【文章內容簡介】 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 產品所需的流程。 In planning HSF product realization, the anization shall determine the following, as appropriate: 在規(guī)劃實現(xiàn) HSF 產品時，若適當?shù)脑?，組織應決定下列項目： a) quality objectives and requirements for the HSF product。 a) HSF 產品的質 量目標與要求： 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，并提供針對 HSF 產品的資源； 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) 針對 HSF 產品所需之特定的查證、確認、監(jiān)測、檢驗及試驗活動，以及產品之允收準則。若適當?shù)脑?，應包含信息服務供貨商? IECQ QC 080000 中英文對照表 DNV Taiwan 7/14 IECQ QC 080000 IECQ QC 080000 中譯本 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) 對使用限制性物質的流程所準備的文件化程序或作業(yè)指示，包括如何預防可能的污染： e) records needed to provide evidence that the HSF realization processes and resulting product meet requirements. e) 提供 HSF 實現(xiàn)流程與產出產品符合要求所需的證據(jù)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。 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 (包括產品實現(xiàn)流程 )以及應用于特定產品的資源，可當成質量計劃參照 Customerrelated process 客戶有關之過程 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 Determination of requirements related to the HSF product HSF 產品之相關要求決定 The anization shall determine 組織應決定 : a) HSF requirements specified by the customer, a) 客戶規(guī)定之 HSF 要求。 b) HSF requirements not stated by the customer but necessary for specified or intended uses, where known. b) 非客戶所陳述之要求，但為已知的特定或意圖使用所必需者。 c) HSF statutory and regulatory requirements related to the product, and c) 與產品相關的 HSF 法令與規(guī)章要求。 d) any additional HSF requirements determined by the anization. d) 組織所決定的任何額外 HSF 要求。 Review of HSF requirements related to the product HSF產品有關要求之審查 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。 組織應審查與 HSF 產品有關之要求。此審查應在組織承諾供應產品給顧客之前，且應確保： a) HSF product requirements are defined, and a) HSF 產品要求已予界定 b) the anization has the ability to meet the HSF defined requirements. b) 組織有能力符 合所界定之 HSF 要求 c) any use of or possibility of contamination or mixing of processes or product that contain c) 任何包含限制性物質的流程或產品之使用、污染可能性或混合，均應向客戶說明， IECQ QC 080000 中英文對照表 DNV Taiwan 8/14 IECQ QC 080000 IECQ QC 080000 中譯本 restricted substances shall be municated to the customer. d) Records of the results of the HSF review and actions arising from the review shall be kept and maintained. d) HSF 評估結果記錄及評估后產生之行動記錄均應保存與維護 Design and development 設計與開發(fā) 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 design and development planning . HSF 設計與開發(fā)規(guī)劃 The anization shall plan and control the design and development of HSF product. 組織應規(guī)劃并管制 HSF 產品的設計與開發(fā)。 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)劃設計時，任何限制性物質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。 HSF Design and development inputs HSF 設計與開發(fā)輸入 Inputs relating to HSF product requirements shall be determined and records maintained. 與 HSF 產品要求相關之輸入，應予以決定并將紀錄加以維持 HSF inputs shall be reviewed for adequacy. Requirements shall be plete, unambiguous and not in conflict with each other. 應檢視 HSF 輸入之充足性。要求應完整、不模擬兩可且不彼此沖突。 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。 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時，應發(fā)展文件化程序。以管制、識別、監(jiān)督與量測納入外包產品之流程／產品， HSF Design and development review HSF設計與開發(fā)審查 At suitable stages, systematic reviews of the design and development shall be performed in accordance with the HSF plan. 在適當階段，應依所規(guī)劃的安排事項執(zhí)行 HSF設計與開發(fā)之系統(tǒng)性審查。 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 HSF設計與開發(fā)變更之管制 IECQ QC 080000 中英文對照表 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 設計與開發(fā)變更應予以鑒別并將紀錄予以維持。適當時，變更應予以審查、查證及確認，且在實施前予以核準。 Purchasing of HSF products . HSF 產品之采購 The requirements of ISO 9001 shall apply along with the additional requireme