International Organization for Standardization

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ImplementationGuidanceforISO9001:2015

CONTENTS

1.0 INTRODUCTION

2.0 BACKGROUNDONISO9001:2015REVISIONPROCESS

3.0USERGROUPS

4.0 IMPLEMENTATIONGUIDANCE

4.1 GENERICGUIDANCE

4.2 SPECIFICGUIDANCETOUSERGROUPS

5.0 FREQUENTLYASKEDQUESTIONS

6.0 AUTHENTICITYOFINFORMATIONREGARDINGISO9001:2015

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IMPLEMENTATION GUIDANCE FOR ISO 9001:2015

1.INTRODUCTION

ThisImplementationGuidancehasbeendevelopedtoassistusersinunderstandingtheissues
thatneedtobeconsideredduringthecoexistenceperiodbetweenISO9001:2008andISO
9001:2015.

Awidediffusionofthisimplementationguidanceisrecommended,inparticularthecomparison
tablebetweenISO9001:2008andISO9001:2015matrixshowingthecorrelationbetweenthe
clausesoftheseinternationalstandardscanbefoundonthewww.iso.org/tc176/sc02/public
website.

TherevisionofISO9001:2015introducesanew10clausestructure,manynewrequirementsand
manyterms.Userswillneedtotakeintoconsiderationthatchangesmaybenecessarytotheir
QMS.

2.BACKGROUNDTOTHEISO9001:2015REVISIONPROCESS

InordertoassistorganizationstohaveafullunderstandingofthenewISO9001:2015,itmaybe
usefultohaveaninsightontherevisionprocess,howthisrevisionreflectstheinputsreceived
fromusersofthestandard,andtheconsiderationgiventobenefitsandimpactsduringits
development.

Priortothecommencementofarevision(oramendment)toamanagementsystemstandard,a
JustificationStudyispreparedtopresentacasefortheproposedprojectwhichoutlinesdetails
ofthedataandinputsusedtosupportitsarguments.InrelationtothedevelopmentofISO
9001:2015userneedswereidentifiedfromthefollowing:
ISOAnnexSLprovidesacommonstructure,text,termsanddefinitionsformanagement
systemstandards.
theresultsofaformalSystematicReviewonISO9001:2008thatwasperformedbythe
membersofISO/TC176/SC2
feedbackfromtheISO/TC176/SC2WorkingGrouponInterpretations
anextensiveworldwideUserFeedbackSurveyonISO9001wasperformedbyISO/TC
176/SC2

TheJustificationStudyidentifiedtheneedforarevisionto:
adapttoachangingworld
enhanceanorganization'sabilitytosatisfyitscustomers
provideaconsistentfoundationforthefuture
reflecttheincreasinglycomplexenvironmentsinwhichorganizationsoperate
ensurethenewstandardreflectstheneedsofallrelevantinterestedparties
alignwithothermanagementsystems

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IMPLEMENTATION GUIDANCE FOR ISO 9001:2015

ThekeyfocusesoftheISO9001:2015revisionweretoenhanceclarityandcompatibilitywith
othermanagementsystemstandards.

ThebenefitsidentifiedfortheISO9001:2015edition:
Providesclarity
Enhancedleadershipinvolvementinthemanagementsystem
Riskbasedthinking
Simplifiedlanguage,commonstructureandterms
AligningQMSpolicyandobjectiveswiththestrategyoftheorganization

3.USERGROUPS

3.1IndividualorganizationsusingISO9001(includingindustryassociations)

a)CurrentUsersofISO9001:2008
ThisusergroupisdefinedashavingcompletedorbeingintheprocessofimplementingISO
9001:2008,regardlessofwhethertheyarecertifiedornot,orwhethertheyintendtobecertified
ornot.

b)NewUsers
ANewUserisdefinedasanorganisationthatiseitherbeginningtouseISO9001:2008orISO
9001:2015forthefirsttimeorisapotentialuserofthestandardinthefuture.

c)UsersofIndustrySectorSchemesbasedonISO9001:2015
TheseusergroupsaredefinedasthoseusingqualitymanagementsystemprogramsbasedonISO
9001:2015thatincludeadditionalrequirements,thateithercanbecertifiedoraccreditedunder
theguidanceofaparticularIndustrySectorScheme(e.g.ISO/TS16949Qualitysystems
Automotivesuppliers).

