InternationalOrganizationforStandardization

BIBCII,ChemindeBlandonnet8,CP401,1214Vernier,Geneva,Switzerland
Tel:+41227490111,Web:www.iso.org

THEPROCESSAPPROACHINISO9001:2015
Purposeofthispaper

ThepurposeifthispaperistoexplaintheprocessapproachinISO9001:2015.Theprocess
approachcanbeappliedtoanyorganizationandanymanagementsystemregardlessoftype,
sizeorcomplexity.

Whatistheprocessapproach?

Allorganizationsuseprocessestoachievetheirobjectives.

Aprocess:

setofinterrelatedorinteractingactivitiesthatuseinputstodeliveranintendedresult

NOTE:Inputsandoutputsmaybetangible(e.g.materials,componentsorequipment)or
intangible(e.g.data,informationorknowledge).

Theprocessapproachincludesestablishingtheorganizationsprocessestooperateasan
integratedandcompletesystem.

Themanagementsystemintegratesprocessesandmeasurestomeetobjectives
Processesdefineinterrelatedactivitiesandchecks,todeliverintendedoutputs
Detailedplanningandcontrolscanbedefinedanddocumentedasneeded,depending
ontheorganizationscontext.

Riskbasedthinking,PDCAandtheprocessapproach

ThesethreeconceptstogetherformanintegralpartoftheISO9001:2015standard.Risksthatmay
impactonobjectivesandresultsmustbeaddressedbythemanagementsystem.Riskbasedthinking

isusedthroughouttheprocessapproachto:

Decidehowrisk(positiveornegative)isaddressedinestablishingtheprocessesto
improveprocessoutputsandpreventundesirableresults
Definetheextentofprocessplanningandcontrolsneeded(basedonrisk)
improvetheeffectivenessofthequalitymanagementsystem
maintainandmanageasystemthatinherentlyaddressesriskandmeetsobjectives
ISO/TC 176/SC 2/N1289

www.iso.org/tc176/sc02/public


PDCAisatoolthatcanbeusedtomanageprocessesandsystems.PDCAstandsfor:

P Plan:settheobjectivesofthesystemandprocessestodeliverresults(Whattodo
andhowtodoit)
D Do:implementandcontrolwhatwasplanned
C Check:monitorandmeasureprocessesandresultsagainstpolicies,objectivesand
requirementsandreportresults
A Act:takeactionstoimprovetheperformanceofprocesses

PDCAoperatesasacycleofcontinualimprovement,withriskbasedthinkingateachstage.

Whatarethepossiblebenefits?

Afocusonthemoreimportant(highrisk)processesandtheiroutputs
improvedunderstanding,definitionandintegrationofinterdependentprocesses
systematicmanagementofplanning,implementation,checksandimprovementof
processesandthemanagementsystemasawhole.
betteruseofresourcesandincreasedaccountability
moreconsistentachievementofthepoliciesandobjectives,intendedresultsand
overallperformance
processapproachcanfacilitatetheimplementationofanymanagementsystem
enhancedcustomersatisfactionbymeetingcustomerrequirements
enhancedconfidenceintheorganization.

ThepracticalstepsinusingaprocessapproachinISO9001:2015areexplainedbelowin
AppendixA.

Otherusefuldocuments

ISO9001:2015TheProcessApproach
(apowerpointpresentationonwww.io.org/tc176/sc02/public)

ISO/TC 176/SC 2/N1289

www.iso.org/tc176/sc02/public

AppendixA

TheprocessapproachinISO9001:2015

InaccordancewiththerequirementsofISO9001thefollowingsequenceofactionsprovides
examplesofhowanorganizationmaychoosetobuildandcontroltheprocessesofitsquality
managementsystem.PerformancecanbemanagedandimprovedbyapplyingthePlanDoCheck
Act(PDCA)cycle.Thisappliesequallytothesystemasawhole,toindividualprocessesandto
operationalactivities.

Stepsinthe
process
approach

Whattodo?

Guidance

PLAN
Definethe
contextofthe
organization

Theorganization
shouldidentifyits
responsibilities,the
relevantinterested
partiesandtheir
relevant
requirements,needs
andexpectationsto
definethe
organizations
intendedpurpose.

