ISO9001:2015(ExtractfromStandardforTrainingpurpose)

Introduction
1.1General
Theadoptionofaqualitymanagementsystemisastrategicdecisionforanorganizationthatcanhelp
toimproveitsoverallperformanceandprovideasoundbasisforsustainabledevelopment
initiatives.

Thepotentialbenefitstoanorganizationofimplementingaqualitymanagementsystembasedon
thisInternationalStandardare:
a) the ability to consistently provide products and services that meet customer and
applicablestatutoryandregulatoryrequirements;

b) facilitatingopportunitiestoenhancecustomersatisfaction;

c) addressingrisksandopportunitiesassociatedwithitscontextandobjectives;

d) the ability to demonstrate conformity to specified quality management system

requirements.ThisInternationalStandardcanbeusedbyinternalandexternalparties.
ItisnottheintentofthisInternationalStandardtoimplytheneedfor:
uniformityinthestructureofdifferentqualitymanagementsystems;
alignmentofdocumentationtotheclausestructureofthisInternationalStandard;
theuseofthespecificterminologyofthisInternationalStandardwithintheorganization.
ThequalitymanagementsystemrequirementsspecifiedinthisInternationalStandard
arecomplementarytorequirementsforproductsandservices.
ThisInternationalStandardemploystheprocessapproach,whichincorporatesthePlanDoCheck
Act(PDCA)cycleandriskbasedthinking.
Theprocessapproachenablesanorganizationtoplanitsprocessesandtheirinteractions.
ThePDCAcycleenablesanorganizationtoensurethatitsprocessesareadequatelyresourced
andmanaged,andthatopportunitiesforimprovementaredeterminedandactedon.

Riskbasedthinkingenablesanorganizationtodeterminethefactorsthatcouldcauseitsprocessesand
itsqualitymanagementsystemtodeviatefromtheplannedresults,toputinplacepreventivecontrols
tominimizenegativeeffectsandtomakemaximumuseofopportunitiesastheyarise(seeClauseA.4).

Consistentlymeetingrequirementsandaddressingfutureneedsandexpectationsposesachallengefor
organizations in an increasingly dynamic and complex environment. To achieve this objective, the
organizationmightfinditnecessarytoadoptvariousformsof improvementinadditiontocorrection
andcontinualimprovement,suchasbreakthroughchange,innovationandreorganization.
InthisInternationalStandard,thefollowingverbalformsareused:
shallindicatesarequirement;
shouldindicatesarecommendation;
mayindicatesapermission;
canindicatesapossibilityoracapability.
InformationmarkedasNOTEisforguidanceinunderstandingorclarifyingtheassociatedrequirement.
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1.2Qualitymanagementprinciples

ThisInternationalStandardisbasedonthequalitymanagementprinciplesdescribedinISO9000.The
descriptionsincludeastatementofeachprinciple,arationaleofwhytheprincipleisimportantforthe
organization,someexamplesofbenefitsassociatedwiththeprincipleandexamplesoftypicalactions
toimprovetheorganizationsperformancewhenapplyingtheprinciple.
Thequalitymanagementprinciplesare:
customerfocus;
leadership;
engagementofpeople;
processapproach;
improvement;
evidencebaseddecisionmaking;
relationshipmanagement.
1.3Processapproach
1.3.1General

This International Standard promotes the adoption of a process approach when developing,
implementingandimprovingtheeffectivenessofaqualitymanagementsystem,toenhancecustomer
satisfaction by meeting customer requirements. Specific requirements considered essential to the
adoptionofaprocessapproachareincludedin4.4.

Understanding and managing interrelated processes as a system contributes to the organizations

effectivenessandefficiencyinachievingitsintendedresults.Thisapproachenablestheorganizationto
control the interrelationships and interdependencies among the processes of the system, so that the
overallperformanceoftheorganizationcanbeenhanced.

The process approach involves the systematic definition and management of processes, and their
interactions,soastoachievetheintendedresultsinaccordancewiththequalitypolicyandstrategic
directionoftheorganization.Managementoftheprocessesandthesystemasawholecanbeachieved
usingthePDCAcycle(see0.3.2)withanoverallfocusonriskbasedthinking(see0.3.3)aimedattaking
advantageofopportunitiesandpreventingundesirableresults.
Theapplicationoftheprocessapproachinaqualitymanagementsystemenables:
a) understandingandconsistencyinmeetingrequirements;

b) theconsiderationofprocessesintermsofaddedvalue;

c) theachievementofeffectiveprocessperformance;

d) improvementofprocessesbasedonevaluationofdataandinformation.

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1.3.2PlanDoCheckActcycle
ThePDCAcyclecanbeappliedtoallprocessesandtothequalitymanagementsystemasawhole.

NOTE NumbersinbracketsrefertotheclausesinthisInternationalStandard.

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ThePDCAcyclecanbebrieflydescribedasfollows:

Plan:establishtheobjectivesofthesystemanditsprocesses,andtheresources neededtodeliver
results in accordance with customers requirements and the organizations policies, and identify
andaddressrisksandopportunities;
Do:implementwhatwasplanned;

Check:monitorand(whereapplicable)measureprocessesandtheresultingproductsandservices
againstpolicies,objectives,requirementsandplannedactivities,andreporttheresults;
Act:takeactionstoimproveperformance,asnecessary.
1.3.3Riskbasedthinking

Riskbasedthinking(seeClauseA.4)isessentialforachievinganeffectivequalitymanagementsystem.
TheconceptofriskbasedthinkinghasbeenimplicitinpreviouseditionsofthisInternationalStandard
including,forexample,carryingoutpreventiveactiontoeliminatepotentialnonconformities,analysing
anynonconformitiesthatdooccur,andtakingactiontopreventrecurrencethatisappropriateforthe
effectsofthenonconformity.

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

Opportunitiescanariseasaresultofasituationfavourabletoachievinganintendedresult,forexample,
a set of circumstances that allow the organization to attract customers, develop new products and
services, reduce waste or improve productivity. Actions to address opportunities can also include
consideration of associated risks. Risk is the effect of uncertainty and any such uncertainty can have
positiveornegativeeffects.Apositivedeviationarisingfromariskcanprovideanopportunity,butnot
allpositiveeffectsofriskresultinopportunities.
1.4Relationshipwithothermanagementsystemstandards

ThisInternationalStandardappliestheframeworkdevelopedby ISOtoimprovealignmentamongits
InternationalStandardsformanagementsystems(seeClauseA.1).

This International Standard enables an organization to use the process approach, coupled with the
PDCA cycle and riskbased thinking, to align or integrate its quality management system with the
requirementsofothermanagementsystemstandards.
ThisInternationalStandardrelatestoISO9000andISO9004asfollows:

ISO9000QualitymanagementsystemsFundamentalsandvocabularyprovidesessential
backgroundfortheproperunderstandingandimplementationofthisInternationalStandard;

ISO9004ManagingforthesustainedsuccessofanorganizationAqualitymanagementapproach
provides guidance for organizations that choose to progress beyond the requirements of this
InternationalStandard.

ThisInternationalStandarddoesnotincluderequirementsspecifictoothermanagementsystems,such
as those for environmental management, occupational health and safety management, or financial
management.

SectorspecificqualitymanagementsystemstandardsbasedontherequirementsofthisInternational
Standard have been developed for a number of sectors. Some of these standards specify additional
quality management system requirements, while others are limited to providing guidance to the
applicationofthisInternationalStandardwithintheparticularsector.
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QualitymanagementsystemsRequirements

1Scope
ThisInternationalStandardspecifiesrequirementsforaqualitymanagementsystemwhenan
organization:

a) needstodemonstrateitsabilitytoconsistentlyprovideproductsandservicesthatmeetcustomer
andapplicablestatutoryandregulatoryrequirements,and

b) aims to enhance customer satisfaction through the effective application of the system, including
processes for improvement of the system and the assurance of conformity to customer and
applicablestatutoryandregulatoryrequirements.
AlltherequirementsofthisInternationalStandardaregenericandareintendedtobeapplicabletoany
organization,regardlessofitstypeorsize,ortheproductsandservicesitprovides.
NOTE1InthisInternationalStandard,thetermsproductorserviceonlyapplytoproductsandservices
intendedfor,orrequiredby,acustomer.

NOTE2Statutoryandregulatoryrequirementscanbeexpressedaslegalrequirements.

2Normativereferences
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references,thelatesteditionofthereferenceddocument(includinganyamendments)applies.
ISO9000:2015,QualitymanagementsystemsFundamentalsandvocabulary
3Termsanddefinitions
Forthepurposesofthisdocument,thetermsanddefinitionsgiveninISO9000:2015apply.

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4Contextoftheorganization

4.1Understandingtheorganizationanditscontext
The organization shall determine external and internal issues that are relevant to its purpose and its
strategicdirectionandthataffectitsabilitytoachievetheintendedresult(s)ofitsqualitymanagement
system.
Theorganizationshallmonitorandreviewinformationabouttheseexternalandinternalissues.
NOTE1Issuescanincludepositiveandnegativefactorsorconditionsforconsideration.

NOTE 2 Understanding the external context can be facilitated by considering issues arising from legal,
technological, competitive, market, cultural, social and economic environments, whether international, national,
regionalorlocal.

NOTE3Understandingtheinternalcontextcanbefacilitatedbyconsideringissuesrelatedtovalues,culture,
knowledgeandperformanceoftheorganization.

4.2Understandingtheneedsandexpectationsofinterestedparties
Duetotheireffectorpotentialeffectontheorganizationsabilitytoconsistentlyprovideproductsand
services that meet customer and applicable statutory and regulatory requirements, the organization
shalldetermine:
a) theinterestedpartiesthatarerelevanttothequalitymanagementsystem;

b) therequirementsoftheseinterestedpartiesthatarerelevanttothequalitymanagementsystem.

Theorganizationshallmonitorandreviewinformationabouttheseinterestedpartiesandtheir
relevantrequirements.

4.3Determiningthescopeofthequalitymanagementsystem
Theorganizationshalldeterminetheboundariesandapplicabilityofthequalitymanagementsystem
toestablishitsscope.
Whendeterminingthisscope,theorganizationshallconsider:
a) theexternalandinternalissuesreferredtoin4.1;

b) therequirementsofrelevantinterestedpartiesreferredtoin4.2;

c) theproductsandservicesoftheorganization.

TheorganizationshallapplyalltherequirementsofthisInternationalStandardiftheyareapplicable
withinthedeterminedscopeofitsqualitymanagementsystem.

The scope of the organizations quality management system shall be available and be maintained as
documentedinformation.Thescopeshallstatethetypesofproductsandservicescovered,andprovide
justificationforanyrequirementofthisInternationalStandardthattheorganizationdeterminesisnot
applicabletothescopeofitsqualitymanagementsystem.

ConformitytothisInternationalStandardmayonlybeclaimediftherequirementsdeterminedasnot
beingapplicabledonotaffecttheorganizationsabilityorresponsibilitytoensuretheconformityofits
productsandservicesandtheenhancementofcustomersatisfaction.

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4.4Qualitymanagementsystemanditsprocesses

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

Theorganizationshalldeterminetheprocessesneededforthequalitymanagementsystemandtheir
applicationthroughouttheorganization,andshall:
a) determinetheinputsrequiredandtheoutputsexpectedfromtheseprocesses;

b) determinethesequenceandinteractionoftheseprocesses;

c) determineandapplythecriteriaandmethods(includingmonitoring,measurementsandrelated
performanceindicators)neededtoensuretheeffectiveoperationandcontroloftheseprocesses;

d) determinetheresourcesneededfortheseprocessesandensuretheiravailability;

e) assigntheresponsibilitiesandauthoritiesfortheseprocesses;

f) addresstherisksandopportunitiesasdeterminedinaccordancewiththerequirementsof6.1;

g) evaluate these processes and implement any changes needed to ensure that these processes
achievetheirintendedresults;
h)improvetheprocessesandthequalitymanagementsystem.

4.4.2 Totheextentnecessary,theorganizationshall:

a) maintaindocumentedinformationtosupporttheoperationofitsprocesses;

b) retaindocumentedinformationtohaveconfidencethattheprocessesarebeingcarriedoutas
planned.

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5Leadership

5.1Leadershipandcommitment

5.1.1 General

Topmanagementshalldemonstrateleadershipandcommitmentwithrespecttothe
qualitymanagementsystemby:
a) takingaccountabilityfortheeffectivenessofthequalitymanagementsystem;

b) ensuringthatthequalitypolicyandqualityobjectivesareestablishedforthequalitymanagement
systemandarecompatiblewiththecontextandstrategicdirectionoftheorganization;

c) ensuringtheintegrationofthequalitymanagementsystemrequirementsintotheorganizations
businessprocesses;

d) promotingtheuseoftheprocessapproachandriskbasedthinking;

e) ensuringthattheresourcesneededforthequalitymanagementsystemareavailable;

f) communicatingtheimportanceofeffectivequalitymanagementandofconformingtothequality
managementsystemrequirements;

g) ensuringthatthequalitymanagementsystemachievesitsintendedresults;

h) engaging,directingandsupportingpersonstocontributetotheeffectivenessofthequality
managementsystem;

i) promotingimprovement;

j) supportingotherrelevantmanagementrolestodemonstratetheirleadershipasitappliestotheir
areasofresponsibility.
NOTEReferencetobusinessinthisInternationalStandardcanbeinterpretedbroadlytomeanthoseactivities
thatarecoretothepurposesoftheorganizationsexistence,whethertheorganizationispublic,private,forprofit
ornotforprofit.

