ISO9001：2015自我评估检查表英文版

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GapAnalysisChecklist

ISO9001:2015Self-assessment

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Thegapanalysischecklistisoneofthefirsttoolsavailablefromtheauditor’stoolbox.Theself-assessmentquestionswillhelpyoutoidentifygapsbetweenyourexistingQualityManagementSystemandtherequirementsofISO9001:2015.

GapAnalysisChecklist

ISO9001:2015Self-assessment

TableofContents

Guidance

2

AboutthisChecklist

2

SummaryofKeyChanges

2

ProcessApproach

2

ContextoftheOrganization

2

ScopeoftheQualityManagementSystem

3

Leadership

3

RisksandOpportunities

3

ProductsandServices

3

ControlofExternallyProvidedProducts&Services

3

DocumentedInformation

3

Non-conformingProcesses

4

HowtoMaketheChanges

4

ExistingISO9001:2008Documentation

4

Self-assessmentChecklist

6

ContextoftheOrganisation

6

Leadership

8

Planning

10

Support

11

Operation

13

PerformanceEvaluation

16

Improvement

17

Guidance

AboutthisChecklist

ThisgapanalysischecklisthighlightsthenewrequirementscontainedinISO9001:2015,andisnotintendedtocoveralloftherequirementsfromISO9001:2015comprehensively.Theuniqueknowledgeobtainedaboutthestatusyourexistingqualitymanagementsystemwillbeakeydriverofthesubsequentimplementationapproach.Armedwiththisknowledge,itallowsyoutoestablishaccuratebudgets,timelinesandexpectationswhichareproportionaltothestateofyourcurrentmanagementsystemwhendirectlycomparedtotherequirementsofthestandards.

YourorganizationmayalreadyhaveinplaceanISO9001:2008compliantqualitymanagementsystemoryoumightberunninganuncertifiedsystem.Ifthisisthecase,youwillwanttodeterminehowcloselyyoursystemconformstotherequirementsISO9001:2015.Theresultsofagapanalysisexercisewillhelptodeterminethedifferences,orgaps,betweenyourexistingmanagementsystemandthenewrequirements.Notonlywillthisanalysistemplatehelpyoutoidentifythegaps,itwillalsoallowyoutorecommendhowthosegapsshouldbefilled.

Thegapanalysisoutputprovidesavaluablebaselinefortheimplementationprocessasawholeandformeasuringprogress.Trytounderstandeachbusinessprocessinthecontextofeachoftherequirementsbycomparingdifferentactivitiesandprocesseswithwhatthestandardrequires.Attheendofthisactivityyouwillhavealistofactivitiesandprocessesthatcomplyandonesthatdonotcomply.Thelatterlistnowbecomesthetargetofyourimplementationplan.

SummaryofKeyChanges

ProcessApproach

TheprocessapproachwaspromotedbyISO9001:2008andisnowarequirementinitsownright,whichsetsoutthespecificrequirementsfortheadoptionofaprocessapproach.

ContextoftheOrganization

Anewclauseandsubclausesarebeingintroducedrelatingtothecontextoftheorganization.Yourorganizationisnowrequiredtoidentifyandassesallinternalandexternalissuesthatcouldimpactuponyourqualitymanagementsystem’sabilitytodeliveritsintendedresults.Youwillneedtodevelopamethodologytounderstandtheneedsandexpectationsofallinterestedparties.

ScopeoftheQualityManagementSystem

Greateremphasishasbeenplacedonthedefinitionofscopeofthequalitymanagementsystem.Thescopeofqualitymanagementsystemshouldbedeterminedinconsiderationtoyourorganization’scontext.

Leadership

ThepreviouslytitledManagementResponsibilityfromISO9001:2008hasbeenreplacedwith‘Leadership’.Topmanagementarenowrequiredtobeactivelyinvolvedintheoperationofthequalitymanagementsystem.Theremovaloftheroleof‘managementrepresentative’reinforcesaneedtoseethequalitymanagementsystemembeddedintoroutinebusinessoperations,ratherthanoperatingasanindependentsysteminitsownrightwithitsowndedicatedmanagementstructure.

RisksandOpportunities

AllreferencestopreventiveactionhavebeenremovedfromtheISO9001:2015andreplacedwithClause6.1-ActionstoAddressRisksandOpportunities.Yourorganizationisnowrequiredtodetermine,considerand,wherenecessary,takeactiontoaddressanyrisksoropportunitiesthatmightimpactyourqualitymanagementsystem’sabilitytodeliverconformance,orwhichmightadverselyimpactcustomersatisfaction.

ProductsandServices

Theterm‘product’isbeingreplacedby‘productsandservices’.Byincludingspecificreferencetoservicesaswellasproducts,ISO9001:2015reinforcestheideathatqualitymanagementsystemsareapplicabletoalltypesofbusinessandnotjusttoaremanufacturingorsupplyingproducts.

ControlofExternallyProvidedProducts&Services

ISO9001:2008Clause7.4–Purchasinghasbeenreplacedwithclause8.4‘Controlofexternallyprovidedproductsandservices’.Thisclauseaddressesalltypesofexternalprovision,purchasingfromasupplier,orthroughtheoutsourcingofprocesses.Yourorganizationisnowrequiredtotakearisk-basedapproachtodeterminethetypeandextentofcontrolsthatareappropriateforeachexternalproviderandalloutsourcedprocesses.

DocumentedInformation

Requirementsforadocumentedqualitymanual,documentedproceduresandrecordshavebeenremovedandreplacedwiththeterm‘DocumentedInformation’.Thisistheinformationyourorganizationisrequiredtocontrol,retainandmaintain.

Non-conformingProcesses

TheControlofnon-conformingproductsnowincludesnon-conformingprocesses.Yourorganizationisnowrequiredtoevaluatewhetheraprocessisnotconformingtoplannedarrangementsand,wherenecessary,investigatethecauseandtakeactiontopreventrecurrence.

HowtoMaketheChanges

PurchasecopiesofISO9000:2015andISO9001:2015.Readthembothandmakeyourselffamiliarwiththeirlanguageandconcepts.Althoughitiswritteninadense,formallanguage,theclausetitlesinISO9001:2015arefairlyself-explanatory.WesuggestthatyouusethefamiliarPlan-Do-Check-Act(PDCA)methodologytomanageyourorganization’stransitionfromtheoldtothenewrequirements.Thefollowingguidanceprovidesninesimplestepstomakethetransition,usingthePDCAapproach:

Plan:UndertakeagapanalysistounderstandhowtherequirementsaffectyourQMSandthenpreparethetransitionplanbasedontheresults.

Do:ImplementthetransitionplanbyensuringthatthenewrequirementsareembeddedintoyourQMSandyourprocesses.

Check:Evaluatetheeffectivenessofthenewlyimplementedaspectsbyperformingafullsystem(element)audit,reviewthefindingsandimplementanycorrectiveactions.

Act:TakeactiontoaddresstransitionanyproblemsandimprovetheQMSbeforebeginningprocessauditing.

ExistingISO9001:2008Documentation

Theextentofthedocumentedinformationwilldifferfromyourorganizationtoanotherbecauseoftothesizeoforganizationanditsactivities,processes,productsandservices;thecomplexityofprocessesandtheirinteractions,andthecompetenceofpersonnel.InISO9001:2008,thequalitymanualhelpedtoestablishanddocumenttheframeworkofyourorganization'squalitymanagementsystemwhilearticulatingthoseaspectsoftheQMStoanyinterestedparties.

WhilethereisnorequirementforaqualitymanualoranydocumentedproceduresinISO9001:2015,itissuggestedthatiftheyaddvalue,thentheyshouldnotsimplybebinned.YouwillbeexpectedtomaintaintheintegrityoftheQMSduringthetransitionprocess.Youdonotneedtorenumberyourexistingdocumentationtocorrespondtothenewclauses.Itisdowntoeachorganizationtodeterminewhetherthebenefitsgainedfromrenumberingwillexceedtheeffortinvolved.

