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IECQQC080000IECQQC080000中譯本4Generalrequirements4.品質管理系統4.1QualityManagementSystem4.1一般要求事项TherequirementsofISO9001shallapplyalongwiththeadditionalrequirementsbelow:ISO9001的要求事項應適用，並增加下列要求4.1.1General4.1.1概述EachorganizationshallincludeinitsISO9001:2000mandatedqualitymanagementsystemtheprocedures,documentation,andprocessmanagementpracticesnecessarytoachieveHSFproductandproductionprocesses.組織應在其ISO9001:2000指定品質管理系統中，加入達成HSF產品與作業流程所需之程序、文件與流程管理實務。Theorganizationshall組織應a)Identifyanddocumentallhazardoussubstancesinuseintheorganization.a)確認與記錄組織使用的所有有害物質。b)identifythespecificprocessestobemanagedrelevanttoitsHSFgoals.b)確認與HSF目標相關且待管理的特定流程。c)determinetheinterdependenceandinteractionoftheseprocessesanddevelopanappropriateHSFprocessmanagementplan.c)決定這些流程的相互依賴關係與交互作用，並發展適當之HSF流程管理計畫。d)establishcriteriauponwhichtoobjectivelydeterminetheeffectivenessoftheorganization’sHSFprocessmanagement.d)建立能客觀決定組織HSF流程管理功效的條件。e)ensuretheavailabilityofresourcesandinformationneededtosupporteffectiveHSFprocessmanagement.e)確保支援有效HSF流程管理所需之資源與資訊容易取得f)monitor,measureandanalyzetheseprocesses,andf)監督、量測與分析這些流程。g)implementactionstoensurecontinuousprocessimprovementinachievingHSF.g)採取行動以確保流程之持續改善以達成HSF。h)haveaprocessestablishedtorestrictand/oreliminatetheuseofhazardoussubstancesfromproductsandprocesses.h)建立流程，以限制及（或）中止對產品與在流程中使用有害物質。4.1.2RelationshipwithISO90014.1.2與ISO9001:2000的關連TheintentionofthisdocumentisthatHSFprocessmanagementistobecongruentwiththeelementsofISO9001:2000internationalStandard.本文件的目的是要讓HSF流程管理符合ISO9001:2000國際標準的要項。IECQQC080000IECQQC080000中譯本4.1.3Outsourcing4.1.3委外Whereanorganizationchoosestooutsourceanyprocessthataffectsitsproducts’HSFcharacteristics,andacceptintoitsoperationstheproductofprocessesoutsideitsownoperations,theorganizationshallensuremanagementofandcontroloversuchprocesses.若組織選擇將任何會影響其產品HSF特性的流程外包出去，並將外包流程之產品引進其本身的作業，則該組織應確保此等流程之管理與管制。4.2Documentationrequirements4.2文件要求TherequirementsofISO9001shallapplyalongwiththeadditionalrequirementsbelow:ISO9001的要求事項應適用，並增加下列要求4.2.1General4.2.1概述Thequalitymanagementsystemdocumentationshallinclude品質管理系統文件化應包括a)TheHSFrequirementsshallbeanintegralpartoftheorganization’squalitymanagementsystemandshallincludea)HSF要求應為組織品質管理系統中不可或缺的部份，並應包含下列各項：b)alistofallhazardoussubstancesusedwithintheorganization.b)組織內使用之所有有害物質清單。c)statementsofHSFpolicyandobjectiveswithinclusionofatimelineforeliminationofuseofallhazardoussubstances,asappropriatec)HSF政策與目標之聲明。若適當的話，包含停止使用所有有害物質之時程。d)intheorganization’squalitymanualasectionontheHSFprocessmanagementplanandobjectivesandreferencetoHSFdocumentedproceduresd)組織的品質手冊中應說明HSF流程管理計畫與目標、以及HSF文件化程序之參考章節e)documentedproceduresasrequiredbytheorganization’sHSFprocessmanagementplanwithcontrolofallsuchdocumentsexecutedasrequiredbysection4.2.4oftheISO9001:2000internationalStandard.e)按照組織HSF流程管理計畫要求之文件化程序，並按ISO9001:2000國際標準第4....