【正文】 ased 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) 應全面了解采購商品之采購流程，并驗明任何可能造成限制性有害物質(zhì)污染的流程。 d) procurement of restricted substances shall be clearly identified on the purchase document and upon receipt of the material. d) 限 制性物質(zhì)的采購應在采購文件上與接收材料時清楚確認。 Purchasing of HSF products . HSF 產(chǎn)品之采購 The requirements of ISO 9001 shall apply along with the additional requirements below: ISO 9001 的要求事項應適用，并增加下列要求 a) The anization shall ensure that procured product conforms to HSF requirements. a) 組織應確保采購品符合 HSF 要求。 Design and development verification 設計與開發(fā)查驗 The requirements of ISO 9001 shall apply ISO 9001 的要求事項應適用 Design and development validation 設計與開發(fā)確效 The requirements of ISO 9001 shall apply ISO 9001 的要求事項應適用 Control of HSF design and development changes HSF設計與開發(fā)變更之管制 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 設計與開發(fā)變更應予以鑒別并將紀錄予以維持。 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. 當設計要求使用限制性物質(zhì)時，應發(fā)展文件化程序。要求應完整、不模擬兩可且不彼此沖突。 In planning the design, the use of any restricted substance shall be identified in the documentation and a plan for control and eventual 在規(guī)劃設計時，任何限制性物質(zhì)的使用應記錄在文件、以及一個用于管制及最終取代／演除該零件的計劃內(nèi)。 組織應審查與 HSF 產(chǎn)品有關(guān)之要求。 d) any additional HSF requirements determined by the anization. d) 組織所決定的任何額外 HSF 要求。 b) HSF requirements not stated by the customer but necessary for specified or intended uses, where known. b) 非客戶所陳述之要求，但為已知的特定或意圖使用所必需者。 f) The output of this HSF planning shall be in a form suitable for the anization’s method of operations. f) 此 HSF 規(guī)劃應以適合組織作業(yè)方法的格式輸出。 c) 針對 HSF 產(chǎn)品所需之特定的查證、確認、監(jiān)測、檢驗及試驗活動，以及產(chǎn)品之允收準則。 a) HSF 產(chǎn)品的質(zhì)量目標與要求： b) the need to establish HSF processes, documents, and provide resources specific to the HSF product。 7 Product Realization 7. 產(chǎn)品實現(xiàn) Planning of HSF process and product realization HSF 流程與產(chǎn)品實現(xiàn)之規(guī)劃 The requirements of ISO 9001 shall apply along with the additional requirements below: ISO 9001 的要求事項應適用，并增加下列要求 The anization shall plan and develop the processes needed for HSF product realization. 組織應規(guī)劃并發(fā)展實現(xiàn) HSF 產(chǎn)品所需的流程。 中國最大的管 理 資料下載中心 (收集 \整理 . 大量免費資源共享 ) 第 6 頁 共 14 頁 IECQ QC 080000 IECQ QC 080000 中譯本 and e) maintain appropriate records of education, training, skills and experience. e) 維持教育、訓練、技術(shù)與經(jīng)驗的適當記錄。 b) provide training specific to the HSF plan for the identification, use, and elimination of hazardous substances. b) 專為 HSF 計劃規(guī)劃，以識別、使用與消除有害物質(zhì)，提供訓練 c) evaluate the effectiveness of the actions taken, c) 評估已采取之行動的有效性。 Management review 管理階層審查 The requirements of ISO 9001 shall apply along with the additional requirements below: ISO 9001 的要求事項應適用，并增加下列要求 General 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, nonconformance’s and corrective actions. 在例行管理階層審查時， 高階主管應納入并回報 HSF 計劃相關(guān)活動，例如有害物質(zhì)之識別與使用、不符合事項與矯正措施 6. Resource Management 6. 資源管理 Provision of resources 資源提供 The requirements of ISO 9001 shall apply along with the additional requirements below: ISO 9001 的要求事項應適用，并增加下列要求 The anization shall determine and provide the resources needed to implement and maintain HSF processes and products 組織應決定并提供實施與維護 HSF 流程與產(chǎn)品所需之資源。 Internal Communication 內(nèi)部溝通 a) Top management shall ensure that the anization’s personnel are informed of performance effectiveness and issues as relate to the HSF policies a) 高階主管應確保已向員工溝通與 HSF 政策及執(zhí)行相關(guān)之績效與議題。 c) ensuring that HSF related requirements and responsibilities are municated and understood throughout the anization. c) 確定 HSF 相關(guān)要求與責任均已在組織內(nèi)充份溝通與了解。 Management representative 管理代表 Top management shall appoint a member of management who, irrespective of other responsibilities, shall have responsibility and authority that includes 最高管理階層應在管理階層中指派一員擔任管理代表，該代表不受其它責任所影響，明訂其責任與職權(quán)，包括 a) ensuring that processes, procedures, and practices are established pursuant to achieving HSF goals. a) 確保流程、 程序與實務是為達成 HSF 目標而建立。 HSF planning HSF 規(guī)劃 Top management shall ensure that 高階主管應確保下列各項 a) the practices required to achieve HSF are integrated into the quality management system planning and are elements in the quality objectives, and a) 達成 HSF 所需之實務已整合至質(zhì)量管理系統(tǒng)規(guī)劃當中，并為質(zhì)量目標之一 b) the continuity of the HSF effort is maintained as improvements and changes are executed. b) 藉由改善與變更，維持持續(xù) HSF 的努力。 中國最大的管 理 資料下載中心 (收集 \整理 . 大量免費資源共享 ) 第 4 頁 共 14 頁 IECQ QC 080000 IECQ QC 080000 中譯本 measurable and consistent with the HSF policy. 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 目標應包括一份時程表。 c) is municated and understood within the anization, and c) 已在組織內(nèi)溝通且為了解 d) is reviewed for continuing suitability. d) 已對持續(xù)適用性完成評估 Planning 規(guī)劃 The requirements of ISO 9001 shall apply along with the additional requirements below: ISO 9001 的要求事項應適用，并增加下列要求 HSF objective