Quality management systems — Requirements Systèmes de management de la qualité — Exigences

INTERNATIONALSTANDARD

ISO9001

Fifth edition2015‐09‐15

Quality management systems—Requirements

Systèmesdemanagementdelaqualité—Exigences

Reference numberISO9001:2015(E)

©ISO 2015

ISO9001:2015(E)

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Contents Page

Foreword...........................................................................................................................................................................v

Introduction..................................................................................................................................................................vi

1 Scope...................................................................................................................................................................1

2 Normativereferences....................................................................................................................................1

3 Termsanddefinitions...................................................................................................................................1

4 Contextoftheorganization.........................................................................................................................14.1 Understandingtheorganizationanditscontext...................................................................................14.2 Understandingtheneedsandexpectationsofinterestedparties..................................................24.3 Determiningthescopeofthequalitymanagementsystem.............................................................24.4 Qualitymanagementsystemanditsprocesses.....................................................................................2

5 Leadership........................................................................................................................................................35.1 Leadershipandcommitment........................................................................................................................3

5.1.1 General..................................................................................................................................................35.1.2 Customerfocus...................................................................................................................................3

5.2 Policy.......................................................................................................................................................................45.2.1 Establishingthequalitypolicy....................................................................................................45.2.2 Communicatingthequalitypolicy.............................................................................................4

5.3 Organizationalroles,responsibilitiesandauthorities.........................................................................4

6 Planning.............................................................................................................................................................46.1 Actionstoaddressrisksandopportunities.............................................................................................46.2 Qualityobjectivesandplanningtoachievethem..................................................................................56.3 Planningofchanges...........................................................................................................................................5

7 Support...............................................................................................................................................................67.1 Resources...............................................................................................................................................................6

7.1.1 General..................................................................................................................................................67.1.2 People....................................................................................................................................................67.1.3 Infrastructure.....................................................................................................................................67.1.4 Environmentfortheoperationofprocesses.........................................................................67.1.5 Monitoringandmeasuringresources.......................................................................................77.1.6 Organizationalknowledge............................................................................................................7

7.2 Competence..........................................................................................................................................................87.3 Awareness.............................................................................................................................................................87.4 Communication...................................................................................................................................................87.5 Documentedinformation................................................................................................................................8

7.5.1 General..................................................................................................................................................87.5.2 Creatingandupdating.....................................................................................................................97.5.3 Controlofdocumentedinformation..........................................................................................9

8 Operation...........................................................................................................................................................98.1 Operationalplanningandcontrol................................................................................................................98.2 Requirementsforproductsandservices...............................................................................................10

8.2.1 Customercommunication..........................................................................................................108.2.2 Determiningtherequirementsforproductsandservices............................................108.2.3 Reviewoftherequirementsforproductsandservices..................................................108.2.4 Changestorequirementsforproductsandservices........................................................11

8.3 Designanddevelopmentofproductsandservices...........................................................................118.3.1 General...............................................................................................................................................118.3.2 Designanddevelopmentplanning.........................................................................................118.3.3 Designanddevelopmentinputs..............................................................................................118.3.4 Designanddevelopmentcontrols...........................................................................................128.3.5 Designanddevelopmentoutputs............................................................................................128.3.6 Designanddevelopmentchanges...........................................................................................12

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8.4 Controlofexternallyprovidedprocesses,productsandservices...............................................138.4.1 General...............................................................................................................................................138.4.2 Typeandextentofcontrol.........................................................................................................138.4.3 Informationforexternalproviders.........................................................................................13

8.5 Productionandserviceprovision.............................................................................................................148.5.1 Controlofproductionandserviceprovision......................................................................148.5.2 Identificationandtraceability..................................................................................................148.5.3 Propertybelongingtocustomersorexternalproviders...............................................158.5.4 Preservation.....................................................................................................................................158.5.5 Post‐deliveryactivities................................................................................................................158.5.6 Controlofchanges.........................................................................................................................15

8.6 Releaseofproductsandservices..............................................................................................................158.7 Controlofnonconformingoutputs...........................................................................................................16

9 Performanceevaluation............................................................................................................................169.1 Monitoring,measurement,analysisandevaluation.........................................................................16

9.1.1 General...............................................................................................................................................169.1.2 Customersatisfaction...................................................................................................................179.1.3 Analysisandevaluation...............................................................................................................17

9.2 Internalaudit....................................................................................................................................................179.3 Managementreview.......................................................................................................................................18

9.3.1 General...............................................................................................................................................189.3.2 Managementreviewinputs.......................................................................................................189.3.3 Managementreviewoutputs....................................................................................................18

10 Improvement.................................................................................................................................................1910.1 General.................................................................................................................................................................1910.2 Nonconformityandcorrectiveaction.....................................................................................................1910.3 Continualimprovement................................................................................................................................19

AnnexA(informative)Clarificationofnewstructure,terminologyandconcepts...............................21

AnnexB(informative)OtherInternationalStandardsonqualitymanagementandqualitymanagementsystemsdevelopedbyISO/TC176...............................................................................25

Bibliography................................................................................................................................................................28

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Foreword

ISO(theInternationalOrganizationforStandardization)isaworldwidefederationofnationalstandardsbodies (ISOmemberbodies).Theworkofpreparing InternationalStandards isnormally carriedoutthrough ISO technical committees. Eachmember body interested in a subject forwhich a technicalcommittee has been established has the right to be represented on that committee. Internationalorganizations, governmental and non‐governmental, in liaisonwith ISO, also take part in thework.ISO collaborates closely with the International Electrotechnical Commission (IEC) on allmatters ofelectrotechnicalstandardization.

The procedures used to develop this document and those intended for its furthermaintenance aredescribedintheISO/IECDirectives,Part1.InparticularthedifferentapprovalcriterianeededforthedifferenttypesofISOdocumentsshouldbenoted.ThisdocumentwasdraftedinaccordancewiththeeditorialrulesoftheISO/IECDirectives,Part2(seewww.iso.org/directives).

Attentionisdrawntothepossibilitythatsomeoftheelementsofthisdocumentmaybethesubjectofpatentrights.ISOshallnotbeheldresponsibleforidentifyinganyorallsuchpatentrights.DetailsofanypatentrightsidentifiedduringthedevelopmentofthedocumentwillbeintheIntroductionand/orontheISOlistofpatentdeclarationsreceived(seewww.iso.org/patents).

Anytradenameusedinthisdocumentisinformationgivenfortheconvenienceofusersanddoesnotconstituteanendorsement.

ForanexplanationonthemeaningofISOspecifictermsandexpressionsrelatedtoconformityassessment,aswellasinformationaboutISO’sadherencetotheWorldTradeOrganization(WTO)principlesintheTechnicalBarrierstoTrade(TBT)seethefollowingURL:www.iso.org/iso/foreword.html.

ThecommitteeresponsibleforthisdocumentisTechnicalCommitteeISO/TC176,Qualitymanagementandqualityassurance,SubcommitteeSC2,Qualitysystems.

Thisfiftheditioncancelsandreplacesthefourthedition(ISO9001:2008),whichhasbeentechnicallyrevised, throughtheadoptionofarevisedclausesequenceandtheadaptationof therevisedqualitymanagementprinciplesandofnewconcepts. It alsocancelsandreplaces theTechnicalCorrigendumISO9001:2008/Cor.1:2009.

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Introduction

1.1 General

Theadoptionofaqualitymanagementsystemisastrategicdecisionforanorganizationthatcanhelptoimproveitsoverallperformanceandprovideasoundbasisforsustainabledevelopmentinitiatives.

ThepotentialbenefitstoanorganizationofimplementingaqualitymanagementsystembasedonthisInternationalStandardare:

a) theabilitytoconsistentlyprovideproductsandservicesthatmeetcustomerandapplicablestatutoryandregulatoryrequirements;

b) facilitatingopportunitiestoenhancecustomersatisfaction;

c) addressingrisksandopportunitiesassociatedwithitscontextandobjectives;

d) theabilitytodemonstrateconformitytospecifiedqualitymanagementsystemrequirements.

ThisInternationalStandardcanbeusedbyinternalandexternalparties.

ItisnottheintentofthisInternationalStandardtoimplytheneedfor:

— uniformityinthestructureofdifferentqualitymanagementsystems;

— alignmentofdocumentationtotheclausestructureofthisInternationalStandard;

— theuseofthespecificterminologyofthisInternationalStandardwithintheorganization.

Thequalitymanagementsystemrequirementsspecified inthis InternationalStandardarecomplementarytorequirementsforproductsandservices.

ThisInternationalStandardemploystheprocessapproach,whichincorporatesthePlan‐Do‐Check‐Act(PDCA)cycleandrisk‐basedthinking.

Theprocessapproachenablesanorganizationtoplanitsprocessesandtheirinteractions.

ThePDCA cycle enables an organization to ensure that its processes are adequately resourced andmanaged,andthatopportunitiesforimprovementaredeterminedandactedon.

Risk‐basedthinkingenablesanorganizationtodeterminethefactorsthatcouldcauseitsprocessesanditsqualitymanagementsystemtodeviatefromtheplannedresults,toputinplacepreventivecontrolstominimizenegativeeffectsandtomakemaximumuseofopportunitiesastheyarise(seeClauseA.4).

Consistentlymeeting requirements and addressing futureneedsand expectationsposes a challengefororganizationsinanincreasinglydynamicandcomplexenvironment.Toachievethisobjective,theorganizationmightfinditnecessarytoadoptvariousformsofimprovementinadditiontocorrectionandcontinualimprovement,suchasbreakthroughchange,innovationandre‐organization.

