ISO9004质量管理体系业绩改进指南「」

ISO9004质量管理体系业绩改进指南「」ISO9004,titled"GuidelinesforPerformanceImprovementofQualityManagementSystems,"isastrategicdecisionforthetopmanagementofanyorganization.Thefollowingcontentprovidesadetailedoverview,invitingreaderstodelvedeeperintoitsimplications.Introduction0.1GeneralPrinciplesTheadoptionofaqualitymanagementsystemisastrategicchoicefororganizationalleaders.Thedesignandimplementationofsuchasystemareinfluencedbyvariousfactors,includingspecificneeds,objectives,productsoffered,processesemployed,andtheorganization'ssizeandstructure.Thisstandardisgroundedineightfundamentalprinciplesofqualitymanagement.Itdoesnotprescribeauniformstructureordocumentationforqualitymanagementsystems.Theobjectiveofanorganizationisto:--Continuouslyimprovetheoverallperformanceandcapabilitiesoftheorganization.0.2ProcessApproachThisstandardencouragestheuseofaprocessapproachwhenestablishing,implementing,andimprovingtheeffectivenessandefficiencyofaqualitymanagementsystem,withtheaimofsatisfyingstakeholderrequirementsandenhancingtheirsatisfaction.Thesystematicapplicationofprocesseswithinanorganization,alongwiththeidentificationandinteractionoftheseprocessesandtheirmanagement,isreferredtoas"processapproach."Theadvantageoftheprocessapproachliesinitsabilitytoprovidecontinuouscontrolovertheinterlinkedprocessesandtheirinteractionswithinasystem.Whenapplyingtheprocessapproachtoaqualitymanagementsystem,itisimportanttoemphasizethefollowingaspects:a)understandingandmeetingrequirements;b)consideringtheneedforprocessvalueaddition;c)obtainingresultsintermsofprocessperformanceandeffectiveness;d)providingobjectivemeasuresforcontinuousprocessimprovement.Theprocess-basedmodelofaqualitymanagementsystem,asdepictedinFigure1,illustratestheinterrelationshipsofprocessesoutlinedinchapters4to8.Thisrepresentationhighlightsthesignificantroleofstakeholdersindefininginputrequirementsandtheneedtomonitorstakeholdersatisfactionbyevaluatinginformationontheirperceptionsofwhethertheorganizationhasmettheirrequirements(process-basedmodelofaqualitymanagementsystem-notshownhere).0.3RelationshipwithGB/T19001GB/T19001specifiestherequirementsforaqualitymanagementsystemthatcanbeusedwithinanorganizationorforcontractualpurposes.Itfocusesontheeffectivenessofthequalitymanagementsysteminmeetingcustomerrequirements.Tofacilitateunderstandingandapplication,thisstandardincludestheessentialcontentofGB/T19001requirementsinboxes,followingrelevantclauses.Notesprovideguidanceforinterpretingthestandard.Thisstandarddoesnotincludeguidancespecifictoothermanagementsystems,suchasenvironmentalmanagement,occupationalhealthandsafetymanagement,financialmanagement,orriskmanagement.However,itallowsorganizationstointegratetheirqualitymanagementsystemswithotherrelevantmanagementsystems.Inestablishingaqualitymanagementsystemguidedbythisstandard,organizationsmayneedtomodifytheirexistingmanagementsystems.GuidelinesforPerformanceImprovementofQualityManagementSystemsGB/T19004-2000iidt9004:2000ReplacesGB/T19004.1-1994AppendicesAandBprovideexamplesofself-assessmentandtheprocessofcontinuousimprovement.GB/T19001-2000QualityManagementSystemRequirements4QualityManagementSystem4.1GeneralRequirementsAnorganizationshouldestablish,document,implement,maintain,andcontinuallyimproveitsqualitymanagementsysteminaccordancewiththisstandard.Theorganizationshould:a)Identifytheprocessesrequiredforthequalitymanagementsystemandtheirapplicationwithintheorganization(see1.2);b)Determinethesequenceandinteractionoftheseprocesses;c)Ensuretheestablishmentofcriteriaandmethodsnecessaryfortheeffectiveoperationandcontroloftheseprocesses;d)Ensuretheavailabilityofresourcesandinformationnecessarytosupporttheoperationandmonitoringoftheseprocesses;e)Monitor,measure,andanalyzetheseprocesses;f)Implementnecessaryactionstoachieveplannedresultsandcontinualimprovementoftheseprocesses.Theorganizationshouldmanagetