ISO9000-2015-FDIS英文英文英文

PAGEPAGE13FINALDRAFT（草案）ISO/TC176/SC1Secretariat:ANSIVotingbeginson:（开始于）20150709Votingterminateson:20150909RECIPIENTSOFTHISDRAFTAREINVITEDTOSUBMIT,WITHTHEIRCOMMENTS,NOTIFICATIONOFANYRELEVANTPATENTRIGHTSOFWHICHTHEYAREAWAREANDTOPROVIDESUPPORTINGDOCUMENTATION.该草案的接受者被邀请TOSUBMIT，提出意见，NOTIFICATIONOFWHICHTHEY任何相关的专利授权被认识并提供支持性文件。INADDITIONTOTHEIREVALUATIONASBEINGACCEPTABLEFORINDUSTRIAL,TECHNOLOGICAL,除了自己的评价ASBEING可以接受，工业，科技，COMMERCIALANDUSERPURPOSES,DRAFTINTERNATIONALSTANDARDSMAYONOCCASIONHAVETOBECONSIDEREDINTHELIGHTOFTHEIRPOTENTIALTOBECOMESTANDARDSTOWHICHREFERENCEMAYBEMADEINNATIONALREGULATIONS.商业和使用者施行，国际标准草案MAYONOCCASION必须考虑THELIGHT及其潜力成为标准

到可以参照的国家条例。INTERNATIONALISO/FDISSTANDARD9000国际ISO/FDIS

标准9000Qualitymanagementsystems—Fundamentalsandvocabulary质量管理体系—基础和术语Systèmesdemanagementdelaqualité—PrincipesessentielsetvocabulairePleaseseetheadministrativenotesonpageiiiReferencenumberISO/FDIS9000:2015(E)请参见第三页的管理注释

参考编号

ISO/FDIS9000：2015年（E）.ISO2015ISO/FDIS9000:2015(E)COPYRIGHTPROTECTEDDOCUMENT.ISO2015,PublishedinSwitzerlandAllrightsreserved.Unlessotherwisespecified,nopartofthispublicationmaybereproducedorutilizedotherwiseinanyformorbyanymeans,electronicormechanical,includingphotocopying,orpostingontheinternetoranintranet,withoutpriorwrittenpermission.PermissioncanberequestedfromeitherISOattheaddressbeloworISO’smemberbodyinthecountryoftherequester.ISOcopyrightofficeCh.deBlandonnet8.CP401CH1214Vernier,GenevaTel.+41227490111Fax+41227490947copyright@.ISO2015–Allrightsreserved

ISO/FDIS9000:2015(E)ISO/CENPARALLELPROCESSINGThisfinaldrafthasbeendevelopedwithintheInternationalOrganizationforStandardization(ISO),andprocessedundertheISO-leadmodeofcollaborationasdefinedintheViennaAgreement.Thefinaldraftwasestablishedonthebasisofcommentsreceivedduringaparallelenquiryonthedraft.ThisfinaldraftisherebysubmittedtotheISOmemberbodiesandtotheCENmemberbodiesforaparalleltwomonthapprovalvoteinISOandformalvoteinCEN.Positivevotesshallnotbeaccompaniedbycomments.Negativevotesshallbeaccompaniedbytherelevanttechnicalreasons..ISO2015–Allrightsreserved

ISO/FDIS9000:2015(E)ContentsPageForewordvIntroductionvi1Scope12Fundamentalconceptsandqualitymanagementprinciples12.1General12.2Fundamentalconcepts2.2.1Quality2.2.2tymanagementsystem22.2.3Contextofanorganization2.2.4Interestedparties2.2.5Support2.3Qualitymanagementprinciples32.3.1Customerfocus2.3.2Leadership42.3.3Engagementofpeople52.3.4Processapproach62.3.5Improvement2.3.6Evidencebaseddecisionmaking72.3.7Relationshipmanagement82.4DevelopingtheQMSusingfundamentalconceptsandprinciples92.4.1QMSmodel2.4.2DevelopmentofaQMS2.4.3QMSstandards,othermanagementsystemsandexcellencemodels103Termsanddefinitions103.1Termsrelatedtopersonorpeople103.2ermsroorganization113.3Termsroactivity133.4ermsroprocess153.5ermsrosystem163.6ermsrorequirement183.7ermsroresult203.8ermsrodata,informationanddocument233.9Termsrocustomer253.10ermsrocharacteristic263.11ermsrodetermination273.12ermsroaction293.13ermsroaudit30AnnexA(informative)Conceptrelationshipsandtheirgraphicalrepresentation33Bibliography47Index49.ISO2015–Allrightsreserved

