、e quality management principles stated in ISO 9000 and ISO 9004 have been taken into consideration during the development of this International Standard. 本标准的制定已经考虑了ISO9000和ISO9004中所阐明的质量管理原则。0.2 Process Approach 过程方法This International Standard promotes the adoption of a process approach when develo

13、ping, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements. 本标准鼓励在建立、实施质量管理体系以及改进其有效性时采用过程方法，通过满足顾客要求，增强顾客满意。For an organization to function effectively, it has to determine and manage numerous linked activitie

14、s. 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 process directly forms the input to the next.为使组织有效运作，必须识别和管理众多相互关联的活动。通过使用资源和管理，将输入转化为输出的活动可视为过程。通常，一个过程的输出直接形成下一个

15、过程的输入。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”. 组织内诸过程的系统的应用，连同这些过程的识别和相互作用及其管理，可称为“过程方法”。An advantage of th

16、e 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.过程方法的优点是对诸过程的系统中单个过程之间的联系以及过程的组合和相互作用进行连续控制。When used within a quality management system, such an approach em

17、phasizes the importance of a) understanding and meeting requirements, b) the need to consider processes in terms of added value, c) obtaining results of process performance and effectiveness, and d) continual improvement of processes based on objective measurement过程方法在质量管理体系中应用时，强调以下方面的重要性：a） 理解并满足要

18、求；b） 需要从增值的角度考虑过程；c） 获得过程业绩和有效性的结果；d） 基于客观的测量，持续改进过程。The model of a process-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

19、 customer satisfaction requires the evaluation of information relating 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.图1所反

20、映的以过程为基础的质量管理体系模式展示了48章中所提出的过程联系。这种展示反映了在规定输入要求时，顾客起着重要作用。对顾客满意的监视要求对顾客有关组织是否已满足其要求的感受的信息进行评价。该模式虽覆盖了本标准的所有要求，但却未详细地反映各过程。NOTE In addition, the methodology known as “Plan-Do-Check-Act” (PDCA) can be applied to all processes. PDCA can be briefly described as follows. Plan: establish the objectives an

21、d 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 requirements for the product and report the results. Act: take actions to c

22、ontinually improve process performance. 注：此外，称之为“PDCA”的方法适用于所有过程。PDCA模式可简述如下：P策划：为符合顾客的要求和组织的方针的这个结果，建立目标和需要的过程；D实施：实施过程；C检查：根据方针、目标和产品要求，对过程和产品进行监视和测量，并报告结果A处置：采取措施，以持续改过程业绩。FIGURE 1 - Model of a Process-Based Quality Management System 图1 以过程为基础的质量管理体系模式1. Scope 1.1 General This standard includes I

23、SO 9001:20081 quality management system requirements and specifies additional aviation, space and defense industry requirements, definitions and notes as shown in bold, italic text.本标准包括了ISO 9001：20081质量管理体系要求并对航空, 航天和国防工业质量管理体系规定了附加要求。附加的航空要求用斜体字表示。It is emphasized that the requirements specified i

24、n this standard are complementary (not alternative) to contractual and applicable statutory 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.必须强调，本标准规定的质量管理体系要求是对合同和

25、适用的法律法规要求的补充（不是替代）。This International Standard specifies requirements for a quality management system where an organization a) needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and b) aims to enhance customer sa

26、tisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.本标准为有以下需求的组织规定了质量管理体系要求：a) 需要证实其有能力稳定地提供满足顾客和适用的法律法规要求的产品；b) 通过体系的有效运用，包括体系持续改进的过程以

27、及保证符合顾客与适用的法律法规要求，旨在增强顾客满意。NOTE 1 In this International Standard, the term “product” only applies toa) product intended for, or required by, a customer, b) any intended output resulting from the product realization processes. 注1：在本标准中，术语“产品”仅适用于a) 预期提供给顾客或顾客所要求的产品。b) 任何产品实现过程的预期输出结果。NOTE 2: Statutor

28、y and regulatory requirements may be expressed as legal requirements. 注2： 当本标准的要求与适用的法律或法规要求发生冲突时，应当以法规要求为准。1.2 Application 1.2 应用All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided. 本标准规定的所

