ISO 9001-2026《质量管理体系-要求》 英文条款对照表（含变化标识）（雷泽佳编制-2026年9月）

ISO9001-2026《质量管理体系——要求》英文条款对照表（含变化标识）（雷泽佳编制-2026年9月）ISO9001:2026条款号ISO9001:2026条款原文（变化部分粗体）ISO9001:2015条款号ISO9001:2015条款原文ForewordISO(theInternationalOrganizationforStandardization)isaworldwidefederationofnationalstandardsbodies(ISOmemberbodies).TheworkofpreparingInternationalStandardsisnormallycarriedoutthroughISOtechnicalcommittees.Eachmemberbodyinterestedinasubjectforwhichatechnicalcommitteehasbeenestablishedhastherighttoberepresentedonthatcommittee.Internationalorganizations,governmentalandnon-governmental,inliaisonwithISO,alsotakepartinthework.ISOcollaboratescloselywiththeInternationalElectrotechnicalCommission(IEC)onallmattersofelectrotechnicalstandardization.

TheproceduresusedtodevelopthisdocumentandthoseintendedforitsfurthermaintenancearedescribedintheISO/IECDirectives,Part1.Inparticular,thedifferentapprovalcriterianeededforthedifferenttypesofISOdocumentshouldbenoted.ThisdocumentwasdraftedinaccordancewiththeeditorialrulesoftheISO/IECDirectives,Part2(see

/directives).

ISOdrawsattentiontothepossibilitythattheimplementationofthisdocumentmayinvolvetheuseof(a)patent(s).ISOtakesnopositionconcerningtheevidence,validityorapplicabilityofanyclaimedpatentrightsinrespectthereof.Asofthedateofpublicationofthisdocument,ISOhadnotreceivednoticeof(a)patent(s)whichmayberequiredtoimplementthisdocument.However,implementersarecautionedthatthismaynotrepresentthelatestinformation,whichmaybeobtainedfromthepatentdatabaseavailableat

/patents.ISOshallnotbeheldresponsibleforidentifyinganyorallsuchpatentrights.

Anytradenameusedinthisdocumentisinformationgivenfortheconvenienceofusersanddoesnotconstituteanendorsement.

Foranexplanationofthevoluntarynatureofstandards,themeaningofISOspecifictermsandexpressionsrelatedtoconformityassessment,aswellasinformationaboutISO'sadherencetotheWorldTradeOrganization(WTO)principlesintheTechnicalBarrierstoTrade(TBT),see

/iso/foreword.html.

ThisdocumentwaspreparedbyTechnicalCommitteeISO/TC176,Qualitymanagementandqualityassurance,SubcommitteeSC2,Qualitysystems,incollaborationwiththeEuropeanCommitteeforStandardization(CEN),inaccordancewiththeAgreementontechnicalcooperationbetweenISOandCEN(ViennaAgreement).

Thissixtheditioncancelsandreplacesthefifthedition(ISO9001:2015),whichhasbeentechnicallyrevised.ItalsoincorporatestheAmendmentISO9001:2015/Amd1:2024.

Themainchangesareasfollows:

InclusionofcoreISOmanagementsystemtermsanddefinitions:Clause3ofthedocumentnowincludesalimitednumberoftermsanddefinitions.ISO9000remainsthenormativereferenceforallqualitymanagementtermsanddefinitions.

Introductionofqualitycultureandethicalbehaviour:Qualitycultureandethicalbehaviourarenowaddressedwithintherequirements,particularlyinrelationtoleadership,awarenessandtheenvironmentfortheoperationofprocesses.

Separationofrisksandopportunities:Risksandopportunitiesaremoreclearlydistinguished,withseparateconsiderationofactionstoaddresseach.

Strengthenedmanagementofchange:Requirementsrelatedtochangestothequalitymanagementsystemhavebeenreinforcedtosupporttheachievementofintendedresults.

