品质管理系统要求.docx

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