InternationalOrganizationforStandardization

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

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.
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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:

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a)Documentedinformationneededtobemaintainedbytheorganizationforthepurposesof
establishingaQMS(highleveltransversaldocuments).Theseinclude:
Thescopeofthequalitymanagementsystem(clause4.3).
Documentedinformationnecessarytosupporttheoperationofprocesses(clause4.4).
Thequalitypolicy(clause5.).
Thequalityobjectives(clause6.2).
Thisdocumentedinformationissubjecttotherequirementsofclause7.5.

b)Documentedinformationmaintainedbytheorganizationforthepurposeofcommunicating
theinformationnecessaryfortheorganizationtooperate(lowlevel,specificdocuments).See
4.4.AlthoughISO9001:2015doesnotspecificallyrequiresanyofthem,examplesofdocuments
thatcanaddvaluetoaQMSmayinclude:
Organizationcharts
Processmaps,processflowchartsand/orprocessdescriptions
Procedures
Workand/ortestinstructions
Specifications
Documentscontaininginternalcommunications
Productionschedules
Approvedsupplierlists
Testandinspectionplans
Qualityplans
Qualitymanuals
Strategicplans
Forms
Whereitexists,allsuchdocumentedinformation,isalsosubjecttotherequirementsclause
7.5.

c)Documentedinformationneededtoberetainedbytheorganizationforthepurposeof
providingevidenceofresultachieved(records).Theseinclude:
Documentedinformationtotheextentnecessarytohaveconfidencethatthe
processesarebeingcarriedoutasplanned(clause4.4).
Evidenceoffitnessforpurposeofmonitoringandmeasuringresources(clause7.1.5.1).
Evidenceofthebasisusedforcalibrationofthemonitoringandmeasurement
resources(whennointernationalornationalstandardsexist)(clause7.1.5.2).
Evidenceofcompetenceofperson(s)doingworkunderthecontroloftheorganization
thataffectstheperformanceandeffectivenessoftheQMS(clause7.2).
Resultsofthereviewandnewrequirementsfortheproductsandservices(clause
8.2.3).
Recordsneededtodemonstratethatdesignanddevelopmentrequirementshavebeen
met(clause8.3.2)
Recordsondesignanddevelopmentinputs(clause8.3.3).
Recordsoftheactivitiesofdesignanddevelopmentcontrols(clause8.3.4).
Recordsofdesignanddevelopmentoutputs(clause8.3.5).
Designanddevelopmentchanges,includingtheresultsofthereviewandthe
authorizationofthechangesandnecessaryactions(clause8.3.6).
Recordsoftheevaluation,selection,monitoringofperformanceandreevaluationof
externalprovidersandanyandactionsarisingfromtheseactivities(clause8.4.1)
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Evidenceoftheuniqueidentificationoftheoutputswhentraceabilityisarequirement
(clause8.5.2).
Recordsofpropertyofthecustomerorexternalproviderthatislost,damagedor
otherwisefoundtobeunsuitableforuseandofitscommunicationtotheowner
(clause8.5.3).
Resultsofthereviewofchangesforproductionorserviceprovision,thepersons
authorizingthechange,andnecessaryactionstaken(clause8.5.6).
Recordsoftheauthorizedreleaseofproductsandservicesfordeliverytothecustomer
includingacceptancecriteriaandtraceabilitytotheauthorizingperson(s)(clause8.6).
Recordsofnonconformities,theactionstaken,concessionsobtainedandthe
identificationoftheauthoritydecidingtheactioninrespectofthenonconformity
(clause8.7).
ResultsoftheevaluationoftheperformanceandtheeffectivenessoftheQMS(clause
911)
Evidenceoftheimplementationoftheauditprogrammeandtheauditresults(clause
9.2.2).
Evidenceoftheresultsofmanagementreviews(clause9.3.3).
Evidenceofthenatureofthenonconformitiesandanysubsequentactionstaken
(clause10.2.2).;
Resultsofanycorrectiveaction(clause10.2.2).

Organizationsarefreetodevelopotherrecordsthatmaybeneededtodemonstrate
conformityoftheirprocesses,productsandservicesandqualitymanagementsystem.
Wheretheyexists,allsuchrecordsarealsosubjecttotherequirementsclause7.5.

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:
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AnorganizationwithanexistingQMSshouldnotneedtorewriteallofitsdocumented
informationinordertomeettherequirementsofISO9001:2015.Thisisparticularly
trueifanorganizationhasstructureditsQMSbasedonthewayiteffectivelyoperates,
usingaprocessapproach.
Anorganizationmaybeabletocarryoutsomesimplificationand/orconsolidationof
existingdocumentedinformationinordertosimplifyitsQMS.

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.

ISO/TC 176/SC2/N1286

www.iso.org/tc176/sc02/public