ie工业工程_iecqqc080000中英文对照表

IECQ QC 中英文对照表IECQ QC IECQ QC 中译本4 General requirements 4. 一般要求事项4.1 Quality Management System4.1 质量管理系统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4.1.1 General4.1.1 概述Each organization shall include in its ISO 9001:2000 mandated quality management system the procedures, documentation, and process management practices necessary to achieve HSF product and production processes.组织应在其 ISO 9001:2000指定质量管理系统中，加入达成 HSF 产品与作业流程所需之程序、文件与流程管理实务。The organization shall组织应a) Identify and document all hazardous substances in use in the organization.a) 确认与记录组织使用的所有有害物质。b) identify the specific processes to be managed relevant to its HSF goals.b) 确认与 HSF目标相关且待管理的特定流程。c) determine the interdependence and interaction of these processes and develop an appropriate HSF process management plan.c) 决定这些流程的相互依赖关系与交互作用，并发展适当之 HSF 流程管理计划。d) establish criteria upon which to objectively determine the effectiveness of the organizations HSF process management.d) 建立能客观决定组织 HSF 流程管理功效的条件。e) ensure the availability of resources and information needed to support effective HSF process management.e) 确保支持有效 HSF 流程管理所需之资源与信息容易取得f) monitor, measure and analyze these processes, andf) 监督、量测与分析这些流程。g) implement actions to ensure continuous process improvement in achieving HSF.g) 采取行动以确保流程之持续改善以达成HSF。h) have a process established to restrict and/or eliminate the use of hazardous substances from products and processes.h) 建立流程，以限制及（或）中止对产品与在流程中使用有害物质。4.1.2 Relationship with ISO 90014.1.2 与ISO 9001:2000的关连The intention of this document is that HSF process management is to be congruent with the elements of ISO 9001:2000 international Standard.本文件的目的是要让 HSF 流程管理符合 ISO 9001:2000 国际标准的要项。4.1.3 Outsourcing4.1.3 委外Where an organization chooses to outsource any process that affects its products HSF characteristics, and accept into its operations the product of processes outside its own operations, the organization shall ensure management of and control over such processes.若组织选择将任何会影响其产品 HSF 特性的流程外包出去，并将外包流程之产品引进其本身的作业，则该组织应确保此等流程之管理与管制。4.2 Documentation requirements4.2 文件要求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4.2.1 General4.2.1概述The quality management system documentation shall include质量管理系统文件化应包括a) The HSF requirements shall be an integral part of the organizations quality management system and shall includea) HSF 要求应为组织质量管理系统中不可或缺的部份，并应包含下列各项：b) a list of all hazardous substances used within the organization.b) 组织内使用之所有有害物质清单。c) statements of HSF policy and objectives with inclusion of a timeline for elimination of use of all hazardous substances, as appropriatec) HSF 政策与目标之声明。若适当的话，包含停止使用所有有害物质之时程。d) in the organizations quality manual a section on the HSF process management plan and objectives and reference to HSF documented proceduresd) 组织的质量手册中应说明 HSF 流程管理计划与目标、以及 HSF 文件化程序之参考章节e) documented procedures as required by the organizations HSF process management plan with control of all such documents executed as required by section 4.2.4 of the ISO 9001:2000 international Standard.e) 按照组织 HSF 流程管理计划要求之文件化程序，并按 ISO 9001:2000 国际标准第 4.2.4 节之规定控管所有此类文件。f) records of the organizations HSF process management performance.f) 组织 HSF 流程管理绩效之记录，Note: Consistent with the ISO 9001:2000 international Standard, “documented procedures” means that the procedure is established, documented, implemented and maintained. Additionally, the extent of documentation required is specific to the size of the organization, complexity of processes, and the competence of personnel.说明：与ISO 9001:2000 国际标准一致，文件化程序指程序应建立、记录、执行与维护。此外，文件记录的程序应按照组织规模、流程复杂度与人员的能力而定5. Management Responsibility5. 管理责任5.1 Management Commitment5.1承诺证据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Top management shall provide evidence of its commitment to the development and implementation of practices consistent with achieving HSF products and production processes and the continuous improvement of such by 高阶主管应就符合 HSF 产品与作业流程、及该等产品与作业流程之持续改进，就实务发展与实施提供承诺证据，其方法如下：a) communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements.a) 与组织组织沟通达到客户要求与达到法定与规章要求同等重要。b) establishing the HSF policy.b) 建立 HSF 政策。c) ensuring that HSF objectives are established.c) 确定 HSF 目标的建立d) including HSF in management reviews, andd) 在管理阶层审查时纳入 HSF ，以及e) providing resources to ensure progress toward HSF products and production processes.e) 提供资源以确保朝 HSF 产品与作业流程发展。 f) ensuring the list of hazardous substances is communicated throughout the organization.f) 确保全组织均了解有害物质清单。 