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ISO9001:2015QualityManagementSystemAssessmentChecklistRP-2
TableofContents
Introduction
AssessmentSummarySheet-Sample
AssessmentSummarySheet
-ContextoftheOrganization
-Leadership
77167
-PlanningfortheQualityManagementSystem7—Support777777777777777777777777
8-Operation
77777777777777777777777
777777777777777
9-PerformaneeEvaluation10-Improvement777777777777777777777
TheQualitySystemChecklistsintendedtohelpyougainabetterunderstandingoftherequirementsofISO9001:2015.ISO9001:2015requirestheadoptionoftheprocessapproachwhichextendstointernalqualityaudits.Thischecklistfollowsthestructureofthe
standard,thusitisnotprocessbased.Forthisreasonitisnot
intendedtobeusedastheonlytoolforinternalqualityaudit
YoucangainabetterunderstandingofISO9001:2015Standardas
itappliestoyourcompanybyreviewingthesequestions.Youmaywishtodiscuss themwithyourauditorstoenhanceeveryones'
understandingoftheISO9001:2015requirementsandtheassessmentprocess.
YoushouldbeawarethatalthoughthefollowingquestionsincludemostoftherequirementsoftheISO9001:2015standard,theydonotnecessarilycoverallaspectsoftheStandard.So,theuseofthischecklistwillgiveyouonlyasampleofyourorganizationconformancetotheISO9001:2015standard.
AssessmentSummarySheet
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,allprocessesoftheorganizationneedtobeidentifiedandtheir
interrelationdefined.Aprocessisasetofactivitiesthattransforminputsintooutputs.Theoutputsofoneprocessmaybetheinputofanotherprocess,orthefinishedproduct.Althoughaprocessmapisnotrequired,itisaneffectivemethodfordemonstratingprocessinterrelation.Anyothermethodwillequallymeettherequirementsofthestandardaslongastheprocessinteractionissomehowshown.
Anexampleofatypicalprocessmapisnotedonthenextpage.Pleasenotethataprocessmapisnotaprocessflowdiagram,butmerelyhighlightsthemainprocessesoftheorganizationthatareneededtobeeffectivelymonitoredtoensure“consistentandpredictableresAulsltos,theprocessesnotedarenotthenamesofthefunctionswithintheorganization,butvalueaddedactivitieswithintheorganizationthatmayinvolvesub processesthatwillhavetobefurtherdefined.
CustomerSatisfaction
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AssessmentSummarySheetSAMPLE
ISO9001:2015
ProcessesoftheOrganization
DiscrepancyRefereneeNumbe
QualityManagement
Systems:
Requirements
eS
gE
c
P
1
Yu
P
CXICHJUUOOO.
RH
o
g
Clause
Number
Clause
Description
4.1
Understandingtheorganizationanditscontext
X
X
4.2
NeedsandExpectationsoftheInterested
Parties
X
X
X
X
X
X
X
X
X
X
X
X
X
■X
X
X
4.3
Determiningthescopeofthequalitymanagementsystem
X
4.4
QualityManagementSystemanditsprocesses
X
5.1
_eadershipandcommitment
X
X
5.2
QualityPolicy
X
X
X
X
X
X
X
X
X
X
X
X
X
■X
X
X
X
5.3
Organizationalroles,responsibilitiesandauthorities
X
X
X
X
D
X
X
X
X
X
X
X
X
■X
X
X
X
6.1
Actionstoaddressrisksandopportunities
X
X
X
X
X
X
X
X
X
X
X
X
X
■X
X
X
X
6.2
Qualityobjectivesandplanningtoachievethem
X
X
X
X
X
X
X
X
X
X
X
X
X
■X
X
X
X
6.3
Planningofchanges
D
X
7.1
Resources
X
X
X
X
X
X
X
X
X
X
X
X
X
■X
X
X
X
7.1.1
General
X
7..1.2
People
D
D
D
D
D
D
D
D
D
D
D
7.1.3
nfrastructure
X
X
X
X
X
X
X
X
7.1.4
Environmentfortheoperationofprocesses
X
X
X
X
X
X
X
X
X
7.1.5
MonitoringandMeasuring
X
D
X
X
X
X
7.1.6
OrganizationalKnowledge
X
X
X
X
X
X
X
