【正文】 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 13 頁 共 14 頁 IECQ QC 080000 IECQ QC 080000 中譯本 contain restricted substances from being shipped unless otherwise allowed. b) Records of the nature of nonconformities and subsequent actions taken shall be maintained and clearly identified as to what restricted substance was detected b) 不符合情況之性質(zhì)與后續(xù)動作之記錄應妥善保存，并清楚說明偵測到的限制性物質(zhì)。 How these processes are to be controlled, monitored and measured shall be documented. 這些流程之管制、監(jiān)督與量測均應以文件記錄。 b) Processes that include any restricted substance shall be uniquely identified and segregated to prevent bination with HSF product. b) 包含任何限制性物質(zhì)的流程應個別辨識，并加以隔離，以避免與 HSF 產(chǎn)品結合。當適用時，管制情況應包括： a) the availability of HSF information that describes the characteristics of the product, a) 描述 HSF 產(chǎn)品特性信息之備妥 (可用性 ) 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 10 頁 共 14 頁 IECQ QC 080000 IECQ QC 080000 中譯本 b) the availability of HSF work instructions, as necessary, b) 若需要時， HSF 工作說明書之備妥 (可用 性 ) c) the use of suitable HSF equipment, c) 適當 HSF 設備之使用 d) the availability and use of HSF monitoring and measuring devices, d) HSF 監(jiān)督與量測裝置之備妥與使用。 e) Verification of HSF purchased product e) HSF 采購產(chǎn)品之查驗 f) The anization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified HSF purchase requirements. f) 組織應建立與實施必要之檢驗或其它活動，以確保采購產(chǎn)品符合詳細載明的 HSF 采購要求。 HSF Design and development outputs HSF 設計與開發(fā)輸出 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 設計與開發(fā)之輸出，應以一種能針對設計與開發(fā)輸入進行查證之形式予以提供，并在發(fā) 行前應加以核準。 c) HSF statutory and regulatory requirements related to the product, and c) 與產(chǎn)品相關的 HSF 法令與規(guī)章要求。 In planning HSF product realization, the anization shall determine the following, as appropriate: 在規(guī)劃實現(xiàn) HSF 產(chǎn)品時，若適當?shù)脑?，組織應決定下列項目： a) quality objectives and requirements for the HSF product。 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 5 頁 共 14 頁 IECQ QC 080000 IECQ QC 080000 中譯本 and execution plan. b) Hazardous substances information shall be municated, as required throughout the anization. b) 當需要時，應在組織內(nèi)溝通有害物質(zhì)之信息。若適當時，按表除去在流程或產(chǎn)品（包括采購產(chǎn)品）中所識別出與使用中之有害物質(zhì)。 c) ensuring that HSF objectives are established. c) 確定 HSF 目標的建立 d) including HSF in management reviews, and d) 在管理階層審查時納入 HSF ，以及 e) providing resources to ensure progress toward HSF products and production processes. e) 提供資源以確保朝 HSF 產(chǎn)品與作業(yè)流程發(fā)展。 Outsourcing 委外 Where an anization chooses to outsource any process that affects its products’ HSF characteristics, and accept into its operations the product of processes 若組織選擇將任何會影響其產(chǎn)品 HSF 特性的流程外包出去，并將外包流程之產(chǎn)品引進其本身的作業(yè)，則該組織應確保此等流程之管理與管制。 The anization shall 組織應 a) Identify and document all hazardous substances in use in the anization. a) 確認與記錄組織使用的所有有害物質(zhì)。 g) implement actions to ensure continuous process improvement in achieving HSF. g) 采取行動以確保流程之持續(xù)改善以達成 HSF。 f) records of the anization’s HSF process management performance. f) 組織 HSF 流程管理績效之記錄， Note: Consistent with the ISO 9001:2020 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 anization, plexity of processes, and the petence of personnel. 說明：與 ISO 9001:2020 國際標準一致，「文件化程序」指程序應建立、記錄、執(zhí)行與維護。 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 objectives HSF 目標 a) Top management shall ensure that HSF objectives are established at relevant functions and levels within the anization. The HSF objectives shall be a) 高階主管應確保按組織的相關職能與層級建立 HSF 目標。 c) ensuring that HSF related requirements and responsibilities are municated and understood throughout the anization. c) 確定 HSF 相關要求與責任均已在組織內(nèi)充份溝通與了解。 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、技術與經(jīng)驗的適當記錄。 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。 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)。 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。 i) included shall be a process to handle an abnormality/nonconformance. i) 應納入異常／不符合情況之處理流程。 Validation of HSF processes for production and service provision HSF 生產(chǎn)與服務供應流程之確認 The anization shall validate HSF processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any HSF processes where d