AS9100D Sandard E&C

AS9100D Sandard E&C AS 9100D/EN9100:2016 Aerospace Quality Standard ISO9001:2015/EN9100:2016 (Draft,Nov.16,2015) Bureau Veritas Certification China 中文译稿 质量管理体系, Quality Management Systems – Requirements for 航空,航天和防务组织的要求 Aviation, Space, and Defense organization 1.范围 1. Scope 本标准包括ISO9001:2015质量管理体This standard includes ISO 9001:2015 quality management 系要求,并规定了额外的航空,航天和防system requirements and specifies additional aviation, space 务的行业要求,定义和注释。 and defense industry requirements, definitions and notes. It is emphasized that the requirements specified in this 要强调的是本标准所规定的质量管理体standard are complementary (not alternative) to customer and 系要求是对顾客和适用法律法规要求的applicable statutory and regulatory requirements. 补充(不是取代)。 If there is a conflict between the requirements of this standard 如果本标准要求和适用法律法规之间有and applicable statutory or regulatory requirements, the latter 任何冲突,以后者优先. shall take precedence. This International Standard specifies requirements for a quality 本国际标准为有下列需求的组织规定了management system when an organization: 质量管理体系要求: a) needs to demonstrate its ability to consistently provide products a) 需要证实其有能力稳定地提供满足顾and services that meet customer and applicable statutory and 客和适用的法律法规要求的产品; regulatory requirements, and b) 通过对体系的有效应用,包括体系持b) aims to enhance customer satisfaction through the effective 续改进的过程,以及保证符合顾客与application of the system, including processes for improvement of 适用的法律法规要求,旨在增强顾客the system and the assurance of conformity to customer and 满意。 applicable statutory and regulatory requirements. 本国际标准的所有要求是通用的,旨在All the requirements of this International Standard are generic and 适用于各种类型的、不同规模或者提供are intended to be applicable to any organization, regardless of its 的不同产品和服务的组织。 type or size, or the products and services it provides. NOTE 1 In this International Standard, the terms “product” or “service” only 注1:在本国际标准中，术语“产品”或“服apply to products and services intended for, or required by, a customer. 务”仅适用于预期提供给顾客或顾客所要求的 产品的服务。 NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements. 注2:法律法规要求可称作法定要求 2规范性引用文件 2. Normative references 下列文件中的全部或部分内容在本标准The following documents, in whole or in part, are normatively 中并在引用中不可或缺。凡是注日期的referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For 引用文件,仅该版本适用本标准。凡未标undated references, the latest edition of the referenced document 注日期的引用文件，其最新版本适用于(including any amendments) applies. 本标准(包括任何修改)。 ISO 9000:2015, Quality management systems — Fundamentals ISO 9000:2015，质量管理体系–基础and vocabulary 与术语 ISO 9001: 2015 Quality management system-Requirement ISO 9001:2015 质量管理体系-要求 3. Terms and definitions 3(术语与定义 For the purposes of this document, the terms and definitions given 本国际标准采用ISO9000:2015中的术in ISO 9000:2015 apply. 语与定义。 Page 1 of 39 Version Feb. 1, 2016 AS 9100D/EN9100:2016 Aerospace Quality Standard ISO9001:2015/EN9100:2016 (Draft,Nov.16,2015) Bureau Veritas Certification China 中文译稿 3.1 counterfeit parts 3.1假冒零件 An unauthorized copy, imitation, substitute, or modified part 通过未授权的复制，模仿，替代或者改(e.g., material, part, component) which is knowingly 装零件的方式(如材料，零件或组件)，misrepresented as a specified genuine part of an original or 故意误导这是一个原始或者授权厂家指authorized manufacturer. 定的真品。 Note: example of a counterfeit part can include, but are not 注:假冒零件可能包括但不限于:假的标limited to, the false identification of marking or labeling, grade, 识或标签，等级，序列号，日期代码，serial number, date code, documentation, or performance 文件，或者性能特性。 characteristics. 3.2关键项目 3.2 critical items Those items (e.g., functions, parts, software, characteristics, 对产品和服务的提供和使用有重要影响processes) having significant effect on the provision and use 的项目(如功能，零件,软件,特性,过of the products and services; including safety, performance, 程),包括安全，性能，形成，安装，功form, fit, function, producibility, service life, etc.; that require 能,可生产性，使用寿命等，需要特定的specific actions to ensure they are adequately managed. 措施以保证能充分地管理。关键项目举Examples of critical items include safety critical items, fracture 例如安全关键项目，破裂关键项目，任critical items, mission critical items, key characteristics, etc. 务关键项目,关键特性等。 3.3 key characteristic 3.4 关键特性 An attribute or feature whose variation has a significant effect on product fit, form, function, performance, service life or 是一种属性或特征，其变化将对产品安producibility, that requires specific actions for the purpose of 装,形成，功能，性能 ,使用寿命或可controlling variation. 制造性产生重大影响，因而需要采取特 殊措施对其变化进行控制。 3.4 product safety 3.4 产品安全 The state in which a product is able to perform to its designed or intended purpose without causing unacceptable risk of 在没有导致人员伤害或财产损失的风险harm to persons or damage to property. 。 到不可接受情况下，产品能履行其 或者期待的用途3.5 special requirements 3.5 特殊要求 Those requirements identified by the customer, or determined 由顾客识别或组织自己确定的要求,这by the organization, which have high risks to being achieved, 些要求的实现具有高风险性,因而要求thus requiring their inclusion in the risk management process. 它们包含在风险管理过程中。确定特殊Factors used in the determination of special requirements 要求的因素，包括产品或过程的复杂性,include product or process complexity, past experience and 过去的经验，以及产品或过程的成熟度.product or process maturity. Examples of special requirements include performance requirements imposed by 特殊要求的例子包括顾客强制的行业极the customer that are at the limit of the industry’s capability, or 限能力,或者是组织自身确定的技术或requirements determined by the organization to be at the limit 过程的极限能力。 of its technical or process capabilities. 注:特殊要求(3.5)和关键项目(3.2) NOTE Special requirements (3.5) and critical items (3.2), along 以及关键特性是相互关联的。特殊要求是with key characteristics, are interrelated. Special requirements 在确定和评审与产品有关的要求时识别are identified when determining and reviewing requirements 的(见8.2.2和8.2.3)。特殊要求可能related to the product (see 8.2.2 and 8.2.3). Special 要求识别关键项目。设计输出(见8.3.5)requirements can require the identification of critical items. 可能包括识别要求采取特殊措施保证其Design output (see 8.3.5) can include identification of critical 得到充分管理的关键项目。一些关键项目items that require specific actions to ensure they are 由于需要对其变化进行控制,会被进一步adequately managed. Some critical items will be further 分为关键特性。classified as key characteristics because their variation needs to be controlled. Page 2 of 39 Version Feb. 1, 2016 AS 9100D/EN9100:2016 Aerospace Quality Standard ISO9001:2015/EN9100:2016 (Draft,Nov.16,2015) Bureau Veritas Certification China 中文译稿 4 Context of the organization 4 组织环境 4.1 Understanding the organization and its context 4.1 理解组织及其环境 The organization shall determine external and internal issues that 组织应确定与其目标和战略方向相关并影响are relevant to its purpose and its strategic direction and that affect 其实现质量管理体系预期结果的各种外部和its ability to achieve the intended result(s) of its quality management 内部因素。 system. The organization shall monitor and review information about these 组织应对这些内部和外部因素的相关信息进external and internal issues. 行监视和评审。 NOTE 1 Issues can include positive and negative factors or conditions for 注1:这些因素可以包括需要考虑的正面和负consideration. 面要素或条件, NOTE 2 Understanding the external context can be facilitated by 注2:通过考虑国际、国家、地区或当地的法considering issues arising from legal, technological, competitive, market, 律法规、技术、竞争、市场、文化、社会和经cultural, social, and economic environments, whether international, national, regional or local. 济因素～有助于理解外部环境。 NOTE 3 Understanding the internal context can be facilitated by 注3:考虑组织的价值观、文化、知识和绩效considering issues related to values, culture, knowledge and performance of the organization. 等相关因素～有助于理解内部环境。 4.2 Understanding the needs and expectations of 4.2 理解相关方的需求和期望 interested parties 由于相关方对组织持续提供符合顾客要求和Due to their effect or potential effect on the organization’s ability to 适用法律法规要求的产品和服务的能力产生consistently provide products and services that meet customer and 影响或潜在影响，因此，组织应确定: applicable statutory and regulatory requirements, the organization shall determine: a) the interested parties that are relevant to the quality a) 与质量管理体系有关的相关方; management system; b) the requirements of these interested parties that are relevant to b) 这些相关方的要求; the quality management system. 组织应对与这些相关方及其要求的相关信息The organization shall monitor and review information about these 进行监视和评审。 interested parties and their relevant requirements. 4.3 确定质量管理体系的范围 4.3 Determining the scope of the quality management system 组织应明确质量管理体系的边界和适用性，以The organization shall determine the boundaries and applicability of 确定其范围。 the quality management system to establish its scope. When determining this scope, the organization shall consider: 在确定范围时，组织应考虑: a) the external and internal issues referred to in 4.1; a) 各种内部和外部因素，见4.1; b) the requirements of relevant interested parties referred to in 4.2; b) 相关方的要求，见4.2; c) the products and services of the organization. c) 组织的产品和服务。 The organization shall apply all the requirements of this International Standard if they are applicable within the determined scope of its 对于本标准中适用于组织确定的质量管理体quality management system. 系范围的全部要求，组织应予以实施。 The scope of the organization’s quality management system shall 组织的质量管理体系范围应作为形成文件的be available and be maintained as documented information. The 信息加以保持。该范围应描述所覆盖的产品和scope shall state the types of products and services covered, and provide justification for any requirement of this International 服务类型。若组织认为其质量管理体系的应用 Page 3 of 39 Version Feb. 1, 2016 AS 9100D/EN9100:2016 Aerospace Quality Standard ISO9001:2015/EN9100:2016 (Draft,Nov.16,2015) Bureau Veritas Certification China 中文译稿 Standard that the organization determines is not applicable to the 范围不适用本标准的某些要求，应说明理由。 scope of its quality management system. 那些不适用于组织的质量管理体系要求，不能Conformity to this International Standard may only be claimed if the 影响组织确保产品和服务合格以及增强顾客requirements determined as not being applicable do not affect the 满意的能力或责任，否则不能声称符合本标organization’s ability or responsibility to ensure the conformity of its products and services and the enhancement of customer 准。 satisfaction. 4.4 质量管理体系及其过程 4.4 Quality management system and its processes 4.4.1 组织应按本标准的要求，建立、实施、4.4.1 The organization shall establish, implement, maintain and 保持和持续改进质量管理体系、包括所需过程continually improve a quality management system, including the 及其相互作用。 processes needed and their interactions, in accordance with the requirements of this International Standard. The organization’s quality management system shall also 组织的质量管理体系也应考虑顾客和适用法address customer and applicable statutory and regulatory 律法规对质量管理体系要求。 quality management system requirements. 组织应确定质量管理体系所需的过程及其在The organization shall determine the processes needed for the 整个组织中的应用，且应: quality management system and their application throughout the organization, and shall: a) 确定这些过程所需的输入和预期的输出; a) determine the inputs required and the outputs expected from these processes; b) 确定这些过程的顺序和相互作用; b) determine the sequence and interaction of these processes; c) 确定和应用所需的准则和(包括监 c) determine and apply the criteria and methods (including 视、测量和相关绩效指标)，以确保这些monitoring, measurements and related performance indicators) 过程有效运行和有效控制; needed to ensure the effective operation and control of these processes; d) 确定并确保获得这些过程所需的资源; d) determine the resources needed for these processes and ensure their availability; e) 规定与这些过程相关的责任和权限; e) assign the responsibilities and authorities for these processes; f)应对按照6.1 的要求所确定的风险和机遇; f) address the risks and opportunities as determined in accordance with the requirements of 6.1; g)评价这些过程，实施所需的变更，以确保g) evaluate these processes and implement any changes needed 实现这些过程的预期结果; to ensure that these processes achieve their intended results; h)改进过程和质量管理体系。 h) improve the processes and the quality management system. NOTE Subclauses a) through h) are considered essential to 注: 条款a) 到h)被认为是对章节0.3中描述the adoption of a process approach as described in clause 0.3. 的过程方法的采纳。 4.4.2 在必要的程度上，组织应: 4.4.2 To the extent necessary, the organization shall: a) maintain documented information to support the operation of its a) 保持形成文件的信息以支持过程运行; processes; b) 保留确认其过程按策划进行的形成文件的b) retain documented information to have confidence that the 信息。 processes are being carried out as planned. Page 4 of 39 Version Feb. 1, 2016 AS 9100D/EN9100:2016 Aerospace Quality Standard ISO9001:2015/EN9100:2016 (Draft,Nov.16,2015) Bureau Veritas Certification China 中文译稿 The organization shall establish and maintain documented 组织应建立和维护一个文件的信息，包括: information that includes: - a general description of relevant interested parties (see 4.2 -相应相关方的通用描述(见4.2a); a); - the scope of the quality management system, including -质量管理体系的范围，包括边界和适用性(见boundaries and applicability (see 4.3); 4.3); - a description of the processes needed for the quality -质量管理体系所需的过程和其在组织中应用management system and their application throughout the 的描述; organization; - the sequence and interaction of these processes; -这些过程的次序和关系; - assignment of the responsibilities and authorities for these processes; -这些过程的职责分配和权限; - the documented information established for the quality -为质量管理体系而建立或者引用的文件的信management system, or reference to it. 