29、有要求是通用的，旨在适用于各种类型、不同规模和提供不同产品的组织。Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.当本标准的任何要求因组织及其产品的特点而不适用时，可以考虑对其进行删减。Where exclusions are made, claims of conformity to this Internatio

30、nal Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organizations ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements. 除非删减仅限于本标准第7章那些不影响组织提供满足顾客

31、和适用法令和法律法规要求的产品的能力或责任的要求，否则不能声称符合本标准。This standard is intended for use by organizations that design, develop and/or produce aviation, space and defense products; and by organizations providing post-delivery support, including the provision of maintenance, spare parts or materials for their own produ

32、cts.Organizations whose primary business is providing maintenance, repair and overhaul services for aviation commercial and military products; and original equipment manufacturers with maintenance, repair and overhaul operations that operate autonomously, or that are substantially different from the

33、ir manufacturing/production operations; should use the IAQG-developed 9110 standard (see Bibliography). Organizations that procure parts, materials and assemblies and resell these products to a customer in the aviation, space and defense industries, including organizations that procure products and

34、split them into smaller quantities for resale, should use the IAQG-developed 9120 standard (see Bibliography). 1With the permission of the International Organization for Standardization (ISO). The complete standard can be obtained from any ISO member or from the ISO Central Secretariat: 1, ch. de la

35、 Voie-Creuse, Case postale 56, CH-1211 Geneva 20, SWITZERLAND, or visit . Copyright remains with ISO.AS9100 now provides clarification on the scopes of three aviation, space and defense standards: AS9100 is for organizations that design, develop and produce products. 设计，开发和制造组织AS9110 is f

36、or organizations that provide maintenance, repair and overhaul services. 维修组织AS9120 is for organizations that buy products and resell them 销售商将维修组织和销售商单独列出，给出其质量管理体系具体适用的标准。2. Normative references 2 规范性引用文件The following referenced documents are indispensable for the application of this document. For

37、 dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 9000:2005, Quality management systems Fundamentals and vocabulary. 下列文件中的条款通过本标准的引用而构成为本标准的条款。凡是注日期的引用文件，其随后所有的修改单（不包含勘误的内容）或修订版均不适用于本标准，然而

38、，鼓励根据本标准达成协议的各方研究是否可使用这些文件的最新版本。凡是不注日期的引用文件，其最新版本适用于本标准。ISO（国际标准化组织）和IEC（国际电工委员会）的成员保持先行有效的国际标准的目录。ISO 9000：2005 质量管理体系- 基础和术语3. Terms and definitions 3 术语和定义For the purposes of this document, the terms and definitions given in ISO 9000 apply. Throughout the text of this International Standard, wher

39、ever the term “product” occurs, it can also mean “service”. ISO 9001：2000确立的以及下列术语适用于本标准。本标准中所出现的术语“产品”，也可指“服务”。 3.1 Risk 风险An undesirable situation or circumstance that has both a likelihood of occurring and a potentially negative consequence. 3.2 Special requirements 特殊要求Those requirements identif

40、ied by the customer, or determined by the organization, which have high risks to being achieved, thus requiring their inclusion in the risk management process. Factors used in the determination of special requirements include product or process complexity, past experience and product or process matu

41、rity. Examples of special requirements include performance requirements imposed by the customer that are at the limit of the industrys capability, or requirements determined by the organization to be at the limit of its technical or process capabilities. 3.3 Critical items 关键项Those items (e.g., func

42、tions, parts, software, characteristics, processes) having significant effect on the product realization and use of the product; including safety, performance, form, fit, function, producibility, service life, etc.; that require specific actions to ensure they are adequately managed. Examples of cri

43、tical items include safety critical items, fracture critical items, mission critical items, key characteristics, etc. 3.4 Key Characteristic 关键特性An attribute or feature whose variation has a significant effect on product fit, form, function, performance, service life or producibility, that requires