Gather,analyzeanddetermineexternalandinternal
responsibilitiesoftheorganizationtosatisfytherelevant
requirements,needsandexpectationsoftherelevant
interestedparties.Monitororcommunicatefrequentlywith
theseinterestedpartiestoensurecontinualunderstanding
oftheirrequirements,needsandexpectations.

Definethe
scope,
objectivesand
policiesofthe
organization

Basedontheanalysis
oftherequirements,
needsand
expectations
establishthescope,
objectivesand
policiesthatare
relevantforthe
organizationsquality
managementsystem.

Theorganizationshalldeterminethescope,boundariesand
applicabilityofitsmanagementsystemtakinginto
considerationtheinternalandexternalcontextand
interestedpartyrequirements.Decidewhichmarketsthe
organizationshouldaddress.Topmanagementshouldthen
establishobjectivesandpoliciesforthedesiredoutcomes.

Determinethe
processesin
the
organization

Determinethe
processesneededto
meettheobjectives
andpoliciesandto
producetheintended
outputs.

Managementshalldeterminetheprocessesneededfor
achievingtheintendedoutputs.Theseprocessesinclude
management,resources,operations,measurement,analysis
andimprovement.

ISO/TC 176/SC 2/N1289

www.iso.org/tc176/sc02/public

Determinethe
sequenceof
theprocesses

Determinehowthe
processesflowin
sequenceand
interaction.

Definepeople Assignresponsibility
orremitswho andauthorityfor
takeprocess
eachprocess.
ownershipand
accountability

ISO/TC 176/SC 2/N1289

Defineanddescribethenetworkofprocessesandtheir
interaction.Considerthefollowing:
Theinputsandoutputsofeachprocess(whichmaybe
internalorexternal).
Processinteractionandinterfacesonwhichprocesses
dependorenable.
Optimumeffectivenessandefficiencyofthesequence.
Riskstotheeffectivenessofprocessinteraction.
Note:Asanexample,realizationprocesses(suchasthose
neededtoprovidetheproductsorservicesdeliveredtoa
customer)willinteractwithotherprocesses(suchasthe
management,measurement,procurementintheprovision
ofresources).
Processsequencesandtheirinteractionsmaybedeveloped
usingtoolssuchasmodeling,diagrams,matricesand
flowcharts.
TopManagementshouldorganizeanddefineownership,
accountability,individualroles,responsibilities,working
groups,remits,authorityandensurethecompetence
neededfortheeffectivedefinition,implementation,
maintenanceandimprovementofeachprocessandits
interactions.Suchindividualsorremitsareusuallyreferred
toastheProcessOwners.

Tomanageprocessinteractionsitmaybeusefultoalso
establishamanagementsystemteamthathasasystem
overviewacrossalltheprocessesandmayinclude
representativesfromtheinteractingprocessesand
functions.

www.iso.org/tc176/sc02/public

Definethe
needfor
documented
information

Determinethose
processesthatneed
tobeformally
definedandhowthey
aretobe
documented.

Processesexistwithintheorganization.Theymaybeformal
orinformal.Thereisnocatalogueorlistofprocessesthat
havetobeformallydefined.Theorganizationshould
determinewhichprocessesneedtobedocumentedonthe
basisofriskbasedthinking,including,forexample:
Thesizeoftheorganizationanditstypeofactivities.
Thecomplexityofitsprocessesandtheirinteractions.
Thecriticalityoftheprocesses.
Theneedforformallyaccountabilityofperformance.

Processescanbeformallydocumentedusinganumberof
methodssuchasgraphicalrepresentations,userstories,
writteninstructions,checklists,flowcharts,visualmediaor
electronicmethodsincludinggraphicsandsystemization.
However,themethodorthetechnologychosenarenotthe
goals.Theycanbeusedtodescribeprocesses,whicharethe
meanstoachievethegoals.Effectiveandorganized
processescanthendeliverconsistentandaccountable
operationsandthedesiredobjectivesandresultswhichcan
thenbeimproved.
Note:FormoreguidanceseetheISO9000Introductionand
SupportPackagemoduleGuidanceontheDocumented
InformationRequirementsofISO9001:2015

Definethe
interfaces,risks
andactivities
withinthe
process

Determinethe
activitiesneededto
achievetheintended
outputsofthe
processandrisksof
unintendedoutputs.