5.1.2 Customerfocus

Topmanagementshalldemonstrateleadershipandcommitmentwithrespecttocustomerfocus
byensuringthat:
a) customerandapplicablestatutoryandregulatoryrequirementsaredetermined,understoodand
consistentlymet;

b) therisksandopportunitiesthatcanaffectconformityofproductsandservicesandtheabilityto
enhancecustomersatisfactionaredeterminedandaddressed;

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
Topmanagementshallensurethattheresponsibilitiesandauthoritiesforrelevantrolesare
assigned,communicatedandunderstoodwithintheorganization.
Topmanagementshallassigntheresponsibilityandauthorityfor:

a) ensuring that the quality management system conforms to the requirements of this
InternationalStandard;

b) ensuringthattheprocessesaredeliveringtheirintendedoutputs;

c) reportingontheperformanceofthequalitymanagementsystemandonopportunitiesfor
improvement(see10.1),inparticulartotopmanagement;

d) ensuringthepromotionofcustomerfocusthroughouttheorganization;

e) ensuringthattheintegrityofthequalitymanagementsystemismaintainedwhenchangestothe
qualitymanagementsystemareplannedandimplemented.

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6Planning

6.1Actionstoaddressrisksandopportunities

6.1.1 When planning for the quality management system, the organization shall consider the issues
referredtoin4.1andtherequirementsreferredtoin 4.2anddeterminetherisksandopportunities
thatneedtobeaddressedto:
a) giveassurancethatthequalitymanagementsystemcanachieveitsintendedresult(s);

b) enhancedesirableeffects;

c) prevent,orreduce,undesiredeffects;

d) achieveimprovement.

6.1.2 Theorganizationshallplan:

a) actionstoaddresstheserisksandopportunities;

b) howto:

1) integrateandimplementtheactionsintoitsqualitymanagementsystemprocesses(see4.4);

2) evaluatetheeffectivenessoftheseactions.

Actionstakentoaddressrisksandopportunitiesshallbeproportionatetothepotentialimpactonthe
conformityofproductsandservices.
NOTE 1 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 by
informeddecision.
NOTE2Opportunitiescanleadtotheadoptionofnewpractices,launchingnewproducts,openingnewmarkets,
addressing new customers, building partnerships, using new technology and other desirable and viable
possibilitiestoaddresstheorganizationsoritscustomersneeds.

6.2 Qualityobjectivesandplanningtoachievethem

6.2.1Theorganizationshallestablishqualityobjectivesatrelevantfunctions,levelsandprocesses
neededforthequalitymanagementsystem.
Thequalityobjectivesshall:
a) beconsistentwiththequalitypolicy;

b) bemeasurable;

c) takeintoaccountapplicablerequirements;

d) berelevanttoconformityofproductsandservicesandtoenhancementofcustomersatisfaction;

e) bemonitored;

f) becommunicated;

g) beupdatedasappropriate.
Theorganizationshallmaintaindocumentedinformationonthequalityobjectives.
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6.2.2 Whenplanninghowtoachieveitsqualityobjectives,theorganizationshalldetermine:

a) whatwillbedone;

b) whatresourceswillberequired;

c) whowillberesponsible;

d) whenitwillbecompleted;

e) howtheresultswillbeevaluated.

6.3 Planningofchanges
Whentheorganizationdeterminestheneedforchangestothequalitymanagementsystem,the
changesshallbecarriedoutinaplannedmanner(see4.4).

Theorganizationshallconsider:
a) thepurposeofthechangesandtheirpotentialconsequences;

b) theintegrityofthequalitymanagementsystem;

c) theavailabilityofresources;

d) theallocationorreallocationofresponsibilitiesandauthorities.

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7Support

7.1Resources

7.1.1 General

Theorganizationshalldetermineandprovidetheresourcesneededfortheestablishment,
implementation,maintenanceandcontinualimprovementofthequalitymanagementsystem.
Theorganizationshallconsider:
a) thecapabilitiesof,andconstraintson,existinginternalresources;

b) whatneedstobeobtainedfromexternalproviders.

7.1.2 People

Theorganizationshalldetermineandprovidethepersonsnecessaryfortheeffectiveimplementation
ofitsqualitymanagementsystemandfortheoperationandcontrolofitsprocesses.

7.1.3 Infrastructure

Theorganizationshalldetermine,provideandmaintaintheinfrastructurenecessaryfortheoperation
ofitsprocessesandtoachieveconformityofproductsandservices.
NOTE Infrastructurecaninclude:

a) buildingsandassociatedutilities;

b) equipment,includinghardwareandsoftware;

c) transportationresources;

d) informationandcommunicationtechnology.

7.1.4 Environmentfortheoperationofprocesses

Theorganizationshalldetermine,provideandmaintaintheenvironmentnecessaryfortheoperation
ofitsprocessesandtoachieveconformityofproductsandservices.
NOTE Asuitableenvironmentcanbeacombinationofhumanandphysicalfactors,suchas:

a) social(e.g.nondiscriminatory,calm,nonconfrontational);

b) psychological(e.g.stressreducing,burnoutprevention,emotionallyprotective);

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

Thesefactorscandiffersubstantiallydependingontheproductsandservicesprovided.

7.1.5 Monitoringandmeasuringresources

7.1.5.1 General

Theorganizationshalldetermineandprovidetheresourcesneededtoensurevalidandreliableresults
when monitoring or measuring is used to verify the conformity of products and services to
requirements.

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Theorganizationshallensurethattheresourcesprovided:
a) aresuitableforthespecifictypeofmonitoringandmeasurementactivitiesbeingundertaken;

b) aremaintainedtoensuretheircontinuingfitnessfortheirpurpose.

Theorganizationshallretainappropriatedocumentedinformationasevidenceoffitnessforpurpose
ofthemonitoringandmeasurementresources.

