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TheintentionofthisdocumentisthatHSFprocessmanagementistobecongruentwiththeelementsofISO9001:2000international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。---本文来源于网络，仅供参考，勿照抄，如有侵权请联系删除---IECQQC080000IECQQC080000中译本Standard.4.1.3Outsourcing4.1.3委外Whereanorganizationchoosestooutsourceanyprocessthataffectsitsproducts’HSFcharacteristics,andacceptintoitsoperationstheproductofprocessesoutsideitsownoperations,theorganizationshallensuremanagementofandcontroloversuchprocesses.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’sHSFprocessmanagementplanwithcontrolofallsuchdocumentsexecutedasrequiredbysection4.2.4ofth...