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NQA,USAISO9001:2015ClientTransitionChecklist

InstructionsforClient:PleasecompletethechecklistbelowandonefullinternalauditagainsttheISO9001:2015
requirementspriortoyourorganizationstransitionaudit.Oncetheformiscompleted,forwardittoyourCSRand
LeadAuditorpriortothetransitionaudit.Pleaseensurethatthecompletedchecklistandinternalauditrecords
areavailabletoyourauditoratthecommencementofyourtransitionvisit.
Ifyouarenotabletocompletethisdocument,itisastrongindicatorthatyourorganizationmaynotbereadyto
completethetransitiontoISO9001:2015.Inthiscase,pleaseinformyourCSRthatyouneedadditionaltimeto
prepareforthetransitionandtheywillworkwithyoutoselectamutuallyagreeabledatetocompletethe
transition.
NewConcepts&Themes:Pleasecompletethetablesbelowwhichhighlightsomeofthenewconceptsand
themespresentinISO9001:2015.Theseconceptswillbridgemultipleprocesses,clausesandfunctionalareas.
Ensurethatthesenewconceptshavebeendeployedinamannerthatsupportstheprocessapproachandrisk
basedthinking.
NewConcepts
Arethereany
requirementsofISO
9001:2015thatthe
organizationis
consideringnot
applicable?

Instruction
IfYes,pleaselistallnonapplicablerequirementsand
justificationsofwhytheydonotaffectyour
organizationsabilityorresponsibilitytoensurethe
conformityofyourproductsandservicesandthe
enhancementofcustomersatisfaction(ref.ISO
9001:2015,4.3)
IfNo,markresponsecolumnasN/Aandproceedto
nextquestion

Istheorganizationstill
maintaininga
documentedQuality
Manual?

IfYes,markresponsecolumnasN/Aandproceedto
nextquestion
IfNo,pleasedetailhowyourorganizationhas
determinedtheprocessesneeded,andtheir
interactionsinaccordancewithISO9001:2015(ref.ISO
9001:2015,4.4.1)

Istheorganization
stillmaintaining
Documented
Procedures?

IfYes,markresponsecolumnasN/Aandproceedto
nextquestion

Hastheapproach
changedwithregard
totheappointment
ofaManagement
Representative?

OrganizationResponse

IfNo,pleasedescribeonwhatbasisyourorganization
hasdeterminedthatdocumentedinformation(i.e.
procedures)arenotnecessaryfortheeffectivenessof
thequalitymanagementsystem(ref.ISO9001:2015,
7.5.1)
IfYes,pleasedetailhowtopmanagement
demonstratesleadershipandcommitmentwith
respecttothequalitymanagementsystem(ref.ISO
9001:2015,5.1.1)

IfNo,markresponsecolumnasN/Aandproceedto
nextquestion

ISO9001:2015AuditTransitionChecklist(TR002)Rev1

Phase Clauses
Plan
4.1,4.2

Activity
Hasthe organization identified both
internalandexternalissuesand
interestedpartiesthatarerelevant
toand/orsupportthestrategic
directionoftheorganization?

Do

5.2.1

Check

4.1,4.2,
5.1.1,
9.3.2

Isthe strategic direction being

utilizedasaninputtotheQuality
Policy/QualityObjectives/Risk
Management/ManagementReview
processes?
Isthe quality system being assessed
andreviewedinaccordancewiththe
strategicdirection?

Act

10.3

Isthe quality system being updated


asnecessaryinresponsetochanges
inanyoftheabove?

Plan

4.4.1,6.1,
6.2,6.3,
8.5.6

When establishing the QMS and


planningforchange,haverisksto
achievingprocessobjectivesbeen
identified?

Do

8.1

Check

Act

6.1.2,
9.1.3,
9.3.2
10.2.1,
10.3

Havetheidentifiedprocessrisks

beenaddressed?
Isthe organization analyzing the

effectivenessofactionstakento
addressprocessrisks?
Following analysis and corrective

actionisthereevidencethatprocess
riskshavebeenupdated?
Have risks to achieving productor

serviceconformitybeen

NewThemes
Business
Planning
andStrategic
Direction

ProcessRisk

Productand
ServiceRisk

Plan

5.1.2,6.1,
6.2
8.1,

8.2.2,
8.2.3

8.3.2

Evidencetosupportconformance

consideredaspartoftheplanning
foroperationalcontrol?
consideredwhendeterminingand
reviewingcustomerrequirements?
identifiedandhasproduct
complexitybeenconsideredduring
designplanning?

Do

8.1,
8.2.3.1,
8.3.3

Have design and operational controls


toaddresstheidentifiedproductand
servicerisksbeenimplemented?

Check

9.1.3,
9.3.2

Act

10.1

Isthe organization analyzing the

effectivenessofactionstakento
addressproductrisks?
Hasthe organization determined and
selectedopportunitiesfor
improvementonproductand
service?

ISO9001:2015AuditTransitionChecklist(TR002)Rev1

NewThemes

Phase

Riskassociated Plan
withthecontrol
ofexternally
provided
productand
service
Do

Clauses

Activity

Evidencetosupportconformance

6.1

Have risks associated with


externallyprovidedproduct,
process(i.e.formerlynamed
outsourced)orservicebeen
identified?

8.4.1,
8.4.2

Arethe identified risks utilized asan


inputintothe
potentialimpactofexternally
providedproduct,processor
service
typeandextentofcontrols
selectionandevaluationof
externalproviders
degreeofinformationprovided
totheseresources?

Check

8.4.1,
9.3.2

Hasthe organization applied criteria


fortheevaluation,selection,
monitoringofperformanceandre
evaluationofexternalproviders?

Act

9.3.3

Hasthe organization modified the


controlsappliedtoexternal
providersbasedupontheresultsof
evaluation?

ISO9001:2015AuditTransitionChecklist(TR002)Rev1

ISO9001:2015enhancedemphasis:Pleasecompletethetablebelowtodemonstratethateachofthefollowing
requirementshavebeenaddressedwithinthequalitymanagementsystem.
ISO9001:2015
5.1Leadershipandcommitment
(ref.ISO9001:2008,5.1)
6.3Planningofchanges
(ref.ISO9001:2008,5.4.2)
7.1.5Monitoringandmeasuringresources
(ref.ISO9001:2008,7.6)
7.1.6Organizationalknowledge

Evidencetosupportconformance

7.3Awareness
(ref.ISO9001:2008,6.2.2)
7.4Communication
(ref.ISO9001:2008,5.5.3)
8.2Determinationofrequirementsfor
productsandservices(ref.ISO9001:2008,7.2)
8.3Designanddevelopmentofproducts
andservices(ref.ISO9001:2008,7.3)
8.5.5Controlofproductionandservice
Provision(ref.ISO9001:2008,7.5.1)
8.5.6Controlofchanges
(ref.ISO9001:2008,5.4.2)
8.6Releaseofproductsandservices
(ref.ISO9001:2008,8.2.4)
8.7Controlofnonconformingprocessoutputs,
productsandservices(ref.ISO9001:2008,8.3)
9.3Managementreview
(ref.ISO9001:2008,5.6)
10.2Nonconformityandcorrectiveaction
(ref.ISO9001:2008,8.5.2)

Areasforfurtherinvestigation

ISO9001:2015AuditTransitionChecklist(TR002)Rev1