7.1.5.2 Measurementtraceability

Whenmeasurementtraceabilityisarequirement,orisconsideredbytheorganizationtobeanessential
partofprovidingconfidenceinthevalidityofmeasurementresults,measuringequipmentshallbe:

a) calibrated or verified, or both, at specified intervals, or prior to use, against measurement

standardstraceabletointernationalornationalmeasurementstandards;whennosuchstandards
exist,thebasisusedforcalibrationorverificationshallberetainedasdocumentedinformation;

b) identifiedinordertodeterminetheirstatus;

c) safeguarded from adjustments, damage or deterioration that would invalidate the

calibrationstatusandsubsequentmeasurementresults.

The organization shall determine if the validity of previous measurement results has been adversely
affected when measuring equipment is found to be unfit for its intended purpose, and shall take
appropriateactionasnecessary.

7.1.6 Organizationalknowledge

Theorganizationshalldeterminetheknowledgenecessaryfortheoperationofitsprocessesand
toachieveconformityofproductsandservices.
Thisknowledgeshallbemaintainedandbemadeavailabletotheextentnecessary.

Whenaddressingchangingneedsandtrends,theorganizationshallconsideritscurrentknowledge
anddeterminehowtoacquireoraccessanynecessaryadditionalknowledgeandrequiredupdates.
NOTE1Organizationalknowledgeisknowledgespecifictotheorganization;itisgenerallygainedby
experience.Itisinformationthatisusedandsharedtoachievetheorganizationsobjectives.

NOTE2Organizationalknowledgecanbebasedon:

a) internalsources(e.g.intellectualproperty;knowledgegainedfromexperience;lessonslearnedfromfailures
and successful projects; capturing and sharing undocumented knowledge and experience; the results of
improvementsinprocesses,productsandservices);

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

7.2Competence
Theorganizationshall:

a) determinethenecessarycompetenceofperson(s)doingworkunderitscontrolthataffectsthe
performanceandeffectivenessofthequalitymanagementsystem;

b) ensurethatthesepersonsarecompetentonthebasisofappropriateeducation,training,or
experience;

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c) whereapplicable,takeactionstoacquirethenecessarycompetence,andevaluatetheeffectiveness
oftheactionstaken;

d) retainappropriatedocumentedinformationasevidenceofcompetence.
NOTEApplicableactionscaninclude,forexample,theprovisionoftrainingto,thementoringof,orthere
assignmentofcurrentlyemployedpersons;orthehiringorcontractingofcompetentpersons.

7.3Awareness
Theorganizationshallensurethatpersonsdoingworkundertheorganizationscontrolareawareof:
a) thequalitypolicy;

b) relevantqualityobjectives;

c) theircontributiontotheeffectivenessofthequalitymanagementsystem,includingthebenefitsof
improvedperformance;

d) theimplicationsofnotconformingwiththequalitymanagementsystemrequirements.

7.4Communication
Theorganizationshalldeterminetheinternalandexternalcommunicationsrelevanttothequality
managementsystem,including:
a) onwhatitwillcommunicate;

b) whentocommunicate;

c) withwhomtocommunicate;

d) howtocommunicate;

e) whocommunicates.

7.5Documentedinformation

7.5.1 General
Theorganizationsqualitymanagementsystemshallinclude:
a) documentedinformationrequiredbythisInternationalStandard;

b) documented information determined by the organization as being necessary for the

effectivenessofthequalitymanagementsystem.
NOTETheextentofdocumentedinformationforaqualitymanagementsystemcandifferfromoneorganization
toanotherdueto:

thesizeoforganizationanditstypeofactivities,processes,productsandservices;

thecomplexityofprocessesandtheirinteractions;

thecompetenceofpersons.

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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

7.5.3.1DocumentedinformationrequiredbythequalitymanagementsystemandbythisInternational
Standardshallbecontrolledtoensure:
a)itisavailableandsuitableforuse,whereandwhenitisneeded;
b)itisadequatelyprotected(e.g.fromlossofconfidentiality,improperuse,orlossofintegrity).

7.5.3.2Forthecontrolofdocumentedinformation,theorganizationshalladdressthefollowing
activities,asapplicable:
a) distribution,access,retrievalanduse;

b) storageandpreservation,includingpreservationoflegibility;

c) controlofchanges(e.g.versioncontrol);

d) retentionanddisposition.

Documented information of external origin determined by the organization to be necessary for the
planning and operation of the quality management system shall be identified as appropriate, and be
controlled.
Documentedinformationretainedasevidenceofconformityshallbeprotectedfromunintended
alterations.
NOTEAccesscanimplyadecisionregardingthepermissiontoviewthedocumentedinformationonly,orthe
permissionandauthoritytoviewandchangethedocumentedinformation.

8Operation

8.1Operationalplanningandcontrol
The organization shall plan, implement and control the processes (see 4.4) needed to meet the
requirementsforthe provisionof products and services, and to implement the actions determined in
Clause6,by:
a)determiningtherequirementsfortheproductsandservices;
b)establishingcriteriafor:
1)theprocesses;
2)theacceptanceofproductsandservices;
c)determiningtheresourcesneededtoachieveconformitytotheproductandservicerequirements;

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d) implementingcontroloftheprocessesinaccordancewiththecriteria;

e) determining,maintainingandretainingdocumentedinformationtotheextentnecessary:

1) tohaveconfidencethattheprocesseshavebeencarriedoutasplanned;

2) todemonstratetheconformityofproductsandservicestotheirrequirements.
Theoutputofthisplanningshallbesuitablefortheorganizationsoperations.
Theorganizationshallcontrolplannedchangesandreviewtheconsequencesofunintended
changes,takingactiontomitigateanyadverseeffects,asnecessary.
Theorganizationshallensurethatoutsourcedprocessesarecontrolled(see8.4).

8.2Requirementsforproductsandservices

8.2.1 Customercommunication
Communicationwithcustomersshallinclude:
a) providinginformationrelatingtoproductsandservices;

b) handlingenquiries,contractsororders,includingchanges;

c) obtainingcustomerfeedbackrelatingtoproductsandservices,includingcustomercomplaints;

d) handlingorcontrollingcustomerproperty;

e) establishingspecificrequirementsforcontingencyactions,whenrelevant.

8.2.2 Determiningtherequirementsforproductsandservices

Whendeterminingtherequirementsfortheproductsandservicestobeofferedtocustomers,
theorganizationshallensurethat:
a) therequirementsfortheproductsandservicesaredefined,including:

1) anyapplicablestatutoryandregulatoryrequirements;

2) thoseconsiderednecessarybytheorganization;

b) theorganizationcanmeettheclaimsfortheproductsandservicesitoffers.

