3/11/2017 UsingaConformityMatrixtoAlignProcessestoISO9001:2015

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UsingaConformityMatrixtoAlignProcessesto
ISO9001:2015
Noneedtorewriteproceduressimplydemonstratehowtheymeetthe
standardsprovisions

WilliamA.Levinson

Published:11/21/2016

Sept.22,2018,isthedeadlineforregistrationtoISO9001:2015,andthisseemstoalloworganizations
plentyoftimetomakethetransitiontothenewstandard.Thegoodnewsisthat,despitetheradical
changestothestandardsstructure,theunderlyingrequirementsarenotparticularlydifferent.Thismeans
thatnoextensiveoverhaulofexistingdocumentsandprocessesisnecessary.Thebadnewsisthatthe
transitionmustbeperformedwellbeforethedeadline,andISO9001:2015isthereforecloserthanwe
think.

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ISO9001:2008requiresinternalauditsandmanagementreviewsofthequalitymanagementsystem,andit
thereforecomesasnosurprisethatISO9001:2015alsorequiresthem.Thecatchisthat,toqualifyfor
registrationtoISO9001:2015,theinternalauditandmanagementreviewmustmeettherequirementsof
thenewratherthantheoldstandard.

Itisthereforebettertobeginearly,anddiscoverandeliminateanygapsbetweentheQMSandthe
standardsnewrequirements,thantobeginlateandnotcompletetherequiredinternalauditand
managementreviewintimeforathirdpartyauditin2018.Ontheotherhand,theorganizationdoesnot
needanentirelynewsetofproceduresandprocesses.Itneedstoensureonlythattheonesithasemploy
thenewstandardsrequirements.

UseaconformitymatrixtoalignprocessestoISO9001:2015

IfyourQMSmeetstherequirementsofISO9001:2008,italreadymeetsmostoftherequirementsofISO
9001:2015.Thismeansthereisnoneedtorewriteproceduresandworkinstructionsforthesolepurposeof
restructuring.Allthatisnecessaryistodemonstratehowtheymeettheprovisionsofthenewstandard.

WhileISO9001:2015doesnotrequireaqualitymanual,mypersonalpositionwouldbetoretainone,if
fornootherreasonthantocrossreferenceprocedureswiththecurrentversionofthestandard.The
conformitymatrixisausefultoolfordoingthis,andalsotoidentifyanygapsbetweenwhatthe
organizationhasandwhatthenewstandardrequires.

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3/11/2017 UsingaConformityMatrixtoAlignProcessestoISO9001:2015

Aconformitymatrixissimplyamatrixwhoserowsaretheclausesofthestandard,andwhosecolumnsare
theorganizationsproceduresandprocesses.AnXorothermarkisplacedatthecolumnandrow
intersectionwhenaprocedureorprocessmeetsorsupportsthecorrespondingelementofthestandard.A
rowinwhichnoXappearsisanimmediatevisualindicatorofagapbetweentheQMSandthestandard,
andaproceduremustbewrittenorrevisedtoeliminatethegap.

ItispossibletoenhancetheconformitymatrixbyusingtheLTypeMatrixinwhichsomekindof
weightingsymbol,ratherthanjustanXorothercheckmark,isplacedatarowandcolumnintersection.In
thebookCQEPrimer(QualityCouncilofIndiana,2006)BillWortmanandhiscoauthorsusethree
differentsymbolsforstrongrelationship,relationship,andpossiblerelationship.Wecansimilarly
usedifferentsymbolsforprimary,secondary,andsupportingrelationships.

Supposeforexamplethatanorganizationhasaprocedurefordocumentcontrol,whichincludesa
provisionforreviewandapprovalofdocumentchanges,distributionofthecurrentdocument,andremoval
ofobsoletedocuments.ThisprocedurewouldhaveaprimaryrelationshipwithISO9001:2015clause7.5,
Documentedinformation.Thatis,theproceduresexpresspurposeistomeetthedocumented
informationrequirementsofthestandard.

Aprocedureforcalibrationandmeasurementsystemsanalysis(MSA)wouldsimilarlyhaveaprimary
relationshipwith7.1.5,Monitoringandmeasuringresources,whileaprocedureforcontrolofquality
recordswouldhaveonlyasupportingrelationshipwiththisrequirement.CalibrationandMSAwould
certainlygeneratequalityrecordsthatmustberetained,madereadilyavailable,andprotectedfromloss,
buttheprocedureforqualityrecordscannotpossiblyfulfilltherequirementsfor7.1.5byitself.Itcanonly
support7.1.5bypreservingthequalityrecordsthatshowthatgaugesandinstrumentswereinfact
calibrated,andthatrequiredgaugereproducibilityandrepeatabilityanalysiswereinfactperformed.This
meansthat,ifweareusingtheconformitymatrixtoidentifygapsbetweentheQMSandthestandard,a
supportingrelationshipalonedoesnotmeettherequirements.