息。 NOTE The above description of the quality management 注:上述质量管理系统的描述可以遵从一个单system can be complied into a single source of documented 一文件的信息的来源，称为质量手册。 information and referred to as a quality manual. 5 领导作用 5 Leadership 5.1 领导作用和承诺 5.1 Leadership and commitment 5.1.1 总则 5.1.1 General Top management shall demonstrate leadership and commitment 最高管理者应证实其对质量管理体系的领导with respect to the quality management system by: 作用和承诺，通过: a) taking accountability for the effectiveness of the quality a) 对质量管理体系的有效性承担责任; management system; b) ensuring that the quality policy and quality objectives are b) 确保制定质量管理体系的质量方针和质 established for the quality management system and are 量目标，并与组织环境和战略方向相一compatible with the context and strategic direction of the 致; organization; c) 确保质量管理体系要求融入组织的业务c) ensuring the integration of the quality management system 过程; requirements into the organization’s business processes; d) promoting the use of the process approach and risk-based d) 促进使用过程方法和基于风险的思维; thinking; e) 确保获得质量管理体系所需的资源; e) ensuring that the resources needed for the quality management system are available; f) communicating the importance of effective quality management f) 沟通有效的质量管理和符合质量管理体 and of conforming to the quality management system 系要求的重要性; requirements; g) 确保实现质量管理体系的预期结果; g) ensuring that the quality management system achieves its intended results; h) engaging, directing and supporting persons to contribute to the h) 促使、指导和支持员工努力提高质量管理 Page 5 of 39 Version Feb. 1, 2016 AS 9100D/EN9100:2016 Aerospace Quality Standard ISO9001:2015/EN9100:2016 (Draft,Nov.16,2015) Bureau Veritas Certification China 中文译稿 effectiveness of the quality management system; 体系的有效性; i) promoting improvement; i) 推动改进; j) supporting other relevant management roles to demonstrate j) 支持其他管理者履行其相关领域的职责。 their leadership as it applies to their areas of responsibility. NOTE Reference to “business” in this International Standard can be 注:本标准使用的“业务”一词可大致理解为interpreted broadly to mean those activities that are core to the purposes of 涉及组织存在目的的核心活动～无论是公营、the organization’s existence, whether the organization is public, private, for profit or not for profit. 私营、盈利或非盈利组织。 5.1.2 Customer focus 5.1.2 以顾客为关注焦点 Top management shall demonstrate leadership and commitment 最高管理者应证实其以顾客为关注焦点的领with respect to customer focus by ensuring that: 导作用和承诺，通过: a) customer and applicable statutory and regulatory requirements a) 确定、理解并持续满足顾客要求以及适用 are determined, understood and consistently met; 的法律法规要求; b) the risks and opportunities that can affect conformity of products b) 确定和应对能够影响产品和服务的符合and services and the ability to enhance customer satisfaction 性，以及增强顾客满意能力的风险和机are determined and addressed; 遇; c) the focus on enhancing customer satisfaction is maintained; c) 始终致力于增强顾客满意。 d) product and service conformity and on-time delivery d) 产品和服务的符合性和及时交付业绩应performance are measured and appropriate action is taken 得到测量，如果期望的结果不能或将不能if intended results are not, or will not be, achieved. 实现时，应采取适当的措施。 5.2 Policy 5.2 方针 5.2.1 制定质量方针 5.2.1 Developing the quality policy 最高管理者应制定、实施和保持质量方针。质Top management shall establish, implement and maintain a quality 量方针应: policy that: a) 适应组织的宗旨和环境并支持其战略方 a) is appropriate to the purpose and context of the organization 向; and supports its strategic direction; b) 为制定质量目标提供框架; b) provides a framework for setting quality objectives; c) 包括满足适用要求的承诺; c) includes a commitment to satisfy applicable requirements; d) includes a commitment to continual improvement of the quality d) 包括持续改进质量管理体系的承诺。 management system. 5.2.2 沟通质量方针 5.2.2 Communicating the quality policy 质量方针应: The quality policy shall: a) be available and maintained as documented information; a) 作为形成文件的信息，可获得并保持; b) be communicated, understood and applied within the b) 在组织内部得到沟通、理解和应用; organization; c) 适当时，可向有关相关方提供。 c) be available to relevant interested parties, as appropriate. Page 6 of 39 Version Feb. 1, 2016 AS 9100D/EN9100:2016 Aerospace Quality Standard ISO9001:2015/EN9100:2016 (Draft,Nov.16,2015) Bureau Veritas Certification China 中文译稿 5.3 Organizational roles, responsibilities and 5.3 组织的岗位、职责和权限 authorities 最高管理者应确保整个组织内相关的职责、权Top management shall ensure that the responsibilities and 限得到分配、沟通和理解。 authorities for relevant roles are assigned, communicated and understood within the organization. 最高管理者应分配职责和权限，以: Top management shall assign the responsibility and authority for: a) ensuring that the quality management system conforms to the a) 确保质量管理体系符合本标准的要求; requirements of this International Standard; b) 确保各过程获得其预期输出; b) ensuring that the processes are delivering their intended outputs; c) reporting on the performance of the quality management system c) 报告质量管理体系的绩效及改进机会(见and on opportunities for improvement (see 10.1), in particular to 10.1)，特别是向最高管理者报告; top management; d) 确保在整个组织推动以顾客为关注焦点; d) ensuring the promotion of customer focus throughout the organization; e) 确保在策划和实施质量管理体系变更时保e) ensuring that the integrity of the quality management system is 持其完整性。 maintained when changes to the quality management system are planned and implemented. Top management shall appoint a specific member of the 最高管理者应在管理层中任命一个特定人员organization’s management, identified as the management 作为管理者代表，应具有监督上述要求的职责representative, who shall have the responsibility and authority 和授权。 for oversight of the above requirements. The management representative shall have organizational 管理者代表应具有解决有关质量管理问题上freedom and unrestricted access to top management to 的组织自主权和不受限制地可接触到最高管resolve quality management issues. 理层。 NOTE The responsibility of a management representative can 注:管理者代表的职责可包括与质量管理体系include liaison with external parties on matters relating to the quality management system. 有关事宜的外部联络。 6 策划 6 Planning 6.1 应对风险和机遇的措施 6.1 Actions to address risks and opportunities 6.1.1 When planning for the quality management system, the 6.1.1 策划质量管理体系时，组织应考虑4.1 organization shall consider the issues referred to in 4.1 and the 所描述的因素和4.2 所提及的要求，确定需要requirements referred to in 4.2 and determine the risks and 应对的风险和机遇，以便: opportunities that need to be addressed to: a) 确保质量管理体系能够实现其期望结果; a) give assurance that the quality management system can achieve its intended result(s); b) 增强有利影响; b) enhance desirable effects; c) 避免或减少不利影响; c) prevent, or reduce, undesired effects; d) achieve improvement. d) 实现改进。 Page 7 of 39 Version Feb. 1, 2016 AS 9100D/EN9100:2016 Aerospace Quality Standard ISO9001:2015/EN9100:2016 (Draft,Nov.16,2015) Bureau Veritas Certification China 中文译稿 6.1.2 The organization shall plan: 6.1.2 组织应策划: a) 应对这些风险和机遇的措施; a) actions to address these risks and opportunities; b) 如何: b) how to: 1) 在质量管理体系过程中整合并实施这些措1) integrate and implement the actions into its quality management 施(见4.4); system processes (see 4.4); 2) 评价这些措施的有效性。 2) evaluate the effectiveness of these actions. 应对风险和机遇的措施都应与其对于产品和Actions taken to address risks and opportunities shall be proportionate to the potential impact on the conformity of products 服务符合性的潜在影响相适应。 and services. 注1:应对风险可包括规避风险、为寻求机遇NOTE 1 Options to address risks can include avoiding risk, taking risk in 而承担风险、消除风险源、改变风险的可能性order to pursue an opportunity, eliminating the risk source, changing the likelihood or consequences, sharing the risk, or retaining risk by informed 和后果、分担风险、或通过明智决策延缓风险。 decision. 注2:机遇可能会导致采用新实践、推出新产NOTE 2 Opportunities can lead to the adoption of new practices, launching new products, opening new markets, addressing new clients, building 品、开辟新市场、赢得新客户、建立合作伙伴partnerships, using new technology and other desirable and viable 关系、利用新技术以及能够解决组织或其顾客possibilities to address the organization’s or its customers’ needs. 需求的其它有利的可能性。 6.2 Quality objectives and planning to achieve them 6.2 质量目标及其实现的策划 6.2.1 The organization shall establish quality objectives at relevant 6.2.1 组织应对质量管理体系所需的相关职functions, levels and processes needed for the quality management 能、层次、过程设定质量目标。 system. 质量目标应: The quality objectives shall: a) be consistent with the quality policy; a) 与质量方针保持一致; b) be measurable; b) 可测量; c) 考虑到适用的要求; c) take into account applicable requirements; d) be relevant to conformity of products and services and to d) 与提供合格产品和服务以及增强顾客满 enhancement of customer satisfaction; 意相关; e) be monitored; e) 予以监视; f) be communicated; f) 得到沟通; g) be updated as appropriate. g) 适时更新。 The organization shall maintain documented information on the 组织应保留有关质量目标的形成文件的信息。 quality objectives. 6.2.2 策划如何实现质量目标时，组织应确6.2.2 When planning how to achieve its quality objectives, the organization shall determine: 定: a) 采取的措施; a) what will be done; b) 需要的资源; b) what resources will be required; Page 8 of 39 Version Feb. 1, 2016 AS 9100D/EN9100:2016 Aerospace Quality Standard ISO9001:2015/EN9100:2016 (Draft,Nov.16,2015) Bureau Veritas Certification China 中文译稿 c) who will be responsible; c) 由谁负责; d) when it will be completed; d) 何时完成; e) how the results will be evaluated. e) 如何评价结果。 6.3 Planning of changes 6.3 变更的策划 When the organization determines the need for changes to the 当组织确定需要对质量管理体系进行变更时，quality management system, the changes shall be carried out in a 此种变更应经策划并系统地实施(见4.4)。 planned manner (see 4.4). 组织应考虑到: a) 变更的目的及其潜在后果; The organization shall consider: a) the purpose of the changes and their potential consequences; b) 质量管理体系的完整性; b) the integrity of the quality management system; c) 资源的可获得性; c) the availability of resources; d) 职责和权限的分配和再分配。 d) the allocation or reallocation of responsibilities and authorities. 7 支持 7 Support 7.1 资源 7.1 Resources 7.1.1 总则 7.1.1 General The organization shall determine and provide the resources needed 组织应确定并提供为建立、实施、保持和持续for the establishment, implementation, maintenance and continual 改进质量管理体系所需的资源。 improvement of the quality management system. 组织应考虑: The organization shall consider: a) the capabilities of, and constraints on, existing internal a) 现有内部资源的能力和约束; resources; b) 需要从外部供方获得的资源。 b) what needs to be obtained from external providers. 7.1.2 人员 7.1.2 People The organization shall determine and provide the persons 组织应确定并提供所需要的人员，以有效实施necessary for the effective implementation of its quality 质量管理体系并运行和控制其过程。 management system and for the operation and control of its processes. 7.1.3 基础设施 7.1.3 Infrastructure 组织应确定、提供并维护过程运行所需的基础The organization shall determine, provide and maintain the 设施，以获得合格产品和服务。 infrastructure necessary for the operation of its processes and to achieve conformity of products and services. 注:基础设施可包括: NOTE Infrastructure can include: a, 建筑物和相关设施, a) buildings and associated utilities; b, 设备～包括硬件和软件, b) equipment including hardware and software; Page 9 of 39 Version Feb. 1, 2016 AS 9100D/EN9100:2016 Aerospace Quality Standard ISO9001:2015/EN9100:2016 (Draft,Nov.16,2015) Bureau Veritas Certification China 中文译稿 c) transportation resources; c, 运输资源, d) information and communication technology. d,信息和通讯技术。 7.1.4 Environment for the operation of processes 7.1.4 过程运行环境 The organization shall determine, provide and maintain the 组织应确定、提供并维护过程运行所需的环environment necessary for the operation of its processes and to 境，以获得合格产品和服务。 achieve conformity of products and services. NOTE A suitable environment can be a combination of human and physical 注:适当的过程运行的环境可以是人为因素和factors, such as: 物理因素的组合～例如: a) social (e.g. non-discriminatory, calm, non-confrontational); a) 社会因素,如无歧视～和谐稳定～无对抗,, b) psychological (e.g. stress-reducing, burnout prevention, emotionally b) 心理因素,如舒缓心理压力、预防过度疲protective); 劳、保护个人情感,, c) physical (e.g. temperature, heat, humidity, light, airflow, hygiene, c) 物理因素,如温度、热量、湿度、照明、noise). 空气流通、卫生、噪音等,。 These factors can differ substantially depending on the products and services provided. 由于所提供的产品和服务不同～这些因素可能 存在显著差异。 7.1.5 监视和测量资源 7.1.5 Monitoring and measuring resources 7.1.5.1 总则 7.1.5.1 General The organization shall determine and provide the resources needed 当利用监视或测量活动验证产品和服务是否to ensure valid and reliable results when monitoring or measuring is 符合要求时，组织应确定并提供确保结果有效used to verify the conformity of products and services to 和可靠所需的资源。 requirements. The organization shall ensure that the resources provided: 组织应确保所提供的资源: a) are suitable for the specific type of monitoring and measurement a) 适合特定类型的监视和测量活动; activities being undertaken; b) 得到适当的维护，以确保持续适用其用b) are maintained to ensure their continuing fitness for their 途。 purpose. The organization shall retain appropriate documented information 组织应保留作为监视和测量资源适合其用途as evidence of fitness for purpose of the monitoring and 的证据的形成文件的信息。 measurement resources. 