【管理精品】AS9100 STANDARD

【管理精品】AS9100 STANDARD Items of SAE AS 9100:2000 Aerospace Quality Standard SAE AS 9100:2000 航空航天质量 标准 excel标准偏差excel标准偏差函数exl标准差函数国标检验抽样标准表免费下载红头文件格式标准下载 条款 (Rev.B,Aug.2001) (B 版，2002年8月) 中文译稿 Page 1 of 29 Version 05/04/2002 Items of SAE AS 9100:2000 Aerospace Quality Standard SAE AS 9100:2000 航空航天质量标准条款 (Rev.B,Aug.2001) (B 版，2002年8月) 中文译稿 目 录 1范围 ...................................................................................................................................................................................................4 2 引用标准 ........................................................................................................................................................................................5 3(术语与定义 ...............................................................................................................................................................................5 4 质量管理体系 ..............................................................................................................................................................................5 4.1一般要求 .....................................................................................................................................................................................5 4.2文件化要求 ................................................................................................................................................................................6 5 管理者职责 ...................................................................................................................................................................................8 5.1 管理者承诺 ................................................................................................................................................................................8 5.2 顾客为中心 ................................................................................................................................................................................9 5.3 质量方针 .....................................................................................................................................................................................9 5.4 策划 ...............................................................................................................................................................................................9 5.5职责、权限与沟通 ............................................................................................................................................................. 10 5.6 管理评审 .................................................................................................................................................................................. 10 6.资源管理 ..................................................................................................................................................................................... 11 6.1 资源的提供 ............................................................................................................................................................................. 11 6.2 人力资源 .................................................................................................................................................................................. 11 6.3 基础设施 .................................................................................................................................................................................. 12 6.4 工作环境 .................................................................................................................................................................................. 12 7 产品实现 ..................................................................................................................................................................................... 12 7.1 产品实现的策划................................................................................................................................................................... 12 7.2 顾客相关的过程................................................................................................................................................................... 13 Page 2 of 29 Version 05/04/2002 Items of SAE AS 9100:2000 Aerospace Quality Standard SAE AS 9100:2000 航空航天质量标准条款 (Rev.B,Aug.2001) (B 版，2002年8月) 中文译稿 7.3 设计与开发 ............................................................................................................................................................................. 14 7.4 采购 ............................................................................................................................................................................................ 18 7.5 生产及服务提供................................................................................................................................................................... 21 7.6 监控和量测装置的控制 ................................................................................................................................................... 25 8 量测、分析与改进 ................................................................................................................................................................. 26 8.1 通则 ............................................................................................................................................................................................ 26 8.2监控与量测 ............................................................................................................................................................................. 27 8.3. 不合格品的控制 ................................................................................................................................................................. 30 8.4 数据资料的分析................................................................................................................................................................... 31 8.5 改进 ............................................................................................................................................................................................ 31 Page 3 of 29 Version 05/04/2002 Items of SAE AS 9100:2000 Aerospace Quality Standard SAE AS 9100:2000 航空航天质量标准条款 (Rev.B,Aug.2001) (B 版，2002年8月) 中文译稿 质量管理体系,要求 Quality management systems – Requirements 1 Scope 范围 1 1.1 General 1.1 通则 This standard includes ISO 9001:2000 quality 本标准包括ISO9001:2000质量管理体系要求management system requirements and specifies 并规定了航空航天工业质量管理体系的附加要additional requirements for a quality management 求。附加的航空航天要求以加粗斜体表示。 system for the aerospace industry. The additional aerospace requirements are shown in bold, italic text. 要强调的是本标准所规定的质量管理体系要求 是对 合同 劳动合同范本免费下载装修合同范本免费下载租赁合同免费下载房屋买卖合同下载劳务合同范本下载 和适用法律法规要求的补充(不是取It is emphasized that the quality management system 代)。 requirements specified in this standard are complementary (not alternative) to contractual and applicable law and regulatory requirements. This International Standard specifies requirements for a 本国际标准对一个组织的质量管理体系规定了quality management system where an organization 各项要求: a) needs to demonstrate its ability to consistently provide a) 需要展示其有能力连续一贯地提供符合顾客product that meets customer and applicable regulatory 需要和相应法规要求的产品，而且 requirements, and b) aims to enhance customer satisfaction through the b) 是通过对体系，包括体系的持续改进过程，effective application of the system, including processes for 的有效应用，以及保证满足顾客和相应法规continual improvement of the system and the assurance of 要求来达到增进顾客满意的目的。 conformity to customer and applicable regulatory requirements. NOTE In this International Standard, the term “product” 注:在本国际标准中，术语”产品”一词用于有意applies to the product intended for, or required by, a 图向顾客提供，或者根据顾客要求提供的产customer. 品。 1.2 Application 1.2 应用 All requirements of this International Standard are generic and 本国际标准所有的要求是通用性的，其意向是are intended to be applicable to all organizations, regardless 应用于所有的组织，不管行业、规模和所提供of type, size and product provided. 的产品。 Were any requirement(s) of this international Standard cannot 本国际标准的要求，若因组织和它的产品之性be applied due to the nature of an organization and its 质决定无法应用时，可考虑免除这些要求. product, this can be considered for exclusion. 当本国际标准的要求被免除时，除非所免除的Where exclusions are made, claims of conformity to this 要求局限于本国际标准的第7节，而且不影响International Standard are not acceptable unless these 组织能够提供符合顾客要求以及相应法规要求exclusions are limited to requirements within clause 7, and 产品能力或责任的，否则，该组织不可以宣称such exclusions do not affect the organization’s ability, or 符合本国际标准。 responsibility, to provide product that meets customer and applicable regulatory requirements. Page 4 of 29 Version 05/04/2002 Items of SAE AS 9100:2000 Aerospace Quality Standard SAE AS 9100:2000 航空航天质量标准条款 (Rev.B,Aug.2001) (B 版，2002年8月) 中文译稿 2 Normative reference 引用标准 2 The following normative document contains provisions which, through reference in this text, constitute provisions of this 本国际标准引用下列名称文件的内容以构成本International Standard. For dated references, subsequent 国际标准的条款。如果所引用的标准指明日期amendments to, or revisions of, any of these publications do 版次的，其后之修订或改版均不适用于本国际not apply. However, parties to agreements based on this 标准。然而，依据本国际标准达成 协议 离婚协议模板下载合伙人协议 下载渠道分销协议免费下载敬业协议下载授课协议下载 之各方International Standard are encouraged to investigate the 仍应探求使用下列引用标准最新版次的可能possibility of applying the most recent edition of the normative 性。如果引用的标准未指明日期版次的，则应document indicated below. For undated references, the latest 使用该标准的最新版本。ISO(国际标准组织)edition of the normative document referred to applies. 