g) Determining HSF requirements.g) 决定 HSF 需求5.2 Customer focus7.2 客户为重Top management shall ensure that customer HSF requirements are determined, are met and included in the measure of customer satisfaction.高阶管阶层应确定客户的 HSF 要求已决定并已达到，同时纳入客户满意度的量测中。5.3 HSF Policy5.3 HSF 政策 Top management shall ensure that the HSF policy is appropriate for the purpose of the organization, and高阶主管应确定 HSF 政策适合组织的宗旨，并a) includes a commitment to comply with requirements and continually improve the effectiveness of the HSF management practices.a) 包含遵守要求以及持续改善 HSF 管理实务绩效的承诺。b) provides a framework for establishing and reviewing HSF objectives.b) 提供建立与审查 HSF 目标之架构。 c) is communicated and understood within the organization, andc) 已在组织内沟通且为了解d) is reviewed for continuing suitability.d) 已对持续适用性完成评估5.4 Planning5.4 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5.4.1 HSF objectives5.4.1 HSF 目标a) Top management shall ensure that HSF objectives are established at relevant functions and levels within the organization. The HSF objectives shall be measurable and consistent with the HSF policy.a) 高阶主管应确保按组织的相关职能与层级建立 HSF 目标。 HSF 目标应为可量测的，并与 HSF 政策一致。b) The HSF objectives shall include a timeline, as appropriate, for the elimination of hazardous substances identified and used in processes or products including procured products.b) HSF 目标应包括一份时程表。若适当时，按表除去在流程或产品（包括采购产品）中所识别出与使用中之有害物质。 5.4.2 HSF planning5.4.2 HSF 规划Top management shall ensure that高阶主管应确保下列各项a) the practices required to achieve HSF are integrated into the quality management system planning and are elements in the quality objectives, anda) 达成 HSF 所需之实务已整合至质量管理系统规划当中，并为质量目标之一b) the continuity of the HSF effort is maintained as improvements and changes are executed.b) 藉由改善与变更，维持持续HSF的努力。5.5 Responsibility, authority and communication5.5 责任、职权与沟通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5.5.1 Responsibility and authority5.5.1 责任与职权 Top management shall ensure that HSF related responsibilities and authorities are defined and communicated within the organization.高阶主管应确保已制定 HSF 相关责任与职权，并在组织内沟通。5.5.2 Management representative5.5.2 管理代表Top management shall appoint a member of management who, irrespective of other responsibilities, shall have responsibility and authority that includes最高管理阶层应在管理阶层中指派一员担任管理代表，该代表不受其它责任所影响，明订其责任与职权，包括a) ensuring that processes, procedures, and practices are established pursuant to achieving HSF goals.a) 确保流程、程序与实务是为达成 HSF 目标而建立。b) reporting to top management on the organizations performance pursuant to the HSF plan and needs and recommended improvements in execution.b) 向高阶主管回报按照 HSF 计划与需求所达成之组织绩效，并提出执行上的改善建议。c) ensuring that HSF related requirements and responsibilities are communicated and understood throughout the organization.c) 确定 HSF 相关要求与责任均已在组织内充份沟通与了解。d) ensuring the awareness in supplier organizations of their HSF related requirements and responsibilities.d) 确保供货商组织了解 HSF 相关要求与责任。5.5.3 Internal Communication5.5.3 内部沟通a) Top management shall ensure that the organizations personnel are informed of performance effectiveness and issues as relate to the HSF policies and execution plan.a) 高阶主管应确保已向员工沟通与HSF政策及执行相关之绩效与议题。b) Hazardous substances information shall be communicated, as required throughout the organization.b) 当需要时，应在组织内沟通有害物质之信息。5.6 Management review5.6 管理阶层审查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5.6.1 General5.6.1 概述Top management shall include and report on, during the regular management reviews, activities related to the HSF plan with regards to identification, use of hazardous substances, nonconformances and corrective actions.7.8.1 在例行管理阶层审查时，高阶主管应纳入并回报 HSF 计划相关活动，例如有害物质之识别与使用、不符合事项与矫正措施6. Resource Management6. 资源管理6.1 Provision of resources6.1 资源提供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 organization shall determine and provide the resources needed to implement and maintain HSF processes and products组织应决定并提供实施与维护 HSF 流程与产品所需之资源。6.2 Human resources6.2 人力资源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6.2.1 General6.2.1 概述Personnel performing work affecting HSF product shall be competent on the basis of appropriate education, training, skills and experience.8.2.1 职务会影响 HSF 产品之员工，应受过适当的教育训练并具备技术与经验 6.2.2 Competence, awareness and training6.2.2 能力、认知与训练The organization shall组织应：a) determine the necessary competence for personnel performing work affecting HSF product quality,a) 决定职务会影响 HSF 产品质量之员工的必备能力。b) provide training specific to the HSF plan for the identification, use, and elimination of hazardous substances.b) 专为 HSF 计划规划，以识别、使用与消除有害物质，提供训练c) evaluate the effectiveness of the actions taken,c) 评估已采取之行动的有效性。