Qualitymanagementsystems–Requirements1Scope1.1GeneralThisInternationalStandardspecifiesrequirementsforaqualitymanagementsystemwhereanorganizationa)needstodemonstrateitsabilitytoconsistentlyprovideproductthatmeetscustomerandapplicableregulatoryrequirements,andb)aimstoenhancecustomersatisfactionthroughtheeffectiveapplicationofthesystem,includingprocessesforcontinualimprovementofthesystemandtheassuranceofconformitytocustomerandapplicableregulatoryrequirements.NOTEInthisInternationalStandard,theterm“product”appliestotheproductintendedfor,orrequiredby,acustomer.1.2ApplicationAllrequirementsofthisInternationalStandardaregenericandareintendedtobeapplicabletoallorganizations,regardlessoftype,sizeandproductprovided.Wereanyrequirement(s)ofthisinternationalStandardcannotbeappliedduetothenatureofanorganizationanditsproduct,thiscanbeconsideredforexclusion.Whereexclusionsaremade,claimsofconformitytothisInternationalStandardarenotacceptableunlessacceptableunlesstheseexclusionsarelimitedtorequirementswithinclause7,andsuchexclusionsdonotaffecttheorganization’sability,orresponsibility,toprovideproductthatmeetscustomerandapplicableregulatoryrequirements.2NormativereferenceThefollowingnormativedocumentcontainsprovisionswhich,throughreferenceinthistext,constituteprovisionsofthisInternationalStandard.Fordatedreferences,subsequentamendmentsto,orrevisionsof,anyofthesepublicationsdonotapply.However,partiestoagreementsbasedonthisInternationalStandardareencouragedtoinvestigatethepossibilityofapplyingthemostrecenteditionofthenormativedocumentindicatedbelow.Forundatedreferences,thelatesteditionofthenormativedocumentreferred品質管理系統--要求1範圍1.1通則當組織有下列要求時，本國際標準界定其品質管理系統的需求：[a)]需須要展現其能力足以穩定地提供符合客戶及適用法規要求之產品，和a)[b)]透過系統的有效運用，包括持續改善系統之過程與保證符合客戶及適當法規要求，以增進客戶滿意。””備註在本國際標準中，產品一詞適用於預期提供予顧客或其所需要之產品。1.2應用此國際標準的所有要求乃通用性要求且期望能適用於所有組織，無論其行業、規模及所提供的產品。本國際標準的任何要求若因組織或產品之特性而無法適用時可考慮予以排除。當本國際標準的任何要求被排除時，則組織不得宣稱其符合本國際標準，除非所排除的要求侷限於本國際標準的第七節且不影響組織提供符合客戶及適當法規要求產品的能力或責任。2引用標準本國際標準引用下列標準的內容以構成本國際標準的條款。所引用的標準如具日期版次，則其後之修訂或改版均不適用於本國際標準。然而依據本國際標準達成共識之各團體仍應探求使用下列引用標準最新版次的可能。引用的標準如未指定日期版次，則應使用最新的引用標準。ISO及IEC會員皆維持有最新有效國際標準的登錄清單。toapplies.MembersofISOandIECmaintainregistersofcurrentlyvalidInternationalStandards.ISO9000:2000,Qualitymanagementsystems–Fundamentalsandvocabulary.3TermsanddefinitionsForthepurposesofthisInternationalStandard,thetermsanddefinitionsgiveninISO9000apply.Thefollowingitems,usedinthiseditionofISO9001todescribethesupplychain,havebeenchangedtoreflectthevocabularycurrentlyused:supplier→organization→customerTheterm“organization”replacestheterm“supplier”usedinISO9001:1994,andreferstotheunittowhichthisInternationalStandardapplies.Also,theterm“supplier”nowreplacestheterm“subcontractor”.ThroughoutthetextofthisInternationalStandard,wherevertheterm“product”occurs,itcanalsomean“service”.4Qualitymanagementsystem4.1GeneralrequirementsTheorganizationshallest...