7.1.5.2 测量溯源 7.1.5.2 Measurement traceability When measurement traceability is a requirement, or is considered 当要求溯源时，或组织认为测量溯源是信任测by the organization to be an essential part of providing confidence in 量结果有效的前提时，则测量设备应: the validity of measurement results, measuring equipment shall be: a) 对照能溯源到国际或国家标准的测量标a) calibrated or verified, or both, at specified intervals, or prior to 准，按照规定的时间间隔或在使用前进行use, against measurement standards traceable to international or national measurement standards; when no such standards 校准和(或)检定(验证)。当不存在上 exist, the basis used for calibration or verification shall be 述标准时，应保留作为校准或检定(验证)retained as documented information; 依据的形成文件的信息; b) 予以识别，以确定其校准状态; b) identified in order to determine their status; Page 10 of 39 Version Feb. 1, 2016 AS 9100D/EN9100:2016 Aerospace Quality Standard ISO9001:2015/EN9100:2016 (Draft,Nov.16,2015) Bureau Veritas Certification China 中文译稿 c) safeguarded from adjustments, damage or deterioration that c) 予以保护，防止可能使校准状态和随后的would invalidate the calibration status and subsequent 测量结果失效的调整、损坏或劣化。 measurement results. 组织应建立、实施并保持一个需要校准The organization shall establish, implement and maintain a 或检定时对监视和测量设备进行召回的process for the recall of monitoring and measuring equipment requiring calibration or verification. 过程。 The organization shall maintain a register of the monitoring 组织必须保持一份监视和测量设备的清and measuring equipment. The register shall include the 单。清单应包括设备型号、唯一性标识、equipment type, unique identification, location, and the 位置、校准和检定方法、检查频率和接calibration or verification method, frequency, and acceptance 收准则。 criteria. 注:监视和测量设备包括但不限于:试验NOTE Monitoring and measuring equipment can include, but are not 硬件、试验软件、自动试验设备(ATE)limited to: test hardware, test software, automated test equipment 和用于生成检验数据的绘图仪，也包括用(ATE) and plotters used to produce verification data. It also includes 于提供产品符合证据的个人拥有的和顾personally owned and customer supplied equipment used to provide evidence of product and service conformity. 客提供的设备。 Calibration or verification of monitoring and measuring 监视和测量设备的校准或检定应在适宜equipment shall be carried out under suitable environmental 环境条件下实施。 conditions (see 7.1.4). 当发现测量设备不适合其预期用途时，组织应The organization shall determine if the validity of previous 确定以往测量结果的有效性是否受到不利影measurement results has been adversely affected when measuring 响，必要时采取适当的措施。 equipment is found to be unfit for its intended purpose, and shall take appropriate action as necessary. 7.1.6 组织的知识 7.1.6 Organizational knowledge 组织应确定运行过程所需的知识，以获得合格The organization shall determine the knowledge necessary for the 产品和服务。 operation of its processes and to achieve conformity of products and services. 这些知识应予以保持，并在需要范围内可得This knowledge shall be maintained and be made available to the 到。 extent necessary. 为应对不断变化的需求和发展趋势，组织应考When addressing changing needs and trends, the organization shall 虑现有的知识，确定如何获得更多必需的知consider its current knowledge and determine how to acquire or 识，并进行更新。 access any necessary additional knowledge and required updates. 注1:组织的知识是从经验中获得的特定知识～NOTE 1 Organizational knowledge is knowledge specific to the 是实现组织目标所使用的共享信息。 organization; it is gained by experience. It is information that is used and shared to achieve the organization’s objectives. 注2:组织的知识可以基于: NOTE 2 Organizational knowledge can be based on: a) 内部来源,例如知识产权、从经历获得的a) internal sources (e.g. intellectual property; knowledge gained from 知识、从失败和成功项目得到的经验教experience; lessons learned from failures and successful projects; capturing and sharing undocumented knowledge and experience; the 训,得到和分享未形成文件的知识和经 results of improvements in processes, products and services); 验～过程、产品和服务的改进结果,, b) 外部来源,例如标准、学术交流、专业会b) external sources (e.g. standards; academia; conferences; gathering knowledge from customers or external providers). 议～从顾客或外部供方收集的知识,。 7.2 能力 7.2 Competence 组织应: The organization shall: Page 11 of 39 Version Feb. 1, 2016 AS 9100D/EN9100:2016 Aerospace Quality Standard ISO9001:2015/EN9100:2016 (Draft,Nov.16,2015) Bureau Veritas Certification China 中文译稿 a) determine the necessary competence of person(s) doing work a) 确定其控制范围内的人员所需具备的能under its control that affects the performance and effectiveness 力，这些人员从事的工作影响质量管理体of the quality management system; 系绩效和有效性; b) 基于适当的教育、培训或经验，确保这些b) ensure that these persons are competent on the basis of 人员具备所需的能力; appropriate education, training, or experience; c) where applicable, take actions to acquire the necessary c) 适用时，采取措施获得所需的能力，并评competence, and evaluate the effectiveness of the actions 价措施的有效性; taken; d) 保留适当的形成文件的信息，作为人员能 力的证据。 d) retain appropriate documented information as evidence of competence. 注: 定期评审必需的能力应当予以考虑。 NOTE Consideration should be given for the periodic review of the necessary competency. 注:适当的措施可包括对在职人员进行培训、 NOTE Applicable actions can include, for example, the provision of training 辅导或重新分配任务～或者招聘具备能力的人to, the mentoring of, or the re-assignment of currently employed persons; or 员等。 the hiring or contracting of competent persons. 7.3 意识 7.3 Awareness 组织应确保其控制范围内的相关工作人员知The organization shall ensure that persons doing work under the organization’s control are aware of: 晓: a) 质量方针; a) the quality policy; b) 相关的质量目标; b) relevant quality objectives; c) their contribution to the effectiveness of the quality management c) 他们对质量管理体系有效性的贡献，包括 system, including the benefits of improved performance; 改进质量绩效的益处; d) the implications of not conforming with the quality management d) 偏离质量管理体系要求的后果; system requirements; e) 相关的质量管理体系文件的信息以及其e) relevant quality management system documented information and changes thereto; 更改; 他们对产品或服务符合性的贡献; f)f) their contribution to product or service conformity; 他们对产品安全的贡献; g)g) their contribution to product safety; h) the importance of ethical behavior. 道德行为的重要性。 h) 7.4 Communication 7.4 沟通 The organization shall determine the internal and external 组织应确定与质量管理相关的内部和外部沟communications relevant to the quality management system, 通的需求，包括: including: a) on what it will communicate; a) 沟通什么; b) when to communicate; b) 沟通时机; c) with whom to communicate; c) 与谁沟通; d) 如何沟通; d) how to communicate; Page 12 of 39 Version Feb. 1, 2016 AS 9100D/EN9100:2016 Aerospace Quality Standard ISO9001:2015/EN9100:2016 (Draft,Nov.16,2015) Bureau Veritas Certification China 中文译稿 e) who communicates. e) 由谁负责。 注: 交流应包括质量管理体系的内部和外部NOTE Communication should include internal and external feedback relevant to the quality management system. 反馈。 7.5 Documented information 7.5 形成文件的信息 7.5.1 General 7.5.1 总则 The organization’s quality management system shall include 组织的质量管理体系应包括: a) documented information required by this International Standard; a) 本标准要求形成文件的信息; b) documented information determined by the organization as b) 组织确定的为确保质量管理体系有效性being necessary for the effectiveness of the quality 所需的形成文件的信息。 management system. NOTE The extent of documented information for a quality management 注:对于不同组织～质量管理体系形成文件的system can differ from one organization to another due to: 信息的多少与详略成度可以不同～取决于: - 组织的规模、以及活动、过程、产品和服务— the size of organization and its type of activities, processes, products and services; 的类型, — the complexity of processes and their interactions; - 过程的复杂成度及其相互作用, — the competence of persons. - 人员的能力。 7.5.2 Creating and updating 7.5.2 创建与更新 When creating and updating documented information the 在创建与更新形成文件的信息时，组织应确保organization shall ensure appropriate: 适当的: a) identification and description (e.g. a title, date, author, or a) 标识和说明(如:标题、日期、作者、索reference number); 引编号等); b) 格式(如:语言、软件版本、图示)和媒b) format (e.g. language, software version, graphics) and media 介(如:纸质、电子格式); (e.g. paper, electronic); c) 评审和批准，以确保适宜性和充分性。 c) review and approval for suitability and adequacy. 注:批准意味着针对不同类型文件的信NOTE Approval implies authorized persons and approval methods are 息应按组织确定要求识别相应授权人员identified for the relevant types of documented information, as 和批准方法。 determined by the organization. 7.5.3 形成文件的信息的控制 7.5.3 Control of documented Information 7.5.3.1 Documented information required by the quality 7.5.3.1 组织应控制质量管理体系和本标准management system and by this International Standard shall be 所要求的形成文件的信息，以确保: controlled to ensure: a) 无论何时何处需要这些信息，均可获得并a) it is available and suitable for use, where and when it is needed; 适用; b) it is adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity). b) 予以妥善保护(如防止泄密、不当使用或 不完整)。 Page 13 of 39 Version Feb. 1, 2016 AS 9100D/EN9100:2016 Aerospace Quality Standard ISO9001:2015/EN9100:2016 (Draft,Nov.16,2015) Bureau Veritas Certification China 中文译稿 7.5.3.2 For the control of documented information, the organization 7.5.3.2 为控制形成文件的信息，适用时，组shall address the following activities, as applicable: 织应关注下列活动: a) 分发、访问、检索和使用; a) distribution, access, retrieval and use; b) 存储和保护，包括保持可读性; b) storage and preservation, including preservation of legibility; c) control of changes (e.g. version control); c) 变更的控制(比如版本控制); d) retention and disposition; d) 保留和处置。 e) prevention of the unintended use of obsolete documented e) 当出于任何目的需要保留过时文件时，需information by removal or by application of suitable identification or controls if kept for any purpose. 要通过移除或运用适当地标识，防止非预 期的使用无效的文件的信息。 Documented information of external origin determined by the 对确定策划和运行质量管理体系所需的来自organization to be necessary for the planning and operation of the 外部的原始的形成文件的信息，组织应进行适quality management system shall be identified as appropriate, and 当识别和控制。 be controlled. Documented information retained as evidence of conformity shall be 应对所保存的作为符合性证据的形成文件的protected from unintended alterations. 信息予以保护，防止非预期的更改。 When documented information is managed electronically, data 当文件的信息是电子化管理时，数据保护过程protection processes shall be defined (e.g., protection from loss, unauthorized changes, unintended alteration, corruption, 应规定(如防止丢失，非授权更改，无意识的physical damage). 修订，损坏，物理性破坏)。 NOTE Access can imply a decision regarding the permission to view the 注:形成文件的信息的“访问”可能意味着仅documented information only, or the permission and authority to view and change the documented information. 允许查阅、或者意味着允许查阅并授权修改。 8 Operation 8 运行 8.1 运行策划和控制 8.1 Operational planning and control The organization shall plan, implement and control the processes 组织应通过采取下列措施，策划、实施和控制(see 4.4) needed to meet the requirements for the provision of 满足产品和服务要求所需的过程(见4.4)，products and services, and to implement the actions determined in 并实施第6章所确定的措施: Clause 6, by: a) 确定产品和服务的要求; a) determining the requirements for the products and services; NOTE Determination of requirements for the products and services 注: 确定产品和服务的要求应考虑下述方面: can include consideration of: -人员和产品的安全; , - personal and product safety; -, producibility and inspectability; -可生产性和可检验性; , - reliability, availability and maintainability; -可靠性、可用性和可维护性; -使用在产品中的零件和材料的适宜性; , - suitability of parts and materials used in the product; , - selection and development of embedded software; -嵌入式软件的选择和开发; , - product obsolescence; -产品的报废; Page 14 of 39 Version Feb. 1, 2016 AS 9100D/EN9100:2016 Aerospace Quality Standard ISO9001:2015/EN9100:2016 (Draft,Nov.16,2015) Bureau Veritas Certification China 中文译稿 , - prevention, detection, and removal of foreign objects; -预防，探测和移除外来物; -处理，包装和防护; , - handling, packaging and preservation; , - recycling or final disposal of the product at the end of its life. -产品在寿命结束时的回收和最终处理。 b) establishing criteria for: b) 建立以下内容的准则: 1) the processes; 1) 过程; 2) 产品和服务的接收; 2) the acceptance of products and services; NOTE According to the nature of the product and depending on the 注:根据产品特性并取决于指定条件，统计技术specified requirements, statistical techniques can be used to support: 可以用于支持: ,设计验证(如:可靠性、可维修性、产品安全); , - design verification (e.g., reliability, maintainability, product safety); -, process control; ,过程控制: , 关键特性的选择和验证; , selection and verification of key characteristics; , 过程能力测量; , process capability measurements; , 统计过程控制; , statistical process control; , design of experiment; , 实验设计; , - verification; ,验证,和 , - failure mode, effect and criticality analysis. ,失效模式、影响和危害性分析。 c) determining the resources needed to achieve conformity to the product and service requirements and to meet on-time c) 确定符合产品和服务要求以及满足产品 delivery of products and services; 所需的资源; 和服务的准时交付 d) implementing control of the processes in accordance with the d) 按照准则实施过程控制; criteria; e) determining and keeping documented information to the extent e) 在需要的范围和程度上，确定并保持和保 necessary: 留形成文件的信息: 1) to have confidence that the processes have been carried out as 1) 证实过程已经按策划进行; planned; 2) 证明产品和服务符合要求。 