整理ISO9001中英文对照.docx

整理ISO9001中英文对照.docx

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整理ISO9001中英文对照

Qualitymanagementsystems–Requirements

1Scope

1.1General

ThisInternationalStandardspecifiesrequirementsforaqualitymanagementsystemwhereanorganization:

a）needstodemonstrateitsabilitytoconsistentlyprovideproductthatmeetscustomerandapplicableregulatoryrequirements,and

b）aimstoachievecustomersatisfactionthroughtheeffectiveapplicationofthesystem,includingprocessesforcontinualimprovementofthesystemandtheassuranceofconformitytocustomerandapplicableregulatoryrequirements.

NOTE:

InthisInternationalStandard,theterm“product”appliestotheproductintendedfor,orrequiredby,acustomer

1.2Application

AllrequirementsofthisInternationalStandardaregenericandareintendedtobeapplicabletoallorganizations,regardlessoftype,sizeandproductprovided.

Whereanyrequirement（s）ofthisInternationalStandardcannotbeappliedduetothenatureofanorganizationanditsproduct,thiscanbeconsideredforexclusion.

Whereexclusionsaremade,claimsofconformitytothisinternationalStandardarenotacceptableunlesstheseexclusionsarelimitedtorequirementswithinclause7,andsuchexclusionsdonotaffecttheorganization’sability,orresponsibility,toprovideproductthatmeetscustomerandapplicableregulatoryrequirements.

2Normativereference

Thefollowingnormativedocumentcontainsprovisionswhich,throughreferenceinthistext,constituteprovisionsofthisInternationalStandard.Fordatedreferences,subsequentamendmentsto,orrevisionsof,anyofthesepublicationsdonotapply.However,partiestoagreementsbasedonthisInternationalStandardareencouragedtoinvestigatethepossibilityofapplyingthemostrecenteditionofthenormativedocumentindicatedbelow.Forundatedreferences,thelatesteditionofthenormativedocumentindicatedbelow.Forundatedreferences,thelatesteditionofthenormativedocumentreferredtoapplies.MembersofISOandIECmaintainregistersofcurrentlyvalidInternationalStandards.

ISO9000:

2000,Qualitymanagementsystems–Fundamentalsandvocabulary.

3Termsanddefinitions

ForthepurposesofthisInternationalStandard,thetermsanddefinitionsgiveninISO9000apply.

ThefollowingtermsusedinthiseditionofISO9001todescribethesupplychain,havebeenchangedtoreflectthevocabularycurrentlyused:

Supplier---------->organization---------->customer

Theterm“organization”replacestheterm“supplier”usedinISO9001”1994,andreferstotheunit,towhichthisInternationalStandardapplies.Also,theterm“supplier”nowreplacestheterm“subcontractor”.

ThroughoutthetextofthisInternationalStandard,wherevertheterm”product”occurs,itcanalsomean“service”.

4Qualitymanagementsystem

4.1Generalrequirements

Theorganizationshallestablish,document,implementandmaintainaqualitymanagementsystemandcontinuallyimproveitseffectivenessinaccordancewiththerequirementsofthisInternationalStandard.

Theorganizationshall:

a）identifytheprocessesneededforthequalitymanagementsystem,andtheirapplicationthroughouttheorganization（see1.2）;

b）determinethesequenceandinteractionoftheseprocesses;

c）determinecriteriaandmethodsneededtoensurethatboththeoperationandcontroloftheseprocessesareeffective;

d）ensuretheavailabilityofresourcesandinformationnecessarytosupporttheoperationandmonitoringoftheseprocesses;

e）monitor,measureandanalysistheseprocesses,and

f）implementactionnecessarytoachieveplannedresultsandcontinualimprovementoftheseprocesses.

TheseprocessesshallbemanagedbytheorganizationinaccordancewiththerequirementsofthisInternationalStandard.

Whereanorganizationchoosestooutsourceanyprocessthataffectsproductconformitywithrequirements,theorganizationshallensurecontroloversuchprocesses.Controlofsuchoutsourcedprocessesshallbeidentifiedwithinthequalitymanagementsystem.

NOTE:

processesneededforthequalitymanagementsystemreferredtoaboveshouldincludeprocessesformanagementactivities,provisionofresources,productrealizationandmeasurement.

4.2Documentationrequirements

4.2.1General

Thequalitymanagementsystemdocumentationshallinclude:

a）documentedstatementsofaqualitypolicyandqualityobjectives;

b）aqualitymanual;

c）documentedproceduresrequiredbythisInternationalStandard;

d）documentsneededbytheorganizationtoensuretheeffectiveplanningoperationandcontrolofitsprocesses,and

e）recordsrequiredbythisInternationalStandard（see4.2.4）

NOTE1Wheretheterm“documentedprocedure”appearswithinthisInternationalStandard,thismeansthattheprocedureisestablished,documented,implementedandmaintained.