Figure1showsasampleconformitymatrixwithgeneralproceduresandprocessesversusaportionofISO
9001:2015.ThecellsattherightareprogrammedtoaddtheXs,whichreflectaprocessorprocedurethat
meetstherequirementsofthestandard,anduseconditionalformattingtoturnthemredifnoXappears.S
(forsupport)doesnotcount.Asanexample,theQualityRecordsproceduresupports7.2(Competence)
byretainingrecordsoftraining,butitdoesntmakethetraininghappen.OnlywhenweaddtheTraining
procedureseffect(item9)dowegetanXintherowfor7.2andtherebymeettherequirement.This
procedurewouldalmostcertainlyrequiretheorganizationtoretainarecordoftheemployeestrainingwith
therecordretentionperiodspecifiedintheQualityRecordsprocedure.

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3/11/2017 UsingaConformityMatrixtoAlignProcessestoISO9001:2015

Figure1:Aconformitymatrixasavisualcontrol.Clickhereforlargerimage.

Thegoodthingabouttheconformitymatrixisthatiteliminatestheneedtowriteanewqualitymanual
everytimeISO9001isrevised.Itsonlynecessarytocreateanewconformitymatrixthatreflectsthenew
standardsrequirements,andcrossreferencetheexistingQMSaccordingly.Theproceduresandprocesses
canalsobehyperlinkedtotheactualdocumentsoanyauditor,oranybodyelse,canseethedocumentand
verifythatitdoes,infact,meettheindicatedclausesofthestandard.Thisturnstheconformitymatrixinto
avisualcontrolthatmakesgapsimmediatelyvisibleandalsodirectstheusertothenecessaryinformation
withoutmakingthemsearchforit.Theonlycaveatisthatanychangetoadocumentedprocessor
procedurerequiresareviewtoreflectanychangeinthatprocessorproceduresroleinreferencetothe
standard.

Notealsothatacommentcanbeaddedtoanycellbyrightclickingonit,e.g.toprovideasmallamountof
detailonhowtheprocessorproceduredeploystheISOclause.

Thestakeholdermatrix
Anotherusefultoolisthestakeholdermatrix,whichtiesindirectlywithclause4.2Understandingthe
needsandexpectationsofinterestedparties.Thisclauserequirestheorganizationtodeterminethe
requirementsofinterestedpartiesthatarerelevanttothequalitymanagementsystem.Notallinterested
partiesarerelevant,andthestakeholdermatrixmakesthisemphaticallyclear.Whenstakeholders(or
interestedparties)oflittleornoimportanceexercisesignificantinfluence,wehaveahighly
dysfunctionalsituationinwhichthetailisallowedtowagthedog.AcommentatoronSunTzusArtof
War(OxfordUniversityPress,1963)describedthissituationasfollows.Anditissaidonemustconsult
theArmySupervisorinthesematters!Thisisasifinbuildingahousebesidetheroadonetookadvice
fromthosewhopassby.Ofcoursetheworkwouldneverbecompleted!TheVictoriaStateGovernment
referencedefinessimilarlythehighinfluencebutlowimportancestakeholdersasasourceofsignificant
risk.

Conclusion

ThebadnewsisthattherealdeadlineforISO9001:2015ismuchsoonerthanSept.22,2018,becausethe
organizationmustcompleteaninternalauditandmanagementreviewpriortoanauditbyaregistrar.The

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3/11/2017 UsingaConformityMatrixtoAlignProcessestoISO9001:2015

goodnewsisthatfewrealchangesneedtobemadetoexistingqualitysystemstoalignthemwiththenew
standard,butnowisnottoosoontobegin.

AboutTheAuthor

WilliamA.Levinson

WilliamA.Levinson,P.E.,istheprincipalofLevinsonProductivitySystemsP.C.HeisanASQFellow,a
certifiedqualityengineer,qualityauditor,qualitymanager,reliabilityengineer,andSixSigmaBlackBelt.
LevinsonistheauthorofHenryFordsLeanVision:EnduringPrinciplesfromtheFirstFordMotorPlant
(ProductivityPress,2002).HeholdsdegreesinchemistryandchemicalengineeringfromPennStateand
CornellUniversities,andnightschooldegreesinbusinessadministrationandappliedstatisticsfrom
UnionCollege.

2017QualityDigest.CopyrightoncontentheldbyQualityDigestorbyindividualauthors.Contact
QualityDigestforreprintinformation.
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SourceURL(retrievedon03/11/2017):http://www.qualitydigest.com/inside/standardsarticle/112116
usingconformitymatrixalignprocessesiso90012015.html

Links:
[1]http://asq.org/learnaboutquality/newmanagementplanningtools/overview/matrixdiagram.html#L
[2]http://www.qualitycouncil.com/CQE.html
[3]
/IQedit/Images/Articles_and_Columns/2016/November_2016/Levinson/working_clip_image002_0000%20
%20Copy.jpg
[5]http://www.dse.vic.gov.au/effectiveengagement/toolkit/toolstakeholderanalysisstakeholdermatrix
[6]https://www.amazon.com/ArtWarSunTzu/dp/0195015401

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