2) to demonstrate the conformity of products and services to their requirements; f) 确定管理关键项目所需的过程和控f) determining the processes and controls needed to manage 制，包括当关键特性已经识别时的生critical items, including production process controls when 产过程控制; key characteristics have been identified; 受影响的组织职能代表参与运行策划和控g)g) engaging representatives of affected organization functions for operational planning and control; 制; h) determining the process and resources to support the use 确定支持产品和服务的使用和维护的过程h)and maintenance of the products and services; 和资源; i) determining the products and services to be obtained from 确定产品和服务能从外部供方处获取; i)external providers; j) establishing the controls needed to prevent the delivery of Page 15 of 39 Version Feb. 1, 2016 AS 9100D/EN9100:2016 Aerospace Quality Standard ISO9001:2015/EN9100:2016 (Draft,Nov.16,2015) Bureau Veritas Certification China 中文译稿 nonconforming products and services to the customer. j) 建立所需的控制防止交付给顾客不合格的 产品和服务。 NOTE One method to achieve operation planning and control can be through using integrated phased processes. 注: 一种可以取得运行策划和控制的方 法是通过使用整合阶段过程。 As appropriate to the organization, customer requirements, and products and services, the organization shall plan and manage product and service provision in a structured and 适用时，根据组织，顾客要求，产品和controlled manner including scheduled events performed in a 服务情况，组织应以一种结构化和受控planned sequence to meet requirements at acceptable risk, 的方式去策划和管理产品和服务的提with resource and schedule constraints. 供，包括在有资源和时间约束情况下, 预定事件按策划次序执行，并在可接受NOTE This activity is generally referred to as project planning, 的风险内满足要求。 project management, or program management. 注:这些活动通常称为项目策划，项目管The output of this planning shall be suitable for the organization's 理或计划管理。 operations. 策划的输出应适合组织的运行需要。 NOTE As an output of this planning, documented information specifying the processes of the quality management system and the resources to be applied to a specific product, project 注:作为策划的输出，对具体产品，项目or contract can be referred to as a quality plan. 或用形成文件的信息规定质量管理 系统和资源的过程，称为质量计划。 The organization shall control planned changes and review the consequences of unintended changes, taking action to mitigate 组织应控制策划的更改，评审非预期变更的结adverse effects, as necessary. 果，必要时，采取措施消除不利影响。 The organization shall ensure that outsourced processes are controlled (see 8.4). 组织应确保外包过程得到控制(见8.4)。 The organization shall establish, implement and maintain a 组织应建立、实施和保持一个策划和控process to plan and control the temporary or permanent 制临时性或永久性工作转移的过程,以transfer of work, to ensure the continuing conformity of the 保证持续地符合工作的要求。这个过程work to requirements. The process shall ensure that work 应保证工作转移时的影响和风险是在管transfer impacts and risks are managed. 理。 NOTE For the control of work transfer from the organization to 注:对于控制工作转移从组织到外部供an external provider, or from an external provider to another 方，或从一个外部供方转移到另一个外部external provider, see 8.4. For the control of work transfer from 供方，见8.4。对于从组织的一处设施转one organization facility to another, or from an external 移到另一处，或从外部供方转移到组织，provider to the organization, see 8.5. 见8.5. 8.1.1 Operation risk management 8.1.1 运行风险管理 The organization shall plan, implement and control a process 组织应建立、实施和控制运行风险的过for managing operation risks to the achievement of applicable requirements, which includes as appropriate to the 程管理，以实现适用的要求，适当时包organization and the products and services: 括针对组织，产品和服务的要求如下: a) assignment of responsibilities for risk management; 风险管理的职责分配; a) b) definition of risk assessment criteria (e.g., likelihood, 风险评估准则的确定(如:可能性、b)consequences, risk acceptance); 后果,风险接受程度); c) identification, assessment and communication of risks 在运行过程中对风险的识别、评估c)throughout operations; 和交流; d) identification, implementation and management of actions Page 16 of 39 Version Feb. 1, 2016 AS 9100D/EN9100:2016 Aerospace Quality Standard ISO9001:2015/EN9100:2016 (Draft,Nov.16,2015) Bureau Veritas Certification China 中文译稿 to mitigate risks that exceed the defined risk acceptance d) 对于超过确定的风险接受准则时， criteria; 减轻风险的措施的识别、实施和管 理; e) acceptance of risks remaining after implementation of mitigating actions. 减轻风险措施实施后,风险保持在e) 可接受水平上。 NOTE 1 While clause 6.1 addresses the risks and opportunities when planning for the quality management system of the 注1:条款6.1阐明了在策划组织质量管organization, the scope of this clause (8.1.1) is limited to the 理体系时的风险和机遇，条款8.1.1的范risks associated to the operation of products and services 围局限在和产品和服务运行有关的风险(clause 8). 上。 NOTE 2 Within aviation, space and defense, risk is generally expressed in terms of the likelihood of occurrence and the 注2:在航空，航天和防务领域，风险通severity of the consequences. 常依据发生的可能性和后果的严重度进 行表述。 8.1.2 Configuration management 8.1.2 技术状态管理 The organization shall plan, implement and control a process for configuration management as appropriate to the 组织应建立、实施和控制适用于组织，organization and product and services in order to ensure the 产品和服务的技术状态管理过程，目的identification and control of physical and functional attributes 是保证在产品生命周期内物理和功能属throughout the product lifecycle. This process shall: 性的识别和控制。过程应包括: a) control product identity and traceability to requirements, a)与产品标识和追溯要求的控制，包括including the implementation of identified changes; 识别的更改执行情况; b) ensure that the documented information (e.g., requirements, b) 保证文件的信息(如与要求，设计，design, verification, validation and acceptance documentation) is consistent with the actual attributes of the products and 验证，确认和接收有关的文件)是和实际services. 产品和服务的属性相一致; 8.1.3 Product safety 8.1.3产品安全 The organization shall plan, implement and control the 适用于组织和产品时，组织应策划，实processes needed to assure product safety during the entire product life cycle, as appropriate to the organization and the 施和控制在产品整个寿命周期内保证产product. 品安全所需的过程。 NOTE Examples of these processes include: 注: 这些过程例如包括有: , - assessment of hazards and management of associated risks (see 8.1.1); - 危害评估和相关风险管理(见 8.1.1); , - management of safety critical items; -安全关键项目的管理; , - analysis and reporting of occurred events affecting safety; -分析和报告已发生影响安全的事件; ,- communication of these events and training of persons. 8.1.4 Prevention of counterfeit product -交流安全事件并培训人员。 8.1.4 预防假冒件 The organization shall plan, implement and control a process, appropriate to the product, for the prevention of counterfeit or 适用于组织和产品时,组织必须策划，实suspect counterfeit product use and their inclusion in 施和控制预防使用到假冒件或者怀疑的product(s) delivered to the customer. 假冒件，和包含在产品中交付给客户的 过程。 NOTE Counterfeit product prevention processes should consider: 注: 假冒件预防过程应当考虑: Page 17 of 39 Version Feb. 1, 2016 AS 9100D/EN9100:2016 Aerospace Quality Standard ISO9001:2015/EN9100:2016 (Draft,Nov.16,2015) Bureau Veritas Certification China 中文译稿 , -training of appropriate persons in the awareness and prevention of counterfeit product; -对相关人员进行假冒件的意识和预防 培训; -, application of a parts obsolescence monitoring program; -零件报废监控程序的应用; -control for acquiring externally provided product form original manufacturers, authorized distributors, or other -从原始厂家，授权分销商，或者其他批approved sources. 准来源获得部件的控制; - requirements for assuring traceability of parts and -要求保证追溯零部件到它们的原始授components to their original authorized manufacturers; 权厂家; -, verification and test methodologies to detect counterfeit product; -验证和测试方法来发现假冒件; , -monitoring of counterfeit product reporting from external sources; -监控外部对假冒件的报告; , -quarantine and reporting of suspect or detected counterfeit product. -隔离和报告怀疑的或者发现的假冒件。 8.2 Requirements for products and services 8.2 产品和服务的要求 8.2.1 Customer communication 8.2.1 顾客沟通 Communication with customers shall include: 与顾客沟通的内容应包括: a) 提供有关产品和服务的信息; a) providing information relating to products and services; b) 处理问询、合同或订单，包括变更; b) handling enquiries, contracts or orders, including changes; c) obtaining customer feedback relating to products and services, c) 获得有关产品和服务的顾客反馈，包括顾including customer complaints; 客抱怨; d) 处置和控制顾客财产; d) handling or controlling customer property; e) establishing specific requirements for contingency actions, e) 关系重大时，制定有关应急措施的特定要 when relevant. 求。 8.2.2 Determining the requirements related to products and 8.2.2 与产品和服务的要求的确定 services When determining the requirements for the products and services to 在确定向顾客提供的产品和服务要求时，组织be offered to customers, the organization shall ensure that: 应确保: a) the requirements for the products and services are defined, a) 产品和服务的要求得到规定，包括: including: 1) 适用的法律法规要求; 1) any applicable statutory and regulatory requirements; 2) those considered necessary by the organization; 2) 组织认为的必要要求; b) the organization can meet the claims for the products and b) 对其所提供产品和服务的要求，能够满足services it offers; 组织声称的要求。 c) special requirements of the products and services are determined; c) 产品和服务的特殊要求得到确定; d) operation risks (e.g., new technology, ability and capacity Page 18 of 39 Version Feb. 1, 2016 AS 9100D/EN9100:2016 Aerospace Quality Standard ISO9001:2015/EN9100:2016 (Draft,Nov.16,2015) Bureau Veritas Certification China 中文译稿 to provide, short delivery time frame) have been identified. d) 运行风险(如新的技术,提供的能力和产 能,短的交付期)已经识别。 8.2.3 Review of requirements related to products and services 8.2.3 与产品和服务的要求的评审 8.2.3.1 The organization shall ensure that it has the ability to meet the requirements for products and services to be offered to 8.2.3.1 组织应确保其有能力满足向顾客提customers. The organization shall conduct a review before 供的产品和服务的要求。在承诺向顾客提供产committing to supply products and services to the customer, to 品和服务之前，组织应对以下各项要求进行评include: 审: a) requirements specified by the customer, including the a) 顾客规定的要求，包括对交付及交付后活requirements for delivery and post-delivery activities; 动的要求; b) requirements not stated by the customer, but necessary for the b) 顾客虽然没有明示，但规定的用途或已知specified or intended use, when known; 的预期用途所必需的要求; c) requirements specified by the organization; c) 组织规定的要求; d) statutory and regulatory requirements applicable to the products and services; e) 适用产品和服务的法律法规要求; e) contract or order requirements differing from those previously f) 与先前表述存在差异的合同或订单的要expressed. 求; This review shall be coordinated with applicable functions of the organization. 评审应和组织的相关职能进行协调。 If upon review the organization determines that some 如果依据组织的评审确定顾客的要求不能满customer requirements cannot be met or can only partially be 足或者部分不能满足，组织应与顾客商讨一致met, the organization shall negotiate a mutually acceptable requirement with the customer. 相互可接受的要求。 The organization shall ensure that contract or order requirements 若与先前合同或订单的要求存在差异，组织应differing from those previously defined are resolved. 确保有关事项已得到解决。 The customer requirements shall be confirmed by the organization 若顾客没有提供形成文件的要求，组织在接受before acceptance, when the customer does not provide a 顾客要求前应对顾客要求进行确认。 documented statement of their requirements. NOTE In some situations, such as internet sales, a formal review is 注:在某些情况下～如网上销售～对每一个订impractical for each order. Instead, the review can cover relevant product 单进行正式的评审可能是不实际的～作为替代information, such as catalogues or advertising material. 方法～对有关的产品信息～如产品目录进行评 审。 8.2.3.2 The organization shall retain documented information, as 8.2.3.2 适用时，组织应保留下列形成文件的applicable: 信息: a) on the results of the review; a) 评审结果; b) on any new requirements for the products and services. b) 针对产品和服务的新要求。 8.2.4 Changes to requirements for products and services 8.2.4 产品和服务要求的更改 The organization shall ensure that relevant documented information is amended, and that relevant persons are made aware of the 若产品和服务的要求发生变更，组织应确保相changed requirements, when the requirements for products and 关形成文件的信息得到修改，并确保相关人员services are changed. Page 19 of 39 Version Feb. 1, 2016 AS 9100D/EN9100:2016 Aerospace Quality Standard ISO9001:2015/EN9100:2016 (Draft,Nov.16,2015) Bureau Veritas Certification China 中文译稿 知道已更改的要求。 8.3 Design and development of products and services 8.3 产品和服务的设计和开发 8.3.1 General 8.3.1 总则 The organization shall establish, implement and maintain a design 组织应建立、实施和保持设计和开发过程，以and development process that is appropriate to ensure the subsequent provision of products and services. 确保后续的产品和服务的提供。 8.3.2 Design and development planning 8.3.2 设计和开发策划 In determining the stages and controls for design and development, 在确定设计和开发的各个阶段及其控制时，组the organization shall consider: 织应考虑: a) the nature, duration and complexity of the design and a) 设计和开发活动的性质、持续时间和复杂development activities; 程度; b) the required process stages, including applicable design and b) 所要求的过程阶段，包括适用的设计和开development reviews; 发评审; c) the required design and development verification and validation c) 所要求的设计和开发验证和确认活动; activities; d) the responsibilities and authorities involved in the design and d) 设计和开发过程涉及的职责与权限; development process; e) 产品和服务的设计和开发所需的内部和e) the internal and external resource needs for the design and 外部资源; development of products and services; f) the need to control interfaces between persons involved in the f) 设计和开发过程参与人员之间接口的控design and development process; 制需求; g) the need for involvement of customers and users in the design g) 顾客和使用者参与设计和开发过程中的and development process; 需求; h) the requirements for subsequent provision of products and services; h) 后续产品和服务提供的要求; i) the level of control expected for the design and development i) 顾客和其他相关方期望的设计和开发过process by customers and other relevant interested parties; 程的控制水平; j) the documented information needed to demonstrate that design and development requirements have been met. j) 证实已经满足设计和开发要求所需的形 成文件的信息。 When appropriate, the organization shall divide the design and development effort into distinct activities and, for each activity, 在适用时，组织应将设计和开发工作分解为清define the tasks, necessary resources, responsibilities, design 楚的活动，并对每项活动，确定任务、必需的content, and inputs and outputs. 资源、职责、设计内容、输入和输出。 Design and development planning shall consider the ability to provide, verify, test and maintain the product and service 设计和开发策划应考虑供应，验证，测试和维(reference output of 8.1 a). 修产品和服务的能力(见8.1a的输出)。 8.3.3 Design and development inputs 8.3.3 设计和开发输入 The organization shall determine the requirements essential for the specific types of products and services to be designed and 组织应针对具体类型产品和服务，确定设计和developed. The organization shall consider: 开发的基本要求。组织应考虑: Page 20 of 39 Version Feb. 1, 2016 AS 9100D/EN9100:2016 Aerospace Quality Standard ISO9001:2015/EN9100:2016 (Draft,Nov.16,2015) Bureau Veritas Certification China 中文译稿 a) functional and performance requirements (see 8.1 a); a) 功能和性能的要求; b) information derived from previous similar design and b) 来源于以前类似设计和开发活动的信息; development activities; c) 法律法规要求; c) statutory and regulatory requirements; d) standards or codes of practice that the organization has d) 组织承诺实施的标准或行业规范; committed to implement; e) 由产品和服务性质所决定的，失效的潜在e) potential consequences of failure due to the nature of the 后果。 products and services; f) when applicable, the potential consequences of f) 适用时，性能衰退的潜在后果(如材料，obsolescence (e.g., materials, processes, components, 过程，部件，设备和产品)。 equipment, products). 设计和开发输入应完整、清楚，满足设计和开Inputs shall be adequate for design and development purposes, 发的目的。 complete and unambiguous. Conflicting design and development inputs shall be resolved. 应解决相互冲突的设计和开发输入。 The organization shall retain documented information on design and 组织应保留有关设计和开发输入的形成文件development inputs. 的信息。 NOTE The organization can also consider as design and development inputs other information such as benchmarking, 注:组织也可考虑其它信息如标杆管理，外部external provider feedback, internally generated data and 供方反馈，内部产生数据和服务中数据作为设in-service data. 计和开发的输入。 8.3.4 Design and development controls 8.3.4 设计和开发控制 The organization shall apply controls to the design and development process to ensure that: 组织应对设计和开发过程进行控制，以确保: a) the results to be achieved are defined; a) 规定拟获得的结果; b) reviews are conducted to evaluate the ability of the results of design and development to meet requirements; b) 实施评审活动，以评价设计和开发的结果 满足要求的能力; c) verification activities are conducted to ensure that the design c) 实施验证活动，以确保设计和开发输出满and development outputs meet the input requirements; 足输入的要求; d) validation activities are conducted to ensure that the resulting d) 实施确认活动，以确保产品和服务能够满products and services meet the requirements for the specified application or intended use; 足规定的使用要求或预期用途要求; e) any necessary actions are taken on problems determined e) 针对评审、验证和确认过程中确定的问题during the reviews, or verification and validation activities; 采取必要的措施; f) 保留这些活动的形成文件的信息。 f) documented information of these activities is retained; g) when outputs are not met, they are identified and g) 当输出不能满足时，应被识别并确定必要necessary actions are defined; 措施; h) progression to the next stage is authorized. 进展到下一阶段应被授权批准。 h) Participants in design and development reviews shall include representatives of functions concerned with the design and 设计和开发评审的参与者应包括与评审的设 Page 21 of 39 Version Feb. 1, 2016 AS 9100D/EN9100:2016 Aerospace Quality Standard ISO9001:2015/EN9100:2016 (Draft,Nov.16,2015) Bureau Veritas Certification China 中文译稿 development stage(s) being reviewed. 计和开发阶段有关的职能代表。 NOTE Design and development reviews, verification and validation have 注:设计和开发的评审、验证和确认具有不同distinct purposes. They can be conducted separately or in any combination, as is suitable for the products and services of the organization. 的目的。根据组织的产品和服务的具体情况～ 可以单独或以任意组合进行。 8.3.4.1 When tests are necessary for verification and validation, these tests shall be planned, controlled, reviewed 8.3.4.1当试验对验证和确认是必要时，应对and documented to ensure and prove the following: 这些试验进行策划、控制、评审并形成文件， 以确保证明下列要求: a) test plans or specifications identify the test item being tested and the resources being used, define test objectives a.试验计划或规范确定了要进行试验的项目and conditions, parameters to be recorded and relevant acceptance criteria; 和需要使用的资源;规定了试验目的和条 件、要的参数以及相关接收准则; b) test procedures describe the test methods to be used, how b.试验程序描述了使用的测试方法、如何进行to perform the test, and how to record of the results; 试验，和如何记录结果; c) the correct configuration of the test item is submitted for the test; c.提交试验项目正确的技术状态; d) the requirements of the test plan and the test procedures are observed; d. 遵守了试验计划和试验程序的要求; e) the acceptance criteria are met. e. 满足了接收准则。 Monitoring and measuring devices used for testing shall be 试验中使用的监视和测量设备应按条款7.1.5controlled as defined in clause 7.1.5. 控制. At the completion of design and development, the organization shall ensure that reports, calculations, test results, etc., are able to demonstrate that the product definition meets the 在设计和开发完成时，组织应确保报告、 specification requirements for all identified operational 计算、试验结果等能展示在所有规定的运行条conditions. 件下，产品定义满足规范要求。 8.3.5 设计和开发输出 8.3.5 Design and development outputs The organization shall ensure that design and development outputs: 组织应确保设计和开发输出: a) 满足输入的要求; a) meet the input requirements; b) 对于产品和服务提供的后续过程是充分b) are adequate for the subsequent processes for the provision of 的; products and services; c) include or reference monitoring and measuring requirements, c) 包含或引用监视和测量的要求，适当时，as appropriate, and acceptance criteria; 包括接收准则; d) specify the characteristics of products and services that are d) 规定对于实现预期目的、保证安全和正确essential for their intended purpose and their safe and proper 提供(使用)所必须的产品和服务特性。 provision; e) specify, as applicable, any critical items, including any key e) 适用时，规定任何关键项目包括任何关键 characteristics, and specific actions to be taken for these 特性，以及对这些项目要采取的特殊措items; 施。 f) are approved prior to release. 放行前得到批准。 f) The organization shall define the data required to allow the 组织应确定对产品进行标识、制造、验证、使product to be identified, manufactured, verified, used and Page 22 of 39 Version Feb. 1, 2016 AS 9100D/EN9100:2016 Aerospace Quality Standard ISO9001:2015/EN9100:2016 (Draft,Nov.16,2015) Bureau Veritas Certification China 中文译稿 maintained. 用和维修所需要的数据。 NOTE Data can include: 注: 数据可包括: -, the drawings, part lists and specifications necessary to define the configuration and the design features of the product; -确定产品的技术状态和设计特性的图纸，零 件清单和规范; -,the material, process, manufacturing, assembly, handling, packaging and preservation data needed to provide and -提供和维护产品和服务符合性需要的材料、maintain a conforming product or service; 过程、制造和装配，处理，包装和防护的数据。 , -the technical data and repair schemes for operating and maintaining the product. -运行和维护产品的技术数据和修理。 The organization shall retain documented information on design and 组织应保留有关设计和开发输出的形成文件development outputs. 的信息。 8.3.6 Design and development changes 8.3.6 设计和开发变更 The organization shall identify, review and control changes made during, or subsequent to, the design and development of products 组织应识别、评审和控制在产品和服务设计和and services, to the extent necessary to ensure that there is no 开发期间以及后续所做的变更，以避免不利影adverse impact on conformity to requirements. 响，确保符合要求。 The organization shall implement a process and criteria for notifying its customer, prior to implementation, about changes 组织应履行过程和准则保证在更改实施前，通that affect customer requirements. 知顾客影响到顾客要求的任何更改。 The organization shall retain documented information on: 组织应保留下列形成文件的信息: a) design and development changes; a) 设计和开发变更; b) 评审的结果; b) the results of reviews; c) the authorization of the changes; c) 变更的授权; d) the actions taken to prevent adverse impacts. d) 为防止不利影响所采取的措施。 Design and development changes shall be controlled in accordance with the configuration management process. 设计和开发的更改应按技术状态管理的过程 控制。 8.4 Control of externally provided processes, products and services 8.4 外部提供过程、产品和服务的控制 8.4.1 General 8.4.1 总则 The organization shall ensure that externally provided processes, 组织应确保外部提供的过程、产品和服务符合products, and services conform to requirements. 要求。 The organization shall be responsible for the conformity of all externally provided processes, products and services, 组织必须对所有从外部提供的过程，产品和服including from sources defined by the customer. 务的符合性负责，包括顾客指定的来源。 The organization shall ensure, when required, that 当要求时，组织应确保使用顾客指定或批准的customer-designated or approved external providers, including process sources (e.g., special processes), are used. 外部供方，包括过程来源(如特殊过程); The organization shall identify and manage the risks 组织应识别和管理与外部提供的过程，产品和associated to the external provision of processes, products Page 23 of 39 Version Feb. 1, 2016 AS 9100D/EN9100:2016 Aerospace Quality Standard ISO9001:2015/EN9100:2016 (Draft,Nov.16,2015) Bureau Veritas Certification China 中文译稿 and services, as well as the selection and use of external 服务，以及在挑选和使用外部供方时面对的相providers (e.g., direct and sub-tier external providers and 关风险(如直接和次级的外部供方，和顾客识sources identified by the customer). 别的来源)。 The organization shall require their external providers to apply appropriate controls to their sub-tier providers, to ensure that 组织应要求外部供方对他们的次级供方进行requirements are met. 适当的控制，以保证满足要求。 The organization shall determine the controls to be applied to 在下列情况下，组织应确定对外部提供的过externally provided processes, products and services when: 程、产品和服务实施的控制: a) products and services from external providers are intended for a) 外部供方的过程、产品和服务构成组织自incorporation into the organization’s own products and services; 身的产品和服务的一部分; b) products and services are provided directly to the customer(s) by external providers on behalf of the organization; b) 外部供方代替组织直接将产品和服务提 供给顾客; c) a process, or part of a process, is provided by an external c) 组织决定由外部供方提供过程或部分过provider as a result of a decision by the organization. 程。 The organization shall determine and apply criteria for the evaluation, selection, monitoring of performance, and re-evaluation 组织应基于外部供方提供所要求的过程、产品of external providers, based on their ability to provide processes or 和服务的能力，确定外部供方的评价、选择、products and services in accordance with requirements. The 绩效监视以及再评价的准则，并加以实施。对organization shall retain documented information of these activities 于这些活动和由评价引发的任何必要的措施，and any necessary actions arising from the evaluations. 组织应保留所需的形成文件的信息。 NOTE During external provider selection and evaluation, the organization can use quality data from objective and reliable 注:在选择和评价外部供方时，可使用external sources, as evaluated by the organization (e.g., 来自客观和可靠外部提供的质量数据作information from accredited quality management system or 为组织自己的评估(例如:信息来自授process certification bodies, external provider approvals from 信的质量管理体系或过程认证机构,政government authorities). Use of such data would be only one 府机构对外部供方的批准)。使用这种数element of an organization’s external provider control process 据只能是组织对外部供方控制过程的一and the organization remains responsible for verifying that 个组成部分，组织仍然有验证采购的产externally provided processes, products and services meet 品满足规定采购要求的责任。 specified requirements. 8.4.1.1组织应: 8.4.1.1 The organization shall: 确定批准状态决定，批准状态更改的a)a) define the process, responsibilities and authority for the approval status decision, changes of the approval status 过程,职责和授权，以及根据其批准 and conditions for a controlled use of external providers 状态进行控制使用供方的条件。 depending on their approval status; 保持一份外部供方名录，包括批准状b)b) maintain a register of its external providers that includes 态(如批准，有条件批准，不批准)approval status (e.g., approved, conditional, disapproved) and the scope of the approval (e.g., product type, process 和批准范围(如产品类型、过程类 family); 别); c) periodically review external provider performance 周期性地评估外部供方的业绩,包括c)including product and service conformity and on-time 产品和服务的符合性和准时交付能delivery performance; 力; d) define the necessary actions to take when dealing with external providers that do not meet requirements; 当外部供方不能满足要求时，确定采d) 取必要的措施; e) define the process for controlling documented information e) 确定过程控制由外部供方生成和/或created by and/or retained by external providers. Page 24 of 39 Version Feb. 1, 2016 AS 9100D/EN9100:2016 Aerospace Quality Standard ISO9001:2015/EN9100:2016 (Draft,Nov.16,2015) Bureau Veritas Certification China 中文译稿 保留的文件的信息。 8.4.2 Type and extent of control 8.4.2 控制类型和程度 The organization shall ensure that externally provided processes, 组织应确保外部提供的过程、产品和服务不会products and services do not adversely affect the organization’s 对组织稳定地向顾客交付合格产品和服务的ability to consistently deliver conforming products and services to its customers. 能力产生潜在影响。 