【正文】 The analysis of data shall provide information relating to: 數(shù)據(jù)分析應(yīng)提供下列相關(guān)信息 a) customer satisfaction a) 客戶滿意度 b) conformity to product requirements b) 產(chǎn)品要求的符合性 c) characteristics and trends of processes and products including opportunities for preventive action, and suppliers’ performance. c) 流程與產(chǎn)品的特性與趨勢(shì)，包括采取預(yù)防行動(dòng)的機(jī)會(huì)，以及與供貨商的績效 d) continuous improvement efforts for the elimination of the all hazardous substances, as applicable. d) 若適用的話，消除所有有害物質(zhì)的持續(xù)改善作法。 c) When nonconforming HSF product is detected after delivery or use has started, the anization shall take action to notify customers according to contract agreements or pany process management policy. c) 在交付后或開始使用后才偵測(cè)到不符合 HSF 產(chǎn)品時(shí)，組織應(yīng)根據(jù)與客戶之合約協(xié)議或組織流程管理政策通知客戶。 The anization shall deal with nonconforming product by one or more of the following ways: 組織應(yīng)用以下一種或多種方法，處理不合格品 a) There shall be a clear procedure to handle situations when nonconforming products that contain restricted substances are detected and to prevent products that a) 應(yīng)建立明確的程序，以便在偵測(cè)出含有限制性物質(zhì)之不符合產(chǎn)品時(shí)加以處理，并且避免將含有限制性物質(zhì)的產(chǎn)品付運(yùn)，除非經(jīng)過特別允許。 Product release and delivery shall not proceed until the required reviews have been satisfactorily pleted. 在妥善完成必要的評(píng)估前，產(chǎn)品不得放行與交付。 Evidence of conformity with acceptance criteria for Restricted Substances shall be maintained. Records shall indicate the person(s) authorizing release of product. 符合限制性物質(zhì)合格標(biāo)準(zhǔn)之證據(jù)應(yīng)妥養(yǎng)保存。 Monitoring and measurement of Restricted Substance Product 限制物質(zhì)產(chǎn)品之監(jiān)督 The anization shall establish a documented procedure to monitor and measure the Restricted Substances of the product to verify that product requirements have been met. This shall be carried out at appropriate stages of the product realization process in accordance with the HSF plan. 組織應(yīng)建立文件化程序，以監(jiān)督與量測(cè)產(chǎn)品的限制性物質(zhì)，以驗(yàn)證是否符合產(chǎn)品要求。 Note: See ISO 100111, ISO 100112 and ISO 100113 for guidance 說明：作法請(qǐng)參閱 ISO 100111, ISO 100112 與 ISO 100113 中國最大的管 理 資料下載中心 (收集 \整理 . 大量免費(fèi)資源共享 ) 第 12 頁 共 14 頁 IECQ QC 080000 IECQ QC 080000 中譯本 譯注 : 作法請(qǐng)參閱 ISO 19011 Monitoring of Restricted Substances Processes 限制物質(zhì)流程之監(jiān)督 The anization shall apply suitable methods for monitoring and, where applicable, measurement of the Restricted Substance processes including processes of suppliers/subcontractors and information services providers where the possibility of the use of a restricted substance is identified 組織 應(yīng)采取適當(dāng)方法，以監(jiān)督并在適當(dāng)情況下量測(cè)限制性物質(zhì)流程；包括經(jīng)確認(rèn)有可能使用限制性物質(zhì)之供貨商／承包商、及信息服務(wù)供貨商的流程。 and records showing hazardous substances are segregated and managed separately. 隔離與分開管理之記錄 Control of monitoring and measuring devices used in HSF processes 于 HSF 流程中使用之監(jiān)督與量測(cè)裝置之管制 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 determine the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of HSF product to determined requirements. a) 組織應(yīng)決定所從事之監(jiān)視與 量測(cè)及所需的監(jiān)視與量測(cè)裝置，以提供 HSF 產(chǎn)品對(duì)既定要求的符合性之證據(jù) b) The anization shall establish processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the HSF monitoring and measurement requirements. b) 組織應(yīng)建立 流程以確保監(jiān)視與量測(cè)能被執(zhí)行，并以和 HSF 監(jiān)視與量測(cè)要求一致之狀況下執(zhí)行 8. Measurement, analysis and improvement 8 量測(cè)、分析與改進(jìn) General 概述 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 Organization 組織 The anization shall plan and implement the monitoring, measurement, analysis and improvement processes needed to demonstrate conformity to HSF requirements. 組織應(yīng)規(guī)劃與實(shí)施證明符合 HSF 要求所需之監(jiān)督、量測(cè)、分析與改進(jìn)流程。 Handling of hazardous substances parts 有害物質(zhì)零件之處理 There shall be a documented procedure for the handling and storage of hazardous substances. This 應(yīng)針對(duì)有害物質(zhì)之處理與儲(chǔ)存，建立文件化程序。 c) The anization shall identify the HSF product status with respect to monitoring and measurement requirements. c) 組織應(yīng)根據(jù)監(jiān)督與量測(cè)要求，識(shí)別 HSF 產(chǎn)品狀態(tài)。 HSF identification and traceability HSF 識(shí)別與可追蹤性 a) Where appropriate, the anization shall identify the HSF product by suitable means throughout product realization. a) 適當(dāng)時(shí)，組織應(yīng)藉由適宜之方法，在產(chǎn)品實(shí)現(xiàn)之全程，對(duì) HSF 產(chǎn)品加以識(shí)別。 Validation of HSF processes for production and service provision HSF 生產(chǎn)與服務(wù)供應(yīng)流程之確認(rèn) 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 deficiencies bee apparent only after the product is in use or the service has been delivered. 當(dāng) HSF 生產(chǎn)與服務(wù)提供過程的輸出結(jié)果，無法經(jīng)由后續(xù)的監(jiān)視或量測(cè)加以查證時(shí)，組織應(yīng)對(duì) 該等過程予以確認(rèn)。 g) processes that have the possibility of contamination are identified and documented. g) 識(shí)別并記錄有污染可能性之流程。 e) the implementation of HSF monitoring and measurement, and e) HSF 監(jiān)督與量測(cè)之實(shí)施。 Production and service provision 生產(chǎn)與服務(wù)供應(yīng) 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 Control of HSF production and service provision processes 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 purch