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ISO9001inaNutshell

5Whysmethod

AsimpleoverviewoftheISO9001Standard

Helptoget9001

AnoverviewoftherequirementsofISO9001(2008version)in
plainEnglish.

ISO9001Kit
Makemeetingsuseful
PDSAcycle
Pickingaconsultant
RequirementsofISO9001

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4OverallRequirementsfortheSystem
4.1Setupyourqualitymanagementsystem:develop,useand
improveit.
4.2Documentyoursystemtosayhowitshouldwork.
4.2.1Writedocumentsincludingaqualitypolicy,objectives,
manual,proceduresandrecordsdecidewhatproceduresyou
needforyoursystemmustincludethoselistedbelow
4.2.2Haveaqualitymanual
4.2.3Controlyourdocumentstomakesuretheyareaccurate
andsuitable,includingaprocedure
4.2.4Manageyourrecords(whichshowyoursystemworksas
yousayitdoes)suitably,includingaprocedure.
5RequirementsforManagement
5.1Demonstrateyourcommitmenttothequalitymanagement
systemby
communicatingtopersonnelhowimportantqualityis
settingaqualitypolicyandobjectivesforyoursystem.
providingadequateresources(people,plant,equipment,IT
etc).
ensuringthereisadequateplanning
reviewinghowthesystemperforms.

5.2Focusoncustomers
Identifytheirrequirementsandaimtoenhancetheir
satisfaction.

5.3Writeaqualitypolicy.Useit.
Committomeetingrequirementsofthequalitysystemand
ISO9001,includingcontinualimprovement.
Makesureyoucommunicatethispolicyandthatit's
understood.

5.4Planforquality
5.4.1Setobjectives(aims/goals)thatyoucanmeasure.
5.4.2Havesuitableplanstoachievetheseobjectives

5.5Defineandcommunicate'whodoeswhat'
5.5.1Identifywhohaswhatresponsibilityandauthority
5.5.2Giveaseniormanagerresponsibilityforthequality
systemoverall
5.5.3Haveeffectivemethodsofinternalcommunication.

5.6Reviewyourqualitymanagementsystem(management
review)atregularintervals
5.6.1Reviewthesystemandperformance.
5.6.2Includeconsiderationof:customerfeedback,
performance,nonconformity,audits,actionsraised,changesand

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anyneedtoimprove
5.6.3Keeprecordsofoutcomesfromyourreviewsinclude
decisionsandactions.

6ResourceRequirements
6.1Decidewhatresourcesareneedforthesystem,andto
enhancecustomersatisfaction.Providethem.
6.2Makesurepeoplearecompetent:
6.2.1Includethisforanyonewhoseworkaffectswhetheryour
services/productsmeetrequirements
6.2.2Decidewhatcompetenciesareneededprovide
andmaintainthem
6.3Infrastructure:Decidewhatyouneed(tomeet
requirements).Provideitandmaintainit.
6.4Workenvironment:providewhatyouneedsothatyour
services/productsmeetrequiremnts.
7RequirementsforProductsorServices

7.1Plan
Plananddeveloptheprocessesneededforyour
products/services.

7.2Haveeffective'customerrelated'processes:
7.2.1Knowwhatrequirementsapplytoyourproducts/services
7.2.2Makesureyoucanmeetthem(ordon'ttaketheorder)
7.2.3Haveeffectivewaystocommunicatewithyourcustomers.

7.3Haveeffectiveprocessesfordesigning&developing
products/services
7.3.1Plandesign/development.
7.3.2Definewhatinputsareneededtodesign/create/develop
7.3.3Dothe'design'/planinsomeformthatenablesyouto
verifytheoutput(see7.3.5)
7.3.4Reviewthedesign/planatsuitablestages
7.3.5Makesuretheresultmeetstheagreed&defined
requirements(verification)
7.3.6Validatedesign(wherepracticable).
7.3.7Ifchangeshappenduringdesign,managethem.

7.4Controlwhatyoubuy,outsourceorsubcontract(goods,
materialsorservices)ifitaffectsyourservicesorproducts
7.4.1Makesurewhatyoubuymeetstherequirementsyou
specifiedassessandmonitoryoursuppliers/supplychain.
7.4.2Describewhatyouplantopurchase.
7.4.3Makesureitmeetsrequirements.

7.5Manageyouroperations
7.5.1Haveeffectivewaystocontrolwhatyoudo(providing
products/services)
7.5.2Validateproduction/serviceprovision(ifrequired).
7.5.3Identifyandtrackservices/products(whenappropriate)
7.5.4Takecareofanypropertysuppliedbyyourcustomers,
includingIPandconfidentialinformation
7.5.5Careforproducts/componentsduringstorage/delivery,
etc.tomakesuretheystayingoodcondition
7.6Controlmeasuringandmonitoringequipment
Whenmeasuring,makesureyourresultsarevalid.Identifywhat
equipmentandprocessesyouneedforthis.Choosesuitable
equipmentorinstruments.Makesuretheresultsareandstay
accurate.
8RequirementsforAnalysisandImprovement
8.1Haveprocessessuitabletoensureyourservices/products
meetallrelevantrequirements(customer,yours,contractual,
legal,etc).includeimprovement.


8.2Monitorandmeasureprocessesandservices/products(as
necessary)tocheckyougottheresultsyouwanted:
8.2.1Monitorcustomerperceptionofsatisfaction.
8.2.2Planandimplementasuitableprogramofinternalsystem
audits,includingaprocedure
8.2.3Havesuitablemethodstomonitor/measureyour
processes.
8.2.4Monitorandmeasureproducts/servicesatsuitablestages.
Releasethefinalonlywhenallrequirementsaremet.
8.3Controlnonconformity(services/productsnotmeeting
requirements)insuitableways,includingawrittenprocedure.

8.4Collectandanalyseinformation
Decidewhatinformationisneededtotellyouhowyoursystemis
workingandforimprovement.
Collect,analyseanduseit.

8.5Continuallyimprove.
8.5.1Improveyoursystem.
8.5.2Haveasystematicapproachtofixnonconformityandstop
itrecurring,includingaprocedure.
8.5.3Haveasystematicapproachtopreventpotential
nonconformityorfailureshappening,includingaprocedure.

Note:thenumberscorrespondtotheclausenumbersinthe
Standard.Theystartat#4sincetherequirementsthemselves
areinsections4to8oftheStandard.

Disclaimer:Thisisasimplifiedsummaryonly.No
representationorwarrantyismadefortheaccuracyorthe
completenessofthecontents.Wespecificallydisclaimany
impliedwarrantiesorfitnessforanyparticularpurposeandwill
notbeliableforanylossofprofitoranyothercommercial
damageasaresultofyouractingorrelyinguponanyofthis
information.
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