InthisInternationalStandard,thefollowingverbalformsareused:

— “shall”indicatesarequirement;

— “should”indicatesarecommendation;

— “may”indicatesapermission;

— “can”indicatesapossibilityoracapability.

Informationmarkedas“NOTE”isforguidanceinunderstandingorclarifyingtheassociatedrequirement.

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1.2 Qualitymanagementprinciples

ThisInternationalStandardisbasedonthequalitymanagementprinciplesdescribedinISO9000.Thedescriptionsincludeastatementofeachprinciple,arationaleofwhytheprincipleisimportantfortheorganization,someexamplesofbenefitsassociatedwiththeprincipleandexamplesoftypicalactionstoimprovetheorganization’sperformancewhenapplyingtheprinciple.

Thequalitymanagementprinciplesare:

— customerfocus;

— leadership;

— engagementofpeople;

— processapproach;

— improvement;

— evidence‐baseddecisionmaking;

— relationshipmanagement.

1.3 Processapproach

1.3.1 General

This International Standard promotes the adoption of a process approach when developing,implementingandimprovingtheeffectivenessofaqualitymanagementsystem,toenhancecustomersatisfaction by meeting customer requirements. Specific requirements considered essential to theadoptionofaprocessapproachareincludedin4.4.

Understanding and managing interrelated processes as a system contributes to the organization’seffectivenessandefficiency inachieving its intendedresults.Thisapproachenables theorganizationtocontroltheinterrelationshipsandinterdependenciesamongtheprocessesofthesystem,sothattheoverallperformanceoftheorganizationcanbeenhanced.

The process approach involves the systematic definitionand managementof processes,and theirinteractions,soastoachievetheintendedresultsinaccordancewiththequalitypolicyandstrategicdirectionoftheorganization.ManagementoftheprocessesandthesystemasawholecanbeachievedusingthePDCAcycle(see0.3.2)withanoverallfocusonrisk‐basedthinking(see0.3.3)aimedattakingadvantageofopportunitiesandpreventingundesirableresults.

Theapplicationoftheprocessapproachinaqualitymanagementsystemenables:

a) understandingandconsistencyinmeetingrequirements;

b) theconsiderationofprocessesintermsofaddedvalue;

c) theachievementofeffectiveprocessperformance;

d) improvementofprocessesbasedonevaluationofdataandinformation.

Figure1givesaschematicrepresentationofanyprocessandshowstheinteractionofitselements.Themonitoringandmeasuringcheckpoints,whicharenecessaryforcontrol,arespecifictoeachprocessandwillvarydependingontherelatedrisks.

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Figure1—Schematicrepresentationoftheelementsofasingleprocess

1.3.2 Plan‐Do‐Check‐Actcycle

ThePDCA cycle can be applied to all processes and to the qualitymanagement system as awhole.Figure2illustrateshowClauses4to10canbegroupedinrelationtothePDCAcycle.

NOTE NumbersinbracketsrefertotheclausesinthisInternationalStandard.

Figure2—RepresentationofthestructureofthisInternationalStandardinthePDCAcycle

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ThePDCAcyclecanbebrieflydescribedasfollows:

— Plan:establishtheobjectivesofthesystemanditsprocesses,andtheresourcesneededtodeliverresults inaccordancewithcustomers’ requirementsand theorganization’spolicies,and identifyandaddressrisksandopportunities;

— Do:implementwhatwasplanned;

— Check:monitorand(whereapplicable)measureprocessesandtheresultingproductsandservicesagainstpolicies,objectives,requirementsandplannedactivities,andreporttheresults;

— Act:takeactionstoimproveperformance,asnecessary.

1.3.3 Risk‐basedthinking

Risk‐basedthinking(seeClauseA.4)isessentialforachievinganeffectivequalitymanagementsystem.Theconceptofrisk‐basedthinkinghasbeenimplicitinpreviouseditionsofthisInternationalStandardincluding,forexample,carryingoutpreventiveactiontoeliminatepotentialnonconformities,analysinganynonconformitiesthatdooccur,andtakingactiontopreventrecurrencethatisappropriatefortheeffectsofthenonconformity.

To conform to the requirements of this International Standard, an organization needs to plan andimplement actions to address risks and opportunities. Addressing both risks and opportunitiesestablishes a basis for increasing the effectiveness of the quality management system, achievingimprovedresultsandpreventingnegativeeffects.

Opportunities can arise as a result of a situation favourable to achieving an intended result, forexample,asetofcircumstancesthatallowtheorganizationtoattractcustomers,developnewproductsandservices,reducewasteorimproveproductivity.Actionstoaddressopportunitiescanalsoincludeconsiderationofassociatedrisks.Riskistheeffectofuncertaintyandanysuchuncertaintycanhavepositiveornegativeeffects.Apositivedeviationarisingfromariskcanprovideanopportunity,butnotallpositiveeffectsofriskresultinopportunities.

1.4 Relationshipwithothermanagementsystemstandards

ThisInternationalStandardappliestheframeworkdevelopedbyISOtoimprovealignmentamongitsInternationalStandardsformanagementsystems(seeClauseA.1).

This International Standard enables an organization to use the process approach, coupledwith thePDCA cycle and risk‐based thinking, to align or integrate its quality management system with therequirementsofothermanagementsystemstandards.

ThisInternationalStandardrelatestoISO9000andISO9004asfollows:

— ISO 9000 Quality management systems — Fundamentals and vocabulary provides essentialbackgroundfortheproperunderstandingandimplementationofthisInternationalStandard;

— ISO9004Managingforthesustainedsuccessofanorganization—Aqualitymanagementapproachprovides guidance for organizations that choose to progress beyond the requirements of thisInternationalStandard.

Annex B provides details of other International Standards on quality management and qualitymanagementsystemsthathavebeendevelopedbyISO/TC176.

This International Standard does not include requirements specific to othermanagement systems,such as those for environmental management, occupational health and safety management, orfinancialmanagement.

Sector‐specificqualitymanagementsystemstandardsbasedontherequirementsofthisInternationalStandard have been developed for a number of sectors. Some of these standards specify additionalquality management system requirements, while others are limited to providing guidance to theapplicationofthisInternationalStandardwithintheparticularsector.

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AmatrixshowingthecorrelationbetweentheclausesofthiseditionofthisInternationalStandardandthepreviousedition (ISO9001:2008) canbe foundon the ISO/TC176/SC2openaccesswebsiteat:www.iso.org/tc176/sc02/public.


INTERNATIONALSTANDARD ISO9001:2015(E)

Qualitymanagementsystems—Requirements 1 Scope

This InternationalStandard specifies requirements foraqualitymanagement systemwhen anorganization:

a) needstodemonstrateitsabilitytoconsistentlyprovideproductsandservicesthatmeetcustomerandapplicablestatutoryandregulatoryrequirements,and

b) aims toenhancecustomersatisfaction through theeffectiveapplicationof thesystem, includingprocesses for improvement of the system and the assurance of conformity to customer andapplicablestatutoryandregulatoryrequirements.

AlltherequirementsofthisInternationalStandardaregenericandareintendedtobeapplicabletoanyorganization,regardlessofitstypeorsize,ortheproductsandservicesitprovides.

NOTE1 InthisInternationalStandard,theterms“product”or“service”onlyapplytoproductsandservicesintendedfor,orrequiredby,acustomer.

NOTE2 Statutoryandregulatoryrequirementscanbeexpressedaslegalrequirements.

2 Normativereferences

The followingdocuments, inwhole or inpart, arenormatively referenced in this document and areindispensable for its application. For dated references, only the edition cited applies. For undatedreferences,thelatesteditionofthereferenceddocument(includinganyamendments)applies.

ISO9000:2015,Qualitymanagementsystems—Fundamentalsandvocabulary

3 Termsanddefinitions

Forthepurposesofthisdocument,thetermsanddefinitionsgiveninISO9000:2015apply.

4 Contextoftheorganization 4.1 Understandingtheorganizationanditscontext

Theorganizationshalldetermineexternal and internal issues that are relevant to itspurposeand its strategic direction and that affect its ability to achieve the intended result(s) of its qualitymanagementsystem.

Theorganizationshallmonitorandreviewinformationabouttheseexternalandinternalissues.

NOTE1 Issuescanincludepositiveandnegativefactorsorconditionsforconsideration. NOTE 2 Understanding the external context can be facilitated by considering issues arising from legal,technological,competitive,market,cultural,socialandeconomicenvironments,whetherinternational,national,regionalorlocal.

NOTE3 Understandingtheinternalcontextcanbefacilitatedbyconsideringissuesrelatedtovalues,culture,knowledgeandperformanceoftheorganization.

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4.2 Understandingtheneedsandexpectationsofinterestedparties Duetotheireffectorpotentialeffectontheorganization’sabilitytoconsistentlyprovideproductsandservices thatmeetcustomerandapplicablestatutoryandregulatoryrequirements, theorganizationshalldetermine:

a) theinterestedpartiesthatarerelevanttothequalitymanagementsystem;

b) therequirementsoftheseinterestedpartiesthatarerelevanttothequalitymanagementsystem.

Theorganizationshallmonitorandreviewinformationabouttheseinterestedpartiesandtheirrelevantrequirements.

4.3 Determiningthescopeofthequalitymanagementsystem

Theorganizationshalldeterminetheboundariesandapplicabilityofthequalitymanagementsystemtoestablishitsscope.

Whendeterminingthisscope,theorganizationshallconsider:

a) theexternalandinternalissuesreferredtoin4.1;

b) therequirementsofrelevantinterestedpartiesreferredtoin4.2;

c) theproductsandservicesoftheorganization.

TheorganizationshallapplyalltherequirementsofthisInternationalStandardiftheyareapplicablewithinthedeterminedscopeofitsqualitymanagementsystem.