The organization shall: 组织应: a) 确保外部提供的过程保持在其质量管理a) ensure that externally provided processes remain within the 体系的控制之中; control of its quality management system; b) define both the controls that it intends to apply to an external b) 规定对外部供方的控制及其输出结果的provider and those it intends to apply to the resulting output; 控制; c) take into consideration: c) 考虑: 1) the potential impact of the externally provided processes, 1) 外部提供的过程、产品和服务对组织稳定products and services on the organization’s ability to consistently meet customer and applicable statutory and regulatory 地提供满足顾客和适用的法律法规要求的能requirements; 力的潜在影响; 2) the effectiveness of the controls applied by the external provider; 2) 外部供方自身控制的有效性。 3) the results of the periodic review of external provider performance (see 8.4.1.1 c); 3) 定期评审外部供方业绩的结果(见 8.4.1.1c); d) determine the verification, or other activities, necessary to ensure that the externally provided processes, products and d) 确定必要的验证或其他活动，以确保外部services meet requirements (see 8.4.2.1). 提供的过程、产品和服务满足要求。 Verification activities of externally provided processes, products, and services shall be performed according to the 外部提供的过程，产品和服务的验证活动应按risks identified. These shall include inspection or periodic 识别的风险进行，当存在不合格品或假冒件的testing, as applicable, when there is high risk of 高风险情况下，在适用时应包括检验或定期测nonconformities or counterfeit product. 试。 NOTE 1 Customer verification activities performed at any level 注1 顾客对任何层次的供应链所做的验证活of the supply chain does not absolve the organization of its 动不能免除组织提供可接受的过程，产品和服responsibility to provide acceptable process, products and 务，以及符合所有要求的责任。 services and to comply with all requirements. NOTE 2 Verification activities can include: -,review of objective evidence of the conformity of the 注2验证活动可以包括: processes, products and services from the external provider - 评审从外部供方处获得的过程，产品和服务(e.g., accompanying documentation, certificate of conformity, 的符合性客观证据(如随产品文件，合格证明，test documentation, statistical documentation, process control 测试文件，统计文件，过程控制文件，生产过documentation, results of production process verification and 程验证的结果，和后续生产过程更改的评估); assessment of changes to the production process thereafter); , -inspection and audit at the external provider’s premises; -, review of the required documentation; - 在外部供方处的检验和审核; -, review of production part approval process implementation; - 对要求文件的评审; -, inspection of products or verification of services upon -评审生产件批准过程的执行情况; receipt; Page 25 of 39 Version Feb. 1, 2016 AS 9100D/EN9100:2016 Aerospace Quality Standard ISO9001:2015/EN9100:2016 (Draft,Nov.16,2015) Bureau Veritas Certification China 中文译稿 - 按收货单进行产品检验或服务验证; , -review of delegations of product verification to the external provider. - 评审委托的外部供方的产品验证结果。 When externally provided products are released for production use pending completion of all required verification activities, it 在所有要求的验证活动完成前，当外部提供的shall be identified and recorded to allow recall and 产品被放行用于生产，应对其进行标识和记replacement if it is subsequently found that the product does 录，做到如果后续结果发现产品不符合要求，not meet requirements. 能够对其进行召回和更换。 When the organization delegates verification activities to the external provider, the scope and requirements for delegation 当组织委托代表对外部供方进行验证时，应确shall be defined and a register of delegations maintained. The 定委托的范围和要求，并保持一份委托清单。organization shall periodically monitor the external provider’s 组织应定期监控外部供方的委托验证活动情delegated verification activities. 况。 When external provider test reports are utilized to verify externally provided products, the organization shall have a process to evaluate the data in the test reports to confirm that 当利用外部供方的测试报告来验证外部提供the product meets requirements. When a customer or 的产品时，组织应评估测试报告中的数据用以organization have identified raw material as a significant 确认产品满足要求。当顾客或组织已经识别原operation risk (e.g. critical items), the organization shall 材料是一个重要的运行风险时(如关键项目)，implemented a process to validate the accuracy of test reports. 组织应验证测试报告的准确性。 8.4.3 Information for external providers 8.4.3 外部供方的信息 The organization shall ensure the adequacy of requirements prior to their communication to the external provider. 组织应确保在与外部供方沟通之前所确定的 The organization shall communicate to external providers its 要求是充分的。 requirements for: 组织应与外部供方沟通以下要求: a) the processes, products and services to be provided including the identification of relevant technical data (e.g. a) 所提供的过程、产品和服务，包括相关技specifications, drawings, process requirements, work instructions); 术数据的标识(如规范，图纸，过程要求， 和工作指导书); b) the approval of: b) 对下列内容的批准: 1) products and services; 2) methods, processes and equipment; 3) the release of products and services; 1) 产品和服务; 2) 方法、过程和设备; c) competence, including any required qualification of persons; 3) 产品和服务的放行。 d) the external providers’ interactions with the organization; c) 能力，包括所要求的人员资质; e) control and monitoring of the external providers’ performance to be applied by the organization; d) 外部供方与组织的接口; f) verification or validation activities that the organization, or its e) 组织对外部供方绩效的控制和监视; customer, intends to perform at the external providers’ premises; f) 组织或其顾客拟在外部供方现场实施的 g) design and development control; 验证或确认活动。 h) special requirement, critical items, including key g) 设计和开发控制; characteristics; Page 26 of 39 Version Feb. 1, 2016 AS 9100D/EN9100:2016 Aerospace Quality Standard ISO9001:2015/EN9100:2016 (Draft,Nov.16,2015) Bureau Veritas Certification China 中文译稿 h) 特殊要求，关键项目，包括关键特性 ; i) test, inspection and verification (including production process verification); i) 试验，检验和验证(包括生产过程的验 证);j) the use of statistical techniques for product acceptance and related instructions for acceptance by the j) 使用组织能接受的统计技术来进行产品organization; 验收和相关说明， k) the need to: -, implement a quality management system; k) 需要 -执行的质量管理体系; , -use customer-designated or approved external providers, including process sources (e.g., special processes); -使用顾客指定或批准的外部供方，包括过 程来源(如特殊过程);, -notify the organization of nonconforming processes, products or services and obtain approval for their disposition; -向组织通报不合格的过程，产品或服务并 获得处置批准;, -prevent the use of counterfeit products (see 8.1.4); -预防假冒件的使用(见8.1.4) ; , -notify the organization of changes to processes, products or services, including changes of external providers or location of manufacture, and obtain their approval; -/通知组织过程产品或服务的更改，包括外部 供方的更改，生产地点的更改，并获得批准;, -flow down to their external providers applicable requirements including customer requirements; -向外部供方传递适用的要求，包括顾客要求; , -provide test specimens (e.g., production method, number, storage conditions) for design approval, inspection/ -/提供试验件用于设计批准、检验验证、调查verification, investigation or auditing; 或审核(例如生产方法，编号，储存条件); , -retain documented information, including retention periods -and disposition requirements; 需要保留的文件信息，包括保留期和处置要 求。l) the right of access by the organization, their customer and regulatory authorities to the applicable areas of facilities and i) 在供应链的任何层次，组织及其顾客和法规to applicable documented information, at any level of the ,和适用文机构可接触进入到任何适用的场所supply chain; 件信息的权利。 m) ensuring persons are aware of m) 保证人员意识到 - their contribution to product and service conformity; -他们对产品和服务符合性的贡献; -their contribution to product safety; -他们对产品安全的贡献; -the importance of ethical behavior. -道德行为的重要性。 8.5 Production and service provision 8.5 生产和服务提供 8.5.1 Control of production and service provision 8.5.1 生产和服务提供的控制 The organization shall implement production and service provision under controlled conditions. 组织应在受控条件下进行生产和服务提供。 Controlled conditions shall include, as applicable: 适用时，受控条件应包括: a) 可获得形成文件的信息，以规定以下内a) the availability of documented information that defines: 容: 1) the characteristics of the products to be produced, the services to be provided, or the activities to be performed; 1) 所生产的产品、提供的服务或进行的活动 的特性; 2) the results to be achieved; Page 27 of 39 Version Feb. 1, 2016 AS 9100D/EN9100:2016 Aerospace Quality Standard ISO9001:2015/EN9100:2016 (Draft,Nov.16,2015) Bureau Veritas Certification China 中文译稿 NOTE 1 Documented information that defines characteristics 2) 拟获得的结果。 of products and services can include drawings, parts lists, materials and process specifications. 注1:确定产品和服务特征的文件的信息包括 有图纸、零件清单、材料和工艺规范。 NOTE 2 Documented information for activities to be performed and results to be achieved can include process flow charts, 注2:活动执行和结果取得的文件的信息包括control plans, production documents (e.g., manufacturing 有过程流程图、控制计划，生产文件(如:制plans, travelers, routers, work orders, process cards) and 造计划、路线图、流程卡、工作指令和工艺卡)verification documents. 和验证文件。 b) the availability and use of suitable monitoring and measuring resources; b) 可获得并使用适宜的监测和测量资源; c) the implementation of monitoring and measurement activities at appropriate stages to verify that criteria for control of processes c) 在适当的阶段实施监视和测量活动，以验or outputs, and acceptance criteria for products and services, 证是否符合过程或输出的控制准则以及have been met; 产品和服务的接收准则; 1) ensuring that documented information for monitoring and measurement activity for product acceptance includes: 1) 确保监视和测量产品接收活动的文件, - criteria for acceptance and rejection; 的信息包括有: ,- where in the sequence verification operations are to be -接收和拒收准则; performed; -按顺序进行验证操作; , - measurement results to be retained (at a minimum an indication of acceptance or rejection); -保留测量的结果(至少表明接收或 , - any specific monitoring and measurement equipment 拒收); required and instructions associated with their use; -要求的任何特定的监视和测量设备 2) ensuring that when sampling is used as a means of product 及其相关的使用说明; acceptance, the sampling plan is justified on the basis of 2)当使用抽样检验作为产品接收的recognized statistical principles and appropriate for use (i.e., matching the sampling plan to the criticality of the product and 方法时，抽样计划应基于认可的统计to the process capability). 原理，并适于使用(抽样计划应与产 品的重要性和过程能力相匹配)。 d) the use of suitable infrastructure and environment for the operation of processes; d) 为过程的运行提供适宜的基础设施和环NOTE Suitable equipment can include product specific tools 境; (e.g., jigs, fixtures, molds) and software programs. 注:适宜的设备包括有产品专用工装(如 型架、夹具、模具)和软件程序。 e) the appointment of competent persons, including any required qualification; e) 配备具备能力的人员，包括所要求的资f) the validation, and periodic revalidation, of the ability to achieve 格; planned results of the processes for production and service provision, where the resulting output cannot be verified by f) 若输出结果不能由后续的监测或测量加subsequent monitoring or measurement; 以验证，应对生产和服务提供过程实现策NOTE These processes can be referred to as special 划结果的能力进行确认和定期再确认; processes (see 8.5.1.2). 注:这些过程也被称为特殊过程(见g) the implementation of actions to prevent human error; 8.5.1.2)。 g) 采取措施防止人为错误; h) the implementation of release, delivery and post-delivery activities; h) 实施放行、交付和交付后活动。 Page 28 of 39 Version Feb. 1, 2016 AS 9100D/EN9100:2016 Aerospace Quality Standard ISO9001:2015/EN9100:2016 (Draft,Nov.16,2015) Bureau Veritas Certification China 中文译稿 i) the establishment of criteria for workmanship(e. g. written standards, representative samples, illustrations); i) 工艺准则的建立(如书面标准、代 表性样本,插图); j) accountability for all product during production (e.g., parts quantities, split orders, nonconforming product); j)在生产中对所有产品负有责任(如零 件数量、分作业指令、不合格品); k) control and monitoring of identified critical items, including key characteristics, in accordance with k)按建立的过程，控制和监视已识别的established processes; 关键项目，包括关键特性; l) determination of methods to measure variable data (e.g., tooling, on-machine probing, inspection equipment); i)确定方法来测量可变数据(如工具，m) identifying in-process inspection/verification points when 在线探测，检验设备); adequate verification of conformance cannot be performed at later stages; m)在后续阶段不能进行足够验证时，识 别过程中的检验/验证点; n) the availability of evidence that all production and inspection/verification operations have been completed as planned, or as otherwise documented and authorized; n)可得到所有生产和检验/验证操作已 按计划完成的证据，或者另外文件批准o) provision for the prevention, detection and removal of 和授权; foreign objects; p) control and monitoring of utilities and supplies (e.g., water, o)提供预防、检测和去除外来物; compressed air, electricity, chemical products) to the extent they affect conformity to product requirements (see 7.1.3); p)对会影响产品要求符合性的公用设施 和供给物(如水、压缩空气、电及化学q) the identification and recording of products released for 产品)进行监视和控制， subsequent production use pending completion of all required measuring and monitoring activities, to recall and q)在所有要求的测量和监视活动完成replacement if it is a later found that the product does not 前，产品被放行到后道工序，应对其进meet requirement. 行标识和记录，做到如果后来发现产品 8.5.1.1 Control of production equipment, tools and software 不符合要求，能够对其进行召回和更换。 programs 8.5.1.1 生产设备、工装和软件程序的 控制 Equipment, tools and software programs used to automate, control, monitor or measure production processes shall be 生产设备、工装和用于自动操作，控制，validated prior to final release for production and shall be 监视或测量生产过程的软件程序在最终maintained. 