8.2.3 Reviewoftherequirementsforproductsandservices

8.2.3.1Theorganizationshallensurethatithastheabilitytomeettherequirementsforproductsand
services to be offered to customers. The organization shall conduct a review before committing to
supplyproductsandservicestoacustomer,toinclude:

a) requirementsspecifiedbythecustomer,includingtherequirementsfordeliveryandpost
deliveryactivities;

b) requirementsnotstatedbythecustomer,butnecessaryforthespecifiedorintendeduse,when
known;

c) requirementsspecifiedbytheorganization;

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d) statutoryandregulatoryrequirementsapplicabletotheproductsandservices;

e) contractororderrequirementsdifferingfromthosepreviouslyexpressed.
Theorganizationshallensurethatcontractororderrequirementsdifferingfromthosepreviously
definedareresolved.
Thecustomersrequirementsshallbeconfirmedbytheorganizationbeforeacceptance,whenthe
customerdoesnotprovideadocumentedstatementoftheirrequirements.
NOTEInsomesituations,suchasinternetsales,aformalreviewisimpracticalforeachorder.Instead,thereview
cancoverrelevantproductinformation,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 relevant
persons are made aware of the changed requirements, when the requirements for products and
servicesarechanged.

8.3 Designanddevelopmentofproductsandservices

8.3.1 General

Theorganizationshallestablish,implementandmaintainadesignanddevelopmentprocessthat
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) thelevelofcontrolexpectedforthedesignanddevelopmentprocessbycustomersandother
relevantinterestedparties;

j) the documented information needed to demonstrate that design and development

requirementshavebeenmet.

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8.3.3 Designanddevelopmentinputs

Theorganizationshalldeterminetherequirementsessentialforthespecifictypesofproductsand
servicestobedesignedanddeveloped.Theorganizationshallconsider:
a) functionalandperformancerequirements;
b) informationderivedfromprevioussimilardesignanddevelopmentactivities;

c) statutoryandregulatoryrequirements;

d) standardsorcodesofpracticethattheorganizationhascommittedtoimplement;

e) potentialconsequencesoffailureduetothenatureoftheproductsandservices.Inputs
shallbeadequatefordesignanddevelopmentpurposes,completeandunambiguous.
Conflictingdesignanddevelopmentinputsshallberesolved.

Theorganizationshallretaindocumentedinformationondesignanddevelopmentinputs.

8.3.4 Designanddevelopmentcontrols

Theorganizationshallapplycontrolstothedesignanddevelopmentprocesstoensurethat:
a) theresultstobeachievedaredefined;

b) reviewsareconductedtoevaluatetheabilityoftheresultsofdesignanddevelopmenttomeet
requirements;

c) verificationactivitiesareconductedtoensurethatthedesignanddevelopmentoutputsmeetthe
inputrequirements;

d) validationactivitiesareconductedtoensurethattheresultingproductsandservicesmeetthe
requirementsforthespecifiedapplicationorintendeduse;

e) anynecessaryactionsaretakenonproblemsdeterminedduringthereviews,orverificationand
validationactivities;

f) documentedinformationoftheseactivitiesisretained.
NOTEDesignanddevelopmentreviews,verificationandvalidationhavedistinctpurposes.Theycanbeconducted
separatelyorinanycombination,asissuitablefortheproductsandservicesoftheorganization.

8.3.5 Designanddevelopmentoutputs
Theorganizationshallensurethatdesignanddevelopmentoutputs:
a) meettheinputrequirements;

b) areadequateforthesubsequentprocessesfortheprovisionofproductsandservices;

c) includeorreferencemonitoringandmeasuringrequirements,asappropriate,andacceptancecriteria;

d) specify the characteristics of the products and services that are essential for their intended
purposeandtheirsafeandproperprovision.
Theorganizationshallretaindocumentedinformationondesignanddevelopmentoutputs.

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8.3.6 Designanddevelopmentchanges

Theorganizationshallidentify,reviewandcontrolchangesmadeduring,orsubsequentto,thedesign
and developmentofproductsandservices,totheextentnecessarytoensurethatthereisnoadverse
impactonconformitytorequirements.
Theorganizationshallretaindocumentedinformation
on:
a) designanddevelopmentchanges;

b) theresultsofreviews;
c) theauthorizationofthechanges;

d) theactionstakentopreventadverseimpacts.

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8.4Controlofexternallyprovidedprocesses,productsandservices

8.4.1 General

Theorganizationshallensurethatexternallyprovidedprocesses,productsandservicesconformto
requirements.
Theorganizationshalldeterminethecontrolstobeappliedtoexternallyprovidedprocesses,products
andserviceswhen:
a) products and services from external providers are intended for incorporation into the
organizationsownproductsandservices;

b) productsandservicesareprovideddirectlytothecustomer(s)byexternalprovidersonbehalfof
theorganization;

c) aprocess,orpartofaprocess,isprovidedbyanexternalproviderasaresultofadecisionbythe
organization.

The organization shall determine and apply criteria for the evaluation, selection, monitoring of
performance, and reevaluation of external providers, based on their ability to provide processes or
products and services in accordance with requirements. The organization shall retain documented
informationoftheseactivitiesandanynecessaryactionsarisingfromtheevaluations.

8.4.2 Typeandextentofcontrol

The organization shall ensure that externally provided processes, products and services do not
adverselyaffecttheorganizationsabilitytoconsistentlydeliverconformingproductsandservicestoits
customers.
Theorganizationshall:
a) ensurethatexternallyprovidedprocessesremainwithinthecontrolofitsqualitymanagement
system;

b) define both the controls that it intends to apply to an external provider and those it intends to
applytotheresultingoutput;

c) takeintoconsideration:

1) the potential impact of the externally provided processes, products and services on the
organizations ability to consistently meet customer and applicable statutory and regulatory
requirements;

2) theeffectivenessofthecontrolsappliedbytheexternalprovider;

d) determinetheverification,orotheractivities,necessarytoensurethattheexternallyprovided
processes,productsandservicesmeetrequirements.

8.4.3 Informationforexternalproviders

Theorganizationshallensuretheadequacyofrequirementspriortotheircommunicationtothe
externalprovider.
Theorganizationshallcommunicatetoexternalprovidersitsrequirementsfor:
a) theprocesses,productsandservicestobeprovided;

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b) theapprovalof:

1) productsandservices;

2) methods,processesandequipment;

3) thereleaseofproductsandservices;

c) competence,includinganyrequiredqualificationofpersons;

d) theexternalprovidersinteractionswiththeorganization;

e) controlandmonitoringoftheexternalprovidersperformancetobeappliedbytheorganization;

f) verificationorvalidationactivitiesthattheorganization,oritscustomer,intendstoperformatthe
externalproviderspremises.

