【導讀】序、文件與流程管理實務。a)確認與記錄組織使用的所有有害物質。用，并發(fā)展適當之HSF流程管理計劃。f)監(jiān)督、量測與分析這些流程。ISO9001:2020國際標準的要項。c)HSF政策與目標之聲明。

　　

【正文】 ditional requirements below: ISO 9001 的要求事項應適用，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. 組織應規(guī)劃與實施證明符合 HSF 要求所需之監(jiān)督、量測、分析與改進流程。 IECQ QC 080000 中英文對照表 DNV Taiwan 12/14 IECQ QC 080000 IECQ QC 080000 中譯本 Monitoring and measurement of HSF processes HSF流程的監(jiān)督與量測 Customer satisfaction 客戶滿意度 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 Internal Audit 內部稽核： The anization shall conduct internal assessments at planned intervals to determine whether the anization’s Hazardous Substance Free processes conform to the requirements of this national standard and to customer specifications, and are effectively implemented and maintained. 組織外須定期進行內部稽核，以決定組織之有害物質排除流程是否符合此國家標準與客戶規(guī)格之要求，并有效實施與維護。 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 組織應采取適當方法，以監(jiān)督并在適當情況下量測限制性物質流程；包 括經(jīng)確認有可能使用限制性物質之供貨商／承包商、及信息服務供貨商的流程。 How these processes are to be controlled, monitored and measured shall be documented. 這些流程之管制、監(jiān)督與量測均應以文件記錄。 Monitoring and measurement of Restricted Substance Product 限制物質產(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. 組織應建立文件化程序，以監(jiān)督與量測產(chǎn)品的限制性物質，以驗證是否符合產(chǎn)品要求。此部份應根據(jù) HSF 計劃，在產(chǎn)品實現(xiàn)流程的適當階段執(zhí)行。 Evidence of conformity with acceptance criteria for Restricted Substances shall be maintained. Records shall indicate the person(s) authorizing release of product. 符合限制性物質合格標準之證據(jù)應妥養(yǎng)保存。記錄應顯示授權放行產(chǎn)品之人員。 Product release and delivery shall not proceed 在妥善完成必要的評估前，產(chǎn)品不得放行與交IECQ QC 080000 中英文對照表 DNV Taiwan 13/14 IECQ QC 080000 IECQ QC 080000 中譯本 until the required reviews have been satisfactorily pleted. 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 的要求事項應適用，并增加下列要求 The anization shall ensure that products which do not conform to HSF product requirements are identified and controlled to prevent their unintended use or delivery. . 組織應確保能識別并管制 不符合 HSF 產(chǎn)品要求之產(chǎn)品，以避免意外使用或交付。 The anization shall deal with nonconforming product by one or more of the following ways: 組織應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) 應建立明確的程序，以便在偵測出含有限制性物質之不符合產(chǎn)品時加以處理，并且避免將含有限制性物質的產(chǎn)品付運，除非經(jīng)過特別允許。 b) Records of the nature of nonconformities and subsequent actions taken shall be maintained and clearly identified as to what restricted substance was detected b) 不符合情況之性質與后續(xù)動作之記錄應妥善保存，并清楚說明偵測到的限制性物質。 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到不符合 HSF 產(chǎn)品時，組織應根據(jù)與客戶之合約協(xié)議或組織流程管理政策通知客戶。 Analysis of HSF data HSF 資料分析 The requirements of ISO 9001 shall apply along with the additional requirements below: ISO 9001 的要求事項應適用，并增加下列要求 The anization shall determine, collect and analyze appropriate data to demonstrate the suitability and effectiveness of the HSF process management system. 組織應決定、搜集與分析適當數(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)分析應提供下列相關信息 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，包括采取預防行動的機會，以及與供貨商的績效 IECQ QC 080000 中英文對照表 DNV Taiwan 14/14 IECQ QC 080000 IECQ QC 080000 中譯本 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 的要求事項應適用，并增加下列要求 Continual Improvement 持續(xù)改善 The anization 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. 組織應透過應用質量政策、質量目標、評估結果、數(shù)據(jù)分析、矯正與預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 對已識別 HSF 不符合事項所采取之矯正措施 a) The anization shall take action to eliminate the cause of HSF nonconformities in order to prevent recurrence. a) 組織應采取行動消除造成 HSF 不符合事項的原因，以避免再度發(fā)生 b) A HSF documented procedure shall be established to define requirements for b) 應建立 HSF 文件化程序，以定義下列要求 c) reviewing HSF nonconformities