NOTE2Theextentofthequalitymanagementsystemdocumentationcandifferfromoneorganizationtoanotherdueto:

a）thesizeoforganizationandtypeofactivities;

b）thecomplexityofprocessesandtheirinteractionsand;

c）thecompetenceofpersonnel.

NOTE3Thedocumentationcanbeinanyformortypeofmedium.

4.2.2Qualitymanual

Theorganizationshallestablishandmaintainaqualitymanualthatincludes

a）thescopeofthequalitymanagementsystem,includingdetailsofandjustificationforanyexclusions（see1.2）;

b）thedocumentedproceduresestablishedforthequalitymanagementsystem,orreferencetothem,and

c）adescriptionoftheinteractionbetweentheprocessesofthequalitymanagementsystem.

4.2.3Controlofdocuments

Documentsrequiredbythequalitymanagementsystemshallbecontrolled.Recordsareaspecialtypeofdocumentandshallbecontrolledaccordingtorequirementsgivenin4.2.4.

Adocumentedprocedureshallbeestablishedtodefinethecontrolsneeded:

a）toapprovedocumentsforadequacypriortoissue;

b）toreviewandupdateasnecessaryandre-approvedocuments;

c）toensurethatchangesandthecurrentverisionstatusofdocumentsareidentified;

d）toensurethatrelevantversionsofapplicabledocumentsareavailableatpointsofuse;

e）toensurethatdocumentsremainlegibleandreadilyidentifiable;

f）toensurethatdocumentsofexternaloriginareidentifiedandtheirdistributioncontrolled,and

g）topreventtheunintendeduseofobsoletedocument,andtoapplysuitableidentificationtothemiftheyareretainedforanypurpose.

4.2.4Controlofrecords

Recordsshallbeestablishedandmaintainedtoprovideevidenceofconformitytorequirementsandoftheeffectiveoperationofthequalitymanagementsystem.Recordsshallremainlegible,readilyidentifiableandretrievable.Adocumentedprocedureshallbeestablishedtodefinethecontrolsneededfortheidentification,storage,protection,retrieval,retentiontimeanddispositionofqualityrecords.

5Managementresponsibility

5.1Managementcommitment

Topmanagementshallprovideevidenceofitscommitmenttothedevelopmentandimplementationofthequalitymanagementsystemandcontinuallyimprovingitseffectivenessby:

a）communicatingtotheorganizationtheimportanceofmeetingcustomeraswellasstatutoryandregulatoryrequirements;

b）establishingthequalitypolicy;

c）ensuringthatqualityobjectivesareestablished;

d）conductingmanagementreviews,and

e）ensuringtheavailabilityofresources.

5.2Customerfocus

Topmanagementshallensurethatcustomerrequirementsaredeterminedandmetwiththeaimofenhancingcustomersatisfaction（see7.2.1and8.2.1）.

5.3Qualitypolicy

Topmanagementshallensurethatthequalitypolicy:

a）isappropriatetothepurposeoftheorganization;

b）includesacommitmenttocomplywithrequirementsandcontinuallyimprovetheeffectivenessofthequalitymanagementsystem;

c）providesaframeworkforestablishingandreviewingqualityobjectives;

d）iscommunicatedandunderstoodwithintheorganization;

e）isreviewedforcontinuingsuitability.

5.4Planning

5.4.1Qualityobjectives

Topmanagementshallensurethatqualityobjectives,includingthoseneededtomeetrequirementsforproduct（see7.1a）areestablishedatrelevantfunctionsandlevelswithintheorganization.Thequalityobjectivesshallbemeasuredandconsistentwiththequalitypolicy.

5.4.2Qualitymanagementsystemplanning

Topmanagementshallensurethat

a）theplanningofthequalitymanagementsystemiscarriedoutinordertomeettherequirementsgivenin4.1,aswellasthequalityobjectives,and

b）theintegrityofthequalitymanagementsystemismaintainedwhenchangestothequalitymanagementsystemareplannedandimplemented.

5.5Responsibility,authorityandcommunication

5.5.1Responsibilityandauthority

Topmanagementshallensurethattheresponsibilities,authoritiesaredefinedandcommunicatedwithintheorganization.

5.5.2Managementrepresentative

Topmanagementshallappointamemberofthemanagementwho,irrespectiveofotherresponsibilities,shallhaveresponsibilityandauthoritythatincludes:

a）ensuringthatprocessesneededforthequalitymanagementsystemareestablished,implementedandmaintained;

b）reportingtotopmanagementontheperformanceofthequalitymanagementsystemandanyneedforimprovement,and

c）ensuringthepromotionofawarenessofcustomerrequirementsthroughtheorganization.

NOTE:

Theresponsibilityofamanagementrepresentativecanincludeliaisonwithexternalpartiesonmattersrelatingtothequalitymanagementsystem.

5.5.3Internalcommunication

Topmanagementshallensurethatappropriatecommunicationprocessesareestablishedwithintheorganizationandthatcommunicationtakesplaceregardingtheeffectivenessofthequalitymanagementsystem.

5.6Managementreview

5.6.1General

Topmanagementshallreviewtheorganization’squalitymanageme