ISO/FDIS9000:2015(E)ForewordISO(theInternationalOrganizationforStandardization)isaworldwidefederationofnationalstandardsbodies(ISOmemberbodies).TheworkofpreparingInternationalStandardsisnormallycarriedoutthroughISOtechnicalcommittees.Eachmemberbodyinterestedinasubjectforwhichatechnicalcommitteehasbeenestablishedhastherighttoberepresentedonthatcommittee.Internationaorganizations,governmentalandnongovernmental,inliaisonwithISO,alsotakepartinthework.ISOcollaboratescloselywiththeInternationalElectrotechnicalCommission(IEC)onallmattersofelectrotechnicalstandardization.TheproceduresusedtodevelopthisdocumentandthoseintendedforitsfurthermaintenancearedescribedintheISO/IECDirectives,Part1.InparticularthedifferentapprovalcriterianeededfortheifferenttypesofISOdocumentsshouldbenoted.ThisdocumentwasdraftedinaccordancewithteeditorialrulesoftheISO/IECDirectives,Part2(see/directives).Attentionisdrawntothepossibilitythatsomeoftheelementsofthisdocumentmaybethesubjectofpatentrights.ISOshallnotbeheldresponsibleforidentifyinganyorallsuchpatentrights.DetailsofanyatentrihtsidentifiedduringthedevelopmentofthedocumentwilbeintheIntroductionand/orontheISOlistofpatentdeclarationsreceived(see/patents).Anytradenameusedinthisdocumentisinformationgivenfortheconvenienceofusersanddoesnotconstituteanendorsement.ForanexplanationonthemeaningofISOspecifictermsandexpressionsrelatedtoconformityassessment,aswellasinformationaboutISO’sadherencetotheWTOprinciplesintheTechnicalBarrierstoTrade(TBT)seethefollowingURL:Foreword-SupplementaryinformationThecommitteeresponsibleforthisdocumentisTechnicalCommitteeISO/TC176,Qualitymanagementandqualityassurance,SubcommitteeSC1,Conceptsandterminology.Thisfourtheditioncancelsandreplacesthethirdedition(ISO9000:2005),whichhasbeentechnicallyrevised..ISO2015–AllrightsreservedISO/FDIS9000:2015(E)IntroductionThisInternationalStandardprovidesthefundamentalconcepts,principlesandvocabularyforqualitymanagementsystems(QMS)andprovidesthefoundationforotherQMSstandards.ThisInternationalStandardisintendedtohelptheusertounderstandthefundamentalconcepts,principlesandvocabularyofqualitymanagement,inordertobeabletoeffectivelyandefficientlyimplementaQMSandrealizevaluefromotherQMSstandards.ThisInternationalStandardproposesawell-definedQMS,basedonaframeworkthatintegratesestablishedfundamentalconcepts,principles,processesandresourcesrelatedtoquality,inordertohelporganizationsrealizetheirobjectives.Itisapplicabletoallorganizations,regardlessofsze,complexityorbusinessmode.Itsaimistoincreaseanorganization’sawarenessofitsdutiesandcommitmentinfulfillingtheneedsandexpectationsofitscustomersandinterestedparties,andinachievingsatisfactionwithitsproductsandservices.ThisInternationalStandardcontainssevenqualitymanagementprinciplessupportingthefundamentalconceptsdescribedin2.2.In2.3,foreachqualitymanagementprinciple,thereisa“statement”describingeachprinciple,a“rationale”explainingwhytheorganizationwouldaddresstheprinciple,“keybenefits”thatareattributedtotheprinciples,and“possibleactions”thatanorganizationcantakeinapplyingtheprinciple.ThisInternationalStandardcontainsthetermsanddefinitionsthatapplytoallqualitymanagementandqualitymanagementsystemstandardsdevelopedbyISO/TC176,andothersector-specificQMSstandardsbasedonthosestandards,atthetimeofpublication.Thetermsanddefinitionsarearrangedinconceptualorder,withanalphabeticalindexprovidedattheendofthedocument.AnnexAincludesasetofdiagramsoftheconceptsystemsthatformtheconceptordering.NOTEGuidanceonsomeadditionalfrequently-usedwordsinthequalitymanagementsystemstandardsdevelopedbyISO/TC176,andwhichhaveanidentifieddictionarymeaning,isprovidedinaglossaryavailableat:/iso/terminology_used_in_iso_9000_family.pdf.ISO2015–Allrightsreserved