EnhancedexplanatorycontentinAnnexA:Ithasbeenrevisedtoprovideenhancedclarificationofthestructure,terminologyandintentoftherequirementsasinformativetext,withoutintroducingadditionalrequirements.

RemovalofAnnexB:ItpreviouslyprovidedinformationonotherISO/TC176standards.ReferencestothesestandardsarenowincludedinAnnexAandontheISO/TC176website.

Anyfeedbackorquestionsonthisdocumentshouldbedirectedtotheuser'snationalstandardsbody.Acompletelistingofthesebodiescanbefoundat

/members.html.ForewordISO(theInternationalOrganizationforStandardization)isaworldwidefederationofnationalstandardsbodies(ISOmemberbodies).TheworkofpreparingInternationalStandardsisnormallycarriedoutthroughISOtechnicalcommittees.Eachmemberbodyinterestedinasubjectforwhichatechnicalcommitteehasbeenestablishedhastherighttoberepresentedonthatcommittee.Internationalorganizations,governmentalandnon-governmental,inliaisonwithISO,alsotakepartinthework.ISOcollaboratescloselywiththeInternationalElectrotechnicalCommission(IEC)onallmattersofelectrotechnicalstandardization.

TheproceduresusedtodevelopthisdocumentandthoseintendedforitsfurthermaintenancearedescribedintheISO/IECDirectives,Part1.InparticularthedifferentapprovalcriterianeededforthedifferenttypesofISOdocumentsshouldbenoted.ThisdocumentwasdraftedinaccordancewiththeeditorialrulesoftheISO/IECDirectives,Part2(see

/directives).

Attentionisdrawntothepossibilitythatsomeoftheelementsofthisdocumentmaybethesubjectofpatentrights.ISOshallnotbeheldresponsibleforidentifyinganyorallsuchpatentrights.DetailsofanypatentrightsidentifiedduringthedevelopmentofthedocumentwillbeintheIntroductionand/orontheISOlistofpatentdeclarationsreceived(see

/patents).

Anytradenameusedinthisdocumentisinformationgivenfortheconvenienceofusersanddoesnotconstituteanendorsement.

ForanexplanationonthemeaningofISOspecifictermsandexpressionsrelatedtoconformityassessment,aswellasinformationaboutISO'sadherencetotheWorldTradeOrganization(WTO)principlesintheTechnicalBarrierstoTrade(TBT)seethefollowingURL:

/iso/foreword.html.

ThecommitteeresponsibleforthisdocumentisTechnicalCommitteeISO/TC176,Qualitymanagementandqualityassurance,SubcommitteeSC2,Qualitysystems.

Thisfiftheditioncancelsandreplacesthefourthedition(ISO9001:2008),whichhasbeentechnicallyrevised,throughtheadoptionofarevisedclausesequenceandtheadaptationoftherevisedqualitymanagementprinciplesandofnewconcepts.ItalsocancelsandreplacestheTechnicalCorrigendumISO9001:2008/Cor.1:2009.IntroductionIntroduction0.1GeneralEstablishingandimplementingaqualitymanagementsystemisastrategicdecisionforanorganizationthatsupports

improvedperformance,enhancescustomersatisfaction,andprovidesafoundationforsustainedsuccessandsustainabledevelopmentinitiatives.

Thepotentialbenefitstoanorganizationofimplementingaqualitymanagementsystembasedontherequirementsinthisdocumentare:

a)theabilitytoconsistentlyprovideproductsandservicesthatmeetcustomerandapplicablestatutoryandregulatoryrequirements;

b)

facilitatingopportunitiestoenhancecustomersatisfaction;

c)addressingrisksandopportunitiesassociatedwithitscontextandobjectives;

d)theabilitytodemonstrateconformityto

qualitymanagementsystem

requirements.

Thisdocumentcanbeusedbyinternalandexternalparties.

Thisdocumentdoesnotimplytheneedfor:

uniformityinthestructureofdifferentqualitymanagementsystems;

alignmentofdocumentationtotheclausestructureofthisdocument;

theuseofthespecificterminologyofthisdocumentwithintheorganization.

