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 Whattodo? Guidance

process
approach

PLAN

Definethe Theorganization Gather,analyzeanddetermineexternalandinternal

contextofthe shouldidentifyits responsibilitiesoftheorganizationtosatisfytherelevant
organization responsibilities,the requirements,needsandexpectationsoftherelevant
relevantinterested interestedparties.Monitororcommunicatefrequentlywith
partiesandtheir theseinterestedpartiestoensurecontinualunderstanding
relevant oftheirrequirements,needsandexpectations.
requirements,needs
andexpectationsto
definethe
organizations
intendedpurpose.

Definethe Basedontheanalysis Theorganizationshalldeterminethescope,boundariesand

scope, oftherequirements, applicabilityofitsmanagementsystemtakinginto
objectivesand needsand considerationtheinternalandexternalcontextand
policiesofthe expectations interestedpartyrequirements.Decidewhichmarketsthe
organization establishthescope, organizationshouldaddress.Topmanagementshouldthen
objectivesand establishobjectivesandpoliciesforthedesiredoutcomes.
policiesthatare
relevantforthe
organizationsquality
managementsystem.
Determinethe Determinethe Managementshalldeterminetheprocessesneededfor
processesin processesneededto achievingtheintendedoutputs.Theseprocessesinclude
the meettheobjectives management,resources,operations,measurement,analysis
organization andpoliciesandto andimprovement.
producetheintended
outputs.

ISO/TC 176/SC 2/N1289 www.iso.org/tc176/sc02/public

 Defineanddescribethenetworkofprocessesandtheir
interaction.Considerthefollowing:
Determinethe Determinehowthe
Theinputsandoutputsofeachprocess(whichmaybe
sequenceof processesflowin
internalorexternal).
theprocesses sequenceand
interaction. Processinteractionandinterfacesonwhichprocesses
dependorenable.
Optimumeffectivenessandefficiencyofthesequence.
Riskstotheeffectivenessofprocessinteraction.
Note:Asanexample,realizationprocesses(suchasthose
neededtoprovidetheproductsorservicesdeliveredtoa
customer)willinteractwithotherprocesses(suchasthe
management,measurement,procurementintheprovision
ofresources).
Processsequencesandtheirinteractionsmaybedeveloped
usingtoolssuchasmodeling,diagrams,matricesand
flowcharts.

Definepeople Assignresponsibility TopManagementshouldorganizeanddefineownership,

orremitswho andauthorityfor accountability,individualroles,responsibilities,working
takeprocess eachprocess. groups,remits,authorityandensurethecompetence
ownershipand neededfortheeffectivedefinition,implementation,
accountability maintenanceandimprovementofeachprocessandits
interactions.Suchindividualsorremitsareusuallyreferred
toastheProcessOwners.

Tomanageprocessinteractionsitmaybeusefultoalso
establishamanagementsystemteamthathasasystem
overviewacrossalltheprocessesandmayinclude
representativesfromtheinteractingprocessesand
functions.

ISO/TC 176/SC 2/N1289 www.iso.org/tc176/sc02/public

 Definethe Determinethose Processesexistwithintheorganization.Theymaybeformal
needfor processesthatneed orinformal.Thereisnocatalogueorlistofprocessesthat
documented tobeformally havetobeformallydefined.Theorganizationshould
information definedandhowthey determinewhichprocessesneedtobedocumentedonthe
aretobe basisofriskbasedthinking,including,forexample:
documented. 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 Determinethe Definetherequiredoutputsandinputsoftheprocess.

interfaces,risks activitiesneededto Determinetheriskstoconformityofproducts,servicesand
andactivities achievetheintended customersatisfactionifunintendedoutputsaredelivered.
withinthe outputsofthe Determinetheactivities,measuresandinherentcontrols
process processandrisksof requiredtotransformtheinputsintothedesiredouputs.
unintendedoutputs. Determineanddefinethesequenceandinteractionofthe
activitieswithintheprocess.
Determinehoweachactivitywillbeperformed.
Ensurethatthemanagementsystemasawholetakes
accountofallmaterialriskstotheorganizationandusers.
Note:Insomecasesthecustomermayspecifyrequirements
notonlyfortheoutputsbutalsofortherealizationofa
process.

Definethe Determinewhereand Identifythevalidationnecessarytoassureeffectivenessand

monitoringand howmonitoringand efficiencyoftheprocessesandsystem.Takeintoaccount
measurement measuringshouldbe suchfactorsas:
requirements applied.Thisshould Monitoringandmeasuringcriteria.
bebothforcontrol Reviewsofperformance
andimprovementof Interestedpartiessatisfaction.
theprocessesandthe Supplierperformance.
intendedprocess Ontimedeliveryandleadtimes.
outputs. Failureratesandwaste.
Determinetheneed
Processcosts.
forrecordingresults.
Incidentfrequency.
Othermeasuresofconformitywithrequirements.

ISO/TC 176/SC 2/N1289 www.iso.org/tc176/sc02/public


DO

Implement Implementactions Theorganizationshouldperformactivities,monitoring,

necessarytoachieve measuresandcontrolsofdefinedprocessesandprocedures
plannedactivitiesand (whichmaybeautomated),outsourcingandothermethods
results. necessarytoachieveplannedresults.

Definethe Determinethe Examplesofresourcesinclude:

resources resourcesneededfor Humanresources.
needed theeffective Infrastructure.
operationofeach Environment.
process. Information.
Naturalresources(includingknowledge).
Materials.
Financialresources.

CHECK

Verifythe Confirmthatthe Theorganizationshouldcompareoutputsagainstobjectives

processagainst processiseffective toverifythatalltherequirementsaresatisfied.
itsplanned andthatthe Processesareneededtogatherdata.Examplesinclude
objectives characteristicsofthe measurement,monitoring,reviews,auditsandperformance
processesare analysis.
consistentwiththe
purposeofthe
organization.

ISO/TC 176/SC 2/N1289 www.iso.org/tc176/sc02/public


ACT

Improvement Changethe Actonthefindingstoensureimprovementofprocess

processestoensure effectiveness.(NOTE:Organizationsmayalsowishto
thattheycontinueto improveprocessefficiency,thoughitisnotarequirementof
delivertheintended ISO9001todoso).
outputs
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