X
X
X
X
X
X
■X
X
X
X
7.2
Competenee
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
7.3
Awareness
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
7.4
Communication
X
X
X
X
ISO9001:2015
ProcessesoftheOrganization
11-7
DiscrepancyRefereneeNumbe
QualityManagement
Systems:
Requirements
iT
Ea
rwc
o
S
S
c
P
1n
P
2nP
R
enen
M
o
cm
Clause
Number
Clause
Description
8.5.2
dentificationandtraceability
X
X
X
X
X
8.5.3
Propertybelongingtocustomersorexternalproviders
D
8.5.4
Preservation
X
X
X
X
X
8.5.5
Post-deliveryactivities
X
X
X
X
8.5.6
Controlofchanges
X
X
X
8.6
Releaseofproductsandservices
X
X
X
8.7
Controlofnonconformingproducts
X
X
X
D
X
■X
9.1.1
Monitoring,measurement,analysis
X
X
X
X
X
X
X
X
D
X
X
X
X
■X
X
X
r
I
9.1.2
CustomerSatisfaction
X
X
X
9.1.3
Analysisandevaluation
X
X
X
X
X
X
X
X
D
X
X
X
X
■X
X
X
r
I
9..2
nternalAudits
X
X
9.3
ManagementReview
X
X
10.1
mprovement-General
X
X
X
X
X
X
X
X
D
X
X
X
X
■X
X
X
r
I
10.2
Nonconformity/Corrective
Action
X
X
X
D
X
■X
10.3
Continualimprovement
X
X
X
X
X
X
X
X
D
X
X
X
X
■X
X
X
r
I
*Usean“X” toindicatethattheselwasassessedintheareadescribed.
Usea“Dtoindicatethatadiscrepancywasfound
AssessmentSummarySheet
ISO9001:2015
ProcessesoftheOrganization
DiscrepancyRefereneeNumbe
QualityManagement
Systems:
Requirements
Clause
Number
Clause
Description
4.1
Understandingtheorganizationanditscontext
4.2
NeedsandExpectationsoftheInterested
Parties
4.3
Determiningthescopeofthequalitymanagementsystem
4.4
QualityManagementSystemanditsprocesses
5.1
Leadershipandcommitment
5.2
QualityPolicy
5.3
Organizationalroles,responsibilitiesandauthorities
6.1
Actionstoaddressrisksandopportunities
6.2
Qualityobjectivesandplanningtoachievethem
6.3
Planningofchanges
7.1
Resources
7.1.1
General
7..1.2
People
7.1.3
nfrastructure
7.1.4
Environmentfortheoperationofprocesses
7.1.5
MonitoringandMeasuring
7.1.6
OrganizationalKnowledge
7.2
Competenee
7.3
Awareness
7.4
Communication
ISO9001:2015
ProcessesoftheOrganization
DiscrepancyRefereneeNumbe
QualityManagement
Systems:
Requirements
Clause
Number
Clause
Description
7.5
DocumentedInformation
7.5.1
General
7.5.2
Creatingandupdating
7.5.3
ControlofdocumentedInformation
8.1
Operationalplanningandcontrol
8.2
Determinationofrequirements
8.2.1
Customercommunication
8.2.2
Determinationofrequirementsrelatedtoproductsandservices
8.2.3
8.2.4
Reviewofrequirementsrelatedtoproductsandservices
Changestorequirements
8.3
DesignandDevelopment
8.3.1
General
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
ISO9001:2015
ProcessesoftheOrganization
DiscrepancyRefereneeNumbe
QualityManagement
Systems:
Requirements
Clause
Number
Clause
Description
8.5.2
dentificationandtraceability
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
nternalAudits
9.3
ManagementReview
10.1
mprovement-General
10.2
Nonconformity/Corrective
Action
10.3
Continualimprovement
*Usean“X”toindicate thattheclausewasassessedintheareadescribed.
Usea“Dtoindicatethatadiscrepancywasfound
QualityManagementSystemChecklist
如9001:2015
Clause#
QualityManagementSystemRequirements
DocumentedInformationReferenee
ExplanatoryNotesandComments
4
Contextoftheorganization
4.1
Understandingtheorganizationanditscontext
4.1
Hastheorganizationidentifiedallexternalandinternalissuesrelevanttoitspurposeanddirection?
4.1
Whatistheprocessformonitoringandreviewoftheexternalandinternalissues?
4.2
Understandingtheneedsandexpectationsofinterestedparties
4.2
Hastheorganizationidentifiedallrelevantinterested
partyrequirementsthatarerelevanttothequalitymanagemtntsystem?Howistheinformationmonitored?
e
4.3
DeterminingthescopeoftheQualityManagementSystem
4.3
Isthescopeofthequalitymanagementsystem,includingproductsandservicesprovidedandjustificationforanyexclusion,defined?
4.3
Isthescopeofthequalitymanagementsystemmaintainedasdocumentedinformation?
4.3
Arethefollowingconsideredwhendeterminingthescope?
?ExternalandInternalIssues
?Requirementsofrelevantinterestedparties
?Theproductsandservicesprovided.
4.3
Isthereassuraneethatallrequirementsofthestandardthatcanbeapplied,havebeenappliedbytheorganizationandthosedeterminednon-applicabledonotaffecttheorganizationorresponsibilitytoensureconformity?
'sability
如9001:2015
Clause#
QualityManagementSystemRequirements
DocumentedInformationReferenee
ExplanatoryNotesandComments
4.4
QualityManagementSystemanditsprocesses
4.4
Havetheprocessesoftheorganizationbeenidentified?
?InputsandOutputs
?Sequeneeandinteraction
?Criteria,methodandperformaneeindicators
?Resourcesneeded
? Definedresponsibilityandauthorityforallpers
onnel.
?RisksandOpportunities
?Methodformonitoringandchangetoensureintendedresults
?Opportunitiesforimprovementoftheprocesses
4.4
Hastheorganizationdefined
?Neededdocumentedinformationtosupporttheoperationofitsprocesses?
?Documentedinformationtoberetainedasevide
neethattheprocessesarebeingcarriedoutasplanned.?
5
Leadership
5.1.1
Hastopmanagementdemonstratedleadershipby
?Takingaccountabilityoftheprocess?
?EstablishingtheQualityPolicyandObjectives?
?CommunicatingthePolicy?
?EnsuringQMSRequirementsareintegratedintotheprocesses?
?Makingavailableadequateresources?
?CommunicatingQMSeffectiveness?
?Ensuringachievementofresults?
?Engaging/direct ing/supportingprocesseffective
ness?
?Promotingcontinualimprovement?
?Supportingothermanagementroleswithintheorganizationtodothesame?
如9001:2015
Clause#
QualityManagementSystemRequirements
Documented
Information
Referenee
ExplanatoryNotesandComments
5.1.1
Cantopmanagementdemonstrateevideneeofcommitmenttothedevelopment,implementationandimprovementoftheeffectivenessofthequalitymanagementsystemby:
Communieatingtotheorganization theimportaneeofmeeti
ngcustomerrequirements?
Establishingthequalitypolicy?
Ensuringthatqualityobjectivesareestablished?
Conductingmanagementreviews?
Ensuringtheavailabilityofresources?
5.1.2
CustomerFocus
5.1.2
Hastopmanagementdemonstratedleadershipby
? Identifyingcustomerrequirements?
? Identifyingregulatoryrequirements?
? Identifyingstatutoryrequirements?
?RisksandOpportunitiesdeterminedandaddressed?
?Focustoconsistentlyprovideproducts/services
thatmeetcustomerrequirements?
?Enhancingcustomersatisfaction?
5.2
QualityPolicy
5.2.1
Hastopmanagementestablishedaqualitypolicythat
Isappropriatetotheorganization?
?Allowsforreviewofprocessindicatorsandobjectives?
?Includesacommitmenttosatisfyapplicablerequirements?
? Includesacommitmenttocontinualimprovement?
Iscommunicatedandunderstoodthroughouttheorganization
Isreviewedforcontinuingsuitability?
如9001:2015
Clause#
QualityManagementSystemRequirements
DocumentedInformationReferenee
ExplanatoryNotesandComments
5.2.1
Arethequalityobjectivesmeasurableandconsistentwiththequalitypolicy?
5.2.2
Isthequalitypolicy
Documented?
Communicatedandunderstood?
Availabletorelevantinterestedparties?
