品质管理系统要求.docx
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品质管理系统要求
Qualitymanagementsystems–Requirements
1Scope
1.1General
ThisInternationalStandardspecifiesrequirementsforaqualitymanagementsystemwhereanorganization
a)needstodemonstrateitsabilitytoconsistentlyprovideproductthatmeetscustomerandapplicableregulatoryrequirements,and
b)aimstoenhancecustomersatisfactionthroughtheeffectiveapplicationofthesystem,includingprocessesforcontinualimprovementofthesystemandtheassuranceofconformitytocustomerandapplicableregulatoryrequirements.
NOTEInthisInternationalStandard,theterm“product”appliestotheproductintendedfor,orrequiredby,acustomer.
1.2Application
AllrequirementsofthisInternationalStandardaregenericandareintendedtobeapplicabletoallorganizations,regardlessoftype,sizeandproductprovided.
Wereanyrequirement(s)ofthisinternationalStandardcannotbeappliedduetothenatureofanorganizationanditsproduct,thiscanbeconsideredforexclusion.
Whereexclusionsaremade,claimsofconformitytothisInternationalStandardarenotacceptableunlesstheseexclusionsarelimitedtorequirementswithinclause7,andsuchexclusionsdonotaffecttheorganization’sability,orresponsibility,toprovideproductthatmeetscustomerandapplicableregulatoryrequirements.
2Normativereference
Thefollowingnormativedocumentcontainsprovisionswhich,throughreferenceinthistext,constituteprovisionsofthisInternationalStandard.Fordatedreferences,subsequentamendmentsto,orrevisionsof,anyofthesepublicationsdonotapply.However,partiestoagreementsbasedonthisInternationalStandardareencouragedtoinvestigatethepossibilityofapplyingthemostrecenteditionofthenormativedocumentindicatedbelow.Forundatedreferences,thelatesteditionofthenormativedocumentreferredtoapplies.MembersofISOandIECmaintainregistersofcurrentlyvalidInternationalStandards.
ISO9000:
2000,Qualitymanagementsystems–Fundamentalsandvocabulary.
3Termsanddefinitions
ForthepurposesofthisInternationalStandard,thetermsanddefinitionsgiveninISO9000apply.
Thefollowingitems,usedinthiseditionofISO9001todescribethesupplychain,havebeenchangedtoreflectthevocabularycurrentlyused:
supplier→organization→customer
Theterm“organization”replacestheterm“supplier”usedinISO9001:
1994,andreferstotheunittowhichthisInternationalStandardapplies.Also,theterm“supplier”nowreplacestheterm“subcontractor”.
ThroughoutthetextofthisInternationalStandard,wherevertheterm“product”occurs,itcanalsomean“service”.
4Qualitymanagementsystem
4.1Generalrequirements
Theorganizationshallestablish,document,implementandmaintainaqualitymanagementsystemandcontinuallyimproveitseffectivenessinaccordancewiththerequirementsofthisInternationalStandard.
Theorganizationshall
a)identifytheprocessesneededforthequalitymanagementsystemandtheirapplicationthroughouttheorganization(see1.2),
b)
c)determinethesequenceandinteractionoftheseprocesses,
d)
e)determinecriteriaandmethodsneededtoensurethatboththeoperationandcontroloftheseprocessesareeffective,
f)
g)ensuretheavailabilityofresourcesandinformationnecessarytosupporttheoperationandmonitoringoftheseprocesses,
h)
i)monitor,measureandanalyzetheseprocesses,and
j)
k)implementactionsnecessarytoachieveplannedresultsandcontinualimprovementoftheseprocesses.
l)
TheseprocessesshallbemanagedbytheorganizationinaccordancewiththerequirementsofthisInternationalStandard.
Whereanorganizationchoosestooutsourceanyprocessthataffectsproductconformitywithrequirements,theorganizationshallensurecontroloversuchprocesses.Controlofsuchoutsourcedprocessesshallbeidentifiedwithinthequalitymanagementsystem.
NOTEProcessesneededforthequalitymanagementsystemreferredtoaboveshouldincludeprocessesformanagementactivities,provisionofresources,productrealizationandmeasurement.
4.2Documentationrequirements
4.2.1General
Thequalitymanagementsystemdocumentationshallinclude
a)documentedstatementsofaqualitypolicyandqualityobjectives,
b)
c)aqualitymanual,
d)
e)documentedproceduresrequiredbythisInternationalStandard,
f)
g)documentsneededbytheorganizationtoensuretheeffectiveplanning,operationandcontrolofitsprocesses,and
h)
i)recordsrequiredbythisInternationalStandard(see4.2.4)
j)
NOTE1Wheretheterm“documentedprocedure”appearswithinthisInternationalStandard,thismeansthattheprocedureisestablished,documented,implementedandmaintained.