及IEC(国际电工委员会)会员皆持有国际标Members of ISO (International Organization for 准的最新有效版本。 Standardization) and IEC (International Electrotechnical Commission) maintain registers of currently valid International Standards. ISO 9000:2000, Quality management systems – Fundamentals and vocabulary. ISO 9000:2000质量管理体系–基础与词汇 3 Terms and definitions 3(术语与定义 For the purposes of this International Standard, the terms and definitions given in ISO 9000 apply. ISO9000:2000中之术语与定义均适用于本国 际标准。 The following items, used in this edition of ISO 9001 to describe the supply chain, have been changed to reflect the 本国际标准用于描述供应链的术语更改如下，vocabulary currently used: 以此反映目前的习惯用语: supplier ? organization ? customer 供方 ? 组织 ? 顾客 The term “organization” replaces the term “supplier” used in ISO 9001:1994, and refers to the unit to which this 本版用术语“组织”取代以前ISO9001:1994版International Standard applies. Also, the term “supplier” now 所用的”供方”，“组织”是指采用本国际标准的replaces the term “subcontractor”. 单位。相应用”供方”取代以前的”分承包方”。 Throughout the text of this International Standard, wherever the term “product” occurs, it can also mean “service”. 通贯本国际标准全文，凡是提到”产品”这一词的 地方亦可代表”服务”之意。 Key Characteristics: The features of a material, process, or part whose variation has a significant influence on 关键特性:材料，过程或零件的这样一些特性，product fit, performance, service life, or 其变化将对产品安装、性能、服务寿命或制造manufacturability. 性产生重大影响。 4 Quality management system 4 质量管理体系 4.1 General requirements 4.1一般要求 The organization shall establish, document, implement and maintain a quality management system and continually 组织必须遵照本国际标准的要求建立、文件化、improve its effectiveness in accordance with the requirements 执行、维持质量管理体系并持续改进其有效性。 of this International Standard. The organization shall 组织必须: Page 5 of 29 Version 05/04/2002 Items of SAE AS 9100:2000 Aerospace Quality Standard SAE AS 9100:2000 航空航天质量标准条款 (Rev.B,Aug.2001) (B 版，2002年8月) 中文译稿 a) identify the processes needed for the quality management system and their application throughout the organization a) 识别质量管理体系所必需的过程及其在组(see 1.2), 织中之应用(见1.2)， b) determine the sequence and interaction of these processes, b) 确定这些过程的顺序以及相互作用， c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective, c) 确定及确保这些过程有效运作并加以控制 所必需的判别准则和方法， d) ensure the availability of resources and information necessary to support the operation and monitoring of these d) 确保提供支持这些过程的运作及监控所必processes, 要的各种资源与信息， e) monitor, measure and analyse these processes, and e) 监控、量测及分析这些过程，和 f) implement actions necessary to achieve planned results and continual improvement of these processes. f) 采取必要的行动措施以达到策划所要达到 的结果，并持续改进这些过程。 These processes shall be managed by the organization in accordance with the requirements of this International 组织必须遵照本国际标准的要求管理这些过Standard. 程。 Where an organization chooses to outsource any process that affects product conformity with requirements, the organization 凡是组织选择外部协作的过程中会影响产品符shall ensure control over such processes. Control of such 合性要求的，组织必须确保对这些过程加以控outsourced processes shall be identified within the quality 制。而且对这些外协过程的控制必须在质量管management system. 理体系中加以标识。 NOTE Processes needed for the quality management system 注:上述质量管理体系所必需的过程应该包括referred to above should include processes for management 管理活动过程、资源提供过程、产品实现过程activities, provision of resources, product realization and 与量测过程。 measurement. 4.2 Documentation requirements 4.2文件化要求 4.2.1 General 4.2.1 通则 The quality management system documentation shall include 质量管理体系文件化必须包括: a) documented statements of a quality policy and quality objectives, a)文件化阐明的质量方针与质量目标; b) a quality manual, b)质量手册; c) documented procedures required by this International Standard, c)本国际标准要求的文件化程序; d) documents needed by the organization to ensure the effective planning, operation and control of its processes, d)组织确保对其各种过程进行有效策划、运作 及控制所必需的各种文件; e) records required by this International Standard (see 4.2.4), and e)本国际标准要求的各种记录;以及 (见 4.2.4) f) quality system requirements imposed by the Page 6 of 29 Version 05/04/2002 Items of SAE AS 9100:2000 Aerospace Quality Standard SAE AS 9100:2000 航空航天质量标准条款 (Rev.B,Aug.2001) (B 版，2002年8月) 中文译稿 applicable regulatory authorities. 适用的法规性机构所强制的要求。 f) The organization shall ensure that personnel have access to quality management system documentation 组织必须确保员工可以接触质量管理体系文件and are aware of relevant procedures. Customer and/or 并认知相关程序。顾客和/或法规性机构代表应regulatory authorities representatives shall have access 该可以接触质量管理体系文件。to quality management system documentation. NOTE 1 Where the term “documented procedure” appears within this International Standard, this means that the 注:1本国际标准中出现”文件化程序”之处，系procedure is established, documented, implemented and 要求该程序必须被建立、文件化、实施及维maintained. 持。 NOTE 2 The extent of the quality management system documentation can differ from one organization to another 注:2.一个组织与另一个组织其质量管理体系due to 文件化的程度由于下列原因 可能有所差 别: a) the size of the organization and type of activities, a) 组织的规模及活动的类型， b) the complexity of processes and their interactions, and b) 过程的复杂性以及它们的相互作用， c) the competencies of personnel. c) 员工能力的胜任程度。 NOTE 3 The documentation can be in any form or type of medium. 注:3.文件可能采用各种形式或各种类型的载 体。 4.2.2 Quality manual 4.2.2 质量手册 The organization shall establish and maintain a quality manual that includes 组织必须建立并维持质量手册，其内容包含 a) the scope of the quality management system, including details of and justification for any exclusions (see1.2.), a) 质量管理体系的范围，包括被剪裁部份的详 细内容和理由 (见1.2)， b) the documented procedures established for the quality b) 质量管理体系所建立的文件化程序，或引用management system, or reference to them, and 这些程序，以及 - when referencing the documented procedures, the relationship between the requirements of this ,在引用文件化程序时必须清楚地表明本international Standard and the documented 国际标准要求和文件化程序之间的关系。 procedures shall be clearly shown. c) a description of the interaction between the processes of c) 描述质量管理体系各过程的相互作用。 the quality management system. 4.2.3 Control of documents 4.2.3 文件的控制 Documents required by the quality management system shall 质量管理体系所要求的各种文件必须加以控be controlled. Records are a special type of document and 制。记录是一种特殊形式的文件，应依据条文shall be controlled according to the requirements given in 4.2.4的要求加以控制。 4.2.4. A documented procedure shall be established to define the 必须建立文件化程序，对下列内容规定必需的controls needed 控制: Page 7 of 29 Version 05/04/2002 Items of SAE AS 9100:2000 Aerospace Quality Standard SAE AS 9100:2000 航空航天质量标准条款 (Rev.B,Aug.2001) (B 版，2002年8月) 中文译稿 a) to approve documents for adequacy prior to issue, a) 文件发行前，批准文件的充分性， b) to review and update as necessary and re-approve b) 评审，必要时改版更新和重新批准， documents, c) to ensure that changes and the current version status of c) 确保对文件所作更改的内容以及现行有效documents are identified, 更改版次状态加以标识， d) to ensure that relevant versions of applicable documents d) 确保使用文件各场所，持有相应版次的适用are available at points of use, 文件， e) to ensure that documents remain legible and readily e) 确保文件保持易于阅读及容易识别， identifiable, f) to ensure that documents of external origin are identified f) 确保外来原始文件加以标识并控制其分发，and their distribution controlled, and 和 g) to prevent the unintended use of obsolete documents, and g) 防止作废文件被误用，如因任何目的而要留to apply suitable identification to them if they are retained 存时，应加以适当的标识。 for any purpose. The organization shall coordinate document changes 组织必须按合同或法规要求与顾客和/或法规with customers and/or regulatory authorities in 性机构协调文件的更改。accordance with contract or regulatory requirements. 4.2.4 Control of records 4.2.4 记录的控制 Records shall be established and maintained to provide 为了提供证明符合各项要求以及质量管理体系evidence of conformity to requirements and of the effective 有效运作的证据，必须建立与维护各种记录。operation of the quality management system. Records shall 质量记录必须易于阅读、识别及调用。必须建remain legible, readily identifiable and retrievable. A 立文件化程序定义有关记录的标识、储存、调documented procedure shall be established to define the 用、保护、保存期限和处置的控制方法。 controls needed for the identification, storage, protection, retrieval, retention time and disposition of records. The documented procedure shall define the method for 文件化程序必须确定控制供应商生成和/或保controlling records that are created by and/or retained by 存的记录的方法。 suppliers. Records shall be available for review by customers and 根据合同或法规的要求，记录必须可供顾客和regulatory authorities in accordance with contract or 法规性机构进行评审。 regulatory requirements. 4.3 Configuration Management 4.3 技术状态管理 The organization shall establish, document and maintain 组织必须建立、文件化并维持一个适合于产品a configuration management process appropriate to the 技术状态管理的过程。 product. NOTE Guidance on configuration management is given 注:ISO 10007给出了技术状态管理的 in ISO 10007. 指南。 5. Management responsibility 5 管理者职责 5.1 Management commitment 5.1 管理者承诺 Page 8 of 29 Version 05/04/2002 Items of SAE AS 9100:2000 Aerospace Quality Standard SAE AS 9100:2000 航空航天质量标准条款 (Rev.B,Aug.2001) (B 版，2002年8月) 中文译稿 Top management shall provide evidence of its commitment to 最高管理者必须通过下列行为提供证据，证明the development and implementation of the quality 其对质量管理体系的开发、实施以及体系的有management system and continually improving its 效性持续改进所作的承诺: effectiveness by a) communicating to the organization the importance of a) 对组织内部沟通满足顾客要求和法令、法规meeting customer as well as statutory and regulatory 要求的重要性， requirements, b) establishing the quality policy, b) 建立质量方针， c) ensuring that quality objectives are established, c) 确保质量目标的建立， d) conducting management reviews, and d) 执行管理评审，和 e) ensuring the availability of resources. e) 确保具备各种资源。 5.2 Customer focus 5.2 顾客为中心 Top management shall ensure that customer requirements 最高管理者应确保顾客的要求已加以确 定，而are determined and met with the aim of enhancing customer 且得到满足，同时达到提高顾客满意的目的(见satisfaction (see 7.2.1 and 8.2.1). 7.2.1及8.2.1)。 