放行生产前应进行确认，并维护。 Storage requirements shall be defined for production equipment or tooling in storage including any necessary periodic preservation or condition checks. 对储存中的生产设备或工装必须确定储 存要求，包括任何必要的定期防护或状8.5.1.2 Validation and control of special processes 况检查。 8.5.1.2 特殊过程的验证和控制 For processes where the resulting output cannot be verified by subsequent monitoring or measurement, the organization shall establish arrangements for these processes including, as 当过程输出不能由后续的监视或测量加applicable: 以验证，组织应对任何这些过程作出安 排，适用时包括: a) definition of criteria for the review and approval of the processes; 规定过程的评审和批准准则; a) b) determination of conditions to maintain the approval; Page 29 of 39 Version Feb. 1, 2016 AS 9100D/EN9100:2016 Aerospace Quality Standard ISO9001:2015/EN9100:2016 (Draft,Nov.16,2015) Bureau Veritas Certification China 中文译稿 b) 确定保持批准的条件; c) approval of facilities and equipment; 设施和设备的批准; c)d) qualification of persons; 人员资质; d)e) use of specific methods and procedures for implementation and monitoring the processes; 对过程的执行和监控使用特定的方e) 法和程序; f) requirements for documented information to be retained. 要求保留的文件的信息。 f)8.5.1.3 Production process verification 8.5.1.3 生产过程验证 The organization shall implement production process verification activities to ensure the production process is 组织应执行生产过程验证活动以保证生capable of producing products that consistently meet requirements. 产过程有能力持续生产出满足要求的产 品。 NOTE These activities can include risk assessments, capacity studies, capability studies, and control plans. 注: 这些活动包括风险评估，产能研究， 能力研究和控制计划。 The organization shall use a representative item from the first production run of a new part or assembly to verify that the 组织应使用从首批生产的新零件或组件production processes, production documentation and tooling 中确定的有代表性的项目来验证生产过are capable of producing parts and assemblies that meet 程、生产文件和工装能够生产满足要求requirements. This activity shall be repeated when changes 的零件和部件。当发生使原来验证结果occur that invalidate the original results (e.g., engineering 无效的更改时，应进行重新验证过程(如changes, production process changes, tooling changes). 工程更改,制造过程更改,工装更改)。 NOTE This activity can be referred to as first article inspection. The organization shall retain documented information on the 注:此项活动通常被称为首件检验。 results of production process verification. 组织应保留生产过程验证结果的文件的 信息。 8.5.2 Identification and traceability 8.5.2 标识和可追溯性 The organization shall use suitable means to identify outputs when it is necessary to ensure the conformity of products and services. 需要时，组织应采用适当的方法识别输出，以 确保产品和服务合格。 The organization shall maintain the identification of the configuration of the products and services in order to identify any differences between the actual configuration and the 组织应保持产品和服务技术状态的识required configuration. 别，以识别产品实际技术状态和所需技 术状态之间的任何不同。 The organization shall identify the status of outputs with respect to monitoring and measurement requirements throughout production 组织应在产品和服务提供的整个过程中按照and service provision. 监视和测量要求识别输出状态。 When acceptance authority media are used (e.g., stamps, electronic signatures, passwords), the organization shall 当使用可接受授权媒介时(如印章、电establish appropriate controls for the media. 子签名、密码)，组织应对媒介建立适当The organization shall control the unique identification of the outputs 的控制。 when traceability is a requirement, and shall retain the documented information necessary to enable traceability. 若要求可追溯，组织应控制输出的唯一性标 识，且应保留实现追溯性所需的形成文件的信NOTE Traceability requirements can include: 息。 -the identification to be maintained throughout the product Page 30 of 39 Version Feb. 1, 2016 AS 9100D/EN9100:2016 Aerospace Quality Standard ISO9001:2015/EN9100:2016 (Draft,Nov.16,2015) Bureau Veritas Certification China 中文译稿 life; 注:追溯要求包括: -在产品寿命期内能保持标识; ,,the ability to trace all products manufactured from the same batch of raw material, or from the same manufacturing batch, -所有产品能追溯到由同一批原材料制to the destination (e.g., delivery, scrap); 造，或来自相同制造批次，以及最终去 向(如交付、报废); - for an assembly, the ability to trace its components to the assembly and then to the next higher assembly; -对于组件，能追溯其组件以及后面更高 一级的组件; -for a product, a sequential record of its production (manufacture, assembly, inspection/verification) to be retrievable. -对于产品，能追溯其生产的一系列记录 (制造、装配、检验/验证)。 8.5.3 Property belonging to customers or external providers 8.5.3 顾客或外部供方的财产 The organization shall exercise care with property belonging to customers or external providers while it is under the organization’s 组织在控制或使用顾客或外部供方的财产期control or being used by the organization. 间，应对其进行妥善管理。 The organization shall identify, verify, protect and safeguard 对组织使用的或构成产品和服务一部分的顾customers’ or external providers’ property provided for use or incorporation into the products and services. 客和外部供方财产，组织应予以识别、验证、 保护和维护。 When the property of a customer or external provider is lost, damaged or otherwise found to be unsuitable for use, the 若顾客或外部供方的财产发生丢失、损坏或发organization shall report this to the customer or external provider 现不适用情况，组织应向顾客或外部供方报and retain documented information on what has occurred. 告，并保留相关形成文件的信息。 NOTE A customer’s or external provider’s property can include material, components, tools and equipment, premises, intellectual property and 注:顾客或外部供方的财产可能包括原材料、personal data. 零部件、工具和设备、顾客的场所、知识产权 和个人信息。 8.5.4 Preservation 8.5.4 防护 The organization shall preserve the outputs during production and service provision, to the extent necessary to ensure conformity to requirements. 组织应在生产和服务提供过程中对输出进行 必要防护，以确保符合要求。 NOTE Preservation can include identification, handling, contamination control, packaging, storage, transmission or transportation, and protection. 注:防护可包括标识、处置、污染控制、包装、 Preservation of outputs shall also include, when applicable in 储存、传送或运输以及保护。 accordance with specifications and applicable statutory and regulatory requirements, provisions for: 在适用处，按产品规范和适用的法律法 规要求，产品的防护还应包括下列规定: a) cleaning; 清洁; a.b) prevention, detection and removal of foreign objects; 预防、检测并去除外来物; b.c) special handling and storage for sensitive products; 对敏感产品的特殊处理和保存; d) marking and labeling including safety warnings and c. cautions; 标记和挂签，包括安全警示和告诫; d. e) shelf life control and stock rotation; f) special handling and storage for hazardous materials. 有效期控制和库存周转; e. Page 31 of 39 Version Feb. 1, 2016 AS 9100D/EN9100:2016 Aerospace Quality Standard ISO9001:2015/EN9100:2016 (Draft,Nov.16,2015) Bureau Veritas Certification China 中文译稿 f. 对危险材料的特殊处理和保存。 8.5.5 Post-delivery activities 8.5.5 交付后的活动 The organization shall meet requirements for post-delivery activities associated with the products and services. 组织应满足与产品和服务相关的交付后活动 的要求。 In determining the extent of post-delivery activities that are required, the organization shall consider: 在确定交付后的活动的覆盖范围和程度时，组a) statutory and regulatory requirements; 织应考虑: a) 法律法规要求; b) the potential undesired consequences associated with its products and services; b) 与产品和服务相关的潜在的不期望的后c) the nature, use and intended lifetime of its products and 果; services; c) 其产品和服务的特性、用途和预期寿命; d) customer requirements; d) 顾客要求; e) customer feedback; e) 顾客反馈; f) collection and analysis of in-service data (e.g., performance, reliability, lessons learned); f) 对使用中数据的收集和分析(如性 能，可靠性，经验教训); g) control, updating, and provision of technical documentation relating to product use, maintenance, repair and overhaul; 控制，更新和提供关于产品使用，维g) 护，修理和大修的技术文件; h) controls required for work undertaken external to the organization (e.g., off-site work); 在组织外部现场工作的控制要求(如h) 外场工作); i) product/customer support (e.g., queries, training, warranties, maintenance, replacement parts, resources, obsolescence). 产品/客户支援(如询问，培训，索i) 赔，维修，更换零件，资源，报废)。 When problems are detected after delivery, the organization shall take appropriate action including investigation and 当交付后发现问题时，组织应采取的措reporting. 施，包括调查和报告。 NOTE Post-delivery activities can include actions under warranty provisions, contractual obligations such as maintenance services, and 注:交付后活动可能包括担保条款所规定的相supplementary services such as recycling or final disposal. 关活动～诸如合同规定的维护服务～以及回收 或最终报废处置等附加服务。 8.5.6 Control of changes 8.5.6 更改控制 The organization shall review and control changes for production or service provision, to the extent necessary to ensure continuing conformity with requirements. 组织应对生产和服务提供的更改进行必要的 评审和控制，以确保稳定地符合要求。 Persons authorized to approve production or service provision changes shall be identified. 应识别批准提供生产或服务更改的授权 NOTE: production or service provision changes can include 人员。 the changes affecting processes, production equipment, tools, or software program. 注: 提供生产或服务更改会包括影响过 程，生产设备，工具或软件程序的更改。 The organization shall retain documented information describing the results of the review of changes, the person(s) authorizing the 组织应保留形成文件的信息，包括有关更改评change, and any necessary actions arising from the review. Page 32 of 39 Version Feb. 1, 2016 AS 9100D/EN9100:2016 Aerospace Quality Standard ISO9001:2015/EN9100:2016 (Draft,Nov.16,2015) Bureau Veritas Certification China 中文译稿 审结果、授权进行更改的人员以及根据评审所8.6 Release of products and services 采取的必要措施。 The organization shall implement planned arrangements, at 8.6 产品和服务的放行 appropriate stages, to verify that the product and service requirements have been met. 组织应在适当阶段实施策划的安排，以验证产 When product is released for subsequent production use 品和服务的要求已被满足。 pending completion of all required measurement and monitoring activities, it shall be identified and recorded to 在所有要求的测量和监视活动完成前产allow recall and replacement if it is later found that the product 品被放行到后续生产，应对其进行标识does not meet requirements. 和记录，做到如果后来发现产品不符合 要求，能够对其进行召回和更换。 The release of products and services to the customer shall not proceed until the planned arrangements have been satisfactorily 除非得到有关授权人员的批准，适用时得到顾completed, unless otherwise approved by a relevant authority and, as applicable, by the customer. 客的批准，否则在策划的安排已圆满完成之 前，不应向顾客放行产品和交付服务。 The organization shall retain documented information on the release of products and services. The documented information shall include: 组织应保留有关产品和服务放行的形成文件 的信息。形成文件的信息应包括: a) evidence of conformity with the acceptance criteria; a) 符合接收准则的证据; b) traceability to the person(s) authorizing the release. When required to demonstrate product qualification, the b) 授权放行人员的可追溯信息。 organization shall ensure that retained documented information provides evidence that the products and services 当要求展示产品合格时，组织应保证保meet the defined requirements. 留的文件的信息提供证据表明产品和服 务已满足确定的要求。 The organization shall ensure that all documented information required to accompany the products and services are present 组织应保证所有要求的文件的信息应随at delivery. 同产品和服务交付时一起提供。 8.7 Control of nonconforming outputs 8.7 不符合输出的控制 8.7.1 The organization shall ensure that outputs that do not conform to their requirements are identified and controlled to prevent their 8.7.1 组织应确保对不符合要求的输出进行unintended use or delivery. 识别和控制，以防止其非预期的使用或交付。 NOTE The term “nonconforming outputs” includes nonconforming product or service generated internally, 注:术语“不符合输出”包括内部生成，received from an external provider, or identified by a customer. 收到的外部供方或顾客识别的不合格产 品或服务。 The organization shall take appropriate action based on the nature of the nonconformity and its effect on the conformity of products and 组织应根据不符合的性质及其对产品和服务services. This shall also apply to nonconforming products and 的影响采取适当的措施，这也适用于产品交付services detected after delivery of products, during or after the 之后发现的不合格产品，以及在服务提供期间provision of services. 或之后发现的不合格服务。 The organization’s nonconformance control process shall be maintained as documented information including the 组织不符合控制过程应保持下列文件的provisions for: 信息，包括: -defining the responsibility and authority for the review and disposition of nonconforming outputs and the process for -规定对不符合输出的评审和处置的职approving persons making these decisions; 责和权限，以及批准人员作出决定的过 Page 33 of 39 Version Feb. 1, 2016 AS 9100D/EN9100:2016 Aerospace Quality Standard ISO9001:2015/EN9100:2016 (Draft,Nov.16,2015) Bureau Veritas Certification China 中文译稿 -taking actions necessary to contain the effect of the 程; nonconformity on other processes, products or services; -采取必要的措施，控制不符合在其它过 -timely reporting of nonconformities affecting delivered 程，产品或服务的影响; products and services to the customer and to relevant interested parties; -给顾客或相关利益方及时报告影响到 已交付的产品和服务的不符合情况; - defining corrective actions for nonconforming products and services detected after delivery, as appropriate to their -不合格产品和服务在交付后发现时，应impacts (see 10.2). 确定纠正措施，同时适合于它们的影响 NOTE Interested parties requiring notification of (见10.2); nonconforming products and services can include external providers, internal organizations, customers, distributors and 注: 要求通知不合格产品和服务的利益regulatory authorities. 相关方可能包括外部供方、内部组织、 顾客、分销商和法规机构。 