【正文】 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 Internal Audit 內(nèi)部稽核：The organization shall conduct internal assessments at planned intervals to determine whether the organization’s Hazardous Substance Free processes conform to the requirements of this national standard and to customer specifications, and are effectively implemented and maintained.組織外須定期進(jìn)行內(nèi)部稽核，以決定組織之有害物質(zhì)排除流程是否符合此國(guó)家標(biāo)準(zhǔn)與客戶(hù)規(guī)格之要求，并有效實(shí)施與維護(hù)。Note: See ISO 100111, ISO 100112 and ISO 100113 for guidance說(shuō)明：作法請(qǐng)參閱 ISO 100111, ISO 100112 與 ISO 100113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 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(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。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(cè)均應(yīng)以文件記錄。 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(cè)產(chǎn)品的限制性物質(zhì)，以驗(yàn)證是否符合產(chǎn)品要求。此部份應(yīng)根據(jù) HSF 計(jì)劃，在產(chǎn)品實(shí)現(xiàn)流程的適當(dāng)階段執(zhí)行。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。記錄應(yīng)顯示授權(quán)放行產(chǎn)品之人員。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。 Control of nonconforming HSF product 不符合 HSF 產(chǎn)品之管制 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The organization shall ensure that products which do not conform to HSF product requirements are identified and controlled to prevent their unintended use or delivery.. 組織應(yīng)確保能識(shí)別并管制不符合 HSF 產(chǎn)品要求之產(chǎn)品，以避免意外使用或交付。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(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(guò)特別允許。b) Records of the nature of nonconformities and subsequent actions taken shall be maintained and clearly identified as to what restricted substance was detectedb) 不符合情況之性質(zhì)與后續(xù)動(dòng)作之記錄應(yīng)妥善保存，并清楚說(shuō)明偵測(cè)到的限制性物質(zhì)。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(kāi)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(hù)之合約協(xié)議或組織流程管理政策通知客戶(hù)。 Analysis of HSF data HSF 資料分析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 organization shall determine, collect and analyze appropriate data to demonstrate the suitability and effectiveness of the HSF process management system.組織應(yīng)決定、搜集與分析適當(dāng)數(shù)據(jù)，以證明 HSF 流程管理系統(tǒng)之通用性與有效性。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(hù)滿(mǎn)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(shì)，包括采取預(yù)防行動(dòng)的機(jī)會(huì)，以及與供貨商的績(jī)效d) continuous improvement efforts for the elimination of the all hazardous substances, as applicable.d) 若適用的話(huà)，消除所有有害物質(zhì)的持續(xù)改善作法。 Improvement of HSF process management system HSF流程管理系統(tǒng)的改善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 Continual Improvement 持續(xù)改善The organization shall continually improve the effectiveness of HSF process management through the use of the quality policy, quality objectives, assessment results, analysis of data, corrective and preventive actions and management review. 組織應(yīng)透過(guò)應(yīng)用質(zhì)量政策、質(zhì)量目標(biāo)、評(píng)估結(jié)果、數(shù)據(jù)分析、矯正與預(yù)防措施及管理階層審查，持續(xù)改善 HSF 流程管理的有效性。 Corrective action for identified HSF nonconformances 對(duì)已識(shí)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(dòng)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(píng)估 HSF 不符合事項(xiàng)（包括客戶(hù)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(píng)估采?。ǔC正）措施之需要，以確保不會(huì)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?。ǔC正）措施的結(jié)果h) reviewing corrective action taken, andh) 評(píng)估采取的矯正措施i) reporting the status of all HSF corrective actions for management review.i) 提報(bào)所有 HSF 矯正措施的狀態(tài)，供管理階層審查。14 / 14