Thescopeof theorganization’squalitymanagement systemshallbe available andbemaintainedasdocumentedinformation.Thescopeshallstatethetypesofproductsandservicescovered,andprovidejustificationforanyrequirementofthisInternationalStandardthattheorganizationdeterminesisnotapplicabletothescopeofitsqualitymanagementsystem.

ConformitytothisInternationalStandardmayonlybeclaimediftherequirementsdeterminedasnotbeingapplicabledonotaffecttheorganization’sabilityorresponsibilitytoensuretheconformityofitsproductsandservicesandtheenhancementofcustomersatisfaction.

4.4 Qualitymanagementsystemanditsprocesses

4.4.1 The organization shall establish, implement, maintain and continually improve a qualitymanagement system, including the processes needed and their interactions, in accordance with therequirementsofthisInternationalStandard.

Theorganizationshalldeterminetheprocessesneededforthequalitymanagementsystemandtheirapplicationthroughouttheorganization,andshall:

a) determinetheinputsrequiredandtheoutputsexpectedfromtheseprocesses;

b) determinethesequenceandinteractionoftheseprocesses;

c) determineandapplythecriteriaandmethods(includingmonitoring,measurementsandrelatedperformanceindicators)neededtoensuretheeffectiveoperationandcontroloftheseprocesses;

d) determinetheresourcesneededfortheseprocessesandensuretheiravailability;

e) assigntheresponsibilitiesandauthoritiesfortheseprocesses;

f) addresstherisksandopportunitiesasdeterminedinaccordancewiththerequirementsof6.1;

g) evaluatetheseprocessesandimplementanychangesneededtoensurethattheseprocessesachievetheirintendedresults;


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h) improvetheprocessesandthequalitymanagementsystem.

4.4.2 Totheextentnecessary,theorganizationshall:

a) maintaindocumentedinformationtosupporttheoperationofitsprocesses;

b) retain documented information to have confidence that the processes are being carried out asplanned.

5 Leadership 5.1 Leadershipandcommitment 5.1.1 General

Topmanagementshalldemonstrateleadershipandcommitmentwithrespecttothequalitymanagementsystemby:

a) takingaccountabilityfortheeffectivenessofthequalitymanagementsystem;

b) ensuringthatthequalitypolicyandqualityobjectivesareestablishedforthequalitymanagementsystemandarecompatiblewiththecontextandstrategicdirectionoftheorganization;

c) ensuringtheintegrationofthequalitymanagementsystemrequirementsintotheorganization’sbusinessprocesses;

d) promotingtheuseoftheprocessapproachandrisk‐basedthinking;

e) ensuringthattheresourcesneededforthequalitymanagementsystemareavailable;

f) communicatingtheimportanceofeffectivequalitymanagementandofconformingtothequalitymanagementsystemrequirements;

g) ensuringthatthequalitymanagementsystemachievesitsintendedresults;

h) engaging,directingandsupportingpersonstocontributetotheeffectivenessofthequalitymanagementsystem;

i) promotingimprovement;

j) supportingotherrelevantmanagementrolestodemonstratetheirleadershipasitappliestotheirareasofresponsibility.

NOTE Reference to “business” in this International Standard can be interpreted broadly to mean thoseactivitiesthatarecoretothepurposesoftheorganization’sexistence,whethertheorganizationispublic,private,forprofitornotforprofit.

5.1.2 Customerfocus

Topmanagement shall demonstrate leadership and commitmentwith respect to customer focus byensuringthat:

a) customerandapplicablestatutoryandregulatoryrequirementsaredetermined,understoodandconsistentlymet;

b) therisksandopportunitiesthatcanaffectconformityofproductsandservicesandtheabilitytoenhancecustomersatisfactionaredeterminedandaddressed;

c) thefocusonenhancingcustomersatisfactionismaintained.


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5.2 Policy 5.2.1 Establishingthequalitypolicy

Topmanagementshallestablish,implementandmaintainaqualitypolicythat:

a) isappropriatetothepurposeandcontextoftheorganizationandsupportsitsstrategicdirection;

b) providesaframeworkforsettingqualityobjectives;

c) includesacommitmenttosatisfyapplicablerequirements;

d) includesacommitmenttocontinualimprovementofthequalitymanagementsystem.

5.2.2 Communicatingthequalitypolicy

Thequalitypolicyshall:

a) beavailableandbemaintainedasdocumentedinformation;

b) becommunicated,understoodandappliedwithintheorganization;

c) beavailabletorelevantinterestedparties,asappropriate.

5.3 Organizationalroles,responsibilitiesandauthorities

Topmanagementshallensurethattheresponsibilitiesandauthoritiesforrelevantrolesareassigned,communicatedandunderstoodwithintheorganization.

Topmanagementshallassigntheresponsibilityandauthorityfor:

a) ensuringthatthequalitymanagementsystemconformstotherequirementsofthisInternationalStandard;

b) ensuringthattheprocessesaredeliveringtheirintendedoutputs;

c) reportingontheperformanceof thequalitymanagementsystemandonopportunities forimprovement(see10.1),inparticulartotopmanagement;

d) ensuringthepromotionofcustomerfocusthroughouttheorganization;

e) ensuringthattheintegrityofthequalitymanagementsystemismaintainedwhenchangestothequalitymanagementsystemareplannedandimplemented.

6 Planning 6.1 Actionstoaddressrisksandopportunities

6.1.1 Whenplanning for thequalitymanagementsystem, theorganizationshallconsider the issuesreferredtoin4.1andtherequirementsreferredtoin4.2anddeterminetherisksandopportunitiesthatneedtobeaddressedto:

a) giveassurancethatthequalitymanagementsystemcanachieveitsintendedresult(s);

b) enhancedesirableeffects;

c) prevent,orreduce,undesiredeffects;

d) achieveimprovement.


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6.1.2 Theorganizationshallplan:

a) actionstoaddresstheserisksandopportunities;

b) howto:

1) integrateandimplementtheactionsintoitsqualitymanagementsystemprocesses(see4.4);

2) evaluatetheeffectivenessoftheseactions.

Actionstakentoaddressrisksandopportunitiesshallbeproportionatetothepotentialimpactontheconformityofproductsandservices.

NOTE1 Options to address risks can include avoiding risk, taking risk in order to pursue an opportunity,eliminating the risk source, changing the likelihood or consequences, sharing the risk, or retaining risk byinformeddecision.

NOTE2 Opportunitiescanleadtotheadoptionofnewpractices,launchingnew products,openingnewmarkets,addressingnewcustomers,buildingpartnerships,usingnewtechnologyandotherdesirableandviablepossibilitiestoaddresstheorganization’soritscustomers’needs.

6.2 Qualityobjectivesandplanningtoachievethem

6.2.1 The organization shall establish quality objectives at relevant functions, levels and processesneededforthequalitymanagementsystem.

Thequalityobjectivesshall:

a) beconsistentwiththequalitypolicy;

b) bemeasurable;

c) takeintoaccountapplicablerequirements;

d) berelevanttoconformityofproductsandservicesandtoenhancementofcustomersatisfaction;

e) bemonitored;

f) becommunicated;

g) beupdatedasappropriate.

Theorganizationshallmaintaindocumentedinformationonthequalityobjectives.

6.2.2 Whenplanninghowtoachieveitsqualityobjectives,theorganizationshalldetermine:

a) whatwillbedone;

b) whatresourceswillberequired;

c) whowillberesponsible;

d) whenitwillbecompleted;

e) howtheresultswillbeevaluated.

6.3 Planningofchanges

Whentheorganizationdeterminestheneedforchangestothequalitymanagementsystem,thechangesshallbecarriedoutinaplannedmanner(see4.4).


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Theorganizationshallconsider:

a) thepurposeofthechangesandtheirpotentialconsequences;

b) theintegrityofthequalitymanagementsystem;

c) theavailabilityofresources;

d) theallocationorreallocationofresponsibilitiesandauthorities.

7 Support 7.1 Resources 7.1.1 General

Theorganizationshalldetermineandprovidetheresourcesneededfortheestablishment,implementation,maintenanceandcontinualimprovementofthequalitymanagementsystem.

Theorganizationshallconsider:

a) thecapabilitiesof,andconstraintson,existinginternalresources;

b) whatneedstobeobtainedfromexternalproviders.

7.1.2 People

Theorganizationshalldetermineandprovidethepersonsnecessaryfortheeffectiveimplementationofitsqualitymanagementsystemandfortheoperationandcontrolofitsprocesses.

7.1.3 Infrastructure

Theorganizationshalldetermine,provideandmaintaintheinfrastructurenecessaryfortheoperationofitsprocessesandtoachieveconformityofproductsandservices.

NOTE Infrastructurecaninclude:

a) buildingsandassociatedutilities;

b) equipment,includinghardwareandsoftware;

c) transportationresources;

d) informationandcommunicationtechnology. 7.1.4 Environmentfortheoperationofprocesses

Theorganizationshalldetermine,provideandmaintaintheenvironmentnecessaryfortheoperationofitsprocessesandtoachieveconformityofproductsandservices.

NOTE Asuitableenvironmentcanbeacombinationofhumanandphysicalfactors,suchas:

a) social(e.g.non‐discriminatory,calm,non‐confrontational);

b) psychological(e.g.stress‐reducing,burnoutprevention,emotionallyprotective);

c) physical(e.g.temperature,heat,humidity,light,airflow,hygiene,noise).

Thesefactorscandiffersubstantiallydependingontheproductsandservicesprovided.


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7.1.5 Monitoringandmeasuringresources 7.1.5.1 General

The organization shall determine and provide the resources needed to ensure valid and reliableresultswhenmonitoring ormeasuring is used to verify the conformity of products and services torequirements.