d) ensure that personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the HSF objectives, andd) 确保员工知道其活动之关联与重要性，以及如何协助达成 HSF 目标。e) maintain appropriate records of education, training, skills and experience.e) 维持教育、训练、技术与经验的适当记录。 6.3 Infrastructure6.3 基础架构 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 organization shall determine, provide and maintain the infrastructure needed 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 Realization7. 产品实现7.1 Planning of HSF process and product realization7.1 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 organization 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 organization 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 organizations 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 resources to be applied to a specific product can be referred to as a quality plan.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7.2 Customer-related process7.2 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7.2.1 Determination of requirements related to the HSF product7.2.1 HSF 产品之相关要求决定The organization 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, andc) 与产品相关的HSF法令与规章要求。 d) any additional HSF requirements determined by the organization.d) 组织所决定的任何额外HSF要求。7.2.2 Review of HSF requirements related to the product7.2.2 HSF产品有关要求之审查The organization shall review the requirements related to the HSF product. This review shall be conducted prior to the organizations commitment 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, anda) HSF产品要求已予界定b) the organization 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 communicated 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7.3 Design and development7.3 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7.3.1 HSF design and development planning7.3.1. HSF 设计与开发规划The organization 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 replacement/elimination of the part.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。7.3.2 HSF Design and development inputs7.3.2 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 complete, 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。7.3.3 HSF Design and development outputs7.3.3 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，7.3.4 HSF Design and development review7.3.4 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。7.3.5 Design and development verification7.3.5 设计与开发查验The requirements of ISO 9001 shall applyISO 9001的要求事项应适用7.3.6 Design and development validation7.3.6 设计与开发确效The requirements of ISO 9001 shall applyISO 9001的要求事项应适用7.3.7 Control of HSF design and development changes7.3.7 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, verified and validated, as appropriate, and approved before implementation.HSF设计与开发变更应予以鉴别并将纪录予以维持。适当时，变更应予以审查、查证及确认，且在实施前予以核准。7.4 Purchasing of HSF products7.4. HSF 产品之采购 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a) The organization shall ensure that procured product conforms to HSF requirements.a) 组织应确保采购品符合 HSF 要求。b) the organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organizations HSF requirements.b) 组织应根据供货商能否提供符合组织 HSF 要求之产品进行评估并选择供货商c) the organization shall ensure that any HSF part/material is free from possible contamination with a restricted substance.c) 组织应确保任何 HSF 零件材料不可能受到限制性物质的污染。d) procurement of restricted substances shall be clearly identified on the purchase document and upon receipt of the material.d) 限制性物质的采购应在采购文件上与接收材料时清楚确认。 e) Verification of HSF purchased producte) HSF 采购产品之查验 f) The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified HSF purchase requirements.f) 组织应建立与实施必要之检验或其它活动，以确保采购产品符合详细载明的 HSF 采购要求。 g) The procurement route of purchased goods shall be fully understood and any process that has the possibility of contamination by restricted hazardous substances shall be fully identified. A documented procedure shall outline the procurement activities related to the HSF process.g) 应全面了解采购商品之采购流程，并验明任何可能造成限制性有害物质污染的流程。文件化程序应描述与 HSF 流程相关之采购活动。 h) Establish a documented procedure for the inspection and identification of Hazardous substances included in purchased goods. The hazardous substance shall be identified by the type in the inspection data.h) 针对采购物品中有害物质之检验与识别建立文件化程序。有害物质应在检验数据中按类型识别。i) included shall be a process to handle an abnormality/nonconformance.i) 应纳入异常不符合情况之处理流程。j) If the processes are combined with each other a documented procedure shall be established to differentiate between parts.j) 若流程彼此合并，应建立文件化程序以区分零件。7.5 Production and service provision7.5 生产与服务供应 The requirements of ISO 9001 shall