Definetherequiredoutputsandinputsoftheprocess.
Determinetheriskstoconformityofproducts,servicesand
customersatisfactionifunintendedoutputsaredelivered.
Determinetheactivities,measuresandinherentcontrols
requiredtotransformtheinputsintothedesiredouputs.
Determineanddefinethesequenceandinteractionofthe
activitieswithintheprocess.
Determinehoweachactivitywillbeperformed.
Ensurethatthemanagementsystemasawholetakes
accountofallmaterialriskstotheorganizationandusers.
Note:Insomecasesthecustomermayspecifyrequirements
notonlyfortheoutputsbutalsofortherealizationofa
process.

Definethe
monitoringand
measurement
requirements

Determinewhereand
howmonitoringand
measuringshouldbe
applied.Thisshould
bebothforcontrol
andimprovementof
theprocessesandthe
intendedprocess
outputs.
Determinetheneed
forrecordingresults.

Identifythevalidationnecessarytoassureeffectivenessand
efficiencyoftheprocessesandsystem.Takeintoaccount
suchfactorsas:
Monitoringandmeasuringcriteria.
Reviewsofperformance
Interestedpartiessatisfaction.
Supplierperformance.
Ontimedeliveryandleadtimes.
Failureratesandwaste.
Processcosts.
Incidentfrequency.
Othermeasuresofconformitywithrequirements.

ISO/TC 176/SC 2/N1289

www.iso.org/tc176/sc02/public


DO
Implement

Implementactions
necessarytoachieve
plannedactivitiesand
results.

Theorganizationshouldperformactivities,monitoring,
measuresandcontrolsofdefinedprocessesandprocedures
(whichmaybeautomated),outsourcingandothermethods
necessarytoachieveplannedresults.

Definethe
resources
needed

Determinethe
resourcesneededfor
theeffective
operationofeach
process.

Examplesofresourcesinclude:
Humanresources.
Infrastructure.
Environment.
Information.
Naturalresources(includingknowledge).
Materials.
Financialresources.

CHECK
Verifythe
processagainst
itsplanned
objectives

Confirmthatthe
processiseffective
andthatthe
characteristicsofthe
processesare
consistentwiththe
purposeofthe
organization.

ISO/TC 176/SC 2/N1289

Theorganizationshouldcompareoutputsagainstobjectives
toverifythatalltherequirementsaresatisfied.
Processesareneededtogatherdata.Examplesinclude
measurement,monitoring,reviews,auditsandperformance
analysis.

www.iso.org/tc176/sc02/public


ACT

Improvement

Changethe
processestoensure
thattheycontinueto
delivertheintended
outputs

Actonthefindingstoensureimprovementofprocess
effectiveness.(NOTE:Organizationsmayalsowishto
improveprocessefficiency,thoughitisnotarequirementof
ISO9001todoso).

Correctiveactionasaresultofprocessfailureshouldinclude
theidentificationandeliminationoftherootcausesofthe
problems.SystemThinkingrecognizesthataneventinone
processmayhaveacauseoreffectinadependentprocess.
Causesandtheeffectsmaynotbewithinthesameprocess.

Problemsolvingandimprovementtypicallyfollowsthe
essentialstepsof:

definetheproblemsorobjectives
collectandanalyzethedataontheproblemand
relevantprocesses
selectandimplementthepreferredsolutions
evaluatetheeffectivenessofthesolutions.
incorporatethesolutionsintotheroutine

Evenwhenplannedprocessoutputsarebeingachievedand
requirementsfulfilled,theorganizationshouldstillseekto
improveprocessperformance,customersatisfactionand
reputation.Thiscanbeachieved,forexample,bysmallstep
continualimprovement(Kaizen),breakthrough
improvementsand/orbyinnovation.

ISO/TC 176/SC 2/N1289

www.iso.org/tc176/sc02/public