IATF16949 中英文对照版 201710 - 图文(6)

信息，以： 1) 确信过程已按策划进行； 2) 证明产品和服务符合要求。 策划的输出应适于组织的运行。 组织应控制策划的变更，评审非预期变更的后果，必要时，采取措施减轻不利影响。 组织应确保外包过程受控（见8.4）。 2) to demonstrate the conformity of products and services to their requirements. The output of this planning shall be suitable for the organization’s operations. The organization shall control planned changes and review the consequences of unintended changes, taking action to mitigate any adverse effects, as necessary. The organization shall ensure that outsourced processes are controlled (see 8.4). 8..1.1 Operational planning and control - supplemental When planning for product realization，the following topics shall be included: a）customer product requirements and technical 8.1.1 运行策划和控制----补充 specifications； b）logistics requirements； 在对产品实现进行策划时，应包含以下主题： c）manufacturing feasibility； a） 顾客产品要求和技术规范； d）project planning（refer to ISO 9001，Section b） 物流要求； c） 制造可行性； 8.3.2）； d） 项目策划（参加ISO 9001第8.3.2条）； e）acceptance criteria. e） 接受准则。 ISO 9001 第8.1条c）项中的资源是指所要求的产品The resources identified in ISO 9001，Section 8.1 c），特定的验证、确认、监视、测量、检验和试验活动refer to the required verification，validation，以及产品接收准则。 monitoring，measurement，inspection，and test activities specific to the product and the criteria for product acceptance. 8.1.2 Confidentiality The organization shall ensure the confidentiality of customer-contracted products and projects under development，including related product information. 8.1.2 保密 8.2 Requirements for products and services 组织应确保正在开发中的顾客签约产品和项目及有关产品信息的保密。 8.2.1 Customer communication See ISO 9001:2015 requirements. Communication with customers shall include: a) providing information relating to products and services; b) handling enquiries, contracts or orders, including changes; c) obtaining customer feedback relating to products and services, including customer complaints; d) handling or controlling customer property; e) establishing specific requirements for contingency actions, when relevant. 8.2 产品和服务要求 8.2.1 顾客沟通 见ISO 9001:2015的要求。 与顾客沟通的内容应包括： a) 提供有关产品和服务的信息； b) 处理问询，合同或订单，包括更改； c) 获取有关产品和服务的顾客反馈，包括顾客抱怨； d) 处置或控制顾客财产； e)关系重大时，制定应急措施的特定要求。 8.2.1.1 Customer communication - supplemental Written or verbal communication shall be in the language agreed with the customer. The organization shall have the ability to communicate necessary information，including data in a customer-specified 8.2.1.1 顾客沟通----补充 computer language and format（e.g.，computer-aided design data，electronic data interchange）. 应按顾客同意的语言进行书面或口头沟通。组织应 有能力按顾客规定的语言和形式来沟通必要的信息，包括按顾客规定的计算机语言和格式的数据（例8.2.2 Determining the requirements for products and services 如：计算机辅助设计数据、电子数据交换等）。 See ISO 9001:2015 requirements. 8.2.2 与产品和服务要求的确定 见ISO 9001:2015的要求。 When determining the requirements for the products and services to be offered to customers, the organization shall ensure that: a) the requirements for the products and services are defined, including: 1) any applicable statutory and regulatory requirements; 2) those considered necessary by the organization; b) the organization can meet the claims for the products and services it offers. 在确定向顾客提供的产品和服务的要求时，组织应确保： a) 产品和服务的要求得到规定，包括： 1) 适用的法律法规要求； 2) 组织认为的必要要求。 b) 提供的产品和服务能够满足所声明的要求。 8.2.2.1 Determining the requirements for products and services - supplemental These requirements shall include recycling，8.2.2.1 与产品和服务要求的确定----补充 environmental impact，and characteristics identified as a result of the organization's knowledge of the 这些要求应包括回收再利用、对环境的影响，以及product and manufacturing processes. 根据组织对产品和制造过程的认知所识别的特性。 遵守ISO 9001第8.2.2条a）1）项的要求应包括但 Compliance to ISO 9001，Section 8.2.2 item a）1 ），不限于： 所有适用的与材料的获得、存储、搬运、回收、销shall include but not be limited to the following: all 毁或废弃有关的政府。