Thequalitymanagementsystemrequirementsinthisdocumentarecomplementarytorequirementsforproductsandservices.

Consistentlymeetingrequirementsandaddressingfutureneedsandexpectationsofcustomersandotherrelevantinterestedpartiesposesachallengefororganizationsinanincreasinglydynamicandcomplexenvironment.Toachievethisobjective,theorganizationcanpursuecontinualimprovementinvariousways,suchasincrementalorbreakthroughchange,innovationorreorganizationinitiatives.

AnnexAprovidesinformationandclarificationsthatcansupportunderstandingofthestructure,termsandclausesofthisdocument.Itdoesnotcontainanyadditionalrequirements.

Forguidanceontheapplicationofallclausesinthisdocument,seeISO9002[1].0.1GeneralTheadoptionofaqualitymanagementsystemisastrategicdecisionforanorganizationthatcanhelptoimproveitsoverallperformanceandprovideasoundbasisforsustainabledevelopmentinitiatives.

ThepotentialbenefitstoanorganizationofimplementingaqualitymanagementsystembasedonthisInternationalStandardare:

a)theabilitytoconsistentlyprovideproductsandservicesthatmeetcustomerandapplicablestatutoryandregulatoryrequirements;

b)facilitatingopportunitiestoenhancecustomersatisfaction;

c)addressingrisksandopportunitiesassociatedwithitscontextandobjectives;

d)theabilitytodemonstrateconformitytospecifiedqualitymanagementsystemrequirements.ThisInternationalStandardcanbeusedbyinternalandexternalparties.

ItisnottheintentofthisInternationalStandardtoimplytheneedfor:

uniformityinthestructureofdifferentqualitymanagementsystems;

alignmentofdocumentationtotheclausestructureofthisInternationalStandard;

theuseofthespecificterminologyofthisInternationalStandardwithintheorganization.

ThequalitymanagementsystemrequirementsspecifiedinthisInternationalStandardarecomplementarytorequirementsforproductsandservices.

ThisInternationalStandardemploystheprocessapproach,whichincorporatesthePlan-Do-Check-Act(PDCA)cycleandrisk-basedthinking.

Theprocessapproachenablesanorganizationtoplanitsprocessesandtheirinteractions.

ThePDCAcycleenablesanorganizationtoensurethatitsprocessesareadequatelyresourcedandmanaged,andthatopportunitiesforimprovementaredeterminedandactedon.

Risk-basedthinkingenablesanorganizationtodeterminethefactorsthatcouldcauseitsprocessesanditsqualitymanagementsystemtodeviatefromtheplannedresults,toputinplacepreventivecontrolstominimizenegativeeffectsandtomakemaximumuseofopportunitiesastheyarise(seeClauseA.4).

Consistentlymeetingrequirementsandaddressingfutureneedsandexpectationsposesachallengefororganizationsinanincreasinglydynamicandcomplexenvironment.Toachievethisobjective,theorganizationmightfinditnecessarytoadoptvariousformsofimprovementinadditiontocorrectionandcontinualimprovement,suchasbreakthroughchange,innovationandre-organization.

InthisInternationalStandard,thefollowingverbalformsareused:

-"shall"indicatesarequirement;

-"should"indicatesarecommendation;

-"may"indicatesapermission;

-"can"indicatesapossibilityoracapability.

Informationmarkedas"NOTE"isforguidanceinunderstandingorclarifyingtheassociatedrequirement.0.2QualitymanagementprinciplesThisdocumentisbasedonthequalitymanagementprinciplesdescribedinISO9000[2].Thedescriptionsincludeastatementofeachprinciple,arationaleofwhytheprincipleisimportantfortheorganization,someexamplesofbenefitsassociatedwiththeprincipleandexamplesofactionstoimprovetheorganization'sperformancewhenapplyingtheprinciple.

Thequalitymanagementprinciplesare:

-customerfocus;

-leadership;

-engagementofpeople;

-processapproach;

-improvement;

-

evidence-baseddecision-making;

-relationshipmanagement.0.2QualitymanagementprinciplesThisInternationalStandardisbasedonthequalitymanagementprinciplesdescribedinISO9000.Thedescriptionsincludeastatementofeachprinciple,arationaleofwhytheprincipleisimportantfortheorganization,someexamplesofbenefitsassociatedwiththeprincipleandexamplesoftypicalactionstoimprovetheorganization'sperformancewhenapplyingtheprinciple.

Thequalitymanagementprinciplesare:

customerfocus;leadership;engagementofpeople;processapproach;improvement;evidence-baseddecisionmaking;relationshipmanagement.0.3Processapproach0.3Processapproach0.3.1GeneralThisdocumentpromotestheadoptionofaprocessapproachwhenestablishing,implementingandimprovingtheeffectivenessofaqualitymanagementsystem,toenhancecustomersatisfactionbymeetingcustomerrequirements.Specificrequirementsconsideredessentialtotheapplicationofaprocessapproachareincludedin4.4.

Understandingandmanaginginterrelatedprocessesasasystemcontributestotheorganization'seffectivenessandefficiencyinachievingitsintendedresults.Thisapproachenablestheorganizationtocontroltheinterrelationshipsandinterdependenciesamongtheprocessesofthesystem,sothattheoverallperformanceoftheorganizationcanbeenhanced.

Theprocessapproachinvolvesthesystematicdeterminationandmanagementofprocesses,andtheirinteractions,soastoachievetheintendedresultsinaccordancewiththequalitypolicyandstrategicdirectionoftheorganization.ManagementoftheprocessesandthesystemasawholecanbeachievedusingthePlan-Do-Check-Act(PDCA)cycle(see0.3.2)withanoverallfocuson

risk-basedthinking(seeA.6.1.2)aimedatpreventingundesiredresults,andopportunity-basedthinking(seeA.6.1.3)aimedatpursuingdesiredresultsbytakingadvantageofopportunities.

Theapplicationoftheprocessapproachinaqualitymanagementsystemenables:

a)understandingandconsistencyinmeetingrequirements;

b)

considerationofprocessesintermsofrisk,opportunityandaddedvalue;

c)achievementofeffectiveprocessperformance;

d)improvementofprocessesbasedontheresultsofevaluationofdataandinformation.

Figure1givesaschematicrepresentationofanysingleprocessandshowstheinteractionofitselements.Themonitoringandmeasuring

points,whicharenecessaryforcontrol,arespecifictoeachprocessandwillvarydependingontheprocessstepsandrelatedrisks.0.3.1GeneralThisInternationalStandardpromotestheadoptionofaprocessapproachwhendeveloping,implementingandimprovingtheeffectivenessofaqualitymanagementsystem,toenhancecustomersatisfactionbymeetingcustomerrequirements.Specificrequirementsconsideredessentialtotheadoptionofaprocessapproachareincludedin4.4.

Understandingandmanaginginterrelatedprocessesasasystemcontributestotheorganization'seffectivenessandefficiencyinachievingitsintendedresults.Thisapproachenablestheorganizationtocontroltheinterrelationshipsandinterdependenciesamongtheprocessesofthesystem,sothattheoverallperformanceoftheorganizationcanbeenhanced.

Theprocessapproachinvolvesthesystematicdefinitionandmanagementofprocesses,andtheirinteractions,soastoachievetheintendedresultsinaccordancewiththequalitypolicyandstrategicdirectionoftheorganization.ManagementoftheprocessesandthesystemasawholecanbeachievedusingthePDCAcycle(see0.3.2)withanoverallfocusonrisk-basedthinking(see0.3.3)aimedattakingadvantageofopportunitiesandpreventingundesirableresults.