Neitherdoyouneedtorestructureyourmanagementsystemtofollowthesequenceofandtitlesoftherequirements.ProvidingalloftherequirementscontainedinISO9001:2015aremet,yourorganization’squalitymanagementsystemwillbecompliant.

Ifyourqualitymanualfitsyourbusinessandyourcustomersrequireit,keepit!

Ifyourproceduresareeffectiveanddefinehowyourkeyprocessesoperate,keepthem!

Ifthequalitypolicyandrelatedobjectivesalignwithbusinessstrategy,andtheyarecommunicatedandaddingvalue,keepthosetoo!

Thetypeandextentofdocumentedinformationthatyourorganizationshouldretainandmaintain,inordertobecompliantwithISO9001:2015,clearlydependsonthenatureofyourorganization’sproductsandprocesses.ThefollowingcriteriacanbeusedtoassessthedifferenttypesofISO9001:2008documentsandinformationthatyourorganizationshouldretainandmaintainasdocumentedinformationbydeterminingwhethertheinformation:

Communicatesamessageinternallyorexternally;

Providesevidenceofprocessandproductconformity;

Providesevidencethatplannedoutputswereachieved;

Providesknowledgesharing.

Ifanyoftheabovecriteriaapplytoanytypeofdocumentorinformationwithinyourorganization'sdomain,thenitshouldberetainedandmaintainedasaformof'documentedinformation'asperClause7.5ofISO9001:2015.

Self-assessmentChecklist

ContextoftheOrganisation

Ref

GapAnalysisQuestion

Finding

ImplementationPlan(ifNo)

Yes

No

ISOClause

ProcessOwner

ActionNeeded

DatePlanned

DateActual

1

Haveallexternalandinternalissuesthatarerelevanttoyourorganisation’spurposeandtheachievementofcustomersatisfactionandtheorganisation’sstrategicdirectionbeendetermined?

2

Aretheseissuesreviewedandmonitoredonaregularbasis?

3

HavetheneedsandexpectationsofinterestedpartiesthatarerelevanttotheQMSbeendetermined?

4

WasthescopeofyourQMSdeterminedwhilsttakingintoaccountofalltheexternalandinternalissues,theneedsofinterestedpartiesandthescopeyourproductsandservices?

5

IsyourQMSestablished,anddoesitincludeadescriptionoftheprocessesrequiredandtheirsequenceandinteraction?

6

Havethecriteriaformanagingtheseprocessesandtheirinteractionbeenestablished?

7

Haveallresponsibilities,methods,measurementsandrelatedperformanceindicators,neededtoensuretheeffectiveoperationandcontrol,beenestablished?

Leadership

Ref

GapAnalysisQuestion

Finding

ImplementationPlan(ifNo)

Yes

No

ISOClause

ProcessOwner

ActionNeeded

DatePlanned

DateActual

8

HastopmanagementtakenaccountabilityfortheeffectivenessoftheQMS?

9

HavethepolicyandobjectivesfortheQMS,whicharecompatiblewiththestrategicdirectionoftheorganisation,beenestablishedandcommunicated?

10

Havetheobjectivesbeenestablishedatrelevantdepartmentalandindividuallevelswiththebusiness?

11

HavetherequirementsfortheQMSbeenintegratedintothebusinessprocessesandhavemanagementpromotedawarenessoftheprocessapproach?

12

Havecustomerrequirementsandapplicablestatutoryandregulatoryrequirementsbeendetermined,metandcommunicatedthroughouttheorganisation?

13

HavetherisksandopportunitiesthatarerelevanttotheQMSbeenestablished?

14

HastheorganisationestablishedandcommunicatedtheresponsibilitiesandauthoritiesfortheeffectiveoperationoftheQMS?