安全和环境法规。 applicable government，safety，and environmental regulations related to acquisition，storage，handling， 8.2.3 产品和服务要求的评审 8.2.3.1 见ISO 9001:2015的要求。 recycling，elimination，or disposal of material. 8.2.3 Review of the requirements for products and services 8.2.3.1 See ISO 9001:2015 requirements. 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 customers. The organization shall conduct a review before committing to supply 8.2.3.1 组织应确保有能力向顾客提供满足要求的产品和服务。在承诺向顾客提供产品和服务之前，组织应对如下各项要求进行评审： a) 顾客规定的要求，包括对交付和交付后活动的要求； b) 顾客虽然没有明示，但规定的用途或已知的预期用途所必需的要求； c) 组织规定的要求； d) 适用于产品和服务的法律法规要求； e) 与以前表述不一致的合同或订单要求。 若与先期的的合同或订单的要求存在差异，组织应确保有关事项已经得到解决。 若顾客没有提供成文的要求，组织在接受顾客要求前应对顾客要求进行确认。 注：在某些情况下，如网上销售，对每一个订单进行正式的评审可能是不实际的。作为替代方法，可NOTE In some situations, such as internet sales, a formal 评审有关的产品信息，如产品目录。 8.2.3.1.1 产品和服务要求的评审----补充 组织应保留形成文件的证据，证明对ISO 9001第8.2.3.1条中正式评审要求的弃权有顾客授权。 cover relevant product information, such as catalogues. products and services to a customer, to include: a) requirements specified by the customer, including the requirements for delivery and postdelivery activities; b) requirements not stated by the customer, but necessary for the specified or intended use, when known; c) requirements specified by the organization; d) statutory and regulatory requirements applicable to the products and services; e) contract or order requirements differing from those previously expressed. The organization shall ensure that contract or order requirements differing from those previously defined are resolved. The customer’s requirements shall be confirmed by the organization before acceptance, when the customer does not provide a documented statement of their requirements. review is impractical for each order. Instead, the review can 8.2.3.1.1 Review of the requirements for products and services—supplemental The organization shall retain documented evidence of a customer-authorized waiver for the requirements stated in ISO 9001，Section 8.2.3.1，fora formal review. 8.2.3.1.2 Customer-designated special characteristics The organization shall conform to customer requirements for designation，approval 8.2.3.1.2 顾客指定的特殊特性 documentation，and control of special characteristics. 组织应符合顾客对特殊特性的指定、批准文件和控8.2.3.1.3 Organization manufacturing feasibility 制的要求。 The organization shall utilize a multidisciplinary approach to conduct an analysis to determine if it is 8.2.3.1.3 组织制造可行性 组织应采用多方论证方法来进行分析，以确定组织的制造过程是否是可行的，能够始终生产出符合顾客规定的全部工程和产能要求的产品。组织应为任何对其而言新的制造或产品技术，以及任何更改过的制造过程或产品设计进行可行性分析。 此外，组织应当通过生产运行、标杆管理研究或其他适当的方法，确认其能够以所要求的速率生产出feasible that the organization's manufacturing processes are capable of consistently producing product that meets all of the engineering and capacity requirements specified by the customer. The organization shall conduct this feasibility analysis for any manufacturing or product technology new to the organization and for any changed manufacturing process or product design. Additionally，the organization should validate through 符合规范的产品。 8.2.3.2 见ISO 9001:2015的要求。 8.2.3.2 适用时，组织应保留与下列方面有关的成文信息： a) 评审结果； b) 产品和服务的新要求。 production runs，benchmarking studies，or other appropriate methods，their ability to make product to specifications at the required rate. 8.2.3.2 See ISO 9001:2015 requirements. 8.2.3.2 The organization shall retain documented information, as applicable: a) on the results of the review; b) on any new requirements for the products and services. 8.2.4 Changes to requirements for products and services See ISO 9001:2015 requirements. The organization shall ensure that relevant documented information is amended, and that relevant persons are made aware of the changed requirements, when the requirements for products and services are changed. 8.2.4 产品和服务要求的更改 见ISO 9001:2015的要求。 若产品和服务要求发生更改，组织应确保相关的成8.3 Design and development of products and 文信息得到修改，并确保相关人员知道已更改的要services 求。 8.3.1 General See ISO 9001:2015 requirements. 8.3 产品和服务的设计和开发 8.3.1 总则 The organization shall establish, implement and maintain a design and development process that is appropriate to ensure the subsequent provision of products and services. 8.3.1.1 Design and development of products and 见ISO 9001:2015的要求。 services—supplemental 组织应建立、实施和保持适当的设计和开发过程，The requirements of ISO 9001，Section 8.3.1，shall 以便确保后续的产品和服务的提供。 apply to product and manufacturing process design and development and shall focus on error prevention 8.3.1.1产品和服务的设计和开发----补充 rather than detection. ISO 9001 第8.3.1条的要求应适用于产品和制造过The organization shall document the design and 程的设计和开发，并且应着重于错误预防，而不是development process. 探测。 组织应对设计和开发过程形成文件。 8.3.2 Design and development planning See ISO 9001:2015 requirements. In determining the stages and controls for design and development, the organization shall consider: a) the nature, duration and complexity of the design and development activities; b) the required process stages, including applicable design and development reviews; c) the required design and development verification and 8.3.2 设计和开发策划 见ISO 9001:2015的要求。 在确定设计和开发的各个阶段和控制时，组织应考虑： a) 设计和开发活动的性质、持续时间和复杂程度； b) 所需的过程阶段，包括适用的设计和开发评审； c) 所需的设计和开发的验证及确认活动； d) 设计和开发过程涉及的职责和权限； e) 产品和服务的设计和开发所需的内部和外部资源； f) 设计和开发过程参与人员之间接口的控制需求； g) 顾客和使用者参与设计和开发过程的需求； h) 对后续产品和服务提供的要求； i) 顾客和其他相关方期望的设计和开发过程的控制水平； j) 证实已经满足设计和开发要求所需的成文信息。 8.3.2.1设计和开发策划----补充 组织应确保设计和开发策划含该组织内部所有受影响的利益相关者及其（适当的）供应链。使用多方论证方法的方面包括但不限于： a） 项目管理（例如：APQP或VDA-RGA）； b） 产品和制造过程设计活动（如：DFM和DFA），例如：考虑使用替代的设计和制造过程； c） 产品设计风险分析（FMEA）的开发和评审，包括降低潜在风险的措施； d） 制造过程风险分析（如：FMEA、过程流程、控制计划和标准的工作指导书）的开发和评审。 注：多方论证方法通常包括组织的设计、制造、工程、质量、生产、采购、供应、维护和其它适当职能。 validation activities; d) the responsibilities and authorities involved in the design and development process; e) the internal and external resource needs for the design and development of products and services; f) the need to control interfaces between persons involved in the design and development process; g) the need for involvement of customers and users in the design and development process; h) the requirements for subsequent provision of products and services; i) the level of control expected for the design and development process by customers and other relevant interested parties; j) the documented information needed to demonstrate that design and development requirements have been met. 8.3.2.1 Design and development planning—supplemental The organization shall ensure that design and development planning includes all affected stakeholders within the organization and，as appropriate，its supply chain. Examples of areas for using such a multidisciplinary approach include but are not limited to the following: a）project management（for example，APQP or VDA-RGA）； b）product and manufacturing process design activities（for example，DFM and DFA），such as consideration of the use of alternative designs and manufacturing processes； c）development and review of product design risk analysis（FMEAs），including actions to reduce potential risks； d）development and review of manufacturing process risk analysis（for example，FMEAs，process flows，control plans，and standard work instructions）. NOTE A multidisciplinary approach typically includes the organization’s design，manufacturing，engineering，quality，production，purchasing，supplier，maintenance，and other appropriate functions. 8.3.2.2 Product design skills The organization shall ensure that personnel with product design responsibility are competent to