ISO9001自我评估检查表英文版.docx

ISO9001自我评估检查表英文版.docx

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ISO9001自我评估检查表英文版

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:

1.Plan:

UndertakeagapanalysistounderstandhowtherequirementsaffectyourQMSandthenpreparethetransitionplanbasedontheresults.

2.Do:

ImplementthetransitionplanbyensuringthatthenewrequirementsareembeddedintoyourQMSandyourprocesses.

3.Check:

Evaluatetheeffectivenessofthenewlyimplementedaspectsbyperformingafullsystem（element）audit,reviewthefindingsandimplementanycorrectiveactions.

4.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.

1.Ifyourqualitymanualfitsyourbusinessandyourcustomersrequireit,keepit!

2.Ifyourproceduresareeffectiveanddefinehowyourkeyprocessesoperate,keepthem!

3.Ifthequalitypolicyandrelatedobjectivesalignwithbusinessstrategy,andtheyarecommunicatedandaddingvalue,keepthosetoo!

Thetypeandextentofdocumentedinformationthatyourorganizationshouldretainandmaintain,inordertobecompliantwithISO9001:

2015,clearlydependsonthenatureofyourorganization’sproductsandprocesses.ThefollowingcriteriacanbeusedtoassessthedifferenttypesofISO9001:

2008documentsandinformationthatyourorganizationshouldretainandmaintainasdocumentedinformationbydeterminingwhethertheinformation:

1.Communicatesamessageinternallyorexternally;

2.Providesevidenceofprocessandproductconformity;

3.Providesevidencethatplannedoutputswereachieved;

4.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

Havetheobjec