【正文】 Corrective action for identified HSF nonconformances 對已識別 HSF 不符合事項(xiàng)所采取之矯正措施 a) The organization shall take action to eliminate the cause of HSF nonconformities in order to prevent recurrence.a) 組織應(yīng)采取行動消除造成 HSF 不符合事項(xiàng)的原因，以避免再度發(fā)生b) A HSF documented procedure shall be established to define requirements forb) 應(yīng)建立 HSF 文件化程序，以定義下列要求c) reviewing HSF nonconformities (including customer plaints)c) 評估 HSF 不符合事項(xiàng)（包括客戶抱怨）d) determining the causes of nonconformities,d) 決定不符合事項(xiàng)的原因e) evaluating the need for action to ensure that HSF nonconformities do not recur,e) 評估采取（矯正）措施之需要，以確保不會再發(fā)生 HSF 不符合事項(xiàng)f) determining and implementing action needed,f) 決定并實(shí)施必要的（矯正）措施g) records of the results of action taken,g) 記錄采取（矯正）措施的結(jié)果h) reviewing corrective action taken, andh) 評估采取的矯正措施i) reporting the status of all HSF corrective actions for management review.i) 提報所有 HSF 矯正措施的狀態(tài)，供管理階層審查。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 satisfactiona) 客戶滿意度b) conformity to product requirementsb) 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，包括采取預(yù)防行動的機(jī)會，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 organization 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到不符合 HSF 產(chǎn)品時，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 organization 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 contain restricted substances from being shipped unless otherwise allowed.a) 應(yīng)建立明確的程序，以便在偵測出含有限制性物質(zhì)之不符合產(chǎn)品時加以處理，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 ProductThe organization 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：作法請參閱 ISO 100111, ISO 100112 與 ISO 100113譯注: 作法請參閱ISO 19011 Monitoring of Restricted Substances Processes 限制物質(zhì)流程之監(jiān)督The organization 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。此程序應(yīng)包括收取與運(yùn)送記錄；以及顯示有害物質(zhì)經(jīng)過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 organization 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)視與量測及所需的監(jiān)視與量測裝置，以提供HSF產(chǎn)品對既定要求的符合性之證據(jù)b) The organization 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)視與量測能被執(zhí)行，并以和HSF監(jiān)視與量測要求一致之狀況下執(zhí)行8. Measurement, analysis and improvement8 量測、分析與改進(jìn) GeneralThe 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 organization 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、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 procedure shall include records of receiving and shipping。c) The organization shall identify the HSF product status with respect to monitoring and measurement requirements.c) 組織應(yīng)根據(jù)監(jiān)督與量測要求，識別 HSF產(chǎn)品狀態(tài)。 HSF identification and traceability HSF 識別與可追蹤性 a) Where appropriate, the organization shall identify the HSF product by suitable means throughout product realization.a) 適當(dāng)時，組織應(yīng)藉由適宜之方法，在產(chǎn)品實(shí)現(xiàn)之全程，對HSF產(chǎn)品加以識別。 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 organization 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 th