Theorganizationshallensurethattheresourcesprovided:

a) aresuitableforthespecifictypeofmonitoringandmeasurementactivitiesbeingundertaken;

b) aremaintainedtoensuretheircontinuingfitnessfortheirpurpose.

Theorganizationshallretainappropriatedocumentedinformationasevidenceoffitnessforpurposeofthemonitoringandmeasurementresources.

7.1.5.2 Measurementtraceability

Whenmeasurementtraceabilityisarequirement,orisconsideredbytheorganizationtobeanessentialpartofprovidingconfidenceinthevalidityofmeasurementresults,measuringequipmentshallbe:

a) calibratedorverified,orboth,atspecifiedintervals,orpriortouse,againstmeasurementstandardstraceabletointernationalornationalmeasurementstandards;whennosuchstandardsexist,thebasisusedforcalibrationorverificationshallberetainedasdocumentedinformation;

b) identifiedinordertodeterminetheirstatus;

c) safeguardedfromadjustments,damageordeteriorationthatwouldinvalidatethecalibrationstatusandsubsequentmeasurementresults.

Theorganizationshalldetermine if thevalidityofpreviousmeasurementresultshasbeenadverselyaffected when measuring equipment is found to be unfit for its intended purpose, and shall takeappropriateactionasnecessary.

7.1.6Organizationalknowledge

Theorganization shalldetermine theknowledgenecessary for theoperationof itsprocesses and toachieveconformityofproductsandservices.

Thisknowledgeshallbemaintainedandbemadeavailabletotheextentnecessary.

When addressing changing needs and trends, the organization shall consider its current knowledgeanddeterminehowtoacquireoraccessanynecessaryadditionalknowledgeandrequiredupdates.

NOTE 1 Organizational knowledge is knowledge specific to the organization; it is generally gained byexperience.Itisinformationthatisusedandsharedtoachievetheorganization’sobjectives.

NOTE2 Organizationalknowledgecanbebasedon: a) internal sources (e.g. intellectual property; knowledge gained from experience; lessons learned fromfailuresandsuccessfulprojects;capturingandsharingundocumentedknowledgeandexperience;theresultsofimprovementsinprocesses,productsandservices);

b) external sources (e.g. standards; academia; conferences; gathering knowledge from customers orexternalproviders).


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7.2 Competence

Theorganizationshall:

a) determine the necessary competence of person(s) doingwork under its control that affects theperformanceandeffectivenessofthequalitymanagementsystem;

b) ensurethatthesepersonsarecompetentonthebasisofappropriateeducation,training,orexperience;

c) whereapplicable,takeactionstoacquirethenecessarycompetence,andevaluatetheeffectivenessoftheactionstaken;

d) retainappropriatedocumentedinformationasevidenceofcompetence. NOTE Applicableactionscaninclude,forexample,theprovisionoftrainingto,thementoringof,orthere‐assignmentofcurrentlyemployedpersons;orthehiringorcontractingofcompetentpersons.

7.3 Awareness

Theorganizationshallensurethatpersonsdoingworkundertheorganization’scontrolareawareof:

a) thequalitypolicy;

b) relevantqualityobjectives;

c) theircontributiontotheeffectivenessofthequalitymanagementsystem,includingthebenefitsofimprovedperformance;

d) theimplicationsofnotconformingwiththequalitymanagementsystemrequirements.

7.4 Communication

The organization shall determine the internal and external communications relevant to the qualitymanagementsystem,including:

a) onwhatitwillcommunicate;

b) whentocommunicate;

c) withwhomtocommunicate;

d) howtocommunicate;

e) whocommunicates.

7.5 Documentedinformation 7.5.1 General

Theorganization’squalitymanagementsystemshallinclude:

a) documentedinformationrequiredbythisInternationalStandard;

b) documentedinformationdeterminedbytheorganizationasbeingnecessaryfortheeffectivenessofthequalitymanagementsystem.

NOTE Theextentofdocumentedinformationforaqualitymanagementsystemcandifferfromoneorganizationtoanotherdueto:

— thesizeoforganizationanditstypeofactivities,processes,productsandservices;


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— thecomplexityofprocessesandtheirinteractions;

— thecompetenceofpersons. 7.5.2 Creatingandupdating

Whencreatingandupdatingdocumentedinformation,theorganizationshallensureappropriate:

a) identificationanddescription(e.g.atitle,date,author,orreferencenumber);

b) format(e.g.language,softwareversion,graphics)andmedia(e.g.paper,electronic);

c) reviewandapprovalforsuitabilityandadequacy.

7.5.3 Controlofdocumentedinformation

7.5.3.1 DocumentedinformationrequiredbythequalitymanagementsystemandbythisInternationalStandardshallbecontrolledtoensure:

a) itisavailableandsuitableforuse,whereandwhenitisneeded;

b) itisadequatelyprotected(e.g.fromlossofconfidentiality,improperuse,orlossofintegrity).

7.5.3.2 Forthecontrolofdocumentedinformation,theorganizationshalladdressthefollowingactivities,asapplicable:

a) distribution,access,retrievalanduse;

b) storageandpreservation,includingpreservationoflegibility;

c) controlofchanges(e.g.versioncontrol);

d) retentionanddisposition.

Documentedinformationofexternalorigindeterminedbytheorganizationtobenecessaryfortheplanning andoperation of the qualitymanagement system shall be identified as appropriate, andbecontrolled.

Documentedinformationretainedasevidenceofconformityshallbeprotectedfromunintendedalterations.

NOTE Accesscanimplyadecisionregardingthepermissiontoviewthedocumentedinformationonly,orthepermissionandauthoritytoviewandchangethedocumentedinformation.

8 Operation 8.1 Operationalplanningandcontrol

The organization shall plan, implement and control the processes (see 4.4) needed to meet therequirementsfortheprovisionofproductsandservices,andtoimplementtheactionsdeterminedinClause6,by:

a) determiningtherequirementsfortheproductsandservices;

b) establishingcriteriafor:

1) theprocesses;

2) theacceptanceofproductsandservices;

c) determiningtheresourcesneededtoachieveconformitytotheproductandservicerequirements;

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d) implementingcontroloftheprocessesinaccordancewiththecriteria;

e) determining,maintainingandretainingdocumentedinformationtotheextentnecessary:

1) tohaveconfidencethattheprocesseshavebeencarriedoutasplanned;

2) todemonstratetheconformityofproductsandservicestotheirrequirements.

Theoutputofthisplanningshallbesuitablefortheorganization’soperations.

Theorganizationshallcontrolplannedchangesandreviewtheconsequencesofunintendedchanges,takingactiontomitigateanyadverseeffects,asnecessary.

Theorganizationshallensurethatoutsourcedprocessesarecontrolled(see8.4).

8.2 Requirementsforproductsandservices 8.2.1 Customercommunication

Communicationwithcustomersshallinclude:

a) providinginformationrelatingtoproductsandservices;

b) handlingenquiries,contractsororders,includingchanges;

c) obtainingcustomerfeedbackrelatingtoproductsandservices,includingcustomercomplaints;

d) handlingorcontrollingcustomerproperty;

e) establishingspecificrequirementsforcontingencyactions,whenrelevant.

8.2.2 Determiningtherequirementsforproductsandservices

Whendetermining the requirements for the products and services to be offered to customers, theorganizationshallensurethat:

a) therequirementsfortheproductsandservicesaredefined,including:

1) anyapplicablestatutoryandregulatoryrequirements;

2) thoseconsiderednecessarybytheorganization;

b) theorganizationcanmeettheclaimsfortheproductsandservicesitoffers.

8.2.3 Reviewoftherequirementsforproductsandservices

8.2.3.1 Theorganizationshallensurethatithastheabilitytomeettherequirementsforproductsandservicestobeofferedtocustomers.Theorganizationshallconductareviewbeforecommittingtosupplyproductsandservicestoacustomer,toinclude:

a) requirementsspecifiedbythecustomer,includingtherequirementsfordeliveryandpost‐

deliveryactivities;

b) requirementsnot statedby thecustomer,butnecessary for thespecifiedor intendeduse,whenknown;

c) requirementsspecifiedbytheorganization;

d) statutoryandregulatoryrequirementsapplicabletotheproductsandservices;

e) contractororderrequirementsdifferingfromthosepreviouslyexpressed.

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The organization shall ensure that contract or order requirements differing from those previouslydefinedareresolved.

The customer’s requirements shall be confirmed by the organization before acceptance, when thecustomerdoesnotprovideadocumentedstatementoftheirrequirements.

NOTE Insomesituations,suchasinternetsales,aformalreviewisimpracticalforeachorder.Instead,thereviewcancoverrelevantproductinformation,suchascatalogues.

8.2.3.2 Theorganizationshallretaindocumentedinformation,asapplicable:

a) ontheresultsofthereview;

b) onanynewrequirementsfortheproductsandservices.

8.2.4 Changestorequirementsforproductsandservices

The organization shall ensure that relevant documented information is amended, and that relevantpersons are made aware of the changed requirements, when the requirements for products andservicesarechanged.

8.3 Designanddevelopmentofproductsandservices 8.3.1 General

Theorganizationshallestablish, implementandmaintainadesignanddevelopmentprocess that isappropriatetoensurethesubsequentprovisionofproductsandservices.

