iecqqc080000中英文对照表(doc15)-质量检验(编辑修改稿)

iecqqc080000中英文对照表(doc15)-质量检验(编辑修改稿)内容摘要：

d to achieve conformity to HSF process and product requirements. 组织应决定、提供并维护达成 HSF 流程与产品要求所需之基础架构。 7 Product Realization 7. 产品实现 Planning of HSF process and product realization HSF 流程与产品实现之规划 The requirements of ISO 9001 shall apply along with the additional requirements below: ISO 9001 的要求事项应适用，并增加下列要求 The anization shall plan and develop the processes needed for HSF product realization. 组织应规划并发展实现 HSF 产品所需的流程。 In planning HSF product realization, the anization shall determine the following, as appropriate: 在规划实现 HSF 产品时，若适当的话，组织应决定下列项目： a) quality objectives and requirements for the HSF product。 a) HSF 产品的质量目标与要求： b) the need to establish HSF processes, documents, and provide resources specific to the HSF product。 b) 建立 HSF 流程、文件的需求，并提供针对 HSF 产品的资源； c) required verification, validation, monitoring, inspection and test activities specific to the HSF product and the criteria for product acceptance. This shall include information services providers as appropriate。 c) 针对 HSF 产品所需之特定的查证、确认、监测、检验及试验活动，以及产品之允收准则。 若适当的话，应包含信息服务供货商； d) documented procedures or work instructions for processes that include the use of restricted substances to include prevention where the possibility of contamination exists. d) 对使用限制性物质的流程所准备的文件化程序或作业指示，包括如何预防可能的污染： e) records needed to provide evidence that the HSF realization processes and resulting product meet requirements. e) 提供 HSF 实现流程与产出产品符合要求所需的证据记录。 f) The output of this HSF planning shall be in a form suitable for the anization’s method of operations. f) 此 HSF 规划应以适合组织作业方法的格式输出。 Note: A document specifying the HSF processes (including the product realization processes) and the 注 1：指定 HSF 程序的文件 (包括产品实现流程 )以及应用于特定产品的资源，可当成质量计划参照 中国最大的管 理 资料下载中心 (收集 \整理 . 大量免费资源共享 ) 第 7 页 共 14 页 IECQ QC 080000 IECQ QC 080000 中译本 resources to be applied to a specific product can be referred to as a quality plan. Customerrelated process 客户有关之过程 The requirements of ISO 9001 shall apply along with the additional requirements below: ISO 9001 的要求事项应适用，并增加下列要求 Determination of requirements related to the HSF product HSF 产品之相关要求决定 The anization shall determine 组织应决定 : a) HSF requirements specified by the customer, a) 客户规定之 HSF 要求。 b) HSF requirements not stated by the customer but necessary for specified or intended uses, where known. b) 非客户所陈述之要求，但为已知的特定或意图使用所必需者。 c) HSF statutory and regulatory requirements related to the product, and c) 与产品相关的 HSF 法令与规章要求。 d) any additional HSF requirements determined by the anization. d) 组织所决定的任何额外 HSF 要求。 Review of HSF requirements related to the product HSF产品有关要求之审查 The anization shall review the requirements related to the HSF product. This review shall be conducted prior to the anization’s mitment to supply HSF product to the customer and shall ensure that。 组织应审查与 HSF 产品有关之要求。 此审查应在组织承诺供应产品给顾客之前，且应确保： a) HSF product requirements are defined, and a) HSF 产品要求已予界定 b) the anization has the ability to meet the HSF defined requirements. b) 组织有能力符合所界定之 HSF 要求 c) any use of or possibility of contamination or mixing of processes or product that contain restricted substances shall be municated to the customer. c) 任何包含限制性物质的流程或产品之使用、污染可能性或混合，均应向客户说明， d) Records of the results of the HSF review and actions arising from the review shall be kept and maintained. d) HSF 评估结果记录及评估后产生之行动记录均应保存与维护 Design and development 设计与开发 The requirements of ISO 9001 shall apply along with the additional requirements below: ISO 9001 的要求事项应适用，并增加下列要求 HSF design and development planning . HSF 设计与开发规划 The anization shall plan and control the design and development of HSF product. 组织应规划并管制 HSF 产品的设计与开发。 In planning the design, the use of any restricted substance shall be identified in the documentation and a plan for control and eventual 在规划设计时，任何限制性物质的使用应记录在文件、以及一个用于管制及最终取代／演除该零件的计划内。 中国最大的管 理 资料下载中心 (收集 \整理 . 大量免费资源共享 ) 第 8 页 共 14 页 IECQ QC 080000 IECQ QC 080000 中译本 replacement/elimination of the part. HSF Design and development inputs HSF 设计与开发输入 Inputs relating to HSF product requirements shall be determined and records maintained. 与 HSF 产品要求相关之输入，应予以决定并将纪录加以维持 HSF inputs shall be reviewed for adequacy. Requirements shall be plete, unambiguous and not in conflict with each other. 应检视 HSF 输入之充足性。 要求应完整、不模拟两可且不彼此冲突。 HSF Design and development outputs HSF 设计与开发输出 The HSF outputs of design and development shall be provided in a form that enables verification against the design and development input and shall be approved prior to release. HSF 设计与开发之输出，应以一种能针对设计与开发输入进行查证之形式予以提供，并在发 行前应加以核准。 When the design requires the use of a restricted substance a documented procedure shall be developed for the control, identification, monitoring and measurement of the process/product to include subcontracted product. 当设计要求使用限制性物质时，应发展文件化程序。 以管制、识 别、监督与量测纳入外包产品之流程／产品， HSF Design and development review HSF设计与开发审查 At suitable stages, systematic reviews of the design and development shall be performed in accordance with the HSF plan. 在适当阶段，应依所规划的安排事项执行 HSF 设计与开发之系统性审查。 Design and development verification 设计与开发查验 The requirements of ISO 9001 shall apply ISO 9001 的要求事项应适用 Design and development validation 设计与开发确效 The requirements of ISO 9001 shall apply ISO 9001 的要求事项应适用 Control of HSF design and development changes HSF设计与开发变更之管制 HSF design and development changes shall be identified and records maintained. The changes shall be reviewed, verifie。