ISO 9001内审查检表.docx
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ISO 9001内审查检表.docx
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ISO9001内审查检表
Q#
ISO9001:
2015Clause
AuditQuestion
AuditEvidence
4ContextoftheOrganization
4.1Understandingtheorganizationanditscontext
4.1q1
Theorganizationshalldetermineexternalandinternalissuesthatarerelevanttoitspurposeanditsstrategicdirectionandthataffectitsabilitytoachievetheintendedresult(s)ofitsqualitymanagementsystem.
Howhastheorganizationdeterminedexternalandinternalissuesrelevanttoitspurposeandstrategicdirection?
HowdotheseaffecttheabilitytoachievetheintendedresultoftheQMS?
4.1q2
Theorganizationshallmonitorandreviewtheinformationabouttheseexternalandinternalissues.
Howdoyoumonitorandreviewinformationabouttheseinternalandexternalissues?
NOTE1Understandingtheexternalcontextcanbefacilitatedbyconsideringissuesarisingfromlegal,technological,competitive,market,cultural,social,andeconomicenvironments,whetherinternational,national,regionalorlocal.
NOTE2Understandingtheinternalcontextcanbefacilitatedbyconsideringissuesrelatedtovalues,cultureknowledgeandperformanceoftheorganization.
4.2Understandingtheneedsandexpectationsofinterestedparties
4.2q1
Duetotheirimpactorpotentialimpactontheorganization’sabilitytoconsistentlyprovideproductsandservicesthatmeetcustomerandapplicablestatutoryandregulatoryrequirements,theorganizationshalldetermine:
a)theinterestedpartiesthatarerelevanttothequalitymanagementsystem;
b)therequirementsoftheseinterestedpartiesthatarerelevanttothequalitymanagementsystem.
HowhaveyoudeterminedwhatinterestedpartiesarerelevanttotheQMS?
HowhaveyoudeterminedwhatrequirementsthosepartieshavethatarerelevanttotheQMS?
Howhasimpactorpotentialimpactbeendetermined?
4.2q2
Theorganizationshallmonitorandreviewtheinformationabouttheseinterestedpartiesandtheirrelevantrequirements.
Howdoyoumonitorandreviewtheinformationaboutinterestedpartiesandtheirrelevantrequirements?
4.3Determiningthescopeofthequalitymanagementsystem
4.3q1
Theorganizationshalldeterminetheboundariesandapplicabilityofthequalitymanagementsystemtoestablishitsscope.
HowhavetheboundariesandapplicabilityoftheQMSbeenusedtoestablishthescopeoftheorganization?
4.3q2
Whendeterminingthisscope,theorganizationshallconsider:
a)theexternalandinternalissuesreferredtoin4.1;
b)therequirementsofrelevantinterestedpartiesreferredtoin4.2;
c)theproductsandservicesoftheorganization.
Howhave:
Theexternalandinternalissues;
Therequirementsofrelevantinterestedpartiesand;
Theproductsandservicesoftheorganizationbeenconsideredwhendeterminingthescopeoftheorganization?
4.3q3
WherearequirementofthisInternationalStandardwithinthedeterminedscopecanbeapplied,thenitshallbeappliedbytheorganization.
HowhastheapplicationoftheInternationalStandardwithinthescopebeendetermined,andhowhasitbeenappliedbytheorganization?
4.3q4
Ifanyrequirement(s)ofthisInternationalStandardcannotbeapplied,thisshallnotaffecttheorganization’sabilityorresponsibilitytoensureconformityofproductsandservices.
HowhaveanyrequirementsoftheInternationalStandardbeendeterminedasnotapplicable?
Showmehowconformityofproductsandservicesarenotaffectedbythis.
4.3q5
Thescopeshallbeavailableandbemaintainedasdocumentedinformationstatingthe:
-productsandservicescoveredbythequalitymanagementsystem;
-justificationforanyinstancewherearequirementofthisInternationalStandardcannotbeapplied.
Whereisthescopeavailable?
Whereisitmaintainedasdocumentedinformation?
DoesitstatewhatproductsandservicesarecoveredbytheQMS?
DoesitjustifyhowinstancesofrequirementsoftheQMScannotbeapplied?
Scoperequiredasdocumentedinformation.
4.4Qualitymanagementsystemanditsprocesses
4.4q1
Theorganizationshallestablish,implement,maintainandcontinuallyimproveaqualitymanagementsystem,includingtheprocessesneededandtheirinteractions,inaccordancewiththerequirementsofthisInternationalStandard.
HowhastheQMSbeenestablished?
Showmehowthisisimplemented.Howisitmaintainedandcontinuallyimproved?
Howhavetheprocessesbeendeterminedandhowdotheyinteract?