Theapplicationoftheprocessapproachinaqualitymanagementsystemenables:

a)understandingandconsistencyinmeetingrequirements;

b)theconsiderationofprocessesintermsofaddedvalue;

c)theachievementofeffectiveprocessperformance;

d)improvementofprocessesbasedonevaluationofdataandinformation.

Figure1givesaschematicrepresentationofanyprocessandshowstheinteractionofitselements.Themonitoringandmeasuringcheckpoints,whicharenecessaryforcontrol,arespecifictoeachprocessandwillvarydependingontherelatedrisks.0.3.2Plan-Do-Check-ActcycleThePDCAcyclecanbebrieflydescribedasfollows:

-Plan:Establishtheobjectivesofthesystemanditsprocesses,andtheresourcesneededtodeliverresultsinaccordancewith

customerandotherrelevantinterestedparty

requirementsandtheorganization'spolicies,and

determineandaddressrisksandopportunities.

-Do:Implementwhatwasplanned.

-Check:Monitorand,asapplicable,measureprocessesandtheresultingproductsandservicesagainstpolicies,objectives,requirementsandplannedactivities,andreporttheresults.

-Act:Takeactionstoimprove

theperformance

ofthequalitymanagementsystem.

ThePDCAcyclecanbeappliedtoallprocessesandtothequalitymanagementsystemasawhole.Figure2illustrateshowClause4toClause10canbegroupedinrelationtothePDCAcycle.0.3.2Plan-Do-Check-ActcycleThePDCAcyclecanbeappliedtoallprocessesandtothequalitymanagementsystemasawhole.

ThePDCAcyclecanbebrieflydescribedasfollows:

Plan:establishtheobjectivesofthesystemanditsprocesses,andtheresourcesneededtodeliverresultsinaccordancewithcustomers'requirementsandtheorganization'spolicies,andidentifyandaddressrisksandopportunities;

Do:implementwhatwasplanned;

Check:monitorand(whereapplicable)measureprocessesandtheresultingproductsandservicesagainstpolicies,objectives,requirementsandplannedactivities,andreporttheresults;

Act:takeactionstoimproveperformance,asnecessary.0.3.3Risk-basedthinking2026无单独0.3.3；相关概念并入0.3.1、0.3.2、A.6.1.1、A.6.1.2、A.6.1.3。0.3.3Risk-basedthinkingRisk-basedthinking(seeClauseA.4)isessentialforachievinganeffectivequalitymanagementsystem.Theconceptofrisk-basedthinkinghasbeenimplicitinpreviouseditionsofthisInternationalStandardincluding,forexample,carryingoutpreventiveactiontoeliminatepotentialnonconformities,analysinganynonconformitiesthatdooccur,andtakingactiontopreventrecurrencethatisappropriatefortheeffectsofthenonconformity.

ToconformtotherequirementsofthisInternationalStandard,anorganizationneedstoplanandimplementactionstoaddressrisksandopportunities.Addressingbothrisksandopportunitiesestablishesabasisforincreasingtheeffectivenessofthequalitymanagementsystem,achievingimprovedresultsandpreventingnegativeeffects.

Opportunitiescanariseasaresultofasituationfavourabletoachievinganintendedresult,forexample,asetofcircumstancesthatallowtheorganizationtoattractcustomers,developnewproductsandservices,reducewasteorimproveproductivity.Actionstoaddressopportunitiescanalsoincludeconsiderationofassociatedrisks.Riskistheeffectofuncertaintyandanysuchuncertaintycanhavepositiveornegativeeffects.Apositivedeviationarisingfromariskcanprovideanopportunity,butnotallpositiveeffectsofriskresultinopportunities.0.4RelationshipwithothermanagementsystemstandardsThisdocumentapplies

theharmonizedapproachaspublishedintheISO/IECDirectivesrelatedtothedevelopmentofmanagementsystemstandards.Theintentionistosupportalignmentandfacilitatetheintegrationoftherequirementsandrecommendationsofoneormoremanagementsystemstandardsintoanorganization'smanagementsystem.

Formoreinformation,see

/management-system-standards.html.