Planning

Ref

GapAnalysisQuestion

Finding

ImplementationPlan(ifNo)

Yes

No

ISOClause

ProcessOwner

ActionNeeded

DatePlanned

DateActual

15

HavetherisksandopportunitiesthatneedtobeaddressedtogiveassurancethattheQMScanachieveitsintendedresult(s)beenestablished?

16

Hastheorganisationplannedactionstoaddresstheserisksandopportunitiesandintegratedthemintothesystemprocesses?

17

IsthereadefinedprocessforthedeterminingtheneedforchangestotheQMSandmanagingtheirimplementation?

Support

Ref

GapAnalysisQuestion

Finding

ImplementationPlan(ifNo)

Yes

No

ISOClause

ProcessOwner

ActionNeeded

DatePlanned

DateActual

18

Hastheorganisationdeterminedandprovidedtheresourcesneededfortheestablishment,implementation,maintenanceandcontinualimprovementoftheQMS(includingpeople,environmentalandinfrastructurerequirements)?

19

Ifmonitoringormeasuringisusedforevidenceofconformityofproductsandservicestospecifiedrequirements,hastheorganisationdeterminedtheresourcesneededtoensurevalidandreliablemonitoringandmeasuringofresults?

20

Hastheorganisationdeterminedtheknowledgenecessaryfortheoperationofitsprocessesandachievementofconformityofproductsandservicesandimplementedalessonslearntprocess?

21

HastheorganisationensuredthatthosepersonswhocanaffecttheperformanceoftheQMSarecompetentonthebasisofappropriateeducation,training,orexperienceortakenactiontoensurethatthosepersonscanacquirethenecessarycompetence?

22

HasthedocumentedinformationrequiredbythestandardandnecessaryfortheeffectiveimplementationandoperationoftheQMSbeenestablished?

Operation

Ref

GapAnalysisQuestion

Finding

ImplementationPlan(ifNo)

Yes

No

ISOClause

ProcessOwner

ActionNeeded

DatePlanned

DateActual

23

Isthereadefinedprocessfortheprovisionofproductsandservicesthatmeetrequirementsdefinedbythecustomer?

24

Whenchangesareplannedaretheycarriedoutinacontrolledwayandactionstakentomitigateanyadverseeffects?

25

Areanyoutsourcedprocessesmanagedandcontrolled?

26

Isthereadefinedprocessforreviewingandcommunicatingwithcustomersinrelationtoinformationrelatingtoproductsandservices,enquiries,contractsororderhandling?

27

Isthisreviewconductedpriortotheorganisation’scommitmenttosupplyproductsandservices?

28

Ifyoudesignanddevelopproductsorservices,aretheseprocessesestablishedandimplementedinlinewiththerequirementsofthestandard?

29

Doyouensurethatexternallyprovidedprocesses,products,andservicesconformtospecifiedrequirements?

30

Doyouhavecriteriafortheevaluation,selection,monitoringofperformanceandre-evaluationofexternalproviders?

31

Istheprovisionofproductsandservicescarriedoutincontrolledconditionswhichinclude:

theavailabilityofdocumentedinformationthatdefinesthecharacteristicsoftheproductsandservices;

theavailabilityofdocumentedinformationthatdefinestheactivitiestobeperformedandtheresultstobeachieved?

monitoringandmeasurementactivitiesatappropriatestagestoverifythatcriteriaforcontrolofprocessesandprocessoutputs,andacceptancecriteriaforproductsandservices,havebeenmet?

thepeoplecarryingoutthetasksarecompetent?

32

Doyouhaveeffectivemethodsofensuringtraceabilityduringtheoperationprocess?

33

Wherepropertybelongingtocustomersorexternalprovidersisusedintheprovisionoftheproductorservice,isthiscontrolledeffectively?

34

Ifthereisarequirementforpost-deliveryactivitiesassociatedwiththeproductsandse