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GuidanceontherequirementsforDocumentedInformation
ofISO9001:2015
1 Introduction
TwoofthemostimportantobjectivesintherevisionoftheISO9000seriesofstandardshavebeen:
a) todevelopasimplifiedsetofstandardsthatwillbeequallyapplicabletosmallaswellas
mediumandlargeorganizations,and
b) fortheamountanddetailofdocumentationrequiredtobemorerelevanttothedesired
resultsoftheorganizationsprocessactivities.
ISO9001:2015QualitymanagementsystemsRequirementshasachievedtheseobjectives,andthe
purposeofthisadditionalguidanceistoexplaintheintentofthenewstandardwithspecificregard
todocumentedinformation.
ISO9001:2015allowsanorganizationflexibilityinthewayitchoosestodocumentitsquality
managementsystem(QMS).Thisenableseachindividualorganizationtodeterminethecorrect
amountofdocumentedinformationneededinordertodemonstratetheeffectiveplanning,
operationandcontrolofitsprocessesandtheimplementationandcontinualimprovementofthe
effectivenessofitsQMS.
ItisstressedthatISO9001requires(andalwayshasrequired)aDocumentedquality
managementsystem,andnotasystemofdocuments.
2 Whatisdocumentedinformation?Definitionsandreferences
ThetermDocumentedinformationwasintroducedaspartofthecommonHighLevelStructure(HLS)
andcommontermsforManagementSystemStandards(MSS).
ThedefinitionofdocumentedinformationcanbefoundinISO9000clause3.8.
Documentedinformationcanbeusedtocommunicateamessage,provideevidenceofwhatwas
plannedhasactuallybeendone,orknowledgesharing.
Thefollowingaresomeofthemainobjectivesofanorganizationsdocumentedinformation
independentofwhetherornotithasimplementedaformalQMS;
a) CommunicationofInformation
- Asatoolforinformationtransmissionandcommunication.Thetypeandextentofthe
documentedinformationwilldependonthenatureoftheorganizationsproductsand
processes,thedegreeofformalityofcommunicationsystemsandthelevelof
communicationskillswithintheorganization,andtheorganizationalculture.
ISO/TC 176/SC2/N1286 www.iso.org/tc176/sc02/public
b) Evidenceofconformity
- Provisionofevidencethatwhatwasplannedhasactuallybeendone.
c) Knowledgesharing
d) Todisseminateandpreservetheorganizationsexperiences.Atypicalexamplewouldbea
technicalspecification,whichcanbeusedasabasefordesignanddevelopmentofanew
productorservice.
Alistofcommonlyusedtermsanddefinitionsrelatingtodocumentedinformationispresentedin
ISO9001:2015AnnexA.
Itmustbestressedthat,accordingtoISO9001:2015clause7.5.3Controlofdocumentedinformation
requirements,documentsmaybeinanyformortypeofmedium,andthedefinitionofdocument
inISO9000:2015clause3.8.5givesthefollowingexamples:
paper
magnetic
electronicoropticalcomputerdisc
photograph
mastersample
3 ISO9001:2015DocumentationRequirements
ISO9001:2015clause4.4Qualitymanagementsystemsanditsprocessesrequiresanorganizationto
maintaindocumentedinformationtotheextentnecessarytosupporttheoperationofprocessesand
retaindocumentedinformationtotheextentnecessarytohaveconfidentthattheprocessesare
beingcarriedoutasplanned.
Clause7.5.1Generalexplainsthatthequalitymanagementsystemdocumentationshallinclude:
a) documentedinformationrequiredbythisInternationalstandard;
b) documentedinformationdeterminedbytheorganizationasbeingnecessaryforthe
effectivenessofthequalitymanagementsystem
ThenoteafterthisClausemakeitclearthattheextentoftheQMSdocumentedinformationcan
differfromoneorganizationtoanotherduetothe:
a)sizeoforganizationanditstypeofactivities,processes,productsandservices;
b)complexityofprocessesandtheirinteractions,
c)competenceofpersons.
AllthedocumentedinformationthatformspartoftheQMShastobecontrolledinaccordancewith
clause7.5Documentedinformation.
4 GuidanceonClause7.5ofISO9001:2015
ThefollowingcommentsareintendedtoassistusersofISO9001:2015inunderstandingtheintentof
thegeneraldocumentedinformationrequirementsoftheInternationalStandard.Documented
informationcanreferto:
5 OrganizationspreparingtoimplementaQMS
FororganizationsthatareintheprocessofimplementingaQMS,andwishtomeettherequirements
ofISO9001:2015,thefollowingcommentsmaybeuseful.
Fororganizationsthatareintheprocessofimplementingorhaveyettoimplementa
QMS,ISO9001:2015emphasizesaprocessapproach.Thisincludes:
determiningtheprocessesnecessaryfortheeffectiveimplementationofthe
qualitymanagementsystem
determiningtheinteractionsbetweentheseprocesses.
documentingtheprocessestotheextentnecessarytoassuretheireffective
operationandcontrol.(Itmaybeappropriatetodocumenttheprocessesusing
processmappingtools.Itisemphasized,however,thatdocumentedprocess
mappingtoolsarenotarequirementofISO9001:2015).
Analysisoftheprocessesshouldbethedrivingforcefordefiningtheamountof
documentedinformationneededforthequalitymanagementsystem,takinginto
accounttherequirementsofISO9001:2015.Itshouldnotbethedocumented
informationthatdrivestheprocesses.
6 OrganizationswishingtoadaptanexistingQMS
FororganizationsthatcurrentlyhaveaQMSthefollowingcommentsareintendedtoassistin
understandingthechangestodocumentedinformationthatmayberequiredorfacilitatedbythe
transitiontoISO9001:2015:
7 DemonstratingconformitywithISO9001:2015
FororganizationswishingtodemonstrateconformitywiththerequirementsofISO9001:2015,for
thepurposesofcertification/registration,contractual,orotherreasons,itisimportanttoremember
theneedtoprovideevidenceoftheeffectiveimplementationoftheQMS.
Organizationsmaybeabletodemonstrateconformitywithouttheneedforextensive
documentedinformation
ToclaimconformitywithISO9001:2015,theorganizationhastobeabletoprovide
objectiveevidenceoftheeffectivenessofitsprocessesanditsqualitymanagement
system.Clause3.8.3ofISO9000:2015definesobjectiveevidenceasdatasupporting
theexistenceorverityofsomethingaandnotesthatobjectiveevidencemaybe
obtainedthroughobservation,measurement,test,orothermeans.
Objectiveevidencedoesnotnecessarilydependontheexistenceofdocumented
information,exceptwherespecificallymentionedinISO9001:2015.Insomecases,(for
example,inclause8.1(e)Operationalplanningandcontrol,itisuptotheorganization
todeterminewhatdocumentedinformationisnecessaryinordertoprovidethis
objectiveevidence.
Wheretheorganizationhasnospecificdocumentedinformationforaparticular
activity,andthisisnotrequiredbythestandard,itisacceptableforthisactivitytobe
conductedusingasabasistherelevantclauseofISO9001:2015.Inthesesituations,
bothinternalandexternalauditsmayusethetextofISO9001:2015forconformity
assessmentpurposes.