5.3 Quality policy 5.3 质量方针 Top management shall ensure that the quality policy 最高管理者必须确保质量方针 a) is appropriate to the purpose of the organization, a) 与组织的宗旨相协调， b) includes a commitment to comply with requirements and b) 包括符合各项要求以及持续改进质量管理continually improve the effectiveness of the quality 体系有效性的承诺， management system, c) provides a framework for establishing and reviewing quality c) 提供一个建立及评审质量目标的体制， objectives, d) is communicated and understood within the organization, d) 在组织内部得到沟通和理解，以及 and e) is reviewed for continuing suitability. e) 评审其持续的适宜性。 5.4 Planning 5.4 策划 5.4.1 Quality objectives 5.4.1 质量目标 Top management shall ensure that quality objectives, 最高管理者必须确保组织内部各相关职能及各including those needed to meet requirements for product [see 层级都建立有质量目标，其中包括为满足产品7.1 a)], are established at relevant functions and levels within 各项要求(见7.1.a)所必须的各项目标。质量the organization. The quality objectives shall be measurable 目标必须可量测的，而且必须与质量方针相一and consistent with the quality policy. 致。 5.4.2 Quality management system planning 5.4.2 质量管理体系规策划 Top management shall ensure that Page 9 of 29 Version 05/04/2002 Items of SAE AS 9100:2000 Aerospace Quality Standard SAE AS 9100:2000 航空航天质量标准条款 (Rev.B,Aug.2001) (B 版，2002年8月) 中文译稿 最高管理者必须确保: a) the planning of the quality management system is carried out in order to meet the requirements given in 4.1, as well a) 对质量管理体系进行策划，以此满足条文as the quality objectives, and 4.1所提出的各项要求并实现质量目标，而 且 b) the integrity of the quality management system is maintained when changes to the quality management b) 当对质量管理体系的更改进行策划时，以及system are planned and implemented. 对体系实施更改时，维持质量管理体系的完 整性。 5.5 Responsibility, authority and communication 5.5职责、权限与沟通 5.5.1 Responsibility and authority 5.5.1 职责与权限 Top management shall ensure that the responsibilities, authorities are defined and communicated within the 最高管理者必须确保职责、权限加以规定，并organization. 在组织内部进行沟通。 5.5.2 Management representative 5.5.2管理者代表 Top management shall appoint a member of management who, irrespective of other responsibilities, shall have 最高管理者必须指派管理阶层中之一员，不管responsibility and authority that includes 其他职责如何，必须具有下列职责、权限: a) ensuring that processes needed for the quality management system are established, implemented and a) 确保质量管理体系所必需各个过程的建立、maintained, 执行和维持; b) reporting to top management on the performance of the quality management system and any need for b) 向最高管理者报告质量管理体系运作的缋效improvement, 以及任何改进的必要; c) ensuring the promotion of awareness of customer requirements throughout the organization, and c) 确保整个组织对顾客要求认知的提升,及 d) the organizational freedom to resolve matters pertaining to quality. d)解决有关质量事务的组织赋予的特权。 NOTE The responsibility of a management representative can 注:管理者代表的职责可能包括与外部机构进include liaison with external parties on matters relating to the 行有关质量管理体系事务的联系。 quality management system. 5.5.3 Internal communication 5.5.3 内部沟通 Top management shall ensure that appropriate communication processes are established within the 最高管理者必须确保组织内部进行恰当沟通的organization and that communication takes place regarding 过程已建立，并且对于质量管理体系的有效性the effectiveness of the quality management system. 进行沟通。 5.6 Management review 5.6 管理评审 5.6.1 General 5.6.1 通则 Top management shall review the organization’s quality management system, at planned intervals, to ensure its 最高管理者必须按策划规定的间隔期间评审质continuing suitability, adequacy and effectiveness. This 量管理体系，以确保体系的持续适宜性、充分 Page 10 of 29 Version 05/04/2002 Items of SAE AS 9100:2000 Aerospace Quality Standard SAE AS 9100:2000 航空航天质量标准条款 (Rev.B,Aug.2001) (B 版，2002年8月) 中文译稿 review shall include assessing opportunities for improvement 性和有效性。管理评审包括对改进机会的评估and the need for changes to the quality management system, 以及对质量管理体系，包括质量方针与目标更including the quality policy and quality objectives. 改必要性的评估。 Records from management review shall be maintained (see 4.2.4). 管理评审的记录必须加以维持(见4.2. 4)。 5.6.2 Review input 5.6.2 管理评审的输入 The input to management review shall include information on 管理评审的输入必须涵盖下列信息: a) results of audits, a) 各种审核的结果， b) customer feedback, b) 顾客的返馈信息， c) process performance and product conformity, c) 过程的绩效及产品的符合性， d) status of preventive and corrective actions, d) 各项纠正措施与预防措施的执行状况， e) follow-up actions from previous management reviews, e) 以往管理评审所作 决议 历史决议下载古田会议决议全文下载关于若干历史问题的决议下载关于若干历史问题的决议原文关于若干历史问题的决议pdf 事项的跟踪， f) changes that could affect the quality management system, and f) 可能影响质量管理体系的各种更改，和 g) recommendations for improvement. g) 各种改进建议。 5.6.3 Review output 5.6.3 管理评审的输出 The output from the management review shall include any decisions and actions relate to 管理评审的输出必须包括与下列有关内容的各 项决议与行动: a) improvement of the effectiveness of the quality management system and its processes, a)质量管理体系及其过程有效性的改进， b) improvement of product related to customer requirements, and b)与顾客要求有关产品的改进， 和 c) resource needs. c) 必需的资源 。 6 Resource management 6.资源管理 6.1 Provision of resources 6.1 资源的提供 The organization shall determine and provide the resources needed 组织必须确定和提供必要的资源以 a) to implement and maintain the quality management system and continually improve its effectiveness, and a) 实施和维护质量管理体系并持续改进其有效 性，和 b) to enhance customer satisfaction by meeting customer requirements. b) 通过满足顾客的各项要求以增进顾客的满 意。 6.2 Human resources 6.2 人力资源 6.2.1 General Page 11 of 29 Version 05/04/2002 Items of SAE AS 9100:2000 Aerospace Quality Standard SAE AS 9100:2000 航空航天质量标准条款 (Rev.B,Aug.2001) (B 版，2002年8月) 中文译稿 6.2.1 通则 Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, 凡从事对产品质量有影响工作的人员，均必须skills and experience. 在适当的教育、培训、技能和经验的基础上胜 任其职务。 6.2.2 Competence, awareness and training 6.2.2 胜任能力、认知与培训 The organization shall 组织必须: a) determine the necessary competency for personnel performing work affecting product quality, a) 对从事与产品质量有影响工作的人员确定 其必需的胜任能力。 b) provide training or take other actions to satisfy these needs, b) 提供培训或其它措施以满足这些必需的要 求。 c) evaluate the effectiveness of the actions taken, c) 评估所采取措施的有效性， d) ensure that its personnel are aware of the relevance and d) 确保员工认知他们工作的相互关系和重要importance of their activities and how they contribute to the 性，以及他们如何为实现质量目标作贡献achievement of the quality objectives, and 的，以及 e) maintain appropriate records of education, training, skills e) 维持相应的教育、培训、技能及经验的记录and experience (see 4.2.4). (见4.2.4)。 6.3 Infrastructure 6.3 基础设施 The organization shall determine, provide and maintain the 组织必须确定、提供及维护为满足产品要求符infrastructure needed to achieve conformity to product 合性所必需的基础设施。基础设施(在适用时)requirements. Infrastructure includes, as applicable 包括: a) building, workspace and associated utilities; a) 建筑物、工作空间及附属的设施; b) process equipment (both hardware and software), and b) 过程用设备(硬件和软件两方面 )，和 c) supporting services (such as transport or communication). c) 支持性的服务( 例如运输或通讯)。 6.4 Work environment 6.4 工作环境 The organization shall determine and manage the work 组织必须确定和管理为满足产品要求符合性所environment needed to achieve conformity to product 必需的工作环境。 requirements. NOTE Factors that may affect the conformity of the 注:可以影响产品符合性的因素包括温 product include temperature, humidity, lighting, 度，湿度，光线，清洁度，静电防 cleanliness, protection from electrostatic discharge, etc. 护等。 7 Product realization 7 产品实现 7.1 Planning of product realization 7.1 产品实现的策划 The organization shall plan and develop the processes 组织必须策划和开发对产品实现所必需的各种needed for product realization. Planning of product realization 过程，产品实现过程的策划必须与质量管理体shall be consistent with the requirements of the other 系其它过程的要求相协调。 processes of the quality management system (see 4.1). Page 12 of 29 Version 05/04/2002 Items of SAE AS 9100:2000 Aerospace Quality Standard SAE AS 9100:2000 航空航天质量标准条款 (Rev.B,Aug.2001) (B 版，2002年8月) 中文译稿 In planning product realization, the organization shall 在策划产品实现过程时，组织必须，根据具体determine the following, as appropriate: 情况恰当地，确定下列事项: a) quality objectives and requirements for the product; a) 产品的各项质量目标和各项要求; b) the need to establish processes, documents, and provide b) 针对产品必须建立的各种过程、文件，提供resources specific to the product; 各种资源; c) required verification, validation, monitoring, inspection and c) 针对产品必要的验证、确认、监控、检验与test activities specific to the product and the criteria for 试验活动以及产品的合格验收判别准则; product acceptance; d) records needed to provide evidence that the realization d) 用以证明产品实现过程以及最终产品符合processes and resulting product meet requirements (see 要求所必需的各种记录(见 4.2. 4)。 4.2.4); e) the identification of resources to support operation e) 识别支持产品运行及维护的资源。 and maintenance of the product. The output of this planning shall be in a form suitable for the 这项策划工作的输出应采用适合组织运作方式organization’s method of operations. 的格式。 NOTE 1 A document specifying the processes of the quality 注: 1.针对特定产品、专题或合同规定 质量management system (including the product realization 管理体系要采用的各种过程(包括产品实processes) and the resources to be applied to a specific 现过程)以及要用的各种资源的书面文件，product, project or contract, can be referred to as a quality 能称为质量 计划 项目进度计划表范例计划下载计划下载计划下载课程教学计划下载 。 plan. NOTE 2 The organization may also apply the requirement 注:2组织亦可把条文7.3所规定的各项要求given in 7.3 to the development of product realization 用于产品实现过程的开发工作。 processes. 7.2 Customer-related processes 7.2 顾客相关的过程 7.2.1确定产品相关的要求 7.2.1 Determination of requirements related to the product The organization shall determine 组织必须确定 a) requirements specified by the customer, including the a) 顾客已明确规定的各项要求，包括对交付与requirements for delivery and post-delivery activities, 交付以后各项活动的要求， b) requirements not stated by the customer but necessary for b) 顾客并没有规定，但相对于规定的或意向的specified or intended use, where known, 使用来说是必要的，凡是已经认识到的各种 要求。 c) statutory and regulatory requirements related to product, c) 与产品相关法令及法规的要求，和 and d) any additional requirements determined by the d) 组织确定的任何附加要求。 organization. 7.2.2 Review of requirements related to the product 7.2.2 产品相关要求的评审 The organization shall review the requirements related to the 组织必须评审与产品相关的各种要求。此项评 Page 13 of 29 Version 05/04/2002 Items of SAE AS 9100:2000 Aerospace Quality Standard SAE AS 9100:2000 航空航天质量标准条款 (Rev.B,Aug.2001) (B 版，2002年8月) 中文译稿 product. This review shall be conducted prior to the 审必须在向顾客承诺提供产品(即:提出标单、organization’s commitment to supply a product to the 接受合同或订单、接受合同或订单的更改)之前customer (e.g. submission of tenders, acceptance of 完成。并且必须确保 contracts or orders, acceptance of changes to contracts or orders) and shall ensure that a) product requirements are defined, a) 产品的各项要求已被定义， b) contract or order requirements differing from those b) 合同或订单的各项要求与先前表达有所不同previously expressed are resolved, 之处已加以解决， c) the organization has the ability to meet the defined c) 组织有能力满足已定义的各项要求，和 requirements, and d) risks (e.g., new technology, short delivery time scale ) d) 已评估风险(如:新技术，短的交付期)。 have been evaluated. Records of the results of the review and actions arising from 评审结果以及评审所提出的各项行动措施结果the review shall be maintained (see 4.2.4). 的记录必须加以维持(见4.2.4)。 Where the customer provides no documented statement of 凡是顾客不是以文件化提出的各种要求，组织requirement, the customer requirements shall be confirmed 在接受顾客要求之前必须加以确准。 by the organization before acceptance. Where product requirements are changed, the organization 当产品要求有更改时，组织必须确保相关文件shall ensure that relevant documents are amended and that 被修正，以及相关人员都知道更改后的要求。 relevant personnel are made aware of the changed requirements. NOTE: In some situations, such as in internet sales, a formal 注:在某些情况下，例如网络行销，对每一份review is impractical for each order. Instead the review can 订单进行正式评审是不现实的。取代的做法cover relevant product information such as catalogues or 可以对有关产品信息，例如产品目录、或者advertising material. 广告材料等进行评审。 7.2.3 与顾客的沟通 7.2.3 Customer communication The organization shall determine and implement effective 组织必须确定并实施有效的安排，以便与顾客arrangements for communicating with customers in relation 进行有关下列内容的沟通: to: a) product information, a) 产品信息， b) enquiries, contracts or order handling, including b) 询价，合同或订单的处理，包括修改，和 amendments, and c) customer feedback, including customer complaints. c) 顾客返馈，包括顾客的抱怨。 7.3 Design and development 7.3 设计与开发 7.3.1 Design and development planning 7.3.1 设计与开发的策划 The organization shall plan and control design and 组织必须策划和控制产品的设计与开发活动。 development of product. Page 14 of 29 Version 05/04/2002 Items of SAE AS 9100:2000 Aerospace Quality Standard SAE AS 9100:2000 航空航天质量标准条款 (Rev.B,Aug.2001) (B 版，2002年8月) 中文译稿 During the design and development planning, the 在进行设计与开发策划时，组织必须确定 organization shall determine a) the design and development stages, a) 设计与开发工作的各个阶段， - in respect of organization, task sequence, mandatory ,关于机构，任务顺序，委任步骤，重要阶steps, significant stages and method of configuration 段和技术状态控制， control, b) the review, verification and validation that are appropriate b) 与设计和开发工作各个阶段相适应的各种评to each design and development stage, and 审、验证和确认活动，和 c) the responsibilities and authorities for design and c) 设计与开发活动的职责与职权。 development. Where appropriate, due to complexity, the organization 在合适时，根据复杂性，组织必须考虑下述活shall give consideration to the following activities: 动: - structuring the design effort into significant elements; ,将设计努力构作于重要的元素之中; - for each element, analyzing the tasks and the ,对每个元素，分析其设计及开发的任 necessary resources for its design and 务和必要的资源。分析应考虑一个确 development. This analysis shall consider an 认的责任人、设计内容、输入数据、 identified responsible person, design content, input 策划限制和性能条件。每一元素的输 data, planning constraints, and performance 入数据必须被评审以确保与产品要求 conditions. The input data specific to each element 的一致。 shall be reviewed to ensure consistency with requirements. The organization shall manage the interfaces between different groups involved in design and development to 组织必须管理参与设计开发不同群组之间的接ensure effective communication and clear assignment of 口，确保有效的沟通和职责的明确分工。 responsibility. Planning output shall be updated, as appropriate, as the 策划的输出必须根据设计与开发工作的进展做design and development progresses. 相应的更新。 The different design and development tasks to be carried out shall be defined according to specified safety or 必须按照顾客和/或法规性机构的要求根据产functional objectives of the product in accordance with 品特定的安全性或性能目标确定要进行的不同customer and/or regulatory authority requirements. 设计和开发任务。 7.3.2 Design and development inputs 7.3.2 设计与开发的输入 Inputs relating to product requirements shall be determined 有关产品要求的各种输入必须加以确定，记录and records maintained (see 4.2.4). These shall include 必须维持(见4.2.4)。这些必须包括 a) functional and performance requirements, a) 功能与性能要求， b) applicable statutory and regulatory requirements, b) 相应的法规和法令要求， c) where applicable, information derived from previous similar c) 凡应加以采用的，从过去类似设计推导出来designs, and 的各种信息，以及 d) other requirements essential for design and development. d) 其它对设计与开发至关重要的要求。 Page 15 of 29 Version 05/04/2002 Items of SAE AS 9100:2000 Aerospace Quality Standard SAE AS 9100:2000 航空航天质量标准条款 (Rev.B,Aug.2001) (B 版，2002年8月) 中文译稿 These inputs shall be reviewed for adequacy. Requirements 必须评审这些设计输入的充分性。各项要求必shall be complete, unambiguous and not in conflict with each 须完整、没有模棱两可，以及相互之间不产生other. 冲突的。 7.3.3 Design and development outputs 7.3.3 设计与开发的输出 The outputs of design and development shall be provided in a 设计与开发的输出必须在形式上能针对设计与form that enables verification against the design and 开发输入进行验证的，而且在发出前必须加以development input and shall be approved prior to release. 批准。 Design and development outputs shall 设计与开发的输出必须 a) meet the input requirements for design and development, a) 符合设计与开发输入的各项要求， b) provide appropriate information for purchasing , production b) 为采购、生产及服务提供相应的适当信息， and for service provision, c) contain or reference product acceptance criteria, c) 包含或引用产品合格验收用的判别准则， d) specify the characteristics of the product that are essential d) 规定对产品安全以及正当使用至关重要的 for its safe and proper use, and 各种产品特性,和 e) identify key characteristics, when applicable, in e) 适用时，根据设计或合同要求识别关 accordance with design or contract requirements. 键特性。 All pertinent data required to allow the product to be 所有允许产品被确认、制造、检查、使用和维identified, manufactured, inspected, used and 护所要求的相关数据必须由组织确定;例如: maintained shall be defined by the organization; for example: - drawings, part lists, specifications; , 图纸，零件目录，技术条件; - a listing of those drawings, part lists, and , 定义产品技术状态和设计特性所必要 specifications necessary to define the configuration 的这些图纸、零件目录、技术条件的 and the design features of the product; 目录; - information on material, processes, type of , 确保产品符合性所必须的关于产品 manufacturing and assembly of the product 材料、过程、制造和装配形式的信 necessary to ensure the conformity of the product. 息。 7.3.4 Design and development review 7.3.4设计与开发的评审 At suitable stages, systematic reviews of design and 必须按照策划所作安排(见7.3.1)，在相应的development shall be performed in accordance with planned 阶段进行有系统地设计和开发评审，以便 arrangements (see 7.3.1) a) to evaluate the ability of the results of design and a) 评估设计与开发结果满足各项要求的能力，development to meet requirements, 和 b) to identify any problems and propose necessary actions, b) 发现存在的问题并建议必要的措施, and 和 c) to authorize progression to the next stage. c) 认可进入下一阶段。 Participants in such reviews shall include representatives of 参与此类评审者，应包括正在接受评审的与该functions concerned with the design and development 设计与开发阶段有关职能部门的代表。设计评stage(s) being reviewed. Records of the result of the reviews 审结果的记录以及必要行动措施结果的记录必and any necessary actions shall be maintained (see 4.2.4) 须加以维持。(见4.2.4) Page 16 of 29 Version 05/04/2002 Items of SAE AS 9100:2000 Aerospace Quality Standard SAE AS 9100:2000 航空航天质量标准条款 (Rev.B,Aug.2001) (B 版，2002年8月) 中文译稿 7.3.5 Design and development verification 7.3.5 设计与开发的验证 Verification shall be performed in accordance with planned 必须根据策划(见7.3.1)的安排执行设计与开arrangements (see 7.3.1) to ensure that the design and 发的验证，确保设计与开发的输出符合设计与development outputs have met the design and development 开发输入的要求。设计验证结果的记录以及必input requirements. Records of the results of the verification 要行动措施结果的记录必须加以维持(见and any necessary actions shall be maintained (see 4.2.4) 4.2.4)。 NOTE Design and/or development verification may include activities such as: 注:设计和/或开发验证可以包括这样一 些活动: - performing alternative calculations, , 变换方法进行计算; - comparing the new design with a similar proven , 可能时，将新设计与已证实的类似设 design, if available, 计进行比较; - undertaking tests and demonstrations, and , 进行试验和证实,并 - reviewing the design stage documents before , 对发放前的设计阶段文件进行评审。 release. 7.3.6 Design and development validation 7.3.6 设计与开发的确认 Design and development validation shall be performed in 必须根据策划(见7.3.1)的安排执行设计与开accordance with planned arrangements (see 7.3.1) to ensure 发的确认，确保最终产品能够满足所有已经认that the resulting product is capable of meeting the 识到的，各种规定的应用要求，或者意向的使requirements for the specified application or intended use, 用要求。凡是可行的，确认工作必须在产品交where known. Wherever practicable, validation shall be 付或者产品的实际使用之前完成。确认结果的completed prior to the delivery or implementation of the 记录以及必要行动措施结果的记录必须加以维product. Records of the results of validation and any 持。(见4.2. 4)。 necessary actions shall be maintained (see 4.2.4). 注: NOTES , 设计和/或开发确认在成功的设计验 - Design and/or development validation follows 证之后进行; successful design and/or development verification. , 确认通常在规定的操作条件下进行; - Validation is normally performed under defined operating conditions. , 确认通常针对最终产品进行，但产品 - Validation is normally performed on the final 完成前的各阶段也可能需要进行; product, but may be necessary in earlier stages prior to product completion. , 如果有不同的预期用途，业可以进行 - Multiple validations may be performed if there are 多次进行。 different intended uses. 7.3.6.1 设计和/或开发验证和确认的文 7.3.6.1 Documentation of Design and/or Development 件 Verification and Validation 在设计和/或开发完成时，组织必须确保 At the completion of design and/or development, the 报告、计算、试验结果等证明产品定义满足所organization shall ensure that reports, calculations, test 有确定使用条件的规格要求。 results, etc., demonstrate that the product definition meets the specification requirements for all identified operational conditions. 