【正文】 and the petence of personnel.說明：與ISO 9001:2000 國際標準一致，「文件化程序」指程序應建立、記錄、執(zhí)行與維護。The organization shall組織應a) Identify and document all hazardous substances in use in the organization.a) 確認與記錄組織使用的所有有害物質。c) ensuring that HSF objectives are established.c) 確定 HSF 目標的建立d) including HSF in management reviews, andd) 在管理階層審查時納入 HSF ，以及e) providing resources to ensure progress toward HSF products and production processes.e) 提供資源以確保朝 HSF 產(chǎn)品與作業(yè)流程發(fā)展。b) Hazardous substances information shall be municated, as required throughout the organization.b) 當需要時，應在組織內溝通有害物質之信息。 c) HSF statutory and regulatory requirements related to the product, andc) 與產(chǎn)品相關的HSF法令與規(guī)章要求。 e) Verification of HSF purchased producte) HSF 采購產(chǎn)品之查驗 f) The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified HSF purchase requirements.f) 組織應建立與實施必要之檢驗或其它活動，以確保采購產(chǎn)品符合詳細載明的 HSF 采購要求。b) Processes that include any restricted substance shall be uniquely identified and segregated to prevent bination with HSF product.b) 包含任何限制性物質的流程應個別辨識，并加以隔離，以避免與 HSF 產(chǎn)品結合。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。記錄應顯示授權放行產(chǎn)品之人員。h) operational procedures are documented and define preventive measures to prevent possible contamination.h) 以文件記錄作業(yè)程序，并定義預防措施以避免可能的污染。適當時，變更應予以審查、查證及確認，且在實施前予以核準。若適當?shù)脑?，應包含信息服務供貨商?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) 對使用限制性物質的流程所準備的文件化程序或作業(yè)指示，包括如何預防可能的污染： e) records needed to provide evidence that the HSF realization processes and resulting product meet requirements.e) 提供 HSF 實現(xiàn)流程與產(chǎn)出產(chǎn)品符合要求所需的證據(jù)記錄。b) reporting to top management on the organization’s performance pursuant to the HSF plan and needs and remended improvements in execution.b) 向高階主管回報按照 HSF 計劃與需求所達成之組織績效，并提出執(zhí)行上的改善建議。d) in the organization’s quality manual a section on the HSF process management plan and objectives and reference to HSF documented proceduresd) 組織的質量手冊中應說明 HSF 流程管理計劃與目標、以及 HSF 文件化程序之參考章節(jié)e) documented procedures as required by the organization’s HSF process management plan with control of all such documents executed as required by section of the ISO 9001:2000 international Standard.e) 按照組織 HSF 流程管理計劃要求之文件化程序，并按 ISO 9001:2000 國際標準第 節(jié)之規(guī)定控管所有此類文件。b) identify the specific processes to be managed relevant to its HSF goals.b) 確認與 HSF目標相關且待管理的特定流程。 f) ensuring the list of hazardous substances is municated throughout the organization.f) 確保全組織均了解有害物質清單。 Management review 管理階層審查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 General 概述Top management shall include and report on, during the regular management reviews, activities related to the HSF plan with regards to identification, use of hazardous substances, nonconformance’s and corrective actions. 在例行管理階層審查時，高階主管應納入并回報 HSF 計劃相關活動，例如有害物質之識別與使用、不符合事項與矯正措施　6. Resource Management6. 資源管理 Provision of resources 資源提供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 organization shall determine and provide the resources needed to implement and maintain HSF processes and products組織應決定并提供實施與維護 HSF 流程與產(chǎn)品所需之資源。 d) any additional HSF requirements determined by the organization.d) 組織所決定的任何額外HSF要求。 g) The procurement route of purchased goods shall be fully understood and any process that has the possibility of contamination by restricted hazardous substances shall be fully identified. A documented procedure shall outline the procurement activities related to the HSF process.g) 應全面了解采購商品之采購流程，并驗明任何可能造成限制性有害物質污染的流程。c) The organization shall identify the HSF product status with respect to monitoring and measurement requirements.c) 組織應根據(jù)監(jiān)督與量測要求，識別 HSF產(chǎn)品狀態(tài)。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。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。g) processes that have the possibility of contamination are identified and documented.g) 識別并記錄有污染可能性之流程。 Design and development verification 設計與開發(fā)查驗The requirements of ISO 9001 shall applyISO 9001的要求事項應適用 Design and development validation 設計與開發(fā)確效The requirements of ISO 9001 shall applyISO 9001的要求事項應適用 Control of HSF design and development changes HSF設計與開發(fā)變更之管制 HSF design and development changes shall be identified and records maintained. The changes shall be reviewed, verified and validated, as appropriate, and approved before implementation.HSF設計與開發(fā)變更應予以鑒別并將紀錄予以維持。c) 針對HSF產(chǎn)品所需之特定的查證、確認、監(jiān)測、檢驗及試驗活動，以及產(chǎn)品之允收準則。 Management representative 管理代表Top management shall appoint a member of management who, irrespective of other responsibilities, shall have responsibility and authority that includes