Thisdocumentprovidesabasisforanorganizationtoapplytheprocessapproach,coupledwiththePDCAcycle,

risk-basedthinkingandopportunity-basedthinking,inordertoalignorintegrateitsqualitymanagementsystemwiththerequirementsofothermanagementsystemstandards.

Thisdocumentrelatestothefollowingstandards:

ISO9000[2]providesthefundamentalconceptsandvocabularyessentialforunderstandingtherequirementsofthisdocument;

ISO9002providesguidanceontheapplicationoftherequirementsofthisdocument;

ISO9004[3]providesguidanceonenhancingthequalityofanorganizationanditsabilitytoachievesustainedsuccess.

Thisdocumentdoesnotincluderequirementsspecifictoothermanagementsystems,suchasthoseforenvironmentalmanagement,occupationalhealthandsafetymanagement,or

asset

management.

Sector-specificISOqualitymanagementsystemstandardsbasedontherequirementsofthisdocumenthavebeendeveloped.Someofthesestandardsspecifyadditionalqualitymanagementsystemrequirements,whileothersarelimitedtoprovidingguidancetotheapplicationofthisdocumentwithintheparticularsector.0.4RelationshipwithothermanagementsystemstandardsThisInternationalStandardappliestheframeworkdevelopedbyISOtoimprovealignmentamongitsInternationalStandardsformanagementsystems(seeClauseA.1).

ThisInternationalStandardenablesanorganizationtousetheprocessapproach,coupledwiththePDCAcycleandrisk-basedthinking,toalignorintegrateitsqualitymanagementsystemwiththerequirementsofothermanagementsystemstandards.

ThisInternationalStandardrelatestoISO9000andISO9004asfollows:

ISO9000Qualitymanagementsystems—FundamentalsandvocabularyprovidesessentialbackgroundfortheproperunderstandingandimplementationofthisInternationalStandard;

ISO9004Managingforthesustainedsuccessofanorganization—AqualitymanagementapproachprovidesguidancefororganizationsthatchoosetoprogressbeyondtherequirementsofthisInternationalStandard.

AnnexBprovidesdetailsofotherInternationalStandardsonqualitymanagementandqualitymanagementsystemsthathavebeendevelopedbyISO/TC176.

ThisInternationalStandarddoesnotincluderequirementsspecifictoothermanagementsystems,suchasthoseforenvironmentalmanagement,occupationalhealthandsafetymanagement,orfinancialmanagement.

Sector-specificqualitymanagementsystemstandardsbasedontherequirementsofthisInternationalStandardhavebeendevelopedforanumberofsectors.Someofthesestandardsspecifyadditionalqualitymanagementsystemrequirements,whileothersarelimitedtoprovidingguidancetotheapplicationofthisInternationalStandardwithintheparticularsector.

AmatrixshowingthecorrelationbetweentheclausesofthiseditionofthisInternationalStandardandthepreviousedition(ISO9001:2008)canbefoundontheISO/TC176/SC2openaccesswebsiteat:

/tc176/sc02/public.1ScopeThisdocumentspecifiesrequirementsforaqualitymanagementsystemwhenanorganization:

a)needstodemonstrateitsabilitytoconsistentlyprovideproductsandservicesthatmeetcustomerandapplicablestatutoryandregulatoryrequirements;

b)aimstoenhancecustomersatisfactionthroughtheeffectiveapplicationofthesystem,includingprocessesforimprovementofthesystemandtheassuranceofconformitytocustomerandapplicablestatutoryandregulatoryrequirements.

Alltherequirementsofthisdocumentaregeneric.

Thisdocumentisapplicabletoanyorganization,regardlessofitstypeorsize,ortheproductsandservicesitprovides.

NOTE1Inthisdocument,theterms"product"or"service"onlyapplytoproductsandservicesintendedfor,orrequiredby,acustomer.