7.3.6.2 Design and/or Development Verification and 7.3.6.2 设计和/或开发验证和确认试验 Validation Testing Where tests are necessary for verification and validation, 在试验对验证和确认是必要时，则必须策划、 控制、评审并文件化这些试验以确保和证实如 Page 17 of 29 Version 05/04/2002 Items of SAE AS 9100:2000 Aerospace Quality Standard SAE AS 9100:2000 航空航天质量标准条款 (Rev.B,Aug.2001) (B 版，2002年8月) 中文译稿 these tests shall be planned, controlled, reviewed, and 下要求: documented to ensure and prove the following: a.试验计划或技术条件确定了要进行试 a. test plans or specifications identify the 验的产品和所要用的资源;定义了试 product being tested and the resources 验目标和条件、要记录的参数和相应 being used, define test objectives and 的接受判别准则; conditions, parameters to be recorded, and relevant acceptance criteria; b.试验程序描述了操作方法、试验性能 b. test procedures describe the method of 和结果的记录; operation, the performance of the test, and the recording o the results; c.正确的产品技术状态标准被递交于试 c. the correct configuration standard of the 验; product is submitted for the test; d.试验计划和试验程序已被观察; d. the requirements of the test plan and the test procedures are observed; e.验收的判别准则满足条件。 e. the acceptance criteria are met. 7.3.7 Control of design and development changes 7.3.7 设计与开发更改的控制 Design and development changes shall be identified and 设计与开发的各种更改必须加以标识，更改记records maintained. The changes shall be reviewed, verified 录必须加以维持。这种更改必须恰当地评审、and validated, as appropriate, and approved before 验证和确认，并且在执行更改之前加以批准。implementation. The review of design and development 对设计与开发更改所作的评审必须包括更改对changes shall include evaluation of the effect of the changes 其构成部分以及已交付产品影响的评估。 on constituent parts and product already delivered. The organization’s change control process shall provide 当合同或法规要求时，组织的更改控制过程必for customer and/or regulatory authority approval of 须提供给顾客和/或法规性机构以批准更改。 changes, when required by contract or regulatory requirement. Records of the results of the review of changes and any 更改评审结果的各种记录以及必要行动措施结necessary actions shall be maintained (see 4.2.4) 果的记录必须加以维持。(见4.2.4) 7.4 采购 7.4 Purchasing 7.4.1 Purchasing process 7.4.1 采购过程 The organization shall ensure that purchased product 组织必须确保采购品符合规定的各项采购要conforms to specified purchase requirements. The type and 求。对供方以及采购品所施加的控制方式及程extent of control applied to the supplier and the purchased 度必须根据采购品对后续的产品实现或者最终product shall be dependent upon the effect of the purchased 产品的影响程度来决定。 product on subsequent product realization or the final product. The organization shall be responsible for the quality of 组织必须对所有从供应商处采购的产品质量负all products purchased from suppliers, including 责～包括顾客指定的资源。 customer-designated sources. The organization shall evaluate and select suppliers based on 组织必须根据供方能够提供符合组织提出的要their ability to supply product in accordance with the 求产品的能力来评估及选择供方。选择、评估organization’s requirements. Criteria for selection, evaluation 及定期复评供方所用的判别准则必须建立。评and re-evaluation shall be established. Records of the results 估结果的记录以及通过评估提出问题后必须采of evaluations and any necessary actions arising from the 取的行动措施结果的记录必须加以维持(见evaluation shall be maintained (see 4.2.4) 4.2.4)。 Page 18 of 29 Version 05/04/2002 Items of SAE AS 9100:2000 Aerospace Quality Standard SAE AS 9100:2000 航空航天质量标准条款 (Rev.B,Aug.2001) (B 版，2002年8月) 中文译稿 The organization shall: 组织必须: a. maintain a register of approved suppliers that includes the scope of the approval; a。保持一份批准的供应商登记表～包括 b. periodically review supplier performance; records of 批准的范围, these reviews shall be used as a basis for b。周期性地评估供应商的表现,这些评 establishing the level of controls to be implemented; 估记录应用作为确立要实施的控制水 c. define the necessary actions to take when dealing 平的基础, c。在处理不符合要求的供应商时～确定 with suppliers that do not meet requirements; 要采取的必要措施, d. ensure where required that both the organization d。确保在要求的场合～组织和所有供应 and all suppliers use customer-approved special 商双方使用顾客批准的特定过程资源, process sources; e. ensure that the function having responsibility for e。确保具有批准供应商质量体系职责的 approving supplier quality systems has the authority 部门有权不批准资源的使用。to disapprove the use of sources. 7.4.2 Purchasing information 7.4.2 采购信息 Purchasing information shall describe the product to be purchased, including where appropriate 采购信息必须清楚描述要采购的产品，其内容， 根据实际情况，包括 a) requirements for approval of product, procedures, processes and equipment, a) 对产品、程序、过程及设备的批准要求， b) requirements for qualification of personnel, b) 人员的资格鉴定要求，和 c) quality management system requirements, c) 质量管理体系的要求。 d) the name or other positive identification, and applicable issues of specifications, drawings, process d)名称或其他直接的标识～和技术条件～图纸～requirements, inspection instructions and other 过程要求～检验指导书及其他相关技术资料的relevant technical data, 适用版本, e) requirements for design, test, examination, inspection and related instructions for acceptance by the e,组织所接受的设计、试验、考核、检 organization, 验和有关的指导书 f) requirements for test specimens (e.g., production method, number, storage conditions) for design f,用于设计批准、检验、审核研究的的 approval, inspection, investigation or auditing, 试样要求,例如～生产方法～数量。 储藏条件。, g) requirements relative to - supplier notification to organization of g,相关要求: nonconforming product and - arrangements for organization approval of supplier - 供应商向组织通知不合格产品～及 nonconforming material, - 组织批准供应商不合格材料的安排, h) requirements for the supplier to notify the organization of changes in product and/or process definition h,要求供应商将产品和/或过程定义的 and ,where required, obtain organization approval, 变化通知组织～并且在有要求时要获 i) right of access by the organization, their customer, 得组织的批准, and regulatory authorities to all facilities involved in i,组织及其顾客和法规性机构可进入订 the order and to all applicable records, and 单涉及的所有设施和所有适用记录的权利～ 和 Page 19 of 29 Version 05/04/2002 Items of SAE AS 9100:2000 Aerospace Quality Standard SAE AS 9100:2000 航空航天质量标准条款 (Rev.B,Aug.2001) (B 版，2002年8月) 中文译稿 j)requirements for the supplier to flow down to sub-tier j,要求供应商对下一层的供应商按采购 suppliers the applicable requirements in the purchasing 文件要求～包括所要求的关键特性。 documents, including key characteristics where required. The organization shall ensure the adequacy of specified 组织必须在与供方进行沟通之前确保各项规定requirements prior to their communication to the supplier. 要求的充分性。 7.4.3 Verification of purchased product 7.4.3 采购品的验证 The organization shall establish and implement the inspection 组织必须建立和实施为确保采购品符合各项规or other activities necessary for ensuring that purchased 定的采购要求所必需的检验或其它活动。 product meets specified purchase requirements. Verification activities may include 验证活动可以包括 a. obtaining objective evidence of the quality of the a。从供应商处获得产品质量的客观证据 product from suppliers ( e.g., accompanying ,例如～随产品文件～合格证～试验报 documentation, certificate of conformity, test 告～统计记录～过程控制,, reports, statistical records, process control), b. inspection and audit at supplier’s premises, b。在供应商处的检验和审核, c. review of the required documentation, c。评审所要求的文件, d. inspection of products upon receipt, and d。按收货单检验产品～和 e. delegation of verification to the supplier, or supplier e。派员去供应商处验证～或供应商取得 certification. 认证。 Purchased product shall not be used or processed until 采购的产品在已经验证符合规定的要求前不可it has been verified as conforming to specified 被使用或加工～除非是在 追回程序控制下放requirements unless it is released under positive recall 行。 procedure. Where the organization utilizes test reports to verify 在组织利用试验报告来验证采购的产品时～那purchased product, the data in those reports shall be 些报告中的数据按适用的技术条件必须是可接acceptable per applicable specifications. The 受的。组织必须周期性地对原材料确认试验报organization shall periodically validate test reports for 告。 raw material. Where the organization delegates verification activities 在组织派员去供应商处进行验证时～对成员的to the supplier, the requirements for delegation shall be 要求必须被确定～并保持一份成员登记表。 defined and a register of delegations maintained. Where the organization or its customer intends to perform 当组织或其顾客有意在供方处进行验证时，组verification at the supplier’s premises, the organization shall 织必须在采购信息中说明意向的验证工作安排state the intended verification arrangements and method of 以及产品的放行办法。 product release in the purchasing information. Where specified in the contract, the customer or the 在合同中指定的地方～提供顾客或顾客代表权customer’s representative shall be afforded the right to 利～在供应商处和组织处验证分合同产品是否verify at the supplier’s premises and the organization’s 符合规定的要求, premises that subcontracted product conforms to specified requirements. Page 20 of 29 Version 05/04/2002 Items of SAE AS 9100:2000 Aerospace Quality Standard SAE AS 9100:2000 航空航天质量标准条款 (Rev.B,Aug.2001) (B 版，2002年8月) 中文译稿 Verification by the customer shall not be used by the 顾客的验证不应该由组织用作为供应商有效控organization as evidence of effective control of quality by 制质量的证据。顾客的验证既不能减轻杂志提the supplier and shall not absolve the organization of the 供合格产品的责任～也不能排除其后顾客的拒responsibility to provide acceptable product, nor shall it 收。 preclude subsequent rejection by the customer. 7.5 Production and service provision 7.5 生产及服务提供 7.5.1 Control of Production and Service Provision 7.5.1 生产及服务提供之控制 Planning shall consider, as applicable, 适用时，策划必须考虑: - the establishment of process controls and - 建立过程控制并且在关键特性已经识 development of control plans where key 别的方面形成控制计划, characteristics have been identified, - the identification of in-process verification points - 在实现的较后阶段不能充分验证符合 when adequate verification of conformance cannot 性时～识别过程中的验证点, be performed at a later stage of realization, - the design, manufacture, and use of tooling so that - 工装的设计、制造和使用使得可以进 variable measurements can be taken, particularly for 行易变的测量～特别对于关键特性, key characteristics, and 及 - special processes (see 7.5.2) - 特殊过程,见7.5.2)。 The organization shall plan and carry out production and 组织必须策划并在控制状态下进行生产和提供service provision under controlled conditions. Controlled 服务。控制状态必须包括下列应加以采用的项conditions shall include, as applicable 目 a) the availability of information that describes the characteristics of the product, a) 提供描述产品各种特性的信息， b) the availability of work instructions, as necessary, b) 必要时，提供作业指导书， c) the use of suitable equipment, c) 使用合适的设备， d) the availability and use of monitoring and measuring devices, d) 具备并使用监控和量测设备， e) the implementation of monitoring and measurement, and e) 实施监控与量测，和 f) the implementation of release, delivery and post-delivery activities, f) 实施放行、交付与售后之活动。 