8.3.2 Designanddevelopmentplanning

Indeterminingthestagesandcontrolsfordesignanddevelopment,theorganizationshallconsider:

a) thenature,durationandcomplexityofthedesignanddevelopmentactivities;

b) therequiredprocessstages,includingapplicabledesignanddevelopmentreviews;

c) therequireddesignanddevelopmentverificationandvalidationactivities;

d) theresponsibilitiesandauthoritiesinvolvedinthedesignanddevelopmentprocess;

e) theinternalandexternalresourceneedsforthedesignanddevelopmentofproductsandservices;

f) theneedtocontrolinterfacesbetweenpersonsinvolvedinthedesignanddevelopmentprocess;

g) theneedforinvolvementofcustomersandusersinthedesignanddevelopmentprocess;

h) therequirementsforsubsequentprovisionofproductsandservices;

i) the level of control expected for the design and development process by customers and otherrelevantinterestedparties;

j) thedocumented informationneeded todemonstrate thatdesignanddevelopment requirementshavebeenmet.

8.3.3 Designanddevelopmentinputs

The organization shall determine the requirements essential for the specific types of products andservicestobedesignedanddeveloped.Theorganizationshallconsider:

a) functionalandperformancerequirements;

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b) informationderivedfromprevioussimilardesignanddevelopmentactivities;

c) statutoryandregulatoryrequirements;

d) standardsorcodesofpracticethattheorganizationhascommittedtoimplement;

e) potentialconsequencesoffailureduetothenatureoftheproductsandservices.

Inputsshallbeadequatefordesignanddevelopmentpurposes,completeandunambiguous.

Conflictingdesignanddevelopmentinputsshallberesolved.

Theorganizationshallretaindocumentedinformationondesignanddevelopmentinputs.

8.3.4 Designanddevelopmentcontrols

Theorganizationshallapplycontrolstothedesignanddevelopmentprocesstoensurethat:

a) theresultstobeachievedaredefined;

b) reviews are conducted to evaluate the ability of the results of design anddevelopment tomeetrequirements;

c) verificationactivitiesareconductedtoensurethatthedesignanddevelopmentoutputsmeettheinputrequirements;

d) validationactivities are conducted to ensure that the resultingproducts andservicesmeet therequirementsforthespecifiedapplicationorintendeduse;

e) anynecessaryactionsaretakenonproblemsdeterminedduringthereviews,orverificationandvalidationactivities;

f) documentedinformationoftheseactivitiesisretained. NOTE Design and development reviews, verification and validation have distinct purposes. They can beconductedseparatelyorinanycombination,asissuitablefortheproductsandservicesoftheorganization.

8.3.5 Designanddevelopmentoutputs

Theorganizationshallensurethatdesignanddevelopmentoutputs:

a) meettheinputrequirements;

b) areadequateforthesubsequentprocessesfortheprovisionofproductsandservices;

c) includeorreferencemonitoringandmeasuringrequirements,asappropriate,andacceptancecriteria;

d) specifythecharacteristicsoftheproductsandservicesthatareessentialfortheirintendedpurposeandtheirsafeandproperprovision.

Theorganizationshallretaindocumentedinformationondesignanddevelopmentoutputs.

8.3.6 Designanddevelopmentchanges

Theorganizationshallidentify,reviewandcontrolchangesmadeduring,orsubsequentto,thedesignanddevelopmentofproductsandservices,totheextentnecessarytoensurethatthereisnoadverseimpactonconformitytorequirements.

Theorganizationshallretaindocumentedinformationon:

a) designanddevelopmentchanges;

b) theresultsofreviews;

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c) theauthorizationofthechanges;

d) theactionstakentopreventadverseimpacts.

8.4 Controlofexternallyprovidedprocesses,productsandservices 8.4.1 General

Theorganizationshallensure thatexternallyprovidedprocesses,productsandservicesconformtorequirements.

Theorganizationshalldeterminethecontrolstobeappliedtoexternallyprovidedprocesses,productsandserviceswhen:

a) productsandservicesfromexternalprovidersareintendedforincorporationintotheorganization’sownproductsandservices;

b) productsandservicesareprovideddirectlytothecustomer(s)byexternalprovidersonbehalfoftheorganization;

c) aprocess,orpartofaprocess,isprovidedbyanexternalproviderasaresultofadecisionbytheorganization.

The organization shall determine and apply criteria for the evaluation, selection, monitoring ofperformance, and re‐evaluationof external providers, basedon their ability toprovideprocessesorproducts and services in accordance with requirements. The organization shall retain documentedinformationoftheseactivitiesandanynecessaryactionsarisingfromtheevaluations.

8.4.2 Typeandextentofcontrol

The organization shall ensure that externally provided processes, products and services do notadverselyaffecttheorganization’sabilitytoconsistentlydeliverconformingproductsandservicestoitscustomers.

Theorganizationshall:

a) ensure that externallyprovidedprocesses remainwithin the control of itsqualitymanagementsystem;

b) defineboththecontrolsthatitintendstoapplytoanexternalproviderandthoseitintendstoapplytotheresultingoutput;

c) takeintoconsideration:

1) the potential impact of the externally provided processes, products and services on theorganization’sability toconsistentlymeetcustomerandapplicablestatutoryandregulatoryrequirements;

2) theeffectivenessofthecontrolsappliedbytheexternalprovider;

d) determine theverification, or other activities, necessary to ensure that theexternallyprovidedprocesses,productsandservicesmeetrequirements.

8.4.3 Informationforexternalproviders

Theorganizationshallensurethe adequacyofrequirementspriortotheircommunicationtotheexternalprovider.

Theorganizationshallcommunicatetoexternalprovidersitsrequirementsfor:

a) theprocesses,productsandservicestobeprovided;

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b) theapprovalof:

1) productsandservices;

2) methods,processesandequipment;

3) thereleaseofproductsandservices;

c) competence,includinganyrequiredqualificationofpersons;

d) theexternalproviders’interactionswiththeorganization;

e) controlandmonitoringoftheexternalproviders’performancetobeappliedbytheorganization;

f) verificationorvalidationactivitiesthattheorganization,oritscustomer,intendstoperformattheexternalproviders’premises.

8.5 Productionandserviceprovision 8.5.1 Controlofproductionandserviceprovision

Theorganizationshallimplementproductionandserviceprovisionundercontrolledconditions.

Controlledconditionsshallinclude,asapplicable:

a) theavailabilityofdocumentedinformationthatdefines:

1) thecharacteristicsoftheproductstobeproduced,theservicestobeprovided,ortheactivitiestobeperformed;

2) theresultstobeachieved;

b) theavailabilityanduseofsuitablemonitoringandmeasuringresources;

c) theimplementationofmonitoringandmeasurementactivitiesatappropriatestagestoverifythatcriteria for control of processes or outputs, and acceptance criteria for products and services,havebeenmet;

d) theuseofsuitableinfrastructureandenvironmentfortheoperationofprocesses;

e) theappointmentofcompetentpersons,includinganyrequiredqualification;

f) thevalidation,andperiodicrevalidation,oftheabilitytoachieveplannedresultsoftheprocessesforproductionandserviceprovision,wheretheresultingoutputcannotbeverifiedbysubsequentmonitoringormeasurement;

g) theimplementationofactionstopreventhumanerror;

h) theimplementationofrelease,deliveryandpost‐deliveryactivities.

8.5.2 Identificationandtraceability

The organization shall use suitable means to identify outputs when it is necessary to ensure theconformityofproductsandservices.

The organization shall identify the status of outputswith respect tomonitoring andmeasurementrequirementsthroughoutproductionandserviceprovision.

The organization shall control the unique identification of the outputswhen traceability is arequirement,andshallretainthedocumentedinformationnecessarytoenabletraceability.

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8.5.3 Propertybelongingtocustomersorexternalproviders Theorganizationshallexercisecarewithpropertybelongingtocustomersorexternalproviderswhileitisundertheorganization’scontrolorbeingusedbytheorganization.

Theorganizationshallidentify,verify,protectandsafeguardcustomers’orexternalproviders’propertyprovidedforuseorincorporationintotheproductsandservices.

When the property of a customer or external provider is lost, damaged or otherwise found to beunsuitableforuse,theorganizationshallreportthistothecustomerorexternalproviderandretaindocumentedinformationonwhathasoccurred.

NOTE Acustomer’sorexternalprovider’spropertycanincludematerials,components,toolsandequipment,premises,intellectualpropertyandpersonaldata.

8.5.4 Preservation

Theorganization shallpreserve theoutputsduringproductionand serviceprovision, to theextentnecessarytoensureconformitytorequirements.

NOTE Preservationcanincludeidentification,handling,contaminationcontrol,packaging,storage,transmissionortransportation,andprotection.

8.5.5 Post‐deliveryactivities

Theorganization shallmeet requirements for post‐delivery activities associatedwith the productsandservices.

Indeterminingtheextentofpost‐deliveryactivitiesthatarerequired,theorganizationshallconsider:

a) statutoryandregulatoryrequirements;

b) thepotentialundesiredconsequencesassociatedwithitsproductsandservices;

c) thenature,useandintendedlifetimeofitsproductsandservices;

d) customerrequirements;

e) customerfeedback. NOTE Post‐deliveryactivitiescanincludeactionsunderwarrantyprovisions,contractualobligationssuchasmaintenanceservices,andsupplementaryservicessuchasrecyclingorfinaldisposal.

8.5.6 Controlofchanges

Theorganizationshallreviewandcontrolchangesforproductionorserviceprovision,totheextentnecessarytoensurecontinuingconformitywithrequirements.

Theorganizationshallretaindocumentedinformationdescribingtheresultsofthereviewofchanges,theperson(s)authorizingthechange,andanynecessaryactionsarisingfromthereview.

8.6 Releaseofproductsandservices

The organization shall implement planned arrangements, at appropriate stages, to verify that theproductandservicerequirementshavebeenmet.