The organization shall deal with nonconforming outputs in one or more of the following ways: 组织应通过下列一种或多种途径处置不合格 输出: a) correction; a) 纠正; b) segregation, containment, return or suspension of provision of b) 对提供产品和服务进行隔离、限制、退货products and services; 或暂停; c) informing the customer; c) 告知顾客; d) obtaining authorization for acceptance under concession by a relevant authority and, when applicable, by the customer. d) 通过相关法规机构获得让步接收的授权， 适用时，由顾客批准。 Dispositions of use-as-is or repair for the acceptance of nonconforming products shall only be implemented: 原样超差使用或返修处置来接受不合格品应 -after approval by an authorized representative of the 满足下列要求: organization responsible for design or by persons having delegated authority from the design organization; -只有经过负责设计组织的授权代表或者是设 计组织的委托授权人员批准; -after authorization by the customer, if the nonconformity results in a departure from the contract requirements. -如果不合格导致偏离合同要求，应经过顾客 授权批准。 Product dispositioned for scrap shall be conspicuously and permanently marked, or positively controlled, until physically rendered unusable. 处置为报废的产品，必须做出明显的和永久性 的标记，或进行肯定地控制，直至在物理上不Counterfeit, or suspect counterfeit, parts shall be controlled to 可能被使用。 prevent reentry into the supply chain. 假冒件或者是怀疑的假冒件应控制防止再次Conformity to the requirements shall be verified when 进入供应链。 nonconforming outputs are corrected. 对不合格输出进行纠正之后应验证其是否符 合要求。 8.7.2 The organization shall retain documented information that: a) describes the nonconformity; 8.7.2 组织应保留下列形成文件的信息: b) describes the actions taken; a) 有关不合格的描述; b) 所采取措施的描述; c) describes any concessions obtained; Page 34 of 39 Version Feb. 1, 2016 AS 9100D/EN9100:2016 Aerospace Quality Standard ISO9001:2015/EN9100:2016 (Draft,Nov.16,2015) Bureau Veritas Certification China 中文译稿 d) identifies the authority deciding the action in respect of the c) 获得让步的描述; nonconformity. d) 处置不合格的授权标识。 9 Performance evaluation 9 绩效评价 9.1 Monitoring, measurement, analysis and evaluation 9.1 监视、测量、分析和评价 9.1.1 General The organization shall determine: 9.1.1 总则 a) what needs to be monitored and measured; 组织应确定: a) 需要监视和测量的对象; b) the methods for monitoring, measurement, analysis and evaluation needed to ensure valid results; b) 确保有效结果所需的监视、测量、分析和c) when the monitoring and measuring shall be performed; 评价方法; d) when the results from monitoring and measurement shall be c) 实施监视和测量的时机; analysed and evaluated. The organization shall evaluate the performance and the d) 分析和评价监视和测量结果的时机。 effectiveness of the quality management system. 组织应评价质量管理体系的绩效和有效性。组The organization shall retain appropriate documented information 织应保留适当的形成文件的信息，作为结果的as evidence of the results. 证据。 9.1.2 Customer satisfaction 9.1.2 顾客满意 The organization shall monitor customers’ perceptions of the degree to which their needs and expectations have been fulfilled. The 组织应监视顾客对其需求和期望获得满足的organization shall determine the methods for obtaining, monitoring 程度的感受。组织应确定这些信息的获取、监and reviewing this information. 视和评审方法。 NOTE Examples of monitoring customer perceptions can include customer surveys, customer feedback on delivered products and services, meetings 注:监视顾客感受的例子可包括顾客调查、顾with customers, market-share analysis, compliments, warranty claims and dealer reports. 客对交付产品或服务的反馈、顾客会晤、市场 占有率分析、赞扬、担保索赔和经销商报告。 Information to be monitored and used for the evaluation of customer satisfaction shall include, but is not limited to, 监视和用于评价顾客满意的信息应包括，但不product and service conformity, on-time delivery performance, 限于:产品和服务的符合性，准时交付业绩，customer complaints and corrective action requests. 顾客抱怨和纠正措施请求。 The organization shall develop and implement plans for customer satisfaction improvement that address deficiencies 组织应开发和实施顾客满意度改进计划来解identified by these evaluations, and assess the effectiveness of the results. 决评价而识别出的不足，并评估结果的有效 性。 9.1.3 Analysis and evaluation 9.1.3 分析与评价 The organization shall analyse and evaluate appropriate data and information arising from monitoring and measurement. 组织应分析和评价通过监视和测量获得的适 宜数据和信息。 NOTE Appropriate data can include information on product and service problems reported by external sources (e.g., 注:适宜数据包括来源于外部报告的关于产品government/industry alerts, advisories). 和服务问题的信息(如政府或行业通报，公 Page 35 of 39 Version Feb. 1, 2016 AS 9100D/EN9100:2016 Aerospace Quality Standard ISO9001:2015/EN9100:2016 (Draft,Nov.16,2015) Bureau Veritas Certification China 中文译稿 The results of analysis shall be used to evaluate: 告)。 a) conformity of products and services; 应利用分析结果评价: a) 产品和服务的符合性; b) the degree of customer satisfaction; c) the performance and effectiveness of the quality management b) 顾客满意程度; system; c) 质量管理体系的绩效和有效性; d) if planning has been implemented effectively; d) 策划是否得到有效实施; e) the effectiveness of actions taken to address risks and opportunities; e) 针对风险和机遇所采取措施的有效性; f) the performance of external providers; f) 外部供方的绩效; g) the need for improvements to the quality management system. NOTE Methods to analyse data can include statistical techniques. g) 质量管理体系改进的需求。 注:数据分析方法可以包括统计技术。 9.2 Internal audit 9.2 内部审核 9.2.1 The organization shall conduct internal audits at planned intervals to provide information on whether the quality management system; 9.2.1 组织应按照策划的时间间隔进行内部 审核，以提供有关质量管理体系的下列信息: a) conforms to: 1) the organization’s own requirements for its quality management a) 是否符合: system; 1) 组织自身的质量管理体系要求; NOTE The organization’s own requirements can include customer and applicable statutory and regulatory quality 注:组织自身要求包括顾客和适用法规机management system requirements. 构对质量管理体系的要求。 2) the requirements of this International Standard; 2) 本标准的要求。 b) is effectively implemented and maintained. b) 得到有效的实施和保持。 NOTE When conducting internal audits, performance indicators can be evaluated to determine whether the quality 注:进行内部审核时，绩效指标用来评估management system is effectively implemented and 确定质量管理体系是否得到有效实施和maintained. 维护。 9.2.2 The organization shall: a) plan, establish, implement and maintain an audit programme(s) 9.2.2 组织应: including the frequency, methods, responsibilities, planning a) 依据有关过程的重要性、对组织产生影响requirements and reporting, which shall take into consideration 的变化和以往的审核结果，策划、制定、the importance of the processes concerned, changes affecting 实施和保持审核方案，审核方案包括频the organization, and the results of previous audits; 次、方法、职责、策划要求和报告; b) define the audit criteria and scope for each audit; b) 规定每次审核的审核准则和范围; c) select auditors and conduct audits to ensure objectivity and the impartiality of the audit process; c) 选择可确保审核过程客观公正的审核员 实施审核; d) ensure that the results of the audits are reported to relevant management; d) 确保相关管理部门获得审核结果的报告; Page 36 of 39 Version Feb. 1, 2016 AS 9100D/EN9100:2016 Aerospace Quality Standard ISO9001:2015/EN9100:2016 (Draft,Nov.16,2015) Bureau Veritas Certification China 中文译稿 e) take appropriate correction and corrective actions without undue delay; e) 及时采取适当的纠正和纠正措施; f) retain documented information as evidence of the f) 保留作为实施审核方案以及审核结果的implementation of the audit programme and the audit results. 证据的形成文件的信息。 NOTE See ISO 19011 for guidance. 注:相关指南参见 ISO 19011。 9.3 Management review 9.3 管理评审 9.3.1 General 9.3.1 总则 Top management shall review the organization's quality 最高管理者应按策划的时间间隔对组织的质management system, at planned intervals, to ensure its continuing suitability, adequacy, effectiveness and alignment with the strategic 量管理体系进行评审，以确保其持续的保持适direction of the organization. 宜性、充分性和有效性，并与组织的战略方向 一致。 9.3.2 Management review inputs 9.3.2 管理评审输入 The management review shall be planned and carried out taking into consideration: 策划和实施管理评审时应考虑下列内容: a) the status of actions from previous management reviews; a) 以往管理评审所采取措施的实施情况; b) changes in external and internal issues that are relevant to the b) 与质量管理体系相关的内外部因素的变quality management system; 化; c) information on the performance and effectiveness of the quality management system, including trends in: c) 有关质量管理体系绩效和有效性的信息， 包括下列趋势性信息: 1) customer satisfaction and feedback from relevant interested 1) 顾客满意和相关方的反馈; parties; 2) 质量目标的实现程度; 2) the extent to which quality objectives have been met; 3) process performance and conformity of products and services; 3) 过程绩效以及产品和服务的符合性; 4) nonconformities and corrective actions; 4) 不合格以及纠正措施; 5) monitoring and measurement results; 5) 监视和测量结果; 6) audit results; 6) 审核结果; 7) the performance of external providers; 7) 外部供方的绩效。 8) on-time delivery performance; 8) 准时交付业绩; d) the adequacy of resources; d) 资源的充分性; e) the effectiveness of actions taken to address risks and opportunities (see 6.1); e) 应对风险和机遇所采取措施的有效性(见 6.1); f) opportunities for improvement. f) 改进的机会。 9.3.3 Management review outputs 9.3.3 管理评审输出 The outputs of the management review shall include decisions and actions related to: Page 37 of 39 Version Feb. 1, 2016 AS 9100D/EN9100:2016 Aerospace Quality Standard ISO9001:2015/EN9100:2016 (Draft,Nov.16,2015) Bureau Veritas Certification China 中文译稿 管理评审的输出应包括与下列事项相关的决a) opportunities for improvement; 定和措施: a) 改进的机会; b) any need for changes to the quality management system; b) 质量管理体系所需的变更; c) resource needs; c) 资源需求; d) risks identified. d) 风险识别。 The organization shall retain documented information as evidence of the results of management reviews. 组织应保留作为管理评审结果证据的形成文 件的信息。 10 Improvement 10 改进 10.1 General The organization shall determine and select opportunities for 10.1 总则 improvement and implement any necessary actions to meet customer requirements and enhance customer satisfaction. 组织应确定和选择改进的机会，采取必要的措 施，满足顾客要求和增强顾客满意。 These shall include: a) improving products and services to meet requirements as well 这应包括: as to address future needs and expectations; a) 改进产品和服务以满足要求并关注未来 的需求和期望; b) correcting, preventing or reducing undesired effects; b) 纠正、预防或减少不利影响; c) improving the performance and effectiveness of the quality management system. c) 改进质量管理体系的绩效和有效性。 NOTE Examples of improvement can include correction, corrective action, continual improvement, breakthrough change, innovation and 注:改进的例子可包括纠正、纠正措施、持续reorganization. 改进、突变、创新和重组。 10.2 Nonconformity and corrective action 10.2 不合格和纠正措施 10.2.1 When a nonconformity occurs, including any arising from complaints, the organization shall: 10.2.1 若出现不合格，包括由投诉所引起的 不合格，组织应: a) react to the nonconformity and, as applicable: 1) take action to control and correct it; a) 对不合格做出应对，适用时: 1) 采取控制措施予以控制和纠正; 2) deal with the consequences; 2) 处置产生的后果。 b) evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it does not recur or occur elsewhere, by: b) 通过下列活动，评价是否需要采取措施， 以消除产生不合格的原因，避免其再次发1) reviewing and analysing the nonconformity; 生或者在其他场合发生: 2) determining the causes of the nonconformity, including those 1) 评审和分析不合格; related to human factors; 3) determining if similar nonconformities exist, or could potentially 2) 确定不合格的原因, 包括人为因素; occur; 3) 确定是否存在或可能发生类似的不合格。 c) implement any action needed; Page 38 of 39 Version Feb. 1, 2016 AS 9100D/EN9100:2016 Aerospace Quality Standard ISO9001:2015/EN9100:2016 (Draft,Nov.16,2015) Bureau Veritas Certification China 中文译稿 d) review the effectiveness of any corrective action taken; c) 实施所需的措施; e) update risks and opportunities determined during planning, if d) 评审所采取的纠正措施的有效性; necessary; e) 需要时，更新策划期间确定的风险和机 f) make changes to the quality management system, if necessary; 遇; g) flow down corrective action requirements to an external f) 需要时，变更质量管理体系。 provider when it is determined that the external provider is responsible for the nonconformity; g) 当确定是外部供方对不符合负责时，向外 部供方传递纠正措施的要求; h) take specific actions when timely and effective corrective actions are not achieved; 当不能及时和有效地采取纠正措施时,需h)Corrective actions shall be appropriate to the effects of the 采取特定措施。 nonconformities encountered. 纠正措施应与所产生的不合格的影响相适应。 The organization shall maintain documented information that defines the nonconformity and corrective action management process. 组织应保持规定管理不合格和纠正措施过程 的文件的信息。 10.2.2 The organization shall retain documented information as evidence of: 10.2.2 组织应保留形成文件的信息，作为下 列事项的证据: a) the nature of the nonconformities and any subsequent actions taken; a) 不合格的性质及随后所采取的措施; b) the results of any corrective action. b) 纠正措施的结果。 10.3 Continual Improvement 10.3 持续改进 The organization shall continually improve the suitability, adequacy and effectiveness of the quality management system. 组织应持续改进质量管理体系的适宜性、充分The organization shall consider the results of analysis and 性和有效性。 evaluation, and the outputs from management review, to determine if there are needs or opportunities that shall be addressed as part of 组织应考虑管理评审的分析和评价的结果，以continual improvement. 及管理评审的输出，确定是否存在持续改进的 The organization shall monitor the implementation of 需求或机会。 improvement activities and evaluate the effectiveness of the results. 组织应监视改进活动的实施情况，并评价结果 的有效性。 NOTE Continual improvement opportunities can result from lessons learned, problem resolutions and the benchmarking of 注:持续改进机会来自经验教训、问题的解决best practices. 和最佳实践的标杆管理。 Page 39 of 39 Version Feb. 1, 2016