搜索
ISO9001:20002000.12.15~1~Qualitymanagementsystems–Requirements1Scope1.1GeneralThisInternationalStandardspecifiesrequirementsforaqualitymanagementsystemwhereanorganizationa)needstodemonstrateitsabilitytoconsistentlyprovideproductthatmeetscustomerandapplicableregulatoryrequirements,andb)aimstoenhancecustomersatisfactionthroughtheeffectiveapplicationofthesystem,includingprocessesforcontinualimprovementofthesystemandtheassuranceofconformitytocustomerandapplicableregulatoryrequirements.NOTEInthisInternationalStandard,theterm“product”appliestotheproductintendedfor,orrequiredby,acustomer.1.2ApplicationAllrequirementsofthisInternationalStandardaregenericandareintendedtobeapplicabletoallorganizations,regardlessoftype,sizeandproductprovided.Wereanyrequirement(s)ofthisinternationalStandardcannotbeappliedduetothenatureofanorganizationanditsproduct,thiscanbeconsideredforexclusion.Whereexclusionsaremade,claimsofconformitytothisInternationalStandardarenotacceptableunlesstheseexclusionsarelimitedtorequirementswithinclause7,andsuchexclusionsdonotaffecttheorganization’sability,orresponsibility,toprovideproductthatmeetscustomerandapplicableregulatoryrequirements.2NormativereferenceThefollowingnormativedocumentcontainsprovisionswhich,throughreferenceinthistext,constituteprovisionsofthisInternationalStandard.Fordatedreferences,subsequentamendmentsto,orrevisionsof,anyofthesepublicationsdonotapply.However,partiestoagreementsbasedonthisInternationalStandardareencouragedtoinvestigatethepossibilityofapplyingthemostrecenteditionofthenormativedocumentindicatedbelow.Forundatedreferences,thelatesteditionofthenormativedocumentreferredtoapplies.MembersofISOandIECmaintain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。ISO9001:20002000.12.15~2~registersofcurrentlyvalidInternationalStandards.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”.4Qualitymanagementsystem4.1GeneralrequirementsTheorganizationshallestablish,document,implementandmaintainaqualitymanagementsystemandcontinuallyimproveitseffectivenessinaccordancewiththerequirementsofthisInternationalStandard.Theorganizationshalla)identifytheprocessesneededforthequalitymanagementsystemandtheirapplicationthroughouttheorganization(see1.2),b)determinethesequenceandinteractionoftheseprocesses,c)determinecriteriaandmethodsneededtoensurethatboththeoperationandcontroloftheseprocessesareeffective,d)ensuretheavailabilityofresourcesandinformationnecessarytosupporttheoperationandmonitoringoftheseprocesses,e)monitor,measureandanalyzetheseprocesses,andISO9000:2000品質管理系統–綱要與辭彙3名詞與定義ISO9000（2000）中之名詞與定義均適用於本國際標準。本國際標準（ISO9001）用來描述供應鏈之名詞改變如下，以反映目前的用語習慣：供應商→組織→顧客本版次以“組織”取代先前ISO9001：1994版次使用的”供應商”，以表示採用本國際標準的單位。而”供應商”則用來取代之前版次的”分包商”。本國際標準全文之中，”產品”一詞可表示為”服務”的意思。4品質管理系統4.1一般要求組織應遵照本國際標準的要求建立、文件化、執行、維持品質管理系統並持續改善其有效性。組織應：a)鑑別品質管理系統所需的過程及其在組織中之運用(見1.2)，b)決定這些過程的順序及相互關係，c)決定確保這些過程有效運作及管制的必要的準則及方法，d)確保提供支援這些過程的運作及監督必要的資源與資訊，e)監控、量測及分析這些過程，和f)採取必要行動以達成這些過程的預期結果及持ISO9001:20002000.12.15~3~f)implementactionsnecessarytoachieveplannedresultsandcontinualimprovementoftheseprocesses.TheseprocessesshallbemanagedbytheorganizationinaccordancewiththerequirementsofthisInternationalStandard.Whereanorganizationchoosestooutsourceanyprocessthataffectsproductconformitywithrequirements,theorganizationshallensurecontroloversuchprocesses.Controlofsuchoutsourcedprocessesshallbeidentifiedwithinthequalitymanagementsystem.NOTEProcessesneededforthequalitymanagementsystemreferredtoaboveshouldincludeprocessesformanagementactivities,provisionofresources,productrealizationandmeasurement.4.2Documentationrequirements4.2.1GeneralThequalitymanagementsystemdocumentationshallincludea)documentedstatementsofaqualitypolicyandqualityobjectives,b)aqualitymanual,c)documentedproceduresrequiredbythisInternationalStandard,d)documentsneededbytheorganizationtoensuretheeffectiveplanning,operationandcontrolofitsprocesses,ande)recordsrequiredbythisInternationalStandard(see4.2.4)NOTE1Wheretheterm“documentedprocedure”appearswithinthisInternationalStandard,thismeansthattheprocedureisestablished,documented,imple