整理ISO9001中英文对照.docx
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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
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