g) accountability for all product during manufacture (e.g., g)制造时～对所有的产品负有责任,例 parts quantities, split orders, nonconforming product), 如～零件数、分组生产、不合格品,, h) evidence that all manufacturing and inspection h)所有已经按策划完成的生产和检验的 operations have been completed as planned, or as 证据，或以其他的文件或公认的方式; otherwise documented and authorized, i) provision for the prevention, detection, and removal of i)提供对外来物的防止、检测和去除; foreign objects, Page 21 of 29 Version 05/04/2002 Items of SAE AS 9100:2000 Aerospace Quality Standard SAE AS 9100:2000 航空航天质量标准条款 (Rev.B,Aug.2001) (B 版，2002年8月) 中文译稿 j) monitoring and control of utilities and supplies such j)监测和控制公用事业和供应，诸如， as water, compressed air, electricity and chemical 水、压缩空气、电及化学产品，它们 products to the extent they affect product quality, and 在一定程度上影响产品的质量;和 k) criteria for workmanship, which shall be stipulated in k)制造工的准则必须以最清楚实用的方 the clearest practical manner (e.g., written standards, 式来规定(例如，书面的标准、代表 representative samples or illustrations). 性的样品或图例)。 7.5.1.1 Production Documentation 7.5.1.1 生产文件化 Production operations shall be carried out in 生产运行必须按批准的资料进行。按需要，资accordance with approved data. This data shall contain 料必须包括: as necessary a. drawings, parts lists, process flow charts including a. 图纸，零件目录，过程流程图包括检 inspection operations, production documents (e.g., 查指令，生产文件(例如，制造计 manufacturing plans, traveler, router, work order, 划，零件流程，厂房路线，工作指 process cards); and inspection documents 令，工艺卡片);及检查文件(见 (see8.2.4.1), and 8.2.4.1),和 b. a list of specific or non-specific tools and numerical b. 特殊或非特殊工装目录和所要求的数 control (NC) machine programs required and any 控机床项目及任何与其使用有关的特 specific instructions associated with their use. 殊仪器。 7.5.1.2 Control of Production Process Changes 7.5.1.2 生产工艺更改的控制 Persons authorized to approve changes to production 必须确定授权批准生产工艺更改的人员。 processes shall be identified. The organization shall identify and obtain acceptance of 组织必须按合同或法规性要求确认要求顾客和changes that require customer and/or regulatory /或法规性机构认可的更改并获得 authority approval in accordance with contract or 其对更改的接收。 regulatory requirements. Changes affecting processes, production equipment, 影响工艺、生产设备、工装和项目的更改必须tools and programs shall be documented. Procedures 文件化。必须有控制更改执行的程序。shall be available to control their implementation. The results of changes to production processes shall be 对生产工艺更改的结果必须加以评估以确认期assessed to confirm that the desired effect has been 望的影响已达到而对产品质量没有不利的影achieved without adverse effects to product quality. 响。 7.5.1.3 Control of Production Equipment, Tools and 7.5.1.3 生产设备、工装和数控机床的控 Numerical Control (N.C.) Machine Programs 制 Production equipment, tools and programs shall be 生产设备、工装和数控机床在使用前被确认并validated prior to use and maintained and inspected 按文件规定的程序周期性地进行维护和检查。periodically according to documented procedures. 在生产使用前的确认必须包括按设计数据或技Validation prior to production use shall include 术规范生产的首件产品的确认。verification of the first article produced to the design data/specification. Storage requirements, including periodic 对储藏的生产设备或工装必须建立储存要求，preservation/condition checks, shall be established for 包括周期性的防护和状况检查。 Page 22 of 29 Version 05/04/2002 Items of SAE AS 9100:2000 Aerospace Quality Standard SAE AS 9100:2000 航空航天质量标准条款 (Rev.B,Aug.2001) (B 版，2002年8月) 中文译稿 production equipment or tooling in storage. 7.5.1.4 Control of Work Transferred, on a Temporary 7.5.1.4 在组织设施外临时的工作转移的 Basis, Outside the Organization’s Facilities 控制 When planning to temporarily transfer work to a location 当组织策划临时地将工作转移到组织设施外的outside the organization’s facilities, the organization 场所时，组织必须确定控制和确认工作质量的shall define the process to control and validate the 过程。 quality of the work. 7.5.1.5 Control of Service Operations 7.5.1.5 服务运行的控制 Where servicing is a specified requirement, service 当服务是一种特殊要求时，服务运行过程必须operation processes shall provide for 提供: a. a method of collecting and analyzing in-service data, a. 收集和分析服务过程中数据的方法; b. actions to be taken where problems are identified b. 在交付后确认有问题时应采取的措 after delivery, including investigation, reporting 施;包括调查，报告活动以及有关与 activities, and actions on service information 合同和/或法规要求一致的服务信息 consistent with contractual and/or regulatory 的措施; requirements, c. the control and updating of technical c. 技术文件的控制和更新; documentation, d. the approval, control, and use of repair schemes, d. 修理计划的批准、控制和使用; and e. the controls required for off-site work (e.g., e. 现场外工作所央求的控制(例如，组织在顾 organization’s work undertaken at the customer’s 客处承担的工作)。 facilities). 7.5.2 Validation of processes for production and service 7.5.2 生产与服务提供过程的确认 provision The organization shall validate any processes for production 凡是无法对过程的结果输出通过后续的监控或and service provision where the resulting output cannot be 量测进行验证的生产和服务提供过程，组织必 须加以确认。这种过程包括过程的缺陷唯有在verified by subsequent monitoring or measurement. This 产品使用时或者服务已经提供以后才会显现的includes any processes where deficiencies become apparent only after the product is in use or the service has been 任何过程。 delivered. NOTE These processes are frequently referred to as 注:这些过程通常被认为是特殊过程。 special processes. Validation shall demonstrate the ability of these processes to 过程的确认必须展示这些过程具有达成策划所achieve planned results. 要达到结果的能力。 The organization shall establish arrangements for these 组织必须为这些过程做好下列安排，其中，按processes including, as applicable 实际应加以采用的，包括 a) defined criteria for review and approval of the processes, a)规定过程评审与批准所用的判别准则， - qualification and approval of special processes prior ,在使用前鉴定并批准特殊过程; to use, b) approval of equipment and qualification of personnel, b) 设备的批准与人员的资格鉴定; c) use of specified methods and procedures, c) 使用特定的方法和程序， Page 23 of 29 Version 05/04/2002 Items of SAE AS 9100:2000 Aerospace Quality Standard SAE AS 9100:2000 航空航天质量标准条款 (Rev.B,Aug.2001) (B 版，2002年8月) 中文译稿 - control of the significant operations and parameters ,按文件化的工艺规范控制特殊过程 of special processes in accordance with documented 的重要操作和参数; process specifications and changes thereto, d) requirements for records (see 4.2.4), and d) 各种记录要求 (见4.2.4)，和 e) revalidation. e) 再确认。 7.5.3 Identification and Traceability 7.5.3 标识与可追溯性 Where appropriate, the organization shall identify the product 当必需采用时，组织必须在产品实现的整个过by suitable means throughout product realization. 程对产品采用合适的标识。 The organization shall maintain the identification of the 为了识别产品实际技术状态与合同要求技术状configuration of the product in order to identify any 态之间的任何差别，组织必须保持对产品技术differences between the actual configuration and the 状态的识别。 agreed configuration. The organization shall identify the product status with respect 组织必须对产品所处量测与监控要求的各种状to monitoring and measurement requirements. 态加以标识。 When acceptance authority media are used (e.g., stamps, 当使用授权接收媒体时(例如，印章、电子签electronic signatures, passwords), the organization shall 名、密码)，组织必须对媒体建立文件化的控制。establish and document controls for the media. Where traceability is a requirement, the organization shall 凡是可追溯性是一项要求时，组织必须控制及control and record the unique identification of the product (see 记录用于识别产品的唯一性标识 (见4.2.4)。 4.2.4). According to the level of traceability required by 按照合同、法规或其他确立的要求所需追溯性contract, regulatory, or other established requirement, 水平，组织的体系必须提供: the organization’s system shall provide for: a. identification to be maintained throughout the a. 整个寿命期要维持识别; product life; b. all the products manufactured from the same batch b. 要追溯的从同一批原材料或同一制造批生 of raw material or from the same manufacturing 产的所有产品，也包括所有同一批产品的目 batch to be traced, as well as the destination 的地(交付品、报废品); (delivery, scrap) of all products of the same batch; c. for an assembly, the identity of its components and c. 对于装配件，识别其部件及要追溯的 those of the next higher assembly to be traced; 下一步较高层次装配件的部件;d. for a given product, a sequential record of its d. 对一个所给的产品，要能找到其生产 production ( manufacture, assembly, inspection) to 的结果记录(制造、装配、检查)。 be retrieved. NOTE In some industry sectors, configuration management is 注:在某些行业中，技术状态管理是一种用于a means by which identification and traceability are 维持产品标识和可追溯性的方法。(见4.3) maintained. (see 4.3) 7.5.4 Customer property 7.5.4 顾客资产 The organization shall exercise care with customer property 组织必须注意受组织控制的或者组织正在使用while it is under the organization’s control or being used by the 的顾客资产。组织必须标识、验证、保护和安organization. The organization shall identify, verify, protect 全防范好顾客所提供使用的或者结合到产品中and safeguard customer property provided for use or 去的资产。任何顾客资产如发生遗失、损坏或incorporation into the product. If any customer property is lost, 发现不适用时，必须向顾客报告并维持好记录 Page 24 of 29 Version 05/04/2002 Items of SAE AS 9100:2000 Aerospace Quality Standard SAE AS 9100:2000 航空航天质量标准条款 (Rev.B,Aug.2001) (B 版，2002年8月) 中文译稿 damaged or otherwise found to be unsuitable for use, this (见4.2.4)。 shall be reported to the customer and records maintained (see 4.2.4). NOTE Customer property can include intellectual property, 注:顾客资产可能包含知识产权，包括 including customer furnished data used for design, 顾客提供的用于设计、生产和/或检 production and/or inspection. 验的数据。 7.5.5 Preservation of product 7.5.5 产品的防护 The organization shall preserve the conformity of product 组织必须在内部的各个过程以及交付到指定地during internal processing and delivery to the intended 点的过程中防护好产品的符合性。这个防护必destination. This preservation shall include identification, 须包括标识、搬运、包装、储存及保护。防护handling, packaging, storage and protection. Preservation 要求也必须应用于产品的各个组成部分。 shall also apply to the constitute parts of a product. Preservation of product shall also include, where 根据产品技术条件和/或适用的法规，产品防务applicable in accordance with product specifications 也必须包括提供: and/or applicable regulations, provisions for: a. cleaning; a. 清洁; b. prevention, detection and removal of foreign b. 