【正文】 HSF生產(chǎn)與服務(wù)供應(yīng)之管制 The anization shall plan HSF production and service provisions under controlled conditions. Controlled conditions shall include, as applicable 組織應(yīng)在管制之情況下，規(guī) 劃并執(zhí)行 HSF 生產(chǎn)與服務(wù)供應(yīng)。 i) included shall be a process to handle an abnormality/nonconformance. i) 應(yīng)納入異常／不符合情況之處理流程。 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) 針對(duì)采購(gòu)物品中有害物質(zhì)之檢驗(yàn)與識(shí)別建立文件化程序。 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) 應(yīng)全面了解采購(gòu)商品之采購(gòu)流程，并驗(yàn)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(gòu)應(yīng)在采購(gòu)文件上與接收材料時(shí)清楚確認(rèn)。 Purchasing of HSF products . HSF 產(chǎn)品之采購(gòu) The requirements of ISO 9001 shall apply along with the additional requirements below: ISO 9001 的要求事項(xiàng)應(yīng)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(yīng)確保采購(gòu)品符合 HSF 要求。 Design and development verification 設(shè) 計(jì)與開發(fā)查驗(yàn) The requirements of ISO 9001 shall apply ISO 9001 的要求事項(xiàng)應(yīng)適用 Design and development validation 設(shè)計(jì)與開發(fā)確效 The requirements of ISO 9001 shall apply ISO 9001 的要求事項(xiàng)應(yīng)適用 Control of HSF design and HSF設(shè)計(jì)與開發(fā)變更之管制 IECQ QC 080000 中英文對(duì)照表 DNV Taiwan 9/14 IECQ QC 080000 IECQ QC 080000 中譯本 development changes 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(shè)計(jì)與開發(fā)變更應(yīng)予以鑒別并將紀(jì)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(dāng)設(shè)計(jì)要求使用限制性物質(zhì)時(shí)，應(yīng)發(fā)展文件化程序。要求應(yīng)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 replacement/elimination of the part. 在規(guī)劃設(shè)計(jì)時(shí)，任何限制性物質(zhì)的使用應(yīng)記錄在文件、以及一個(gè)用于管制及最終取代／演除該零件的計(jì)劃內(nèi)。 組織應(yīng)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(yīng)以適合組織作業(yè)方法的格式輸出。 c) 針對(duì) HSF 產(chǎn)品所需之特定的查證、確認(rèn)、監(jiān)測(cè)、檢驗(yàn)及試驗(yàn)活動(dòng)，以及產(chǎn)品之允收準(zhǔn)則。 a) HSF 產(chǎn)品的質(zhì) 量目標(biāo)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(shí)現(xiàn) Planning of HSF process and product realization HSF 流程與產(chǎn)品實(shí)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(xiàng)應(yīng)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(yīng)規(guī)劃并發(fā)展實(shí)現(xiàn) HSF 產(chǎn)品所需的流程。 e) maintain appropriate records of education, training, skills and experience. e) 維持教育、訓(xùn)練、技術(shù)與經(jīng)驗(yàn)的適當(dāng)記錄。 b) provide training specific to the HSF plan for the identification, use, and elimination of hazardous substances. b) 專為 HSF 計(jì)劃規(guī)劃，以識(shí)別、使用與消除有害物質(zhì)，提供訓(xùn)練 c) evaluate the effectiveness of the actions taken, c) 評(píng)估已采取之行動(dòng)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(xiàng)應(yīng)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(shí)，高階主管應(yīng)納入并回報(bào) HSF 計(jì)劃相關(guān)活 動(dòng)，例如有害物質(zhì)之識(shí)別與使用、不符合事項(xiàng)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(xiàng)應(yīng)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(yīng)決定并提供實(shí)施與維護(hù) 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 and execution plan. a) 高階主管應(yīng)確保已向員工溝通與 HSF 政策及執(zhí)行相關(guān)之績(jī)效與議題。 IECQ QC 080000 中英文對(duì)照表 DNV Taiwan 5/14 IECQ QC 080000 IECQ QC 080000 中譯本 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(zé)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(yīng)在管理階層中指派一員擔(dān)任管理代表，該代表不受其它責(zé)任所影響，明訂其責(zé)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(shí)務(wù)是為達(dá)成 HSF 目標(biāo)而建立。 HSF planning HSF 規(guī)劃 Top management shall ensure that 高階主管應(yīng)確保下列各項(xiàng) 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(dá)成 HSF 所需之實(shí)務(wù)已整合至質(zhì)量管理系統(tǒng)規(guī)劃當(dāng)中，并為質(zhì)量目標(biāo)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 。 b