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IECQQC080000中英文对照表IECQQC080000IECQQC080000中译本4Generalrequirements4.一般要求事项4.1QualityManagementSystem4.1质量管理系统TherequirementsofISO9001shallapplyalongwiththeadditionalrequirementsbelow:ISO9001的要求事项应适用，并增加下列要求4.1.1General4.1.1概述EachorganizationshallincludeinitsISO9001:2000mandatedqualitymanagementsystemtheprocedures,documentation,andprocessmanagementpracticesnecessarytoachieveHSFproductandproductionprocesses.组织应在其ISO9001:2000指定质量管理系统中，加入达成HSF产品与作业流程所需之程序、文件与流程管理实务。Theorganizationshall组织应a)Identifyanddocumentallhazardoussubstancesinuseintheorganization.a)确认与记录组织使用的所有有害物质。b)identifythespecificprocessestobemanagedrelevanttoitsHSFgoals.b)确认与HSF目标相关且待管理的特定流程。c)determinetheinterdependenceandinteractionoftheseprocessesanddevelopanappropriateHSFprocessmanagementplan.c)决定这些流程的相互依赖关系与交互作用，并发展适当之HSF流程管理计划。d)establishcriteriauponwhichtoobjectivelydeterminetheeffectivenessoftheorganization’sHSFprocessmanagement.d)建立能客观决定组织HSF流程管理功效的条件。e)ensuretheavailabilityofresourcesandinformationneededtosupporteffectiveHSFprocessmanagement.e)确保支持有效HSF流程管理所需之资源与信息容易取得f)monitor,measureandanalyzetheseprocesses,andf)监督、量测与分析这些流程。g)implementactionstoensurecontinuousprocessimprovementinachievingHSF.g)采取行动以确保流程之持续改善以达成HSF。h)haveaprocessestablishedtorestrictand/oreliminatetheuseofhazardoussubstancesfromproductsandprocesses.h)建立流程，以限制及（或）中止对产品与在流程中使用有害物质。4.1.2RelationshipwithISO90014.1.2与ISO9001:2000的关连TheintentionofthisdocumentisthatHSFprocessmanagementistobecongruentwiththeelementsofISO9001:2000internationalStandard.本文件的目的是要让HSF流程管理符合ISO9001:2000国际标准的要项。4.1.3Outsourcing4.1.3委外Whereanorganizationchoosestooutsourceanyprocessthataffectsitsproducts’HSF若组织选择将任何会影响其产品HSF特性的流程外包出去，并将外包流程之产品引进其IECQQC080000IECQQC080000中译本characteristics,andacceptintoitsoperationstheproductofprocessesoutsideitsownoperations,theorganizationshallensuremanagementofandcontroloversuchprocesses.本身的作业，则该组织应确保此等流程之管理与管制。4.2Documentationrequirements4.2文件要求TherequirementsofISO9001shallapplyalongwiththeadditionalrequirementsbelow:ISO9001的要求事项应适用，并增加下列要求4.2.1General4.2.1概述Thequalitymanagementsystemdocumentationshallinclude质量管理系统文件化应包括a)TheHSFrequirementsshallbeanintegralpartoftheorganization’squalitymanagementsystemandshallincludea)HSF要求应为组织质量管理系统中不可或缺的部份，并应包含下列各项：b)alistofallhazardoussubstancesusedwithintheorganization.b)组织内使用之所有有害物质清单。c)statementsofHSFpolicyandobjectiveswithinclusionofatimelineforeliminationofuseofallhazardoussubstances,asappropriatec)HSF政策与目标之声明。若适当的话，包含停止使用所有有害物质之时程。d)intheorganization’squalitymanualasectionontheHSFprocessmanagementplanandobjectivesandreferencetoHSFdocumentedproceduresd)组织的质量手册中应说明HSF流程管理计划与目标、以及HSF文件化程序之参考章节e)documentedproceduresasrequiredbytheorganization’sHSFprocessmanagementplanwithcontrolofallsuchdocumentsexecutedasrequiredbysection4.2.4oftheISO9001:2000internationalStandard.e)按照组织HSF流程管理计划要求之文件化程序，并按ISO9001:2000国际标准第4.2.4节之规定控管所有此类文件。f)recordsoftheorganization’sHSFprocessmanagementperformance.f)组织HSF流程管理绩效之记录，Note:ConsistentwiththeISO9001:2000internationalStandard,“documentedprocedures”meansthattheprocedureisestablished,documented,implementedandmaintained.Additionally,theextentofdocumentationrequiredisspecifictothesizeoftheorganization,complexityofprocesses,andthecompetenceofpersonnel.说明：与ISO9001:2000国际标准一致，「文件化程序」指程序应建立、记录、执行与维护。此外，文件记录的程序应按照组织规模、流程复杂度与人员的能力而定5.ManagementResponsibility5.管理责任5.1ManagementCommitment5.1．承诺证据TherequirementsofISO9001shallapplyISO9001的要求事项应适用，并增加下列要求IECQQC080000IECQQC080000中译本alongwiththeadditionalrequirementsbelow:TopmanagementshallprovideevidenceofitscommitmenttothedevelopmentandimplementationofpracticesconsistentwithachievingHSFproductsandproductionprocessesandthecontinuousimprovementofsuchby高阶主管应就符合HSF产品与作业流程、及该等产品与作业流程之持续改进，就实务发展与实施提供承诺证据，其方法如下：a)communicatingtotheorganizationtheimportanceofmeetingcustomeraswellasstatutoryandregulatoryrequirements.a)与组织组织沟通达到客户要求与达到法定与规章要求同等重要。b)establishingtheHSFpolicy.b)建立HSF政策。c)ensuringthatHSFobjectivesareestablished.c)确定HSF目标的建立d)includingHSFinmanagementreviews,andd)在管理阶层审查时纳入HSF，以及e)providingresourcestoensureprogresstowardHSFproductsandproductionprocesses.e)提供资源以确保朝HSF产品与作业流程发展。f)ensuringthelistofhazardoussubstancesiscommunicatedthroughouttheorganization.f)确保全组织均了解有害物质清单。g)DeterminingHSFrequirements.g)决定HSF需求5.2Customerfocus7.2客户为重TopmanagementshallensurethatcustomerHSFrequirementsaredetermined,aremetandincludedinthemeasureofcustomersatisfaction.高阶管阶层应确定客户的HSF要求已决定并已达到，同时纳入客户满意度的量测中。5.3HSFPolicy5.3HSF政策TopmanagementshallensurethattheHSFpolicyisappropriateforthepurposeoftheorganization,and高阶主管应确定HSF政策适合组织的宗旨，并a)includesacommitmenttocomplywithrequirementsandcontinuallyimprovetheeffectivenessoftheHSFmanagementpractices.a)包含遵守要求以及持续改善HSF管理实务绩效的承诺。b)providesaframeworkforestablishingandreviewingHSFobjectives.b)提供建立与审查HSF目标之架构。c)iscommunicatedandunderstoodwithintheorganization,andc)已在组织内沟通且为了解d)isreviewedforcontinuingsuitability.d)已对持续适用性完成评估5.4Planning5.4规划TherequirementsofISO9001shallapplyalongwiththeadditionalrequirementsbelow:ISO9001的要求事项应适用，并增加下列要求IECQQC080000IECQQC080