4.4q2
Theorganizationshalldeterminetheprocessesneededforthequalitymanagementsystemandtheirapplicationthroughouttheorganizationandshalldetermine:
a)theinputsrequiredandtheoutputsexpectedfromtheseprocesses;
b)thesequenceandinteractionoftheseprocesses;
c)thecriteria,methods,includingmeasurementsandrelatedperformanceindicatorsneededtoensuretheeffectiveoperation,andcontroloftheseprocesses;
d)theresourcesneededandensuretheiravailability;
e)theassignmentoftheresponsibilitiesandauthoritiesfortheseprocesses;
f)therisksandopportunitiesinaccordancewiththerequirementsof6.1,andplanandimplementtheappropriateactionstoaddressthem;
g)themethodsformonitoring,measuring,asappropriate,andevaluationofprocessesand,ifneeded,thechangestoprocessestoensurethattheyachieveintendedresults;
h)opportunitiesforimprovementoftheprocessesandthequalitymanagementsystem.
HowhavetheprocessesbeendeterminedfortheQMS?
Whataretheinputsandoutputsforthoseprocesses?
Whatisthesequenceandinteractionoftheprocesses?
Whatarethecriteria,methods,measurementandrelatedperformanceindicatorsneededtooperateandcontrolthoseprocesses?
Whatresourcesareneededandhowarethesemadeavailable?
Howareresponsibilitiesandauthoritiesassignedforthoseprocesses?
Howarerisksandopportunitiesconsideredandwhatplansaremadetoimplementactionstoaddressthem?
Whatmethodsareusedtomonitor,measureandevaluateprocessesand,ifneeded,whatchangesaremadetoachieveintendedresults?
HowareopportunitiestoimprovetheprocessesandtheQMSdetermined?
4.4q3
Theorganizationshallmaintaindocumentedinformationtotheextentnecessarytosupporttheoperationofprocessesandretaindocumentedinformationtotheextentnecessarytohaveconfidencethattheprocessesarebeingcarriedoutasplanned.
Whatdocumentedinformationexiststosupporttheoperationofprocesses?
Howisthisdocumentedinformationretained?
Howisconfidencethattheprocessesarebeingcarriedoutasplanneddetermined?
Documentedinformationtosupporttheoperationofprocesses.
5Leadership
5.1Leadershipandcommitment
5.1.1Leadershipandcommitmentforthequalitymanagementsystem
5.1.1q1
Topmanagementshalldemonstrateleadershipandcommitmentwithrespecttothequalitymanagementsystemby:
a)takingaccountabilityoftheeffectivenessofthequalitymanagementsystem;
b)ensuringthatthequalitypolicyandqualityobjectivesareestablishedforthequalitymanagementsystemandarecompatiblewiththestrategicdirectionandthecontextoftheorganization;
c)ensuringthatthequalitypolicyiscommunicated,understoodandappliedwithintheorganization;
d)ensuringtheintegrationofthequalitymanagementsystemrequirementsintotheorganization’sbusinessprocesses;
e)promotingawarenessoftheprocessapproach;
f)ensuringthattheresourcesneededforthequalitymanagementsystemareavailable;
g)communicatingtheimportanceofeffectivequalitymanagementandofconformingtothequalitymanagementsystemrequirements;
h)ensuringthatthequalitymanagementsystemachievesitsintendedresults;
i)engaging,directingandsupportingpersonstocontributetotheeffectivenessofthequalitymanagementsystem;
j)promotingcontinualimprovement;
k)supportingotherrelevantmanagementrolestodemonstratetheirleadershipasitappliestotheirareasofresponsibility.
Showmehowtopmanagementdemonstratesleadershipandcommitmentw.r.t.theQMSbytakingaccountabilityoftheeffectivenessoftheQMS.
HowisthequalitypolicyandobjectivesestablishedfortheQMSandhowaretheycompatiblewiththestrategicdirectionandtheorganizationalcontext?
Howisthequalitypolicycommunicatedwithintheorganization?
Showmehowthisisunderstoodandapplied.
HowaretherequirementsoftheQMSintegratedintothebusinessprocesses?
Howdoyoupromoteawarenessoftheprocessapproach?
HowdoyouensurethatresourcesneededfortheQMSareaavailable?
Howdoyoucommunicatetheimportanceofeffectivequalitymanagement?
HowdoyoucommunicatetheimportanceofconformingtotheQMSrequirements?
HowdoyouensurethattheQMSachievesitsintendedresults?
Howdoyouengage,directandsupportpeopletocontributetotheeffectivenessoftheQMS?
Howdoyoupromotecontinualimprovement?
Howdoyousupportotherrelevantmanagementrolestodemonstrateleadershipintheirareasofresponsibility?
NOTEReferenceto“business”inthisInternationalStandardcanbeinterpretedbroadlytomeanthoseactivitiesthatarecoretothepurposesoftheorganization’sexistence;whethertheorganizationispublic,private,forprofitornotforprofit.
5.1.2Customerfocus
5.1.2q1
Topmanagementshalldemonstrateleadershipandcommitmentwithrespecttocustomerfocusbyensuringthat:
a)customerrequirementsandapplicablestatutoryandregulatoryrequirementsaredeterminedandmet;
b)therisksandopportunitiesthatcanaffectconformityofproductsandservicesandtheabilitytoenhancecustomersatisfactionaredeterminedandaddressed;
c)thefocusonconsistentlyprovidingproductsandservicesthatmeetcustomerandapplicablestatutory
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- 关 键 词:
- ISO 9001内审查检表 9001 审查
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