NOTE2Theextentofthequalitymanagementsystemdocumentationcandifferfromoneorganizationtoanotherdueto
a)thesizeoftheorganizationandtypeofactivities,
b)
c)thecomplexityofprocessesandtheirinteractions,and
d)
e)thecompetenciesofpersonnel.
f)
NOTE3Thedocumentationcanbeinanyformortypeofmedium.
4.2.2Qualitymanual
Theorganizationshallestablishandmaintainaqualitymanualthatincludes
a)thescopeofthequalitymanagementsystem,includingdetailsofandjustificationforanyexclusions(see1.2.),
b)
c)thedocumentedproceduresestablishedforthequalitymanagementsystem,orreferencetothem,and
d)
e)adescriptionoftheinteractionbetweentheprocessesofthequalitymanagementsystem.
f)
4.2.3Controlofdocuments
Documentsrequiredbythequalitymanagementsystemshallbecontrolled.Recordsareaspecialtypeofdocumentandshallbecontrolledaccordingtotherequirementsgivenin4.2.4.
Adocumentedprocedureshallbeestablishedtodefinethecontrolsneeded
a)toapprovedocumentsforadequacypriortoissue,
b)
c)toreviewandupdateasnecessaryandre-approvedocuments,
d)
e)toensurethatchangesandthecurrentversionstatusofdocumentsareidentified,
f)
g)toensurethatrelevantversionsofapplicabledocumentsareavailableatpointsofuse,
h)
i)toensurethatdocumentsremainlegibleandreadilyidentifiable,
j)
k)toensurethatdocumentsofexternaloriginareidentifiedandtheirdistributioncontrolled,and
l)
m)topreventtheunintendeduseofobsoletedocuments,andtoapplysuitableidentificationtothemiftheyareretainedforanypurpose.
n)
4.2.4Controlofrecords
Recordsshallbeestablishedandmaintainedtoprovideevidenceofconformitytorequirementsandoftheeffectiveoperationofthequalitymanagementsystem.Recordsshallremainlegible,readilyidentifiableandretrievable.Adocumentedprocedureshallbeestablishedtodefinethecontrolsneededfortheidentification,storage,protection,retrieval,retentiontimeanddispositionofrecords.
5Managementresponsibility
5.1Managementcommitment
Topmanagementshallprovideevidenceofitscommitmenttothedevelopmentandimplementationofthequalitymanagementsystemandcontinuallyimprovingitseffectivenessby
a)communicatingtotheorganizationtheimportanceofmeetingcustomeraswellasstatutoryandregulatoryrequirements,
b)
c)establishingthequalitypolicy,
d)
e)ensuringthatqualityobjectivesareestablished,
f)
g)conductingmanagementreviews,and
h)
i)ensuringtheavailabilityofresources.
j)
5.2Customerfocus
Topmanagementshallensurethatcustomerrequirementsaredeterminedandmetwiththeaimofenhancingcustomersatisfaction(see7.2.1and8.2.1).
5.3Qualitypolicy
Topmanagementshallensurethatthequalitypolicy
a)isappropriatetothepurposeoftheorganization,
b)
c)includesacommitmenttocomplywithrequirementsandcontinuallyimprovetheeffectivenessofthequalitymanagementsystem,
d)
e)providesaframeworkforestablishingandreviewingqualityobjectives,
f)
g)iscommunicatedandunderstoodwithintheorganization,and
h)
i)isreviewedforcontinuingsuitability.
j)
5.4Planning
5.4.1Qualityobjectives
Topmanagementshallensurethatqualityobjectives,includingthoseneededtomeetrequirementsforproduct[see7.1a)],areestablishedatrelevantfunctionsandlevelswithintheorganization.Thequalityobjectivesshallbemeasurableandconsistentwiththequalitypolicy.
5.4.2Qualitymanagementsystemplanning
Topmanagementshallensurethat
a)theplanningofthequalitymanagementsystemiscarriedoutinordertomeettherequirementsgivenin4.1,aswellasthequalityobjectives,and
b)
c)theintegrityofthequalitymanagementsystemismaintainedwhenchangestothequalitymanagementsystemareplannedandimplemented.
d)
5.5Responsibility,authorityandcommunication
5.5.1Responsibilityandauthority
Topmanagementshallensurethattheresponsibilities,authoritiesaredefinedandcommunicatedwithintheorganization.
5.5.2Managementrepresentative
Topmanagementshallappointamemberofmanagementwho,irrespectiveofotherresponsibilities,shallhaveresponsibilityandauthoritythatincludes
a)ensuringthatprocessesneededforthequalitymanagementsystemareestablished,implementedandmaintained,
b)
c)reportingtotopmanagementontheperformanceofthequalitymanagementsystemandanyneedforimprovement,and
d)
e)ensuringthepromotionofawarenessofcustomerrequirementsthroughouttheorganization.
f)
NOTETheresponsibilityofamanagementrepresentativecanincludeliaisonwithexternalpartiesonmatt