ISO 9001内审查检表Word文档格式.docx

ISO 9001内审查检表Word文档格式.docx

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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