ISO9001：2015 English Version

ISO90012015QUALITYMANAGEMENTSYSTEMSREQUIREMENTSINTRODUCTION01GENERALTHEADOPTIONOFAQUALITYMANAGEMENTSYSTEMISASTRATEGICDECISIONFORANORGANIZATIONTHATCANHELPTOIMPROVEITSOVERALLPERFORMANCEANDPROVIDEASOUNDBASISFORSUSTAINABLEDEVELOPMENTINITIATIVESTHEPOTENTIALBENEFITSTOANORGANIZATIONOFIMPLEMENTINGAQUALITYMANAGEMENTSYSTEMBASEDONTHISINTERNATIONALSTANDARDAREATHEABILITYTOCONSISTENTLYPROVIDEPRODUCTSANDSERVICESTHATMEETCUSTOMERANDAPPLICABLESTATUTORYANDREGULATORYREQUIREMENTSBFACILITATINGOPPORTUNITIESTOENHANCECUSTOMERSATISFACTIONCADDRESSINGRISKSANDOPPORTUNITIESASSOCIATEDWITHITSCONTEXTANDOBJECTIVESDTHEABILITYTODEMONSTRATECONFORMITYTOSPECIFIEDQUALITYMANAGEMENTSYSTEMREQUIREMENTSTHISINTERNATIONALSTANDARDCANBEUSEDBYINTERNALANDEXTERNALPARTIESITISNOTTHEINTENTOFTHISINTERNATIONALSTANDARDTOIMPLYTHENEEDFORUNIFORMITYINTHESTRUCTUREOFDIFFERENTQUALITYMANAGEMENTSYSTEMSALIGNMENTOFDOCUMENTATIONTOTHECLAUSESTRUCTUREOFTHISINTERNATIONALSTANDARDTHEUSEOFTHESPECIFICTERMINOLOGYOFTHISINTERNATIONALSTANDARDWITHINTHEORGANIZATIONTHEQUALITYMANAGEMENTSYSTEMREQUIREMENTSSPECIFIEDINTHISINTERNATIONALSTANDARDARECOMPLEMENTARYTOREQUIREMENTSFORPRODUCTSANDSERVICESTHISINTERNATIONALSTANDARDEMPLOYSTHEPROCESSAPPROACH,WHICHINCORPORATESTHEPLANDOCHECKACTPDCACYCLEANDRISKBASEDTHINKINGTHEPROCESSAPPROACHENABLESANORGANIZATIONTOPLANITSPROCESSESANDTHEIRINTERACTIONSTHEPDCACYCLEENABLESANORGANIZATIONTOENSURETHATITSPROCESSESAREADEQUATELYRESOURCEDANDMANAGED,ANDTHATOPPORTUNITIESFORIMPROVEMENTAREDETERMINEDANDACTEDONRISKBASEDTHINKINGENABLESANORGANIZATIONTODETERMINETHEFACTORSTHATCOULDCAUSEITSPROCESSESANDITSQUALITYMANAGEMENTSYSTEMTODEVIATEFROMTHEPLANNEDRESULTS,TOPUTINPLACEPREVENTIVECONTROLSTOMINIMIZENEGATIVEEFFECTSANDTOMAKEMAXIMUMUSEOFOPPORTUNITIESASTHEYARISESEECLAUSEA4CONSISTENTLYMEETINGREQUIREMENTSANDADDRESSINGFUTURENEEDSANDEXPECTATIONSPOSESACHALLENGEFORORGANIZATIONSINANINCREASINGLYDYNAMICANDCOMPLEXENVIRONMENTTOACHIEVETHISOBJECTIVE,THEORGANIZATIONMIGHTFINDITNECESSARYTOADOPTVARIOUSFORMSOFIMPROVEMENTINADDITIONTOCORRECTIONANDCONTINUALIMPROVEMENT,SUCHASBREAKTHROUGHCHANGE,INNOVATIONANDREORGANIZATIONINTHISINTERNATIONALSTANDARD,THEFOLLOWINGVERBALFORMSAREUSED“SHALL”INDICATESAREQUIREMENT“SHOULD”INDICATESARECOMMENDATION“MAY”INDICATESAPERMISSION“CAN”INDICATESAPOSSIBILITYORACAPABILITYINFORMATIONMARKEDAS“NOTE”ISFORGUIDANCEINUNDERSTANDINGORCLARIFYINGTHEASSOCIATEDREQUIREMENT02QUALITYMANAGEMENTPRINCIPLESTHISINTERNATIONALSTANDARDISBASEDONTHEQUALITYMANAGEMENTPRINCIPLESDESCRIBEDINISO9000THEDESCRIPTIONSINCLUDEASTATEMENTOFEACHPRINCIPLE,ARATIONALEOFWHYTHEPRINCIPLEISIMPORTANTFORTHEORGANIZATION,SOMEEXAMPLESOFBENEFITSASSOCIATEDWITHTHEPRINCIPLEANDEXAMPLESOFTYPICALACTIONSTOIMPROVETHEORGANIZATIONSPERFORMANCEWHENAPPLYINGTHEPRINCIPLETHEQUALITYMANAGEMENTPRINCIPLESARECUSTOMERFOCUSLEADERSHIPENGAGEMENTOFPEOPLEPROCESSAPPROACHIMPROVEMENTEVIDENCEBASEDDECISIONMAKINGRELATIONSHIPMANAGEMENT03PROCESSAPPROACH031GENERALTHISINTERNATIONALSTANDARDPROMOTESTHEADOPTIONOFAPROCESSAPPROACHWHENDEVELOPING,IMPLEMENTINGANDIMPROVINGTHEEFFECTIVENESSOFAQUALITYMANAGEMENTSYSTEM,TOENHANCECUSTOMERSATISFACTIONBYMEETINGCUSTOMERREQUIREMENTSSPECIFICREQUIREMENTSCONSIDEREDESSENTIALTOTHEADOPTIONOFAPROCESSAPPROACHAREINCLUDEDIN44UNDERSTANDINGANDMANAGINGINTERRELATEDPROCESSESASASYSTEMCONTRIBUTESTOTHEORGANIZATIONSEFFECTIVENESSANDEFFICIENCYINACHIEVINGITSINTENDEDRESULTSTHISAPPROACHENABLESTHEORGANIZATIONTOCONTROLTHEINTERRELATIONSHIPSANDINTERDEPENDENCIESAMONGTHEPROCESSESOFTHESYSTEM,SOTHATTHEOVERALLPERFORMANCEOFTHEORGANIZATIONCANBEENHANCEDTHEPROCESSAPPROACHINVOLVESTHESYSTEMATICDEFINITIONANDMANAGEMENTOFPROCESSES,ANDTHEIRINTERACTIONS,SOASTOACHIEVETHEINTENDEDRESULTSINACCORDANCEWITHTHEQUALITYPOLICYANDSTRATEGICDIRECTIONOFTHEORGANIZATIONMANAGEMENTOFTHEPROCESSESANDTHESYSTEMASAWHOLECANBEACHIEVEDUSINGTHEPDCACYCLESEE032WITHANOVERALLFOCUSONRISKBASEDTHINKINGSEE033AIMEDATTAKINGADVANTAGEOFOPPORTUNITIESANDPREVENTINGUNDESIRABLERESULTSTHEAPPLICATIONOFTHEPROCESSAPPROACHINAQUALITYMANAGEMENTSYSTEMENABLESAUNDERSTANDINGANDCONSISTENCYINMEETINGREQUIREMENTSBTHECONSIDERATIONOFPROCESSESINTERMSOFADDEDVALUECTHEACHIEVEMENTOFEFFECTIVEPROCESSPERFORMANCEDIMPROVEMENTOFPROCESSESBASEDONEVALUATIONOFDATAANDINFORMATIONFIGURE1GIVESASCHEMATICREPRESENTATIONOFANYPROCESSANDSHOWSTHEINTERACTIONOFITSELEMENTSTHEMONITORINGANDMEASURINGCHECKPOINTS,WHICHARENECESSARYFORCONTROL,ARESPECIFICTOEACHPROCESSANDWILLVARYDEPENDINGONTHERELATEDRISKS032PLANDOCHECKACTCYCLETHEPDCACYCLECANBEAPPLIEDTOALLPROCESSESANDTOTHEQUALITYMANAGEMENTSYSTEMASAWHOLEFIGURE2ILLUSTRATESHOWCLAUSES4TO10CANBEGROUPEDINRELATIONTOTHEPDCACYCLETHEPDCACYCLECANBEBRIEFLYDESCRIBEDASFOLLOWSPLANESTABLISHTHEOBJECTIVESOFTHESYSTEMANDITSPROCESSES,ANDTHERESOURCESNEEDEDTODELIVERRESULTSINACCORDANCEWITHCUSTOMERSREQUIREMENTSANDTHEORGANIZATIONSPOLICIESANDIDENTIFYANDADDRESSRISKSANDOPPORTUNITIESDOIMPLEMENTWHATWASPLANNEDCHECKMONITORANDWHEREAPPLICABLEMEASUREPROCESSESANDTHERESULTINGPRODUCTSANDSERVICESAGAINSTPOLICIES,OBJECTIVESANDREQUIREMENTSANDPLANNEDACTIVITIES,ANDREPORTTHERESULTSACTTAKEACTIONSTOIMPROVEPERFORMANCE,ASNECESSARY033RISKBASEDTHINKINGRISKBASEDTHINKINGSEECLAUSEA4ISESSENT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