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1、internationalStandardarenotacceptableunlesstheseexclusionsare合本国际标准，ThroughoutthetextofthisInternationalStandard,wherevertheterm”product”occurs,itcanalsomean“service”.,”产品”一词亦等同于”服务Qualitymanagementsystems-RequirementsScopeGeneralThisInternationalStandardspecifiesrequirementsforaqualitymanagementsys
2、temwhereanorganization:a) needstodemonstrateitsabilitytoconsistentlyprovideproductthatmeetscustomerandapplicableregulatoryrequirements,andaimstoachievecustomersatisfactionthroughtheeffectiveapplicationofthesystem,includingprocessesforcontinualimprovementofthesystemandtheassuranceofconformitytocustom
3、erandapplicableregulatoryrequirements.NOTE:InthisInternationalStandard,theterm“product”appliestotheproductintendedfor,orrequiredby,acustomerApplicationAllrequirementsofthisInternationalStandardaregenericandareintendedtobeapplicabletoallorganizations,regardlessoftype,sizeandproductprovided.Whereanyre
4、quirement(s)ofthisInternationalStandardcannotbeappliedduetothenatureofanorganizationanditsproduct,thiscanbeconsideredforexclusion.Whereexclusionsaremade,claimsofconformitytothislimitedtorequirementswithinclause7,andsuchexclusionsdonotaffecttheorganizationsability,orresponsibility,toprovideproducttha
5、tmeetscustomerandapplicableregulatoryrequirements.NormativereferenceThefollowingnormativedocumentcontainsprovisionswhich,throughreferenceinthistext,constituteprovisionsofthisInternationalStandard.Fordatedreferences,subsequentamendmentsto,orrevisionsof,anyofthesepublicationsdonotapply.However,parties
6、toagreementsbasedonthisInternationalStandardareencouragedtoinvestigatethepossibilityofapplyingthemostrecenteditionofthenormativedocumentindicatedbelow.Forundatedreferences,thelatesteditionofthenormativedocumentindicatedbelow.Forundatedreferences,thelatesteditionofthenormativedocumentreferredtoapplie
7、s.MembersofISOandIECmaintainregistersofcurrentlyvalidInternationalStandards.ISO9000:2000,Qualitymanagemenstystems-Fundamentalsandvocabulary.TermsanddefinitionsForthepurposesofthisInternationalStandard,thetermsanddefinitionsgiveninISO9000apply.ThefollowingtermsusedinthiseditionofISO9001todescribethes
8、upplychain,havebeenchangedtoreflectthevocabularycurrentlyused:SupplierorganizationcustomerTheterm“organization”replacestheterm“supplier”usedinISO9001”1994,andreferstotheunit,towhichthisInternationalStandardapplies.Also,theterm“supplier”nowreplacestheterm“subcontractor”.质量管理体系-要求范围通则本国际标准规定了质量管理体系的各项
9、要求，以满足当组织有下列需求时:须要展现其能力足以稳定地提供符合客户或适当法规要求之产品,和透过体系的有效运用，包括持续改善与保证达成客户和法规要求的流程，达到客户满意备注：本国际标准中，产品一词适用于预期提供予顾客或其所需要之产品。1 应用此国际标准的所有要求乃通用性要求且期望能适用于所有组织,无论其行业、规模及所提供的产品，本国际标准的任何要求若因组织或产品之特性而无法适用时可考虑予以排除当本国际标准的任何要求被排除时，则组织不得宣称其符除非所排除的要求局限于本国际标准的第七章，且不影响组织提供符合客户及适当法规要求产品的能力或责任引用标准本国际标准引用下列标准的内容以构成本国际标准的条款
10、，所引用的标准如具日期版次，则其后之修订或改版均不适用于本国际标准然而依据本国际标准达成共识之各团体仍应探求使用下列标准档最新版次的可能。引用的标准如未指定日期版次，则应使用最新的引用标准ISO及IEC会员皆维持有最新有效国际标准的登录清单。ISO9000:2000质量管理体系-原理与词汇名词与定义ISO9000:2000中之与定义均适用于本国际标准。本国际标准用来描述供应链之名词更动如下，以反映目前的习惯用语：供货商组织顾客本版次以“组织”取代先前1994版次使用的”供货商”，以表示采用本国际标准的单位。而”供货商”则用来取代之前版次的”分包商”。Qualitymanagementsyste
11、mGeneralrequirementsTheorganizationshallestablish,document,implementandmaintainaqualitymanagementsystemandcontinuallyimproveitseffectivenessinaccordancewiththerequirementsofthisInternationalStandard.Theorganizationshall:a) identifytheprocessesneededforthequalitymanagementsystem,andtheirapplicationth
12、roughouttheorganization(see1.2);determinethesequenceandinteractionoftheseprocesses;determinecriteriaandmethodsneededtoensurethatboththeoperationandcontroloftheseprocessesareeffective;ensuretheavailabilityofresourcesandinformationnecessarytosupporttheoperationandmonitoringoftheseprocesses;monitor,mea
13、sureandanalysistheseprocesses,andimplementactionnecessarytoachieveplannedresultsandcontinualimprovementoftheseprocesses.质量管理体系一般要求组织应遵照本际际标准的要求建立、档化、执行、维持质量管理体系并持续改善其有效性。组织应：a) 鉴别质量管理体系所需的过程及其在组织中之运用(见b) 1.2)决定这些过程的顺序及相互关系决定确保这些过程有效运作及管制的必要的准则及方c) 方法，确保提供支持这些过程的运作及监督必要的资源与信d) 息；量测、监控及分析这些流程，和采取必要行动以
14、达成这些过程预期的结果及持续改善Theseprocessesshallbemanagedbytheorganizationinaccordance组织应遵照本国际标准的要求管理这些过程withtherequirementsofthisInternationalStandard.Whereanorganizationchoosestooutsourceanyprocessthataffects当组织选用任何满足产品与要求所需的外来资源流程时，productconformitywithrequirements,theorganizationshallensure组织应确认能掌控这些流程。质量管理体
15、系之外来资源流controloversuchprocesses.Controlofsuchoutsourcedprocesses程的控制应被定义。shallbeidentifiedwithinthequalitymanagementsystem.NOTE:processesneededforthequalitymanagementsystem备注：上述质量管理体系所须之过程包括管理活动、资源referredtoaboveshouldincludeprocessesformanagement提供、产品实现与量测等过程。activities,provisionofresources,product
16、realizationandmeasurement.DocumentationrequirementsGeneralThequalitymanagementsystemdocumentationshallinclude:a) documentedstatementsofaqualitypolicyandqualityobjectives;aqualitymanual;documentedproceduresrequiredbythisInternationalStandard;documentsneededbytheorganizationtoensuretheeffectiveplanningoperationandcontrolofitsprocesses,andrecordsrequiredbythisInternationalStandard(see4.2.4)NOTE1Wheretheterm“documentedpro