5.3
Organizationalroles,responsibilitiesandauthorities
5.3
Hastopmanagementdefined
?Responsibilityandauthorityforallpersonnelaffectingquality?
?Ensuringthattheprocessesareeffectiveanddeliveringtheirintendedresults?
?ReportingontheperformaneeoftheQMSandopportunities?
?EnsuringCustomerFocusthroughouttheorganization?
?MaintainingtheintegrityofQMSwhenchanges
areimplemented?
6
PlanningfortheQualityManagementSystem
6.1.1
Hastheorganizationconsideredrisksandopportunitiesnotedin4.1and4.2andhaveassurancesthatQMS
?Canachieveitsintendedresults?
?MitigateRiskbypreventionorreductionofundesiredeffects?
? Enhancedesirableeffects?
? Achieveimprovements?
6.1.2
Doestheorganizationplan
? Actionsneededtoaddressrisksandopportunities?
?IntegrateactionsintoitsQMSprocesses?
?Evaluatetheeffectivenessofactions?
如9001:2015
Clause#
QualityManagementSystemRequirements
Documented
Information
Referenee
ExplanatoryNotesandComments
6.2.1
Hastheorganization establishedQualityobjectivesthatare:
? ConsistentwiththeQualityPolicy?
? Aremeasurable?
?Consideredapplicablerequirements?
?Relevant?
?Monitored?
?Communicated?
?Updated?
6.2.2
Hastheorganizationplannedhowtoachieveitsqualityobjectivesby
Identifyingwhathastobedone?
Identifyingtheneededresources?
Identifyingtheresponsibility forachievement?
Duedateforachievement?
Evaluationoftheresults?
6.3
ForchangestotheQMS,hastheorganizationproceededinaplannedandsystemicmannerby
? Identifyingthechangesandtheirconsequenee?
?TheintegrityoftheQMS?
? Availabilityofresources?
? Allocationorreallocationof
responsibilitiesandauthorities?
7
Support
7.1.1
Hastheorganization determinedtheneededresourceswhilecon
sidering
* Limitationsofinternalresources?
?Whathastobeobtainedfromexternalproviders?
7.1.2
People
7.1.2
Areadequatehumanresourcesinplacetoensurecomplianeewiththecustomerandapplicableregulatoryandstatutoryrequirements?
如9001:2015
Clause#
QualityManagementSystemRequirements
Documented
Information
Referenee
ExplanatoryNotesandComments
7.1.3
Infrastructure
7.1.3
Hastheorganization identified theinfrastructure neededfor
effectiveoperationoftheQMS,,including
Maintenanceofequipment?
Buildingsandassociatedutilities?
Transportation?
InformationandCommunication
Technology?
7.1.4
Environmentfortheoperationofprocesses
7.1.4
Howwillitbedemonstratedthattheorganizationdeterminesandmanagestheworkenvironmentneededtoachieveconformitytoproductandservicerequirements?
7.1.5
Monitoringandmeasuringresources
7.1.5
Hastheorganizationdeterminedthemonitoringandmeasurementtobeundertaken,andthemonitoringandmeasurementresourcesneededtoprovideevideneeofconformitytodeterminedrequirements?
7.1.5
Aresuitablemonitoringandmeasuringresourcesavailableto
ensurevalidandreliableresults,including
?Ensuringsuitableresources?
?Resourcesaremaintainedtoensuretheircontinuedfitnessfortheirpurpose?
?Maintainingdocumentedinformationasevideneeoffitnessofthemonitoringandmeasuringresources?
?Determiningsuitability ofthespecifictypeofmoi
itoringandmeasurementactivities?
n
7.1.5
Haveallmonitoringandmeasuringactivitiesdetermined?
ISO9OO1:2O15
Clause#
QualityManagementSystemRequirements
Documented
Information
Referenee
ExplanatoryNotesandComments
7.1.5
Aremonitoringandmeasuringresources ?Suitability
maintained?
7.1.5
Whatdocumentedinformationismaintainedasevideneeoffitnessforthemonitoringandmeasurementresources?
7.1.5
?Ismeasuringequipmentcalibratedorverified, or
both,atspecifiedintervalsorpriortouseagainsttraceableinternationalornationalmeasurementstandards?(Ifinternationalornationalme
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