防止、检测并去除外来物; objects; c. special handling for sensitive products; c. 敏感性产品的特殊处理; d. marking and labeling including safety warnings; d. 作记号和挂牌，包括安全警告; e. shelf life control and stock rotation; e. 货架寿命控制和库存转移; f. special handling for hazardous materials. f. 有害材料的特殊处理。 The organization shall ensure that documents required 组织必须确保合同/定单所要求的随产品文件by the contract/order to accompany the product are 在交付时齐全并被防护以防丢失和损坏。 present at delivery and are protected against loss and deterioration. 7.6 Control of monitoring and measuring devices 7.6 监控和量测装置的控制 组织必须确定要加以监控和量测的工作，并确The organization shall determine the monitoring and measurement to be undertaken and the monitoring and 定为了证明产品满足各项确定要求(见7.2.1)measuring devices needed to provide evidence of conformity 符合性所必需的监控和量测装置。 of product to determined requirements (see 7.2.1). The organization shall maintain a register of these 组织必须保持一份这些监控和测量装置的登记monitoring and measuring devices, and define the 表;并确定校正所采用的过程，包括详细的设process employed for their calibration including details 备型号、唯一的识别、所在位置、检查频率、of equipment type, unique identification, location, 检查方法和接收的准则。 frequency of checks, check method and acceptance criteria. 注: NOTE Monitoring and measuring devices include, but are 监控和测量装置包括，但不限于:试验硬件、not limited to: test hardware, test software, automated 试验软件、自动试验设备(ATE)和生成检验数test equipment (ATE) and plotters used to produce 据的绘图机。也包括个人拥有的和顾客提供的inspection data. It also includes personally owned and 用于提供产品合格证据的设备。 customer supplied equipment used to provide evidence of product conformity. The organization shall establish processes to ensure that 组织必须建立为确保监控与量测工作能够执行 Page 25 of 29 Version 05/04/2002 Items of SAE AS 9100:2000 Aerospace Quality Standard SAE AS 9100:2000 航空航天质量标准条款 (Rev.B,Aug.2001) (B 版，2002年8月) 中文译稿 monitoring and measurement can be carried out and are 的各种过程，而且监控和量测的方式符合监控carried out in a manner that is consistent with the monitoring 与量测要求。 and measurement requirements. The organization shall ensure that environmental 组织必须确保环境条件适合要进行的校正、检conditions are suitable for the calibrations, inspections, 验、测量和试验。 measurements and tests being carried out. Where necessary to ensure valid results, measuring 凡是必需要确保结果有效而用的量测设备必须 equipment shall a) be calibrated or verified at specified intervals, or prior to a) 按规定的周期，或在使用之前，根据可追溯use, against measurement standards traceable to 至国际或国家的量测标准进行校准或者验international or national measurement standards; where no 证;如果没有这种标准时，必须记录校准或such standards exist, the basis used for calibration or 者验证时所使用的标准。 verification shall be recorded; b) be adjusted or re-adjusted as necessary; b) 经过调整的，或者，必要时重新调整; c) be identified to enable the calibration status to be c) 加以标识，足以识别其校准状态; determined; d) be safeguarded from adjustments that would invalidate the d) 采取安全防范措施，以防止产生会使量测结measurement result; 果失效的调整; e) be protected from damage and deterioration during e) 在搬运、维护与储存过程中加以保护以免造handling, maintenance and storage; 成损坏及变坏。 f) be recalled to a defined method when requiring f) 在要求校正时，按规定的方法被召回。 calibration. In addition, the organization shall assess and record the 除此之外，当发现设备不符合要求时，组织必validity of the previous measuring results when the equipment 须评估先前量测结果的有效性并作记录。组织is found not to conform to requirements. The organization 必须对该设备及受到影响之任何产品采取适当 的措施。校准和验证结果的记录必须加以维持shall take appropriate action on the equipment and any (见4.2.4)。 product affected. Records of the results of calibration and verification shall be maintained (see 4.2.4). When used in the monitoring and measurement of specified 凡是用于监控和量测规定要求的计算机软件，requirements, the ability of computer software to satisfy the 必须在首次使用之前确认其具备足够之能力满intended application shall be confirmed. This shall be 足预期之应用，必要时进行重新确认。 undertaken prior to initial use and reconfirmed as necessary. NOTE See ISO 10012-1 and ISO 10012-2 for guidance. 注:详见ISO10012-1及ISO10012-2 8 Measurement, analysis and improvement 8 量测、分析与改进 8.1 General 8.1 通则 The organization shall plan and implement the monitoring, 组织必须策划并执行用以满足下列要求所必需measurement, analysis and improvement processes needed 的各种监控、量测、分析及改进过程: a) to demonstrate conformity of the product, a) 展示产品的符合性， b) to ensure conformity of the quality management system, b) 确保质量管理体系的符合性， Page 26 of 29 Version 05/04/2002 Items of SAE AS 9100:2000 Aerospace Quality Standard SAE AS 9100:2000 航空航天质量标准条款 (Rev.B,Aug.2001) (B 版，2002年8月) 中文译稿 and c) to continually improve the effectiveness of the quality c) 持续改进质量管理体系的有效性。 management system. This shall include determination of applicable methods, 这方面必须包括确定各种适用的方法，含各种including statistical techniques, and the extent of their use. 统计技术，及其使用的程度。 NOTE 注: According to the nature of the product and depending on 按照产品的性质并取决于规定的要求，可以使the specified requirements, statistical techniques may be 用统计技术以支持: used to support: - design verification (e.g., reliability, maintainability, ,设计验证(例如，可靠性、维护性、安全性); safety); - process control: ,过程控制: - selection and inspection of key characteristics; ,关键特性的选择和检查; - process capability measurements; ,过程能力测量; - statistical process control; ,统计过程控制; - design of experiment; ,实验的设计; - inspection – matching sampling rate to the criticality ,检查,取样率与产品的关键性及过程 of the product and to the process capability; 能力的匹配; - failure mode and effect analysis. ,破坏模式和影响分析。 8.2 Monitoring and measurement 8.2监控与量测 8.2.1 Customer satisfaction 8.2.1 顾客满意 As one of the measurement of the performance of the quality 作为量测质量管理体系缋效的方法之一，组织management system, the organization shall monitor 必须监控顾客所感知的，认为组织是否满足顾information relating to customer perceptions as to whether the 客要求的有关信息。如何取得以及利用这些信 息的方法必须加以确定。 organization has met customer requirements. The methods for obtaining and using this information shall be determined. 8.2.2 Internal audit 8.2.2 内部审核 The organization shall conduct internal audits at planned 组织必须按照策划规定的间隔期间执行内部审intervals to determine whether the quality management 核，以确定质量管理体系是否 system a) conforms to the planned arrangements (see 7.1), to the a) 符合策划(见7.1)所作的安排，符合本国requirements of this International Standard and to the 际标准的各项要求，符合组织所建立的质量quality management system requirements established by 管理体系的要求，和 the organization, and b) is effectively implemented and maintained. b) 有效地加以执行和维持。 An audit programme shall be planned, taking into 必须策划编制审核大纲，策划时必须考虑被审consideration the status and importance of the processes and 核的过程与区域的状态及其重要性,还要考虑areas to be audited, as well as the results of previous audits. 以前的审核结果。审核用的判别准则、范围、The audit criteria, scope, frequency and methods shall be 频率与方法必须加以定义。审核人员的指派及defined. Selection of auditors and conduct of audits shall 审核工作的执行必须确保审核过程的客观性与 Page 27 of 29 Version 05/04/2002 Items of SAE AS 9100:2000 Aerospace Quality Standard SAE AS 9100:2000 航空航天质量标准条款 (Rev.B,Aug.2001) (B 版，2002年8月) 中文译稿 ensure objectivity and impartiality of the audit process. 公正性。审核员不准审核他们自己所做的工作。 Auditors shall not audit their own work. The responsibilities and requirements for planning and 对于审核的策划、执行，以及审核结果报告和conducting audits, and for reporting results and maintaining 记录维持(见4.2.4)的职责和要求必须在文件records (see 4.2.4) shall be defined in a documented 化程序中加以规定。 procedure. The management responsible for the area being audited shall 负责正被审核区域的管理者必须确保立即采取ensure that actions are taken without undue delay to eliminate 纠正措施，如期消除所发现的不符合以及它们detected non-conformities and their causes. Follow-up 的原因。跟踪活动中必须包括对所采取措施的activities shall include the verification of the actions taken and 验证，并报告验证的结果 (见8.5.2) the reporting of verification results (see 8.5.2). Detailed tools and techniques shall be developed such 必须开发具体的工具和方法，诸如检查表、工as checksheets, process flowcharts, or any similar 艺流程图，或任何支持质量管理体系审核的类method to support audit of the quality management 似方法。所选择工具的接收性可根据内审过程system requirements. The acceptability of the selected 的有效性及整个组织的业绩来量测。 tools will be measured against the effectiveness of the internal audit process and overall organization performance. Internal audits shall also meet contract and/or regulatory 内审也必须适合合同和/或法规的要求。 requirements. NOTE See ISO 10011-1, ISO 10011-2 and ISO 10011-3 for 注:详见 ISO10011-1，ISO10011-2及guidance. ISO10011-3。 8.2.3 Monitoring and measurement of processes 8.2.3 过程的监控与量测 The organization shall apply suitable methods for monitoring 组织必须采用适用的方法对质量管理体系的过and, where applicable, measurement of the quality 程进行监控，凡是应加以量测的，必须对过程management system processes. These methods shall 进行量测。这些方法必须展示过程的能力达到demonstrate the ability of the processes to achieve planned 策划所确定的结果。当策划确定的结果达不到 时，必须采取纠正及纠正措施以确保产品的符results. When planned results are not achieved, correction 合性。 and corrective action shall be taken, as appropriate, to ensure conformity of the product. In the event of process non-conformity, the organization shall 发生过程不合格情况时，组织必须: a. take appropriate action to correct the non-conforming process, a. 采取合适的措施以纠正不合格过程;b. evaluate whether the process non-conformity has resulted in product non-conformity, and b. 评估过程的不合格是否已引起产品的 c. identify and control the non-conforming product in 不合格 accordance with clause 8.3 c. 按8.3条款识别和控制不合格产品。 8.2.4 Monitoring and measurement of product 8.2.4 产品的监控与量测 The organization shall monitor and measure the 组织必须监控与量测产品的特性，以此验证产characteristics of the product to verify that product 品的各项要求已经达成。这种监控与量测工作requirements have been met. This shall be carried out at 必须根据策划所作安排(见7.1)在产品实现过appropriate stages of the product realization process in 程的相应阶段进行。 accordance with the planned arrangements (see 7.1). Page 28 of 29 Version 05/04/2002 Items of SAE AS 9100:2000 Aerospace Quality Standard SAE AS 9100:2000 航空航天质量标准条款 (Rev.B,Aug.2001) (B 版，2002年8月) 中文译稿 When key characteristics have been identified, they shall 当关键特性已被识别时，应对其实行监视和控be monitored and controlled. 制。 When the organization uses sampling inspection as a 当组织使用抽样检查作为产品接收的方法时，means of product acceptance, the plan shall be 策划应被统计地确认，并合适地使用。