3.2Otherusergroups

Thesearedefinedasbeing:
a)NationalStandardsBodies(NSBs)
b)AccreditationBodies(ABs)
c)Certification/RegistrationBodies(CB/RBs)
d)TrainersandConsultants

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IMPLEMENTATION GUIDANCE FOR ISO 9001:2015

4.IMPLEMENTATIONGUIDANCE

4.1Genericguidance

AllusersgroupsarestronglyadvisedtonotetheIAFsInformativeDocumentID9:2015(see:
http://www.iaf.nu/upFiles/IAFID9Transition9001PublicationVersion.pdf)forimplementation
ofaccreditedcertificationtoISO9001:2015,whichdetailstheagreedimplementationplan
foraccreditedcertificationasfollows:

AccreditedcertificationtoISO9001:2015shallnotbegranteduntilthepublicationof
ISO9001:2015asanInternationalStandard.
CertificationofconformitytoISO9001:2015and/ornationalequivalentsshallonlybe
issuedafterofficialpublicationofISO9001:2015(whichshouldtakeplacebeforetheend
of2015)andafteraroutinesurveillanceorrecertificationauditagainstISO9001:2015.

ValidityofcertificationstoISO9001:2008
ISO9001:2008certificationswillnotbevalidafterthreeyearsfrompublicationofISO
9001:2015.
TheexpirydateofcertificationstoISO9001:2008issuedduringthetransitionperiod
needstocorrespondtotheendofthethreeyeartransitionperiod.

Figure1ImplementationtimetableforISO9001:2015,forallusergroups

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IMPLEMENTATION GUIDANCE FOR ISO 9001:2015

TobenefitfromthechangesintroducedintoISO9001:2015,users(fromallusergroups)should
notetherecommendationsgiveninthetablebelow.Recommendationsforspecificusergroups
aregiveninsection4.2furtherdown.

Togetacquaintedwiththeneweditionofthestandarduse
thefollowingresources:
AnnexA(informative)Newstructure,conceptsand
terminology

Supportmaterialfoundat
www.iso.org/tc176/sc02/public:
ISO9001:2015ChangeSummary
CorrelationmatricesbetweenISO9001:2008andISO
9001:2015,whichprovidesabeforeandafterviewof
theclauses
RiskBasedThinking
ProcessApproach
Determinetheimpactofthechangesofthenewversionon
yourcurrentuseofISO9001andplananynecessary
remedialactions.

UsethePlanDoCheckActmethodologytomanagethe
implementation.

Notethattheactionsmayneedtovaryaccordingtoyour
usergroup(see4.2below).

4.2 Guidanceforspecificusergroups
Theserecommendationscomplementthegenericguidancetoallusergroupsgiveninsection3.0
above.

4.2.1 OrganizationsusingISO9001:2008

a)Currentusers
OrganisationsthatarealreadycertifiedtoISO9001:2008shouldcontacttheir
certification/registrationbodies(CB/RB)toagreeaprogramforanalysingtheclarificationsinISO
9001:2015inrelationtotheirindividualqualitymanagementsystemsandforupgradingtheir
certificates.

CertifiedorganizationsshouldbearinmindthatISO9001:2008certificateshavethesamestatus
asnewISO9001:2015certificatesduringthecoexistenceperiod.

OrganizationsintheprocessofcertificationtoISO9001:2008shouldchangetousingISO
9001:2015andapplyforcertificationtoit.

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IMPLEMENTATION GUIDANCE FOR ISO 9001:2015

b)Newusers
NewusersshouldstartbyusingISO9001:2015.

c)IndustrySectorSchemes
Usersofspecificsectorschemesarerecommendedtorefertotheorganizationthatis
responsiblethatsectorscheme,e.g.for:
ISO/TS16949refertotheIATF(www.iatfglobaloversight.org)
TL9000refertotheQuESTForum(www.questforum.org)
AS9100/EN9100refertoIAQG(www.iaqg.org)

4.2.2 NationalStandardsBodies

Informationregardingthe2015editionofISO9001shouldbecommunicatedtostandardusers,
inatimelymanner,bythenationalstandardsbodies(NSBs).ItisrecommendedthatNSBactions
besynchronizedwiththeinformationflowsfromISOandISO/TC176/SC2.