Thereleaseofproductsandservicestothecustomershallnotproceeduntiltheplannedarrangementshave been satisfactorily completed, unless otherwise approved by a relevant authority and, asapplicable,bythecustomer.

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Theorganizationshall retaindocumented informationon thereleaseofproductsandservices.Thedocumentedinformationshallinclude:

a) evidenceofconformitywiththeacceptancecriteria;

b) traceabilitytotheperson(s)authorizingtherelease.

8.7 Controlofnonconformingoutputs

8.7.1 Theorganizationshallensurethatoutputsthatdonotconformtotheirrequirementsareidentifiedandcontrolledtopreventtheirunintendeduseordelivery.

Theorganizationshalltakeappropriateactionbasedonthenatureofthenonconformityanditseffecton the conformity of products and services. This shall also apply to nonconforming products andservicesdetectedafterdeliveryofproducts,duringoraftertheprovisionofservices.

Theorganizationshalldealwithnonconformingoutputsinoneormoreofthefollowingways:

a) correction;

b) segregation,containment,returnorsuspensionofprovisionofproductsandservices;

c) informingthecustomer;

d) obtainingauthorizationforacceptanceunderconcession.

Conformitytotherequirementsshallbeverifiedwhennonconformingoutputsarecorrected.

8.7.2 Theorganizationshallretaindocumentedinformationthat:

a) describesthenonconformity;

b) describestheactionstaken;

c) describesanyconcessionsobtained;

d) identifiestheauthoritydecidingtheactioninrespectofthenonconformity.

9 Performanceevaluation 9.1 Monitoring,measurement,analysisandevaluation 9.1.1 General

Theorganizationshalldetermine:

a) whatneedstobemonitoredandmeasured;

b) themethodsformonitoring,measurement,analysisandevaluationneededtoensurevalidresults;

c) whenthemonitoringandmeasuringshallbeperformed;

d) whentheresultsfrommonitoringandmeasurementshallbeanalysedandevaluated.

Theorganizationshallevaluatetheperformanceandtheeffectivenessofthequalitymanagementsystem.

Theorganizationshallretainappropriatedocumentedinformationasevidenceoftheresults.

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9.1.2 Customersatisfaction The organization shall monitor customers’ perceptions of the degree to which their needs andexpectations have been fulfilled. The organization shall determine the methods for obtaining,monitoringandreviewingthisinformation.

NOTE Examples of monitoring customer perceptions can include customer surveys, customer feedbackon delivered products and services,meetingswith customers,market‐share analysis, compliments,warrantyclaimsanddealerreports.

9.1.3 Analysisandevaluation

Theorganizationshallanalyseandevaluateappropriatedataandinformationarisingfrommonitoringandmeasurement.

Theresultsofanalysisshallbeusedtoevaluate:

a) conformityofproductsandservices;

b) thedegreeofcustomersatisfaction;

c) theperformanceandeffectivenessofthequalitymanagementsystem;

d) ifplanninghasbeenimplementedeffectively;

e) theeffectivenessofactionstakentoaddressrisksandopportunities;

f) theperformanceofexternalproviders;

g)theneedforimprovementstothequalitymanagementsystem.

NOTEMethodstoanalysedatacanincludestatisticaltechniques.

9.2 Internalaudit

9.2.1 Theorganizationshall conduct internalauditsatplanned intervals toprovide informationonwhetherthequalitymanagementsystem:

a) conformsto:

1) theorganization’sownrequirementsforitsqualitymanagementsystem;

2) therequirementsofthisInternationalStandard;

b) iseffectivelyimplementedandmaintained.

9.2.2 Theorganizationshall:

a) plan,establish,implementandmaintainanauditprogramme(s)includingthefrequency,methods,

responsibilities, planning requirements and reporting, which shall take into consideration theimportance of the processes concerned, changes affecting the organization, and the results ofpreviousaudits;

b) definetheauditcriteriaandscopeforeachaudit;

c) selectauditorsandconductauditstoensureobjectivityandtheimpartialityoftheauditprocess;

d) ensurethattheresultsoftheauditsarereportedtorelevantmanagement;

e) takeappropriatecorrectionandcorrectiveactionswithoutunduedelay;

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f) retaindocumentedinformationasevidenceoftheimplementationoftheauditprogrammeandtheauditresults.

NOTE SeeISO19011forguidance.

9.3 Managementreview 9.3.1 General

Topmanagementshallreviewtheorganization’squalitymanagementsystem,atplannedintervals,toensureitscontinuingsuitability,adequacy,effectivenessandalignmentwiththestrategicdirectionoftheorganization.

9.3.2 Managementreviewinputs

Themanagementreviewshallbeplannedandcarriedouttakingintoconsideration:

a) thestatusofactionsfrompreviousmanagementreviews;

b) changesinexternalandinternalissuesthatarerelevanttothequalitymanagementsystem;

c) informationon theperformance and effectivenessof thequalitymanagement system, includingtrendsin:

1) customersatisfactionandfeedbackfromrelevantinterestedparties;

2) theextenttowhichqualityobjectiveshavebeenmet;

3) processperformanceandconformityofproductsandservices;

4) nonconformitiesandcorrectiveactions;

5) monitoringandmeasurementresults;

6) auditresults;

7) theperformanceofexternalproviders;

d) theadequacyofresources;

e) theeffectivenessofactionstakentoaddressrisksandopportunities(see6.1);

f) opportunitiesforimprovement.

9.3.3 Managementreviewoutputs

Theoutputsofthemanagementreviewshallincludedecisionsandactionsrelatedto:

a) opportunitiesforimprovement;

b) anyneedforchangestothequalitymanagementsystem;

c) resourceneeds.

Theorganizationshallretaindocumentedinformationasevidenceoftheresultsofmanagementreviews.

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10 Improvement 10.1 General

Theorganizationshalldetermineandselectopportunitiesforimprovementandimplementanynecessaryactionstomeetcustomerrequirementsandenhancecustomersatisfaction.

Theseshallinclude:

a) improvingproducts and services tomeet requirements aswell as to address futureneeds andexpectations;

b) correcting,preventingorreducingundesiredeffects;

c) improvingtheperformanceandeffectivenessofthequalitymanagementsystem. NOTE Examples of improvement can include correction, corrective action, continual improvement,breakthroughchange,innovationandre‐organization.

10.2 Nonconformityandcorrectiveaction 10.2.1 Whenanonconformityoccurs,includinganyarisingfromcomplaints,theorganizationshall:

a) reacttothenonconformityand,asapplicable:

1) takeactiontocontrolandcorrectit;

2) dealwiththeconsequences;

b) evaluatetheneedforactiontoeliminatethecause(s)ofthenonconformity,inorderthatitdoesnotrecuroroccurelsewhere,by:

1) reviewingandanalysingthenonconformity;

2) determiningthecausesofthenonconformity;

3) determiningifsimilarnonconformitiesexist,orcouldpotentiallyoccur;

c) implementanyactionneeded;

d) reviewtheeffectivenessofanycorrectiveactiontaken;

e) updaterisksandopportunitiesdeterminedduringplanning,ifnecessary;

f) makechangestothequalitymanagementsystem,ifnecessary.

Correctiveactionsshallbeappropriatetotheeffectsofthenonconformitiesencountered.

10.2.2 Theorganizationshallretaindocumentedinformationasevidenceof:

a) thenatureofthenonconformitiesandanysubsequentactionstaken;

b) theresultsofanycorrectiveaction.

10.3 Continualimprovement

Theorganizationshall continually improve thesuitability,adequacyandeffectivenessof thequalitymanagementsystem.

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The organization shall consider the results of analysis and evaluation, and the outputs frommanagementreview,todetermineifthereareneedsoropportunitiesthatshallbeaddressedaspartofcontinualimprovement.

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AnnexA(informative)

Clarificationofnewstructure,terminologyandconcepts

A.1 Structureandterminology

The clause structure (i.e. clause sequence) and some of the terminology of this edition of thisInternationalStandard,incomparisonwiththepreviousedition(ISO9001:2008),havebeenchangedtoimprovealignmentwithothermanagementsystemsstandards.

ThereisnorequirementinthisInternationalStandardforitsstructureandterminologytobeappliedtothedocumentedinformationofanorganization’squalitymanagementsystem.

Thestructureofclausesisintendedtoprovideacoherentpresentationofrequirements,ratherthanamodelfordocumentinganorganization’spolicies,objectivesandprocesses.Thestructureandcontentofdocumentedinformationrelatedtoaqualitymanagementsystemcanoftenbemorerelevanttoitsusersif itrelatestoboththeprocessesoperatedbytheorganizationandinformationmaintainedforotherpurposes.

ThereisnorequirementforthetermsusedbyanorganizationtobereplacedbythetermsusedinthisInternationalStandardtospecifyqualitymanagementsystemrequirements.Organizationscanchoosetouse termswhich suit theiroperations (e.g.using “records”, “documentation”or “protocols” ratherthan“documentedinformation”;or“supplier”,“partner”or“vendor”ratherthan“externalprovider”).Table A.1 shows the major differences in terminology between this edition of this InternationalStandardandthepreviousedition.

TableA.1—MajordifferencesinterminologybetweenISO9001:2008andISO9001:2015

ISO9001:2008 ISO9001:2015

Products Productsandservices

Exclusions Notused

(SeeClauseA.5forclarificationofapplicability)

Managementrepresentative Notused

(Similarresponsibilitiesandauthoritiesareassignedbutnorequirementforasinglemanagementrepre‐sentative)

Documentation,qualitymanual,documentedpro‐cedures,records

Documentedinformation

Workenvironment Environmentfortheoperationofprocesses

Monitoringandmeasuringequipment Monitoringandmeasuringresources

Purchasedproduct Externallyprovidedproductsandservices

Supplier Externalprovider

A.2 Productsandservices

ISO9001:2008usedtheterm“product”toincludealloutputcategories.ThiseditionofthisInternationalStandarduses“productsandservices”.“Productsandservices”includealloutputcategories(hardware,services,softwareandprocessedmaterials).