NOTE2Statutoryandregulatoryrequirementscanbeexpressedaslegalrequirements.1ScopeThisInternationalStandardspecifiesrequirementsforaqualitymanagementsystemwhenanorganization:

a)needstodemonstrateitsabilitytoconsistentlyprovideproductsandservicesthatmeetcustomerandapplicablestatutoryandregulatoryrequirements,and

b)aimstoenhancecustomersatisfactionthroughtheeffectiveapplicationofthesystem,includingprocessesforimprovementofthesystemandtheassuranceofconformitytocustomerandapplicablestatutoryandregulatoryrequirements.

AlltherequirementsofthisInternationalStandardaregenericandareintendedtobeapplicabletoanyorganization,regardlessofitstypeorsize,ortheproductsandservicesitprovides.

NOTE1InthisInternationalStandard,theterms"product"or"service"onlyapplytoproductsandservicesintendedfor,orrequiredby,acustomer.

NOTE2Statutoryandregulatoryrequirementscanbeexpressedaslegalrequirements.2NormativereferencesThefollowingdocumentsarereferredtointhetextinsuchawaythatsomeoralloftheircontentconstitutesrequirementsofthisdocument.Fordatedreferences,onlytheeditioncitedapplies.Forundatedreferences,thelatesteditionofthereferenceddocument(includinganyamendments)applies.

ISO9000,Qualitymanagement-Fundamentalsandvocabulary2NormativereferencesThefollowingdocuments,inwholeorinpart,arenormativelyreferencedinthisdocumentandareindispensableforitsapplication.Fordatedreferences,onlytheeditioncitedapplies.Forundatedreferences,thelatesteditionofthereferenceddocument(includinganyamendments)applies.

ISO9000:2015,Qualitymanagementsystems—Fundamentalsandvocabulary3TermsanddefinitionsForthepurposesofthisdocument,thetermsanddefinitionsgiveninISO9000andthefollowingapply.

ISOandIECmaintainterminologydatabasesforuseinstandardizationatthefollowingaddresses:

-

ISOOnlinebrowsingplatform:availableat

/obp

-

IECElectropedia:availableat

3TermsanddefinitionsForthepurposesofthisdocument,thetermsanddefinitionsgiveninISO9000:2015apply.3.1organizationpersonorgroupofpeoplethathasitsownfunctionswithresponsibilities,authoritiesandrelationshipstoachieveitsobjectives(3.6)

Note1toentry:Theconceptoforganizationincludes,butisnotlimitedto,sole-trader,company,corporation,firm,enterprise,authority,partnership,charityorinstitution,orpartorcombinationthereof,whetherincorporatedornot,publicorprivate.

Note2toentry:Iftheorganizationispartofalargerentity,theterm"organization"refersonlytothepartofthelargerentitythatiswithinthescopeofthequalitymanagementsystem(3.4.1).—2015无单独条款；仅引用ISO9000:2015。3.2interestedparty/stakeholderpersonororganization(3.1)thatcanaffect,beaffectedby,orperceiveitselftobeaffectedbyadecisionoractivity

EXAMPLECustomers,owners,peopleinanorganization,providers,bankers,regulatoryauthorities,unions,partnersorsocietythatcanincludecompetitorsoropposingpressuregroups.—2015无单独条款；仅引用ISO9000:2015。3.3topmanagementpersonorgroupofpeoplewhodirectsandcontrolsanorganization(3.1)atthehighestlevel

Note1toentry:Topmanagementhasthepowertodelegateauthorityandprovideresourceswithintheorganization.

Note2toentry:Ifthescopeofthemanagementsystem(3.4)coversonlypartofanorganization,thentopmanagementreferstothosewhodirectandcontrolthatpartoftheorganization.—2015无单独条款；仅引用ISO9000:2015。3.4managementsystemsetofinterrelatedorinteractingelementsofanorganization(3.1)toestablishpolicies(3.5)andobjectives(3.6),aswellasprocesses(3.8)toachievethoseobjectives

Note1toentry:Amanagementsystemcanaddressasingledi