ISO9001内部审核检查表英文版Word下载.docx
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ISO9001内部审核检查表英文版Word下载.docx
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2015requirestheadoptionoftheprocessapproachwhichextendstointernalqualityaudits.Thischecklistfollowsthestructureofthestandard,thusitisnotprocessbased.Forthisreasonitisnotintendedtobeusedastheonlytoolforinternalqualityaudits.
YoucangainabetterunderstandingofISO9001:
2015Standardasitappliestoyourcompanybyreviewingthesequestions.Youmaywishtodiscussthemwithyourauditorstoenhanceeveryones'
understandingoftheISO9001:
2015requirementsandtheassessmentprocess.
YoushouldbeawarethatalthoughthefollowingquestionsincludemostoftherequirementsoftheISO9001:
2015standard,theydonotnecessarilycoverallaspectsoftheStandard.So,theuseofthischecklistwillgiveyouonlyasampleofyourorganizationconformancetotheISO9001:
2015standard.
TheAssessmentSummarySheemtaybeusedforvisualizingthebigpicture:
whatareaswerecheckedandwherediscrepancieswerefound.YoufromthesampleAssessmentSummarySheetthatassessmentofthePurchasingProcessuncovereddiscrepanciesforclauses4.1,5.3,7.1.5,8.1,8.2,8.3.1and8.5.3.Thismaybeasignofproblemsinthatprocess,whichwarrantplanningandclosemonitoringofcorrectiveactions.TheProcessesAssessedcolumnrevealsthatforclause7.1.2forResourceRequirementsor8.2forDeterminationofrequirementsforproductsandservices,discrepancieswereuncoveredinallapplicableareas.Thismaygiveevidenceofasystembreakdown.
OnthesampleAssessmentSummaryShee,thecirclednumberscorrespondtothefollowing:
TheISO9001:
2015AssessmentStandarcdorrespondtotheISO9001:
2015InternationalStandardwhichyourcompanyhasselectedforassessment.
ThecolumnProcessAssessedliststheareas(i.e.process)wherecompliancetogivenclauseswillbeevaluated.
ThesecolumnscontainthelistofclausesfortheapplicableISOStandardtowhichcomplianceisbeingsought.NOTE:
AllclausesoftheISO9001Standardmustbeaddressed.Seesection0.1.F“orward”,forfurtherinformation.
Usethisgridtoindicatewherediscrepanciesarefoundbyenteringaintothecorrespondingboxes.Wherenodiscrepanciesareuncovered,enteran“X”intheappropriateboxes.
0.2ProcessApproach
ISO9001:
2015promotestheadoptionofaprocessapproach.Asafirststep,allprocessesoftheorganizationneedtobeidentifiedandtheirinterrelationdefined.Aprocessisasetofactivitiesthattransforminputsintooutputs.Theoutputsofoneprocessmaybetheinputofanotherprocess,orthefinishedproduct.Althoughaprocessmapisnotrequired,itisaneffectivemethodfordemonstratingprocessinterrelation.Anyothermethodwillequallymeettherequirementsofthestandardaslongastheprocessinteractionissomehowshown.
Anexampleofatypicalprocessmapisnotedonthenextpage.Pleasenotethataprocessmapisnotaprocessflowdiagram,butmerelyhighlightsthemainprocessesoftheorganizationthatareneededtobeeffectivelymonitoredtoensure“consistentandpredictableresAulsltos,the
processesnotedarenotthenamesofthefunctionswithintheorganization,butvalueaddedactivitieswithintheorganizationthatmayinvolvesubprocessesthatwillhavetobefurtherdefined.
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AssessmentSummarySheetSAMPLE
ProcessesoftheOrganization
DiscrepancyRefereneeNumber
QualityManagement
Systems:
Requirements
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ClauseNumber
Clause
Description
4.1
Understandingtheorganizationanditscontext
X
4.2
NeedsandExpectationsoftheInterestedParties
4.3
Determiningthescopeofthequalitymanagementsystem
4.4
QualityManagementSystemanditsprocesses
5.1
Leadershipandcommitment
5.2
QualityPolicy
5.3
Organizationalroles,responsibilitiesandauthorities
D
6.1
Actionstoaddressrisksandopportunities
6.2
Qualityobjectivesandplanningtoachievethem
6.3
Planningofchanges
7.1
Resources
7.1.1
General
7..1.2
People
7.1.3
Infrastructure
7.1.4
Environmentfortheoperationofprocesses
7.1.5
MonitoringandMeasuring
7.1.6
OrganizationalKnowledge
7.2
Competence
7.3
Awareness
7.4
Communication
u
2
u
a
e
7.5
DocumentedInformation
7.5.1
7.5.2
Creatingandupdating
7.5.3
ControlofdocumentedInformation
8.1
Operationalplanningandcontrol
8.2
Determinationofrequirements
8.2.1
Customercommunication
8.2.2
Determinationofrequirementsrelatedtoproductsandservices
x
8.2.3
8.2.4
Reviewofrequirementsrelatedtoproductsandservices
Changestorequirements
8.3
DesignandDevelopment
8.3.1
8.3.2
Designanddevelopmentplanning
8.3.3
Designanddevelopmentinputs
8.3.4
Designanddevelopmentcontrols.
8.3.5
8.3.6
DesignanddevelopmentOutputs
Designanddevelopmentchanges
8.4.2
Typeandextentofcontrolofexternalprovision
8.4.3
Informationforexternalproviders
8.5.1
ControlofproductionandService
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1nP
2n
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8.5.2
Identificationandtraceability
8.5.3
Propertybelongingtocustomersorexternalproviders
8.5.4
Preservation
8.5.5
Post-deliveryactivities
8.5.6
Controlofchanges
8.6
Releaseofproductsandservices
8.7
Controlofnonconformingproducts
9.1.1
Monitoring,measurement,analysis
9.1.2
CustomerSatisfaction
9.1.3
Analysisandevaluation
9..2
InternalAudits
9.3
ManagementReview
10.1
Improvement-General
10.2
Nonconformity/Corrective
Action
10.3
Continualimprovement
*Usean“X”toindicatethattheselwasassessedintheareadescribed.
Usea“D”toindicatethatadiscrepancywasfound
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