策划应statistically valid and appropriate for use. The plan shall 防止接收样品已知不合格的生产批。在要求时，preclude the acceptance of lots whose samples have 策划应递交给顾客批准。 known non-conformities. When required, the plan shall be submitted for customer approval. Product shall not be used until it has been inspected or 产品在检验或以另外方式被验证为符合特定要otherwise verified as conforming to specified 求前不应被使用，在完成所有要求的测量和监requirements, except when product is released under 控活动前除非按照确和确切无疑的追回程序发positive-recall procedures pending completion of all 放产品。 required measurement and monitoring activities. Evidence of conformity with the acceptance criteria shall be 针对验收判别准则符合性的证据必须加以维maintained. Records shall indicate the person(s) authorizing 持。各种记录必须指明授权放行该产品的人员release of product (see 4.2.4) (见4.2.4) Product release and service delivery shall not proceed until 除非经有关当局的批准，凡有规定应由顾客批the planned arrangements (see 7.1) have been satisfactorily 准者外，只有在策划所作安排(见7.1)已经满completed, unless otherwise approved by a relevant authority, 意地完成之后，产品才能放行，服务才能提供。 and where applicable, by the customer. 8.2.4.1 Inspection Documentation 8.2.4.1 检验的文件化 Measurement requirements for product or service 对产品或服务的接收性的量测要求必须文件acceptance shall be documented. This documentation 化。这种文件化可以是生产文件化的一部分，may be part of the production documentation, but shall 但必须包括: include a. criteria for acceptance and/or rejection, a. 接收和/或拒收的判别准则; b. where in the sequence measurement and testing b. 逐一在何处进行测量和试验; operations are performed, c. c. a record of the measurement results, and 测量结果的记录;和 d. type of measurement instruments required and any d. 所要求测量仪器的型号及其使用相关 specific instructions associated with their use. 的特殊说明。 Test records shall show actual test results data when 在技术规格书或接收试验计划要求时，试验记required by specification or acceptance test plan. 录应表明实际的试验结果。 Where required to demonstrate product qualification the 在要求显示产品合格之处，组织必须确保记录organization shall ensure that records provide evidence 提供产品满足规定要求的证据。that the product meets the defined requirements. 8.2.4.2 First Article Inspection 8.2.4.2 首件检验 The organization’s system shall provide a process for the 针对一个新零件首次生产运行的代表性项目，inspection, verification, and documentation of a 或使原先的首件检验结果无效的相继更改所需representative item from the first production run of a new 的的检验、验证和文件化，组织的体系必须提part, or following any subsequent change that 供一个过程。 invalidates the previous first article inspection result. Page 29 of 29 Version 05/04/2002 Items of SAE AS 9100:2000 Aerospace Quality Standard SAE AS 9100:2000 航空航天质量标准条款 (Rev.B,Aug.2001) (B 版，2002年8月) 中文译稿 NOTE See (AS) (EN) (SJAC) 9102 for guidance. 注:相关指南见(AS)(EN)(SJAC)9102 8.3 Control of nonconforming product 8.3. 不合格品的控制 The organization shall ensure that product which does not 组织必须确保不符合产品要求的产品加以标识conform to product requirements is identified and controlled to 和控制，防止误用或交付。对不合格品的各种prevent its unintended use or delivery. The controls and 控制方法以及处理不合格品的有关职责和职权related responsibilities and authorities for dealing with 必须在文件化程序中加以规定。 nonconforming product shall be defined in a documented procedure. NOTE The term “non-conforming product” includes 注:术语“不合格产品”包括从顾客处退 non-conforming product returned from a customer. 回的不合格产品。 The organization’s documented procedure shall define 组织的文件化程序必须规定对不合格产品评估the responsibility for review and authority for the 及处置的职权和批准人员作决策的过程。 disposition of non-conforming product and the process for approving personnel making these decisions. The organization shall deal with nonconforming product by 组织必须针对不合格品采取下列一种或多种途one or more of the following ways: 径进行处理: a) by taking action to eliminate the detected nonconformity; a) 采取行动以消除所发现的不符合; b) by authorizing its use, release or acceptance under b) 经授权批准它的使用、放行，或者经有关授concession by a relevant authority and, where applicable, 权者同意，凡是有规定的，还要经过顾客的by the customer; 同意让步接受。 c) by taking action to preclude its original intended use or c) 采取措施排除其原先打算的使用或者应用。 application. 如果: The organization shall not use dispositions of use-as-is ,产品按顾客的设计而生产，或 or repair, unless specifically authorized by the customer, ,不合格引起违背合同要求 if 组织不可以采用让步接收或返修处置，除非由- the product is produced to customer design, or 顾客特别授权， - the non-conformity results in a departure from the contract requirements. Unless otherwise restricted in the contract, 除非在合同中有其他方面的规定，组织按照顾organization-designed product which is controlled via a 客的技术规范控制设计的产品若不合格不引起customer specification may be dispositioned by the 违背顾客指定的要求时，可由组织作让步接收organization as use-as-is or repair, provided the 或返修处置。 non-conformity does not result in a departure from customer-specified requirements. Product dispositioned for scrap shall be conspicuously 处置为报废的产品在实际致使不可使用前，必and permanently marked, or positively controlled, until 须被醒目地并永久地作出标记或被绝对地控physically rendered unusable. 制。 Records of the nature of the nonconformities and any subsequent actions taken, including concessions obtained, 不符合问题的性质及其后续采取的任何措施，shall be maintained (see 4.2.4). 包括所获得的各种让步接受的记录必须加以维 持(见4.2.4)。 When nonconforming product is corrected it shall be subject to re-verification to demonstrate conformity to the 不合格品在纠正以后必须重新验证以展示其符 Page 30 of 29 Version 05/04/2002 Items of SAE AS 9100:2000 Aerospace Quality Standard SAE AS 9100:2000 航空航天质量标准条款 (Rev.B,Aug.2001) (B 版，2002年8月) 中文译稿 requirements. 合各项要求。 When nonconforming product is detected after delivery or use has started, the organization shall take action appropriate to 当不合格品是在产品交付以后或者已经使用以the effects, or potential effects, of the nonconformity. 后才被发现的，组织必须根据不符合问题的后 果影响，或者潜在的后果影响，采取恰当的措In addition to any contract or regulatory authority 施。 reporting requirements, the organization’s system shall provide for timely reporting of delivered non-conforming 除任何合同或法规性机构要求报告之外，组织product that may affect reliability or safety. Notification 的体系必须及时地提供已交付的可能影响可靠shall include a clear description of the non-conformity, 性或安全性的不合格产品报告。报告必须包括which includes as necessary parts affected, customer 对不合格的清晰叙述，这包括受影响的必要零and/or organization part numbers, quantity, and date(s) 件、顾客和 delivered. /或组织的零件号、数量及交付日期。 NOTE Parties requiring notification of non-conforming 注:需要不合格产品报告的方面可能包括供应product may include suppliers, internal organizations, 商、内部机构、顾客、批发商和法规性机构。 customers, distributors, and regulatory authorities. 8.4 数据资料的分析 8.4 Analysis of data 组织必须确定、收集并分析恰当的数据资料，The organization shall determine, collect and analyse 以此展示质量管理体系的适宜性和有效性，同appropriate data to demonstrate the suitability and 时评估什么地方可能对质量管理体系有效性进effectiveness of the quality management system and to 行持续改进。这方面必须包括监控与量测结果evaluate where continual improvement of the effectiveness of 所产生的各种数据资料以及其它相关的数据资the quality management system can be made. This shall 料的来源。 include data generated as a result of monitoring and measurement and from other relevant sources. 数据资料的分析必须提供下列有关信息 The analysis of data shall provide information relating to a) 顾客满意(见8.2.1)， a) customer satisfaction (see 8.2.1), b) 产品对各项要求的符合性(见7.2.1)， b) conformance to product requirements (see 7.2.1), c) 过程及产品的各种特性及其发展趋势，包括 可采取预防措施的各种机会，和 c) characteristics and trends of processes and products including opportunities for preventive action, and d) 供方的信息。 d) suppliers. 8.5 改进 8.5 Improvement 8.5.1 持续改进 8.5.1 Continual improvement 组织必须通过对质量方针、质量目标、审核结The organization shall continually improve the effectiveness 果、数据资料分析、纠正和预防措施以及管理of the quality management system through the use of the 评审的应用来持续改进质量管理体系的有效quality policy, quality objectives, audit results, analysis of 性。 data, corrective and preventive actions and management review. 8.5.2 Corrective action 8.5.2 纠正措施 The organization shall take action to eliminate the cause of 组织必须采取纠正措施，消除产生不符合问题nonconformities in order to prevent recurrence. Corrective 的原因，防止再次发生。纠正措施必须和所遇actions shall be appropriate to the effects of the 到的不符合问题的后果严重程度相适应。 Page 31 of 29 Version 05/04/2002 Items of SAE AS 9100:2000 Aerospace Quality Standard SAE AS 9100:2000 航空航天质量标准条款 (Rev.B,Aug.2001) (B 版，2002年8月) 中文译稿 nonconformities encountered. A documented procedure shall be established to define 必须建立文件化程序对下列内容规定要求: requirements for a) reviewing nonconformities (including customer a) 不符合问题(含顾客抱怨)的评审， complaints); b) determining the causes of nonconformities, b) 确定不符合问题的各种原因; c) evaluating the need for action to ensure that c) 评估为确保不符合问题不再次发生所必需nonconformities do not recur, 要采取的措施; d) determining and implementing the action needed, d) 确定并实施必要的措施; e) records of the results of action taken (see 4.2.4), e) 记录所采取措施的结果(见4.2.4); f) reviewing corrective action taken, f) 评审已采取的纠正措施; g) flow down of the corrective action requirement to a g) 当确定一个供应商对根本原因负有责 supplier, when it is determined that the supplier is 任时，向下对该供应商提出纠正措施 responsible for the root cause, and 要求;和 h) specific actions where timely and/or effective h) 在没有达到按时和/或有有效的纠正 corrective actions are not achieved. 措施 之处的特别措施。 8.5.3 Preventive action 8.5.3 预防措施 The organization shall determine action to eliminate the 组织必须确定采取措施以消除潜在不符合问题causes of potential nonconformities in order to prevent their 的各种原因，防止潜在不符合问题的发生。预occurrence. Preventive actions shall be appropriate to the 防措施必须和潜在不符合问题的后果严重程度effects of the potential problems. 相适应。 A documented procedure shall be established to define 必须建立文件化程序对下列内容规定要求: requirements for a) determining potential nonconformities and their causes, a) 确定潜在不符合问题及其原因， b) evaluating the need for action to prevent occurrence of b) 评估为预防不符合问题发生所必需要采取nonconformities, 的措施， c) determining and implementing action needed, c) 确定并实施必要的措施， d) records of results of action taken (see 4.2.4), and d) 记录所采取措施的结果(见4.2.4)，和 e) reviewing preventive action taken. e) 评审已采取的预防措施。 Page 32 of 29 Version 05/04/2002 Items of SAE AS 9100:2000 Aerospace Quality Standard SAE AS 9100:2000 航空航天质量标准条款 (Rev.B,Aug.2001) (B 版，2002年8月) 中文译稿 Page 33 of 29 Version 05/04/2002