44、specific actions for the purpose of controlling variation. 关键特性（Key Characteristics）：其波动对产品的装配、性能、使用寿命或可制造性产生重大影响的材料、过程或零件的特性。NOTE Special requirements and critical items are new terms and, along with key characteristics, are interrelated. Special requirements are identified when determining and rev

45、iewing requirements related to the product (see 7.2.1 and 7.2.2). Special requirements can require the identification of critical items. Design output (see 7.3.3) can include identification of critical items that require specific actions to ensure they are adequately managed. Some critical items wil

46、l be further classified as key characteristics because their variation needs to be controlled. 4 Quality management system 4 质量管理体系4.1 General requirements 4.1 总要求The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness

47、in accordance with the requirements of this International Standard. The organizations quality management system shall also address customer and applicable statutory and regulatory quality management system requirements. 组织应按本标准的要求建立质量管理体系，形成文件，加以实施和保持，并持续改进其有效性。组织的质量管理体系也应符合顾客和适用的法令和法律法规质量管理体系要求。The

48、 organization shall a) determine the processes needed for the quality management system and their application throughout the organization (see 1.2), b) determine the sequence and interaction of these processes, c) determine criteria and methods needed to ensure that both the operation and control of

49、 these processes are effective, d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes, e) monitor, measure where applicable, and analyse these processes, and f) Implement actions necessary to achieve planned results and continual

50、 improvement of these processes. 组织应：a) 确定质量管理体系所需的过程及其在组织中的应用（见1.2）；b) 确定这些过程的顺序和相互作用；c) 确定为确保这些过程的有效运行和控制所需的准则和方法；d) 确保可以获得必要的资源和信息，以支持这些过程的运行和对这些过程的监视；e) 适当时监视、测量和分析这些过程；f) 实施必要的措施，以实现对这些过程策划的结果和对这些过程的持续改进。These processes shall be managed by the organization in accordance with the requirements of

51、 this International Standard. 组织应按本标准的要求管理这些过程。Where an organization chooses to outsource any process that affects product conformity to requirements, the organization shall ensure control over such processes 针对组织所选择的任何影响产品符合要求外包过程，组织应确保对其实施控制。The type and extent of control to be applied to these ou

52、tsourced processes shall be defined within the quality management system. 对此类外包过程的控制应在质量管理体系中加以确定。NOTE 1 Processes needed for the quality management system referred to above include processes for management activities, provision of resources, product realization, measurement, analysis and improvemen

53、t. 注1：上述质量管理体系所需的过程包括与管理活动、资源提供、产品实现和测量，分析和改进 有关的过程。NOTE 2 An “outsourced process” is a process that the organization needs for its quality management system and which the organization chooses to have performed by an external party. NOTE 3 Ensuring control over outsourced processes does not absolve

54、the organization of the responsibility of conformity to all customer, statutory and regulatory requirements. The type and extent of control to be applied to the outsourced process can be influenced by factors such as a) the potential impact of the outsourced process on the organizations capability t

55、o provide product that conforms to requirements, b) the degree to which the control for the process is shared, c) the capability of achieving the necessary control through the application of Documentation requirements4.2 文件要求4.2.1 General4.2.1总则The quality management system documentation sha

56、ll includea) documented statements of a quality policy and quality objectives, b) a quality manual, c) documented procedures and records required by this International Standard, and d) documents, including records, determined by the organization to be necessary to ensure the effective planning, oper

57、ation and control of its processes. 质量管理体系文件应包括：a) 形成文件的质量方针和质量目标；b) 质量手册；c) 本标准所要求的形成文件的程序和记录；d) 组织为确保其过程的有效策划、运行和控制所需的文件，包括纪录；The organization shall ensure that personnel have access to, and are aware of, relevant quality management system documentation and changes.组织应确保相应人员能接触到并且了解相关的质量管理体系文件和变化。

58、NOTE 1 Where the term “documented procedure” appears within this International Standard, this means that the procedure is established, documented, implemented and maintained. A single document may address the requirements for one or more procedures. A requirement for a documented procedure may be covered by more than one document注1：本标准出现“形成文件的程序”之处，即要求建立该程序，形成文件，并加以实施和保持。NOTE 2 The extent of the quality management system documentati