FINALDRAFTINTERNATIONALSTANDARDISO/FDIS9000:2015(E)Qualitymanagementsystems—Fundamentalsandvocabulary1ScopeThisInternationalStandarddescribesthefundamentalconceptsandprinciplesofqualitymanagementwhichareuniversallyapplicabletothefollowing:—organizationsseekingsustainedsuccessthroughtheimplementationofaqualitymanagementsystem;—customersseekingconfidenceinanorganization’sabilitytoconsistentlyprovideproductsandservicesconformingtotheirrequirements;—organizationsseekingconfidenceintheirsupplychainthatproductandservicerequirementswillbemet;—organizationsandinterestedpartiesseekingtoimprovecommunicationthroughacommonunderstandingofthevocabularyusedinqualitymanagement;—organizationsperformingconformityassessmentsagainsttherequirementsofISO9001;—providersoftraining,assessmentoradviceinqualitymanagement;—developersofrelatedstandards.ThisInternationalStandardspecifiesthetermsanddefinitionsthatapplytoallqualitymanagementandqualitymanagementsystemstandardsdevelopedbyISO/TC176.2Fundamentalconceptsandqualitymanagementprinciples2.1GeneralThequalitymanagementconceptsandprinciplesdescribedinthisInternationalStandardgivetheorganizationthecapacitytomeetchallengespresentedbyanenvironmentthatisprofoundlydifferentfromrecentdecades.Thecontextinwhichanorganizationworkstodayischaracterizedbyacceleratedchange,globalizationofmarketsandtheemergenceofknowledgeasaprincipalresource.Theimpactofqualityextendsbeyondcustomersatisfaction:itcanalsohaveadirectimpactontheorganization’sreputation.Societyhasbecomebettereducatedandmoredemanding,makinginterestedpartiesincreasinglymoreinfluential.Byprovidingfundamentalconceptsandprinciplestobeusedinthedevelopmentofaqualitymanagementsystem(QMS),thisInternationalStandardprovidesawayofthinkingabouttheorganizationmorebroadly.Allconcepts,principlesandtheirinterrelationshipsshouldbeseenasawholeandnotinisolationofeachother.Noindividualconceptorprincipleismoreimportantthananother.Atanyonetime,findingtherightbalanceinapplicationiscritical.2.2Fundamentalconcepts2.2.1QualityAnorganizationfocusedonqualitypromotesaculturethatresultsinthebehaviour,attitudes,activitiesandprocessesthatdelivervaluethroughfulfillingtheneedsandexpectationsofcustomersandotherrelevantinterestedparties..ISO2015–Allrightsreserved1

ISO/FDIS9000:2015(E)Thequalityofanorganization’sproductsandservicesisdeterminedbytheabilitytosatisfycustomersandtheintendedandunintendedimpactonrelevantinterestedparties.Thequalityofproductsandservicesincludesnotonlytheirintendedfunctionandperformance,butalsotheirperceivedvalueandbenefittothecustomer.2.2.2QualitymanagementsystemAQMScomprisesactivitiesbywhichtheorganizationidentifiesitsobjectivesanddeterminestheprocessesandresourcesrequiredtoachievedesiredresults.TheQMSmanagestheinteractingprocessesandresourcesrequiredtoprovidevalueandrealizeresultsforrelevantinterestedparties,TheQMSenablestopmanagementtooptimizetheuseofresourcesconsideringthelongandshorttermconsequencesoftheirdecision.AQMSprovidesthemeanstoidentifyactionstoaddressintendedandunintendedconsequencesinprovidingproductsandservices.2.2.3ContextofanorganizationUnderstandingthecontextoftheorganizationisaprocess.Thisprocessdeterminesfactorswhichinfluencetheorganization’spurpose,objectivesandsustainability.Itconsidersinternalfactorssuchasvalues,culture,knowledgeandperformanceoftheorganization.Italsoconsidersexternalfactorssuchaslegal,technological,competitive,market,cultural,socialandeconomicenvironments.Examplesofthewaysinwhichanorganization’spurposecanbeexpressedincludeitsvision,mission,policiesandobjectives.2.2.4InterestedpartiesTheconceptofinterestedpartiesextendsbeyondafocussolelyonthecustomer.Itisimportanttoconsiderallrelevantinterestedparties.Partoftheprocessforunderstandingthecontextoftheorganizationistoidentifyitsinterestedparties.Therelevantinterestedpartiesarethosethatprovidesignificantrisktoorganizationalsustainabilityiftheirneedsandexpectationsarenotmet.Organizationsdefinewhatresultsarenecessarytodelivertothoserelevantinterestedpartiestoreducethatrisk.Organizationsattract,captureandretainthesupportoftherelevantinterestedpartiestheydependuponfortheirsuccess.2.2.5SupportGeneralTopmanagementsupportoftheQMSandengagementofpeopleenables:—provisionofadequatehumanandotherresources;—monitoringprocessesandresults;—determiningandevaluatingofrisksandopportunities;—implementingappropriateactions.Responsibleacquisition,deployment,maintenance,enhancementanddisposalofresourcessupporttheorganizationinachievingitsobjectives.2.ISO2015–Allrightsreserved

ISO/FDIS9000:2015(E)PeoplePeopleareessentialresourceswithintheorganization.Theperformanceoftheorganizationisdependentuponhowpeoplebehavewithintesysteminwhichtheywork.Withinanorganization,peoplebecomeengagedandalignedthroughacommonunderstandingofthequalitypolicyandtheorganization’sdesiredresults.CompetenceAQMSismosteffectivewhenallemployeesunderstandandapplytheskills,training,educationandexperienceneededtoperformtheirrolesandresponsibilities.Itistheresponsibilityoftopmanagementtoprovideopportunitiesforpeopletodevelopthesenecessarycompetencies.AwarenesAwarenessisattainedwhenpeopleunderstandtheirresponsibilitiesandhowtheiractionscontributetotheachievementoftheorganization’sobjectives.CommunicationPlannedandeffectiveinternal(i.e.throughouttheorganization)andexternal(i.e.withrelevantinterestedparties)communicationenhancespeople’sengagementandincreasedunderstandingof:—thecontextoftheorganization;—theneedsandexpectationsofcustomersandotherrelevantinterestedparties;—theQMS.2.3Qualitymanagementprinciples2.3.1CustomerfocusStatementTheprimaryfocusofqualitymanagementistomeetcustomerrequirementsandtostrivetoexceedcustomerexpectations.RationaleSustainedsuccessisachievedwhenanorganizationattractsandretainstheconfidenceofcustomersandotherinterestedparties.Everyaspectofcustomerinteractionprovidesanopportunitytocreatemorevalueforthecustomer.Understandingcurrentandfutureneedsofcustomersandotherinterestedpartiescontributestothesustainedsuccessoftheorganization.KeybenefitsSomepotentialkeybenefitsare:—increasedcustomervalue;—increasedcustomersatisfaction;—improvedcustomerloyalty;—enhancedrepeatbusiness;—enhancedreutationoftheorganization;.ISO2015–Allrightsreserved3

ISO/FDIS9000:2015(E)—expandedcustomerbase;—increasedrevenueandmarketshare.PossibleactionsPossibleactionsinclude:—recognizedirectandindirectcustomersasthosewhoreceivevaluefromtheorganization;—understandcustomers’currentandfutureneedsandexpectations;—linktheorganization’sobjectivestocustomerneedsandexpectations;—communicatecustomerneedsandexpectationsthroughouttheorganization;—plan,design,develop,produce,deliverandsupportproductsandservicestomeetcustomerneedsandexpectations;—measureandmonitorcustomersatisfactionandtakeappropriateactions;—determineandtakeactionsoninterestedparties’needsandexpectationsthatcanaffectcustomersatisfaction;—activelymanagerelationshipswithcustomerstoachievesustainedsuccess.2.3.2LeadershipStatementLeadersatalllevelsestablishunityofpurposeanddirectionandcreateconditionsinwhichpeopleareengagedinachievingtheorganization’squalityobjectives.RationaleCreationofunityofpurposeandthedirectionandengagementofpeopleenableanorganizationtoalignitsstrategies,policies,processesandresourcestoachieveitsobjectives.KeybenefitsSomepotentialkeybenefitsare:—increasedeffectivenessandefficiencyinmeetingtheorganization’squalityobjectives;—bettercoordinationoftheorganization’sprocesses;—improvedcommunicationbetweenlevelsandfunctionsoftheorganization;—developmentandimprovementofthecapabilityoftheorganizationanditspeopletodeliveresiredresults.PossibleactionsPossibleactionsinclude:—communicatetheorganization’smission,vision,strategy,policiesandprocessesthroughouttheorganization;—createandsustainsharedvalues,fairnessandethicalmodelsforbehaviouratalllevelsoftheorganization;4.ISO2015–Allrightsreserved

ISO/FDIS9000:2015(E)—establishacultureoftrustandintegrity;—encourageanorganization-widecommitmenttoquality;—ensurethatleadersatalllevelsarepositiveexamplestopeopleintheorganization;—providepeoplewiththerequiredresources,trainingandauthoritytoactwithaccountability;—inspire,encourageandrecognizethecontributionofpeople.2.3.3EngagementofpeopleStatementCompetent,empoweredandengagedpeopleatalllevelsthroughouttheorganizationareessentialtoenhancetheorganization’scapabilitytocreateanddelivervalue.RationaleInordertomanageanorganizationeffectivelyandefficiently,itisimportanttorespectandinvolveallpeopleatalllevels.Recognition,empowermentandenhancementofcompetencefacilitatetheengagementofpeopleinachievingtheorganization’squalityobjectives.KeybenefitsSomepotentialkeybenefitsare:—improvedunderstandingoftheorganization’squalityobjectivesbypeopleintheorganizationandncreasedmotivationtoachievethem;—enhancedinvolvementofpeopleinimprovementactivities;—enhancedpersonaldevelopment,initiativesandcreativity;—enhanceeoplesatisfaction;—enhancedtrustandcollaborationthroughouttheorganization;—increasedattentiontosharedvaluesandculturethroughouttheorganization.PossibleactionsPossibleactionsinclude:—communicatewithpeopletopromoteunderstandingoftheimportanceoftheirindividualcontribution;—promotecollaborationthroughouttheorganization;—facilitateopendiscussionandsharingofknowledgeandexperience;—empowerpeopletodetermineconstraintstoperformanceandtotakeinitiativeswithoutfear;—recognizeandacknowledgepeople’scontribution,learningandimprovement;—enableself-evaluationofperformanceagainstpersonalobjectives;—conductsurveystoassesspeople’ssatisfaction,communicatetheresultsandtakeappropriateactions..ISO2015–Allrightsreserved5

ISO/FDIS9000:2015(E)2.3.4ProcessapproachStatementConsistentandpredictableresultsareachievedmoreeffectivelyandefficientlywhenactivitiesareunderstoodandmanagedasinterrelatedprocessesthatfunctionasacoherentsystem.RationaleTheQMSconsistsofinterrelatedprocesses.Understandinghowresultsareproducedbythissystemenablesanorganizationtooptimizethesystemanditsperformance.KeybenefitsSomepotentialkeybenefitsare:—enhancedabilitytofocuseffortonkeyprocessesandopportunitiesforimprovement;—consistentandpredictableoutcomesthroughasystemofalignedprocesses;—optimizedperformancethrougheffectiveprocessmanagement,efficientuseofresourcesandreducedcross-unctionalbarriers;—enablingtheorganizationtoprovideconfidencetointerestedpartiesrelatedtoitsconsistency,effectivenessandefficiency.PossibleactionsPossibleactionsinclude:—defineobjectivesofthesystemandprocessesnecessarytoachievethem;—establishauthority,responsibilityandaccountabilityformanagingprocesses;—understandtheorganization’scapabilitiesanddetermineresourceconstraintspriortoaction;—determineprocessinterdependenciesandanalysetheeffectofmodificationstoindividualprocessesonthesystemasawhole;—manageprocessesandtheirinterrelationsasasystemtoachievetheorganization’squalityobjectiveseffectivelyandefficiently;—ensurethenecessaryinformationisavailabletooperateandimprovetheprocessesandtomonitor,analyseandevaluatetheperformanceoftheoverallsystem;—manageriskswhichcanaffectoutputsoftheprocessesandoveralloutcomesoftheQMS.2.3.5ImprovementStatementSuccessfulorganizationshaveanongoingfocusonimprovement.RationaleImprovementisessentialforanorganizationtomaintaincurrentlevelsofperformance,toreacttochangesinitsinternalandexternalconditionsandtocreatenewopportunities.6.ISO2015–Allrightsreserved

ISO/FDIS9000:2015(E)KeybenefitsSomepotentialkeybenefitsare:—improvedprocessperformance,organizationalcapabilityandcustomersatisfaction;—enhancedfocusonrootcauseinvestigationanddetermination,followedbypreventionandcorrectiveactions;—enhancedabilitytoanticipateandreacttointernalandexternalrisksandopportunities;—enhancedconsiderationofbothincrementalandbreakthroughimprovement;—improveduseoflearningforimprovement;—enhanceddriveforinnovation.PossibleactionsPossibleactionsinclude:—promoteestablishmentofimprovementobjectivesatalllevelsoftheorganization;—educateandtrainpeopleatalllevelsonhowtoapplybasictoolsandmethodologiestoachieveimprovementobjectives;—ensurepeoplearecompetenttosuccessfullypromoteandcompleteimprovementprojects;—developanddeployprocessestoimplementimprovementprojectsthroughouttheorganization;—track,reviewandaudittheplanning,implementation,completionandresultsofimprovementprojects;—integrateimprovementconsiderationintodevelopmentofnewormodifiedproductsandservicesandprocesses;—recognizeandacknowledgeimprovement.2.3.6Evidence-baseddecisionmakingStatementDecisionsbasedontheanalysisandevaluationofdataandinformationaremorelikelytoproducedesiredresults.RationaleDecision-makingcanbeacomplexprocessanditalwaysinvolvessomeuncertainty.Itofteninvolvesmultipletypesandsourcesofinputs,aswellastheirinterpretation,whichcanbesubjective.Itisimportanttounderstandcauseandeffectrelationshipsandpotentialunintendedconsequences.Facts,evidenceanddataanalysisleadtogreaterobjectivityandconfidenceindecisionmaking.KeybenefitsSomepotentialkeybenefitsare:—improveddecisionmakingprocesses;—improvedassessmentofprocessperformanceandabilitytoachieveobjectives;—imrovedoperationaleffectivenessandefficiency;—increasedabilitytoreview,challengeandchangeopinionsanddecisions;.ISO2015–Allrightsreserved7

ISO/FDIS9000:2015(E)—increasedabilitytodemonstratetheeffectivenessofpastdecisions.PossibleactionsPossibleactionsinclude:—determine,measureandmonitorkeyindicatorstodemonstratetheorganization’sperformance;—makealldataneededavailabletotherelevantpeople;—ensurethatdataandinformationaresufficientlyaccurate,reliableandsecure;—analyseandevaluatedataandinformationusingsuitablemethods;—ensurepeoplearecompetenttoanalyseandevaluatedataasneeded;—makedecisionsandtakeactionsbasedonevidence,balancedwithexperienceandintuition.2.3.7RelationshipmanagementStatementForsustainedsuccess,organizationsmanagetheirrelationshipswithinterestedparties,suchasproviders.RationaleRelevantinterestedpartiesinfluencetheperformanceofanorganization.Sustainedsuccessismorelikelytobeachievedwhentheorganizationmanagesrelationshipswithallofitsinterestedpartiestooptimizetheirimpactonitsperformance.Relationshipmanagementwithitsproviderandpartnernetworksisofparticularimportance.KeybenefitsSomepotentialkeybenefitsare:—enhancedperformanceoftheorganizationanditsinterestedpartiesthroughrespondingtotheopportunitiesandconstraintsrelatedtoeachinterestedparty;—commonunderstandingofobjectivesandvaluesamonginterestedparties;—increasedcapabilitytocreatevalueforinterestedpartiesbysharingresourcesandcompetenceandmanagingqualityrelatedrisks;—awell-managedsupplychainthatprovidesastableflowofproductsandservices.PossibleactionsPossibleactionsinclude:—determinerelevantinterestedparties(suchasproviders,partners,customers,investors,employeesorsocietyasawhole)andtheirrelationshipwiththeorganization;—determineandprioritizeinterestedpartyrelationshipsthatneedtobemanaged;—establishrelationshipsthatbalanceshort-termgainswithlong-termconsiderations;—gatherandshareinformation,expertiseandresourceswithrelevantinterestedparties;—measureperformanceandprovideperformancefeedbacktointerestedparties,asappropriate,toenhanceimprovementinitiatives;8.ISO2015–Allrightsreserved

ISO/FDIS9000:2015(E)—establishcollaborativedevelopmentandimprovementactivitieswithproviders,partnersandotherinterestedparties;—encourageandrecognizeimprovementsandachievementsbyprovidersandpartners.2.4DevelopingtheQMSusingfundamentalconceptsandprinciples2.4.1QMSmodelGeneralOrganizationssharemanycharacteristicswithhumansasalivingandlearningsocialorganism.Eachisadaptiveandcomprisesinteractingsystems,processesandactivities.Inordertoadapttotheirvaryingcontext,eachneedstheabilitytochange.Organizationsofteninnovatetoachievebreakthroughimprovements.Anorganization’sQMSmodelrecognizesthatnotallsystems,processesandactivitiescanbepredetermined;thereforeitneedstobeflexibleandadaptablewithinthecomplexitiesoftheorganizationalcontext.SystemOrganizationsseektounderstandtheinternalandexternalcontexttoidentifytheneedsandexpectationsofrelevantinterestedparties.ThisinformationisusedinthedevelopmentoftheQMStoachieveorganizationalsustainability.Theoutputsfromoneprocesscanbetheinputsintootherprocessesandareinterlinkedintotheoverallnetwork.Althoughoftenappearingtobecomprisedofsimilarprocesses,eachorganizationanditsQMSisunique.ProcessesTheorganizationhasprocessesthatcanbedefined,measuredandimproved.Theseprocessesinteracttodeliverresultsconsistentwiththeorganization’sobjectivesandcrossfunctionalboundaries.Someprocessescanbecriticalwhileothersarenot.Processeshaveinterrelatedactivitieswithinputstodeliveroutputs.ActivityPeoplecollaboratetooperatewithinaprocesstocarryouttheirdailyactivities.Someactivitiesareprescribedanddependonanunderstandingoftheobjectivesoftheorganization,whileothersarenotandreacttoexternalstimulitodeterminetheirnatureandexecution.2.4.2Devel