ISO9001：2015 English Version

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1、ISO9001：2015Qualitymanagementsystems—RequirementsIntroduction0.1GeneralTheadoptionofaqualitymanagementsystemisastrategicdecisionforanorganizationthatcanhelptoimproveitsoverallperformanceandprovideasoundbasisforsustainabledevelopmentinitiatives.Thepotentialbenefitstoanorganizationofi

2、mplementingaqualitymanagementsystembasedonthisInternationalStandardare:a)theabilitytoconsistentlyprovideproductsandservicesthatmeetcustomerandapplicablestatutoryandregulatoryrequirements;b)facilitatingopportunitiestoenhancecustomersatisfaction;c)addressingrisksandopportunitiesassoci

3、atedwithitscontextandobjectives;d)theabilitytodemonstrateconformitytospecifiedqualitymanagementsystemrequirements.ThisInternationalStandardcanbeusedbyinternalandexternalparties.ItisnottheintentofthisInternationalStandardtoimplytheneedfor:—uniformityinthestructureofdifferentqualityma

4、nagementsystems;—alignmentofdocumentationtotheclausestructureofthisInternationalStandard;—theuseofthespecificterminologyofthisInternationalStandardwithintheorganization.ThequalitymanagementsystemrequirementsspecifiedinthisInternationalStandardarecomplementarytorequirementsforproduct

5、sandservices.ThisInternationalStandardemploystheprocessapproach,whichincorporatesthePlan-Do-Check-Act(PDCA)cycleandrisk-basedthinking.Theprocessapproachenablesanorganizationtoplanitsprocessesandtheirinteractions.ThePDCAcycleenablesanorganizationtoensurethatitsprocessesareadequatelyr

6、esourcedandmanaged,andthatopportunitiesforimprovementaredeterminedandactedon.Risk-basedthinkingenablesanorganizationtodeterminethefactorsthatcouldcauseitsprocessesanditsqualitymanagementsystemtodeviatefromtheplannedresults,toputinplacepreventivecontrolstominimizenegativeeffectsandto

7、makemaximumuseofopportunitiesastheyarise(seeClauseA.4).Consistentlymeetingrequirementsandaddressingfutureneedsandexpectationsposesachallengefororganizationsinanincreasinglydynamicandcomplexenvironment.Toachievethisobjective,theorganizationmightfinditnecessarytoadoptvariousformsofimp

8、rovementinadditiont