Professional Documents
Culture Documents
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
utilizedasaninputtotheQuality
Policy/QualityObjectives/Risk
Management/ManagementReview
processes?
Isthe quality system being assessed
andreviewedinaccordancewiththe
strategicdirection?
Act
10.3
Plan
4.4.1,6.1,
6.2,6.3,
8.5.6
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
Check
9.1.3,
9.3.2
Act
10.1
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
8.4.1,
8.4.2
Check
8.4.1,
9.3.2
Act
9.3.3
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