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The specific inclusion of “services” is intended to highlight the differences between products andservicesintheapplicationofsomerequirements.Thecharacteristicofservicesisthatatleastpartoftheoutputisrealizedattheinterfacewiththecustomer.Thismeans,forexample,thatconformitytorequirementscannotnecessarilybeconfirmedbeforeservicedelivery.

Inmost cases, products and services are used together.Most outputs that organizations provide tocustomers, or are supplied to them by external providers, include both products and services. Forexample,atangibleorintangibleproductcanhavesomeassociatedserviceoraservicecanhavesomeassociatedtangibleorintangibleproduct.

A.3 Understandingtheneedsandexpectationsofinterestedparties

Subclause 4.2 specifies requirements for the organization to determine the interested parties thatare relevant to the quality management system and the requirements of those interested parties.However,4.2doesnotimplyextensionofqualitymanagementsystemrequirementsbeyondthescopeofthisInternationalStandard.Asstatedinthescope,thisInternationalStandardisapplicablewherean organization needs to demonstrate its ability to consistently provide products and services thatmeetcustomerandapplicablestatutoryandregulatoryrequirements,andaimstoenhancecustomersatisfaction.

There is no requirement in this International Standard for the organization to consider interestedpartieswhereithasdecidedthatthosepartiesarenotrelevanttoitsqualitymanagementsystem.Itisfortheorganizationtodecideifaparticularrequirementofarelevantinterestedpartyisrelevanttoitsqualitymanagementsystem.

A.4 Risk‐basedthinking

Theconceptofrisk‐basedthinkinghasbeenimplicitinpreviouseditionsofthisInternationalStandard,e.g. through requirements for planning, reviewand improvement.This International Standardspecifiesrequirementsfortheorganizationtounderstanditscontext(see4.1)anddeterminerisksasabasisforplanning(see6.1).Thisrepresentstheapplicationofrisk‐basedthinkingtoplanningandimplementingqualitymanagementsystemprocesses(see4.4)andwillassistindeterminingtheextentofdocumentedinformation.

Oneofthekeypurposesofaqualitymanagementsystemistoactasapreventivetool.Consequently,this International Standard does not have a separate clause or subclause on preventive action. Theconceptofpreventiveactionisexpressedthroughtheuseofrisk‐basedthinkinginformulatingqualitymanagementsystemrequirements.

The risk‐based thinking applied in this International Standard has enabled some reduction inprescriptiverequirementsandtheirreplacementbyperformance‐basedrequirements.Thereisgreaterflexibility than in ISO 9001:2008 in the requirements for processes, documented information andorganizationalresponsibilities.

Although6.1specifiesthattheorganizationshallplanactionstoaddressrisks,thereisnorequirementforformalmethodsforriskmanagementoradocumentedriskmanagementprocess.OrganizationscandecidewhetherornottodevelopamoreextensiveriskmanagementmethodologythanisrequiredbythisInternationalStandard,e.g.throughtheapplicationofotherguidanceorstandards.

Notalltheprocessesofaqualitymanagementsystemrepresentthesamelevelofriskintermsoftheorganization’s ability tomeet its objectives, and the effects of uncertainty are not the same for allorganizations.Undertherequirementsof6.1,theorganizationisresponsibleforitsapplicationofrisk‐basedthinkingandtheactionsittakestoaddressrisk,includingwhetherornottoretaindocumentedinformationasevidenceofitsdeterminationofrisks.

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A.5 Applicability

This International Standard does not refer to “exclusions” in relation to the applicability of itsrequirementstotheorganization’squalitymanagementsystem.However,anorganizationcanreviewtheapplicabilityof requirementsdue to the size or complexity of theorganization, themanagementmodelitadopts,therangeoftheorganization’sactivitiesandthenatureoftherisksandopportunitiesitencounters.

The requirements for applicability are addressed in 4.3, which defines conditions under which anorganizationcandecidethatarequirementcannotbeappliedtoanyoftheprocesseswithinthescopeofitsqualitymanagementsystem.Theorganizationcanonlydecidethatarequirementisnotapplicableifitsdecisionwillnotresultinfailuretoachieveconformityofproductsandservices.

A.6 Documentedinformation

Aspartofthealignmentwithothermanagementsystemstandards,acommonclauseon“documentedinformation” has been adoptedwithout significant change or addition (see 7.5).Where appropriate,text elsewhere in this International Standardhasbeen alignedwith its requirements.Consequently,“documentedinformation”isusedforalldocumentrequirements.

Where ISO 9001:2008 used specific terminology such as “document” or “documented procedures”,“qualitymanual”or“qualityplan”,thiseditionofthisInternationalStandarddefinesrequirementsto“maintaindocumentedinformation”.

Where ISO 9001:2008 used the term “records” to denote documents needed to provide evidenceof conformity with requirements, this is now expressed as a requirement to “retain documentedinformation”.Theorganizationisresponsiblefordeterminingwhatdocumentedinformationneedstoberetained,theperiodoftimeforwhichitistoberetainedandthemediatobeusedforitsretention.

A requirement to “maintain” documented information does not exclude the possibility that theorganizationmightalsoneedto“retain”thatsamedocumentedinformationforaparticularpurpose,e.g.toretainpreviousversionsofit.

WherethisInternationalStandardrefersto“information”ratherthan“documentedinformation”(e.g.in4.1:“Theorganizationshallmonitorandreviewtheinformationabouttheseexternalandinternalissues”),thereisnorequirementthatthisinformationistobedocumented.Insuchsituations,theorganizationcandecidewhetherornotitisnecessaryorappropriatetomaintaindocumentedinformation.

A.7 Organizationalknowledge

In 7.1.6, this International Standard addresses the need to determine and manage the knowledgemaintained by the organization, to ensure the operation of its processes and that it can achieveconformityofproductsandservices.

Requirementsregardingorganizationalknowledgewereintroducedforthepurposeof:

a) safeguardingtheorganizationfromlossofknowledge,e.g.

— throughstaffturnover;

— failuretocaptureandshareinformation;

b) encouragingtheorganizationtoacquireknowledge,e.g.

— learningfromexperience;

— mentoring;

— benchmarking.

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A.8 Controlofexternallyprovidedprocesses,productsandservices

All formsofexternallyprovidedprocesses,productsandservicesareaddressed in8.4,e.g.whetherthrough:

a) purchasingfromasupplier;

b) anarrangementwithanassociatecompany;

c) outsourcingprocessestoanexternalprovider.

Outsourcingalwayshastheessentialcharacteristicofaservice,sinceitwillhaveatleastoneactivitynecessarilyperformedattheinterfacebetweentheproviderandtheorganization.

Thecontrolsrequiredforexternalprovisioncanvarywidelydependingonthenatureoftheprocesses,productsandservices.Theorganizationcanapplyrisk‐basedthinkingtodeterminethetypeandextentofcontrolsappropriate toparticularexternalprovidersandexternallyprovidedprocesses,productsandservices.

ISO9001:2015(E)


AnnexB(informative)

OtherInternationalStandardsonqualitymanagementandqualitymanagementsystemsdevelopedbyISO/TC176

The International Standardsdescribed in this annexhavebeendevelopedby ISO/TC176 toprovidesupporting information for organizations that apply this International Standard, and to provideguidancefororganizationsthatchoosetoprogressbeyonditsrequirements.Guidanceorrequirementscontained in the documents listed in this annex do not add to, ormodify, the requirements of thisInternationalStandard.

Table B.1 shows the relationship between these standards and the relevant clauses of thisInternationalStandard.

This annex does not include reference to the sector‐specific quality management system standardsdevelopedbyISO/TC176.

ThisInternationalStandardisoneofthethreecorestandardsdevelopedbyISO/TC176.

— ISO 9000 Quality management systems— Fundamentals and vocabulary provides an essentialbackground for the proper understanding and implementation of this International Standard.Thequalitymanagementprinciplesaredescribedindetail inISO9000andhavebeentakenintoconsideration during the development of this International Standard. These principles are notrequirements in themselves, but they form the foundationof the requirements specifiedby thisInternational Standard. ISO 9000 also defines the terms, definitions and concepts used in thisInternationalStandard.

— ISO9001(thisInternationalStandard)specifiesrequirementsaimedprimarilyatgivingconfidenceintheproductsandservicesprovidedbyanorganizationandtherebyenhancingcustomersatisfaction.Its proper implementation can also be expected to bring other organizational benefits, such asimprovedinternalcommunication,betterunderstandingandcontroloftheorganization’sprocesses.

— ISO9004Managingforthesustainedsuccessofanorganization—Aqualitymanagementapproachprovides guidance for organizations that choose to progress beyond the requirements of thisInternationalStandard,toaddressabroaderrangeoftopicsthatcan leadto improvementoftheorganization’soverallperformance.ISO9004includesguidanceonaself‐assessmentmethodologyforanorganizationtobeabletoevaluatethelevelofmaturityofitsqualitymanagementsystem.

The International Standards outlined below can provide assistance to organizationswhen they areestablishingorseekingtoimprovetheirqualitymanagementsystems,theirprocessesortheiractivities.

— ISO 10001 Quality management— Customer satisfaction— Guidelines for codes of conduct fororganizationsprovidesguidancetoanorganization indetermining that itscustomersatisfactionprovisionsmeetcustomerneedsandexpectations.Itsusecanenhancecustomerconfidenceinanorganizationandimprovecustomerunderstandingofwhattoexpectfromanorganization,therebyreducingthelikelihoodofmisunderstandingsandcomplaints.

— ISO10002Qualitymanagement—Customersatisfaction—Guidelinesforcomplaintshandlingin organizations provides guidance on the process of handling complaints by recognizing andaddressing the needs and expectations of complainants and resolving any complaints received.ISO10002provides an open, effective and easy‐to‐use complaints process, including training ofpeople.Italsoprovidesguidanceforsmallbusinesses.

— ISO10003Qualitymanagement—Customersatisfaction—Guidelinesfordisputeresolutionexternaltoorganizationsprovidesguidanceforeffectiveandefficientexternaldisputeresolutionfor

ISO9001:2015(E)


product‐related complaints. Dispute resolution gives an avenue of redress when organizationsdo not remedy a complaint internally. Most complaints can be resolved successfullywithin theorganization,withoutadversarialprocedures.

— ISO10004Qualitymanagement—Customersatisfaction—Guidelinesformonitoringandmeasuringprovidesguidelinesforactionstoenhancecustomersatisfactionandtodetermineopportunitiesforimprovementofproducts,processesandattributesthatarevaluedbycustomers.Suchactionscanstrengthencustomerloyaltyandhelpretaincustomers.

— ISO 10005 Quality management systems — Guidelines for quality plans provides guidance onestablishingandusingqualityplansasameansofrelatingrequirementsoftheprocess,product,projector contract, toworkmethodsandpractices that supportproduct realization.Benefits ofestablishingaqualityplanareincreasedconfidencethatrequirementswillbemet,thatprocessesareincontrolandthemotivationthatthiscangivetothoseinvolved.

— ISO10006Qualitymanagementsystems—Guidelinesforqualitymanagementinprojectsisapplicabletoprojectsfromthesmalltolarge,fromsimpletocomplex,fromanindividualprojecttobeingpartofaportfolioofprojects.ISO10006istobeusedbypersonnelmanagingprojectsandwhoneedtoensurethattheirorganizationisapplyingthepracticescontainedintheISOqualitymanagementsystemstandards.

— ISO 10007 Qualitymanagement systems— Guidelines for configurationmanagement is to assistorganizationsapplyingconfigurationmanagement forthetechnicalandadministrativedirectionover the life cycle of aproduct. Configurationmanagementcanbe used to meetthe productidentificationandtraceabilityrequirementsspecifiedinthisInternationalStandard.

— ISO 10008 Quality management— Customer satisfaction— Guidelines for business‐to‐consumerelectroniccommercetransactionsgivesguidanceonhoworganizationscanimplementaneffectiveand efficient business‐to‐consumer electronic commerce transaction (B2C ECT) system, andtherebyprovideabasisforconsumerstohaveincreasedconfidenceinB2CECTs,enhancetheabilityoforganizationstosatisfyconsumersandhelpreducecomplaintsanddisputes.

— ISO 10012 Measurement management systems— Requirements for measurement processes andmeasuring equipment provides guidance for the management of measurement processes andmetrologicalconfirmationofmeasuringequipmentusedtosupportanddemonstratecompliancewithmetrologicalrequirements.ISO10012providesqualitymanagementcriteriaforameasurementmanagementsystemtoensuremetrologicalrequirementsaremet.

— ISO/TR10013Guidelines forqualitymanagement systemdocumentationprovides guidelines forthedevelopment andmaintenance of the documentation necessary for a quality managementsystem.ISO/TR10013 canbe used to documentmanagement systemsother than those of theISOqualitymanagementsystemstandards,e.g.environmentalmanagementsystemsandsafetymanagementsystems.

— ISO10014Qualitymanagement—Guidelinesforrealizingfinancialandeconomicbenefitsisaddressedtotopmanagement.Itprovidesguidelinesforrealizingfinancialandeconomicbenefitsthroughtheapplicationofqualitymanagementprinciples. It facilitates applicationofmanagementprinciplesandselectionofmethodsandtoolsthatenablethesustainablesuccessofanorganization.

— ISO10015Qualitymanagement—Guidelinesfortrainingprovidesguidelinestoassistorganizationsinaddressingissuesrelatedtotraining.ISO10015canbeappliedwheneverguidanceisrequiredto interpret references to “education”and “training”within the ISOqualitymanagementsystemstandards.Anyreferenceto“training”includesalltypesofeducationandtraining.

— ISO/TR10017Guidanceonstatistical techniques for ISO9001:2000explainsstatistical techniqueswhichfollowfromthevariabilitythatcanbeobservedinthebehaviourandresultsofprocesses,evenunderconditionsofapparentstability.Statisticaltechniquesallowbetteruseofavailabledatatoassistindecisionmaking,andtherebyhelptocontinuallyimprovethequalityofproductsandprocessestoachievecustomersatisfaction.

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— ISO 10018 Quality management— Guidelines on people involvement and competence providesguidelines which influence people involvement and competence. A quality management systemdepends on the involvement of competent people and the way that they are introduced andintegrated into theorganization. It iscritical todetermine,developandevaluate theknowledge,skills,behaviourandworkenvironmentrequired.

— ISO10019Guidelinesfortheselectionofqualitymanagementsystemconsultantsanduseoftheirservicesprovidesguidancefortheselectionofqualitymanagementsystemconsultantsandtheuseoftheirservices.Itgivesguidanceontheprocessforevaluatingthecompetenceofaqualitymanagementsystemconsultantandprovidesconfidencethattheorganization’sneedsandexpectationsfortheconsultant’sserviceswillbemet.

— ISO19011Guidelinesforauditingmanagementsystemsprovidesguidanceonthemanagementofanauditprogramme,ontheplanningandconductingofanauditofamanagementsystem,aswellasonthecompetenceandevaluationofanauditorandanauditteam.ISO19011isintendedtoapplytoauditors,organizationsimplementingmanagementsystems,andorganizationsneedingtoconductauditsofmanagementsystems.

TableB.1—RelationshipbetweenotherInternationalStandardsonqualitymanagementand

qualitymanagementsystemsandtheclausesofthisInternationalStandard

OtherInterna‐tionalStandard

ClauseinthisInternationalStandard

4 5 6 7 8 9 10

ISO9000 All All All All All All All


ISO10001 8.2.2,8.5.1 9.1.2

ISO10002 8.2.1, 9.1.2 10.2.1

ISO10003 9.1.2

ISO10004 9.1.2,9.1.3

ISO10005 5.3 6.1,6.2 All All 9.1 10.2


ISO10007 8.5.2


ISO10012 7.1.5

ISO/TR10013 7.5


ISO10015 7.2

ISO/TR10017 6.1 7.1.5 9.1


ISO10019 8.4

ISO19011 9.2

NOTE “All”indicatesthatallthesubclausesinthespecificclauseofthisInternationalStandardarerelatedtotheotherInternationalStandard.

ISO9001:2015(E)


Bibliography [1] ISO9004,Managingforthesustainedsuccessofanorganization—Aqualitymanagementapproach

[2] ISO10001,Qualitymanagement—Customersatisfaction—Guidelines forcodesofconduct fororganizations

[3] ISO10002,Qualitymanagement—Customersatisfaction—Guidelinesforcomplaintshandlinginorganizations

[4] ISO 10003, Qualitymanagement— Customer satisfaction— Guidelines for dispute resolutionexternaltoorganizations

[5] ISO10004,Qualitymanagement—Customersatisfaction—Guidelinesformonitoringandmeasuring

[6] ISO10005,Qualitymanagementsystems—Guidelinesforqualityplans

[7] ISO10006,Qualitymanagementsystems—Guidelinesforqualitymanagementinprojects

[8] ISO10007,Qualitymanagementsystems—Guidelinesforconfigurationmanagement

[9] ISO10008,Qualitymanagement—Customersatisfaction—Guidelinesforbusiness‐to‐consumerelectroniccommercetransactions

[10] ISO10012,Measurementmanagementsystems—Requirementsformeasurementprocessesandmeasuringequipment

[11] ISO/TR10013,Guidelinesforqualitymanagementsystemdocumentation

[12] ISO10014,Qualitymanagement—Guidelinesforrealizingfinancialandeconomicbenefits

[13] ISO10015,Qualitymanagement—Guidelinesfortraining

[14] ISO/TR10017,GuidanceonstatisticaltechniquesforISO9001:2000

[15] ISO10018,Qualitymanagement—Guidelinesonpeopleinvolvementandcompetence

[16] ISO 10019,Guidelines for the selectionofqualitymanagement system consultantsanduseoftheirservices

[17] ISO14001,Environmentalmanagementsystems—Requirementswithguidanceforuse

[18] ISO19011,Guidelinesforauditingmanagementsystems

[19] ISO31000,Riskmanagement—Principlesandguidelines

[20] ISO37500,Guidanceonoutsourcing

[21] ISO/IEC90003,Softwareengineering—GuidelinesfortheapplicationofISO9001:2008tocomputersoftware

[22] IEC60300‐1,Dependabilitymanagement—Part1:Guidanceformanagementandapplication

[23] IEC61160,Designreview

[24] Qualitymanagementprinciples,ISO1)

[25] SelectionanduseoftheISO9000familyofstandards,ISO1)

[26] ISO9001forSmallBusinesses—Whattodo,ISO1)

1) Availablefromwebsite:http://www.iso.org.

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[27] Integrateduseofmanagementsystemstandards,ISO1)

[28] www.iso.org/tc176/sc02/public

[29] w w w.iso.org/tc176/ISO9001AuditingPracticesGroup

ISO9001:2015(E)

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Quality management systems — Requirements Systèmes de management de la qualité — Exigences