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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 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 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 (IAQG), 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 system 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 good practice. While primarily developed for the aviation, space 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/Rationale This standard has been revised to incorporate the requirements of ISO 9001:2008. In addition, industry requirements, definitions and notes have been revised and additional requirements have been included in response to stakeholder needs. Introduction 0.1General 0．1总则 The adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organization‘s 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准的目的。 1页
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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 Standard can be used by internal and external parties, including certification bodies, to assess the organization’s ability to meet customer, statutory and regulatory requirements applicable to the product, and the organization’s 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。 The 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 developing, 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 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 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 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. 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 emphasizes 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； 2页
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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 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所反映的以过程为基础的质量管理体系模式展示了4~8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 and processes necessary to deliver results in accordance with customer requirements and the organization’s 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 continually 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 ISO 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 9001：2008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。 1It is emphasized that the requirements specified in 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 3页