NSBsareresponsible,atanationallevel,forcommunicatingtheissuesregardingthechanges
fromISO9001:2008toISO9001:2015toallinterestedpartiesandforprovidingtranslationsof
theneweditionofthestandardintheirnationallanguages.Itisrecommendedthatthey
coordinatetheircommunicationsregardingtheseissueswithotherlocalinterestedparties(for
example:ABs,CB/RBs,professionalqualityassociations,etc.).

TranslationIssuesIfarequirementfortranslationofthenewstandardsexists,thetranslation
processshouldbestartedasearlyaspossible,inordertoprovidetheequivalentnationaledition
assoonaspossible.

AnNSBshouldanalyseifthereareinterpretationproblemsinthenationalISO9001:2008version
duetoformertranslationproblems.InaffirmativecasestheNSBshouldcarryoutanextensive
translationofthestandard.Ifinterpretationdivergencesstillremain,theNSBisrecommendedto
applyforclarificationtotheISO/TC176/SC2InterpretationsWorkingGroupusingthe
establishedInterpretationsprocess(see:www.iso.org/tc176/sc02/public).

4.2.4 AccreditationBodies

ABsshouldrefertotheIAFsInformativeDocumentID9:2015fortheimplementationof
accreditedcertificationtoISO9001:2015(see4.1above).

4.2.5 CertificationBodies

CBsshouldrefertotheIAFsInformativeDocumentID9:2015fortheimplementationof
accreditedcertificationtoISO9001:2015(see4.1above).

CBsshouldrememberthatcertificatesofconformitytoISO9001:2015and/oritsnational
equivalentadoptionscanonlybeissuedaftertheofficialpublicationoftheamendedstandard.

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IMPLEMENTATION GUIDANCE FOR ISO 9001:2015

Itisimportantthataccreditedcertificationbodiesensurethattheirauditorsareawareofthe
clarificationsintroducedinISO9001:2015,andtheirimplications,priortoconductingauditsto
thatstandard.

4.2.6 TrainingBodiesandConsultants

AlltrainersandconsultantsshouldbeawareoftheclarificationsinISO9001:2015.Alltraining
bodiesandconsultantsarerecommendedtodeterminetheneedforupdatingtrainingprograms
anddocumentation,oranyotherchangesnecessary,totheservicestheyprovide.

5.0 FREQUENTLYASKEDQUESTIONS

WhilethisImplementationGuidanceprovidesrecommendationsonanumberofissuesfacing
thedifferentusergroupsduringthecoexistenceperiod,itdoesnotaddressmoregeneral
questionsabouttheISO9000standards.InsteadISO/TC176/SC2haspreparedasetof
frequentlyaskedquestions(FAQs)toprovidesuchadvice.

ItisexpectedthattheFAQswillbeupdatedonamoreregularbasisthanthisImplementation
Guidance.ForthelatestversionoftheFAQs,referenceshouldbemadetotheopenaccessweb
siteatwww.iso.org/tc176/sc02/public.

6.0 AUTHENTICITYOFINFORMATIONREGARDINGISO9001:2015

ThefirstpointofcontactforinformationregardingtherequirementsofISO9001:2015shouldbe
yourNationalStandardsBody(foralistingofISOsmemberNationalStandardsBodies,see
www.iso.org/iso/about/iso_members.htm).

Otherrecommendedsourcesofinformationare:

ISOswebsitewww.iso.orgprovidesgeneralinformationregardingtheISO9001:2015
revisionprogramme(aswellasdetailsofitsmemberNationalStandardsBodies).

TheISO/TC176/SC2website,www.iso.org/tc176/sc02/publicprovidesdetailedinformation
ontheISO9001revisionprogramandisupdatedonaregularbasis.

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