【文章內(nèi)容簡(jiǎn)介】 d to achieve conformity to HSF process and product requirements. 組織應(yīng)決定、提供并維護(hù)達(dá)成 HSF 流程與產(chǎn)品要求所需之基礎(chǔ)架構(gòu)。 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。 In planning HSF product realization, the anization shall determine the following, as appropriate: 在規(guī)劃實(shí)現(xiàn) HSF 產(chǎn)品時(shí)，若適當(dāng)?shù)脑?，組織應(yīng)決定下列項(xiàng)目： a) quality objectives and requirements for the HSF product。 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。 b) 建立 HSF 流程、文件的需求，并提供針對(duì) HSF 產(chǎn)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(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。若適當(dāng)?shù)脑?，?yīng)包含信息服務(wù)供貨商； 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) 對(duì)使用限制性物質(zhì)的流程所準(zhǔn)備的文件化程序或作業(yè)指示，包括如何預(yù)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(shí)現(xiàn)流程與產(chǎn)出產(chǎn)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(yīng)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 注 1：指定 HSF 程序的文件 (包括產(chǎn)品實(shí)現(xiàn)流程 )以及應(yīng)用于特定產(chǎn)品的資源，可當(dāng)成質(zhì)量計(jì)劃參照 中國(guó)最大的管 理 資料下載中心 (收集 \整理 . 大量免費(fèi)資源共享 ) 第 7 頁(yè) 共 14 頁(yè) IECQ QC 080000 IECQ QC 080000 中譯本 resources to be applied to a specific product can be referred to as a quality plan. Customerrelated process 客戶有關(guān)之過(guò)程 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 Determination of requirements related to the HSF product HSF 產(chǎn)品之相關(guān)要求決定 The anization shall determine 組織應(yīng)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(chǎn)品相關(guān)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(chǎn)品有關(guān)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(yīng)審查與 HSF 產(chǎn)品有關(guān)之要求。此審查應(yīng)在組織承諾供應(yīng)產(chǎn)品給顧客之前，且應(yīng)確保： a) HSF product requirements are defined, and a) HSF 產(chǎn)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 restricted substances shall be municated to the customer. c) 任何包含限制性物質(zhì)的流程或產(chǎn)品之使用、污染可能性或混合，均應(yīng)向客戶說(shuō)明， d) Records of the results of the HSF review and actions arising from the review shall be kept and maintained. d) HSF 評(píng)估結(jié)果記錄及評(píng)估后產(chǎn)生之行動(dòng)記錄均應(yīng)保存與維護(hù) Design and development 設(shè)計(jì)與開發(fā) 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 HSF design and development planning . HSF 設(shè)計(jì)與開發(fā)規(guī)劃 The anization shall plan and control the design and development of HSF product. 組織應(yīng)規(guī)劃并管制 HSF 產(chǎn)品的設(shè)計(jì)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 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)。 中國(guó)最大的管 理 資料下載中心 (收集 \整理 . 大量免費(fèi)資源共享 ) 第 8 頁(yè) 共 14 頁(yè) IECQ QC 080000 IECQ QC 080000 中譯本 replacement/elimination of the part. HSF Design and development inputs HSF 設(shè)計(jì)與開發(fā)輸入 Inputs relating to HSF product requirements shall be determined and records maintained. 與 HSF 產(chǎn)品要求相關(guān)之輸入，應(yīng)予以決定并將紀(jì)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(yīng)檢視 HSF 輸入之充足性。要求應(yīng)完整、不模擬兩可且不彼此沖突。 HSF Design and development outputs HSF 設(shè)計(jì)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(shè)計(jì)與開發(fā)之輸出，應(yīng)以一種能針對(duì)設(shè)計(jì)與開發(fā)輸入進(jìn)行查證之形式予以提供，并在發(fā) 行前應(yīng)加以核準(zhǔn)。 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。以管制、識(shí) 別、監(jiān)督與量測(cè)納入外包產(chǎn)品之流程／產(chǎn)品， HSF Design and development review HSF設(shè)計(jì)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(dāng)階段，應(yīng)依所規(guī)劃的安排事項(xiàng)執(zhí)行 HSF 設(shè)計(jì)與開發(fā)之系統(tǒng)性審查。 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 development changes HSF設(shè)計(jì)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, verifie