8.5 Productionandserviceprovision

8.5.1 Controlofproductionandserviceprovision
Theorganizationshallimplementproductionandserviceprovisionundercontrolledconditions.
Controlledconditionsshallinclude,asapplicable:
a) theavailabilityofdocumentedinformationthatdefines:

1) thecharacteristicsoftheproductstobeproduced,theservicestobeprovided,ortheactivities
tobeperformed;

2) theresultstobeachieved;

b) theavailabilityanduseofsuitablemonitoringandmeasuringresources;

c) theimplementationofmonitoringandmeasurementactivitiesat appropriatestagestoverifythat
criteriaforcontrolofprocessesoroutputs,andacceptancecriteriaforproductsandservices,have
beenmet;

d) theuseofsuitableinfrastructureandenvironmentfortheoperationofprocesses;

e) theappointmentofcompetentpersons,includinganyrequiredqualification;

f) thevalidation,andperiodicrevalidation,oftheabilitytoachieveplannedresultsoftheprocesses
forproductionandserviceprovision,wheretheresultingoutputcannotbeverifiedbysubsequent
monitoringormeasurement;

g) theimplementationofactionstopreventhumanerror;

h) theimplementationofrelease,deliveryandpostdeliveryactivities.

8.5.2 Identificationandtraceability

Theorganizationshallusesuitablemeanstoidentifyoutputswhenitisnecessarytoensurethe
conformityofproductsandservices.
Theorganizationshallidentifythestatusofoutputswithrespecttomonitoringandmeasurement
requirementsthroughoutproductionandserviceprovision.
Theorganizationshallcontroltheuniqueidentificationoftheoutputswhentraceabilityisa
requirement,andshallretainthedocumentedinformationnecessarytoenabletraceability.
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8.5.3 Propertybelongingtocustomersorexternalproviders

Theorganizationshallexercisecarewithpropertybelongingtocustomersorexternalproviderswhile
itisundertheorganizationscontrolorbeingusedbytheorganization.
Theorganizationshallidentify,verify,protectandsafeguardcustomersorexternalprovidersproperty
providedforuseorincorporationintotheproductsandservices.

When the property of a customer or external provider is lost, damaged or otherwise found to be
unsuitable for use, the organization shall report this to the customer or external provider and retain
documentedinformationonwhathasoccurred.
NOTEAcustomersorexternalproviderspropertycanincludematerials,components,toolsandequipment,
premises,intellectualpropertyandpersonaldata.

8.5.4 Preservation

Theorganizationshallpreservetheoutputsduringproductionandserviceprovision,tothe
extentnecessarytoensureconformitytorequirements.
NOTEPreservationcanincludeidentification,handling,contaminationcontrol,packaging,storage,transmission
ortransportation,andprotection.

8.5.5 Postdeliveryactivities

Theorganizationshallmeetrequirementsforpostdeliveryactivitiesassociatedwiththeproducts
andservices.
Indeterminingtheextentofpostdeliveryactivitiesthatarerequired,theorganizationshallconsider:
a) statutoryandregulatoryrequirements;

b) thepotentialundesiredconsequencesassociatedwithitsproductsandservices;

c) thenature,useandintendedlifetimeofitsproductsandservices;

d) customerrequirements;

e) customerfeedback.
NOTEPostdeliveryactivitiescanincludeactionsunderwarrantyprovisions,contractualobligationssuchas
maintenanceservices,andsupplementaryservicessuchasrecyclingorfinaldisposal.

8.5.6 Controlofchanges

Theorganizationshallreviewandcontrolchangesforproductionorserviceprovision,totheextent
necessarytoensurecontinuingconformitywithrequirements.
Theorganizationshallretaindocumentedinformationdescribingtheresultsofthereviewofchanges,
theperson(s)authorizingthechange,andanynecessaryactionsarisingfromthereview.

8.6Releaseofproductsandservices
Theorganizationshallimplementplannedarrangements,atappropriatestages,toverifythatthe
productandservicerequirementshavebeenmet.

Thereleaseofproductsandservicestothecustomershallnotproceeduntiltheplannedarrangements
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have been satisfactorily completed, unless otherwise approved by a relevant authority and, as
applicable,bythecustomer.

Theorganizationshallretaindocumentedinformationonthereleaseofproductsandservices.The
documentedinformationshallinclude:
a) evidenceofconformitywiththeacceptancecriteria;

b) traceabilitytotheperson(s)authorizingtherelease.

8.7Controlofnonconformingoutputs

8.7.1Theorganizationshallensurethatoutputsthatdonotconformtotheirrequirementsare
identifiedandcontrolledtopreventtheirunintendeduseordelivery.

Theorganizationshalltakeappropriateactionbasedonthenatureofthenonconformityanditseffect
on the conformity of products and services. This shall also apply to nonconforming products and
servicesdetectedafterdeliveryofproducts,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.

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9Performanceevaluation

9.1Monitoring,measurement,analysisandevaluation

9.1.1 General

Theorganizationshalldetermine:
a) whatneedstobemonitoredandmeasured;

b) themethodsformonitoring,measurement,analysisandevaluationneededtoensurevalidresults;

c) whenthemonitoringandmeasuringshallbeperformed;

d) whentheresultsfrommonitoringandmeasurementshallbeanalysedandevaluated.

Theorganizationshallevaluatetheperformanceandtheeffectivenessofthequalitymanagement
system.Theorganizationshallretainappropriatedocumentedinformationasevidenceoftheresults.

9.1.2 Customersatisfaction

The organization shall monitor customers perceptions of the degree to which their needs and
expectations have been fulfilled. The organization shall determine the methods for obtaining,
monitoringandreviewingthisinformation.
NOTE Examples of monitoring customer perceptions can include customer surveys, customer feedback on
deliveredproductsandservices,meetingswithcustomers,marketshareanalysis,compliments,warrantyclaims
anddealerreports.

9.1.3 Analysisandevaluation

Theorganizationshallanalyseandevaluateappropriatedataandinformationarisingfrommonitoring
andmeasurement.
Theresultsofanalysisshallbeusedtoevaluate:
a) conformityofproductsandservices;

b) thedegreeofcustomersatisfaction;

c) theperformanceandeffectivenessofthequalitymanagementsystem;

d) ifplanninghasbeenimplementedeffectively;

e) theeffectivenessofactionstakentoaddressrisksandopportunities;

f) theperformanceofexternalproviders;

g) theneedforimprovementstothequalitymanagementsystem.
NOTE Methodstoanalysedatacanincludestatisticaltechniques.

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ISO9001:2015(ExtractfromStandardforTrainingpurpose)

9.2Internalaudit

9.2.1Theorganizationshallconductinternalauditsatplannedintervalstoprovideinformationon
whetherthequalitymanagementsystem:
a)conformsto:

1)theorganizationsownrequirementsforitsqualitymanagementsystem;
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 the
importance of the processes concerned, changes affecting the organization, and the results of
previousaudits;

b) definetheauditcriteriaandscopeforeachaudit;

c) selectauditorsandconductauditstoensureobjectivityandtheimpartialityoftheauditprocess;

d) ensurethattheresultsoftheauditsarereportedtorelevantmanagement;

e) takeappropriatecorrectionandcorrectiveactionswithoutunduedelay;
f) retaindocumentedinformationasevidenceoftheimplementationoftheauditprogrammeandthe
auditresults.
NOTE SeeISO19011forguidance.

9.3Managementreview

9.3.1 General

Top managementshallreviewtheorganizations qualitymanagementsystem,atplannedintervals,to

ensureits continuingsuitability, adequacy,effectiveness and alignment withthe strategic directionof
theorganization.

9.3.2 Managementreviewinputs

Themanagementreviewshallbeplannedandcarriedouttakingintoconsideration:
a) thestatusofactionsfrompreviousmanagementreviews;

b) changesinexternalandinternalissuesthatarerelevanttothequalitymanagementsystem;

c) informationontheperformanceandeffectivenessofthequalitymanagementsystem,including
trendsin:

1) customersatisfactionandfeedbackfromrelevantinterestedparties;

2) theextenttowhichqualityobjectiveshavebeenmet;

3) processperformanceandconformityofproductsandservices;

4) nonconformitiesandcorrectiveactions;

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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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10Improvement

10.1General
Theorganizationshalldetermineandselectopportunitiesforimprovementandimplementany
necessaryactionstomeetcustomerrequirementsandenhancecustomersatisfaction.
Theseshallinclude:

a) improvingproductsandservicestomeetrequirementsaswellastoaddressfutureneedsand
expectations;

b) correcting,preventingorreducingundesiredeffects;

c) improvingtheperformanceandeffectivenessofthequalitymanagementsystem.
NOTEExamplesofimprovementcanincludecorrection,correctiveaction,continualimprovement,breakthrough
change,innovationandreorganization.

10.2Nonconformityandcorrectiveaction

10.2.1Whenanonconformityoccurs,includinganyarisingfromcomplaints,theorganizationshall:
a) reacttothenonconformityand,asapplicable:

1) takeactiontocontrolandcorrectit;

2) dealwiththeconsequences;

b) evaluatetheneed for actionto eliminatethecause(s)ofthenonconformity,inorderthatitdoes

notrecuroroccurelsewhere,by:

1) reviewingandanalysingthenonconformity;

2) determiningthecausesofthenonconformity;

3) determiningifsimilarnonconformitiesexist,orcouldpotentiallyoccur;

c) implementanyactionneeded;

d) reviewtheeffectivenessofanycorrectiveactiontaken;

e) updaterisksandopportunitiesdeterminedduringplanning,ifnecessary;

f) makechangestothequalitymanagementsystem,ifnecessary.
Correctiveactionsshallbeappropriatetotheeffectsofthenonconformitiesencountered.

10.2.2Theorganizationshallretaindocumentedinformationasevidenceof:
a) thenatureofthenonconformitiesandanysubsequentactionstaken;

b) theresultsofanycorrectiveaction.

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ISO9001:2015(ExtractfromStandardforTrainingpurpose)

10.3Continualimprovement
Theorganizationshallcontinuallyimprovethesuitability,adequacyandeffectivenessofthequality
managementsystem.

The organization shall consider the results of analysis and evaluation, and the outputs from
managementreview,todetermineifthereareneedsoropportunitiesthatshallbeaddressedaspartof
continualimprovement.

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AnnexA
(informative)

Clarificationofnewstructure,terminologyandconcepts

A.1Structureandterminology
The clause structure (i.e. clause sequence) and some of the terminology of this edition of this
InternationalStandard,incomparisonwiththepreviousedition(ISO9001:2008),havebeenchanged
toimprovealignmentwithothermanagementsystemsstandards.
ThereisnorequirementinthisInternationalStandardforitsstructureandterminologytobeapplied
tothedocumentedinformationofanorganizationsqualitymanagementsystem.

Thestructureofclausesisintendedtoprovideacoherentpresentationofrequirements,ratherthana
modelfordocumentinganorganizationspolicies,objectivesandprocesses.Thestructureandcontent
ofdocumentedinformationrelatedtoaqualitymanagementsystemcanoftenbemorerelevanttoits
users if it relatesto both theprocessesoperated bythe organization and information maintained for
otherpurposes.

Thereisnorequirementforthetermsusedbyanorganizationtobereplacedbythetermsusedinthis
InternationalStandardtospecifyqualitymanagementsystemrequirements.Organizationscanchoose
to use terms which suit their operations (e.g. using records, documentation or protocols rather
thandocumentedinformation;orsupplier,partnerorvendorratherthanexternalprovider).
Table A.1 shows the major differences in terminology between this edition of this International
Standardandthepreviousedition.

TableA.1MajordifferencesinterminologybetweenISO9001:2008andISO9001:2015
ISO9001:2008 ISO9001:2015
Products Productsandservices
Exclusions Notused
(SeeClauseA.5forclarificationofapplicability)
Managementrepresentative Notused
(Similarresponsibilitiesandauthoritiesareassigned
butnorequirementforasinglemanagementrepre
sentative)
Documentation,qualitymanual,documentedpro Documentedinformation
cedures,records
Workenvironment Environmentfortheoperationofprocesses
Monitoringandmeasuringequipment Monitoringandmeasuringresources
Purchasedproduct Externallyprovidedproductsandservices
Supplier Externalprovider

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A.2Productsandservices
ISO9001:2008usedthetermproducttoincludealloutputcategories.ThiseditionofthisInternational
Standardusesproductsandservices.Productsandservicesincludealloutputcategories(hardware,
services,softwareandprocessedmaterials).

The specific inclusion of services is intended to highlight the differences between products and
servicesintheapplicationofsomerequirements.Thecharacteristicofservicesisthatatleastpart of
the output is realized at the interface with the customer. This means, for example, that conformity to
requirementscannotnecessarilybeconfirmedbeforeservicedelivery.

In most cases, products and services are used together. Most outputs that organizations provide to
customers, or are supplied to them by external providers, include both products and services. For
example,atangibleorintangibleproductcanhavesomeassociatedserviceoraservicecanhavesome
associatedtangibleorintangibleproduct.

A.3Understandingtheneedsandexpectationsofinterestedparties
Subclause4.2specifiesrequirementsfortheorganizationtodeterminetheinterestedpartiesthatare
relevanttothequalitymanagementsystemandtherequirementsofthoseinterestedparties.However,
4.2 does not imply extension of quality management system requirements beyond the scope of this
International Standard. As stated in the scope, this International Standard is applicable where an
organization needs to demonstrate its ability to consistently provide products and services that meet
customer and applicable statutory and regulatory requirements, and aims to enhance customer
satisfaction.

There is no requirement in this International Standard for the organization to consider interested
partieswhereithasdecidedthatthosepartiesarenotrelevanttoitsqualitymanagementsystem.Itis
fortheorganizationtodecideifaparticularrequirementofarelevantinterestedpartyisrelevanttoits
qualitymanagementsystem.

A.4Riskbasedthinking
TheconceptofriskbasedthinkinghasbeenimplicitinpreviouseditionsofthisInternationalStandard,
e.g.throughrequirementsforplanning,reviewandimprovement.ThisInternationalStandardspecifies
requirementsfortheorganizationtounderstanditscontext(see4.1)anddeterminerisksasabasisfor
planning (see 6.1). This represents the application of risk based thinking to planning and
implementingqualitymanagementsystemprocesses(see4.4)andwillassistindeterminingtheextent
ofdocumentedinformation.

Oneofthekeypurposesofaqualitymanagementsystemistoactasapreventivetool.Consequently,
this International Standard does not have a separate clause or subclause on preventive action. The
conceptofpreventiveactionisexpressedthroughtheuseofriskbasedthinkinginformulatingquality
managementsystemrequirements.

The riskbased thinking applied in this International Standard has enabled some reduction in
prescriptiverequirementsandtheirreplacementbyperformancebasedrequirements.Thereisgreater
flexibility than in ISO 9001:2008 in the requirements for processes, documented information and
organizationalresponsibilities.

Although6.1specifiesthattheorganizationshallplanactionstoaddressrisks,thereisnorequirement
forformalmethodsforriskmanagementoradocumentedriskmanagementprocess.Organizationscan
decidewhetherornottodevelopamoreextensiveriskmanagementmethodologythanisrequiredby
thisInternationalStandard,e.g.throughtheapplicationofotherguidanceorstandards.

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Notalltheprocessesofaqualitymanagementsystemrepresent thesamelevelofriskintermsofthe
organizations ability to meet its objectives, and the effects of uncertainty are not the same for all
organizations.Undertherequirementsof6.1,theorganizationisresponsibleforitsapplicationofrisk
basedthinkingandtheactionsittakestoaddressrisk,includingwhetherornottoretaindocumented
informationasevidenceofitsdeterminationofrisks.

A.5Applicability
This International Standard does not refer to exclusions in relation to the applicability of its
requirementstotheorganizationsqualitymanagementsystem.However,anorganizationcan review
the applicability of requirements due to the size or complexity of the organization, the management
modelitadopts,therangeoftheorganizationsactivitiesandthenatureoftherisksandopportunitiesit
encounters.

The requirements for applicability are addressed in 4.3, which defines conditions under which an
organizationcandecidethatarequirementcannotbeappliedtoanyoftheprocesseswithinthescope
ofitsqualitymanagementsystem.Theorganizationcanonlydecidethatarequirementisnotapplicable
ifitsdecisionwillnotresultinfailuretoachieveconformityofproductsandservices.

A.6Documentedinformation
Aspartofthealignmentwithothermanagementsystemstandards,acommonclauseondocumented
information has been adopted without significant change or addition (see 7.5). Where appropriate,
textelsewhereinthisInternationalStandardhasbeenalignedwithitsrequirements.Consequently,
documentedinformationisusedforalldocumentrequirements.
Where ISO 9001:2008 used specific terminology such as document or documented procedures,
qualitymanualorqualityplan,thiseditionofthisInternationalStandarddefinesrequirementsto
maintaindocumentedinformation.

Where ISO 9001:2008 used the term records to denote documents needed to provide evidence of
conformity with requirements, this is now expressed as a requirement to retain documented
information.Theorganizationisresponsiblefordeterminingwhatdocumentedinformationneedsto
beretained,theperiodoftimeforwhichitistoberetainedandthemediatobeusedforitsretention.

A requirement to maintain documented information does not exclude the possibility that the
organization might also need to retain that same documented information for a particular purpose,
e.g.toretainpreviousversionsofit.

WherethisInternationalStandardreferstoinformationratherthandocumentedinformation(e.g.in4.1:
Theorganizationshallmonitorandreviewtheinformationabouttheseexternalandinternalissues),there
isnorequirementthatthisinformationistobedocumented.Insuchsituations,theorganizationcandecide
whetherornotitisnecessaryorappropriatetomaintaindocumentedinformation.

A.7Organizationalknowledge
In 7.1.6, this International Standard addresses the need to determine and manage the knowledge
maintained by the organization, to ensure the operation of its processes and that it can achieve
conformityofproductsandservices.
Requirementsregardingorganizationalknowledgewereintroducedforthepurposeof:
a) safeguardingtheorganizationfromlossofknowledge,e.g.

throughstaffturnover;

failuretocaptureandshareinformation;
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b) encouragingtheorganizationtoacquireknowledge,e.g.

learningfromexperience;

mentoring;

benchmarking.

A.8Controlofexternallyprovidedprocesses,productsandservices
Allformsofexternallyprovidedprocesses,productsandservicesareaddressedin8.4,e.g.whether
through:
a) purchasingfromasupplier;

b) anarrangementwithanassociatecompany;

c) outsourcingprocessestoanexternalprovider.

Outsourcingalwayshastheessentialcharacteristicofaservice,sinceitwillhaveatleastoneactivity
necessarilyperformedattheinterfacebetweentheproviderandtheorganization.

Thecontrolsrequiredforexternalprovisioncanvarywidelydependingonthenatureoftheprocesses,
productsandservices.Theorganizationcanapplyriskbasedthinkingtodeterminethetypeandextent
of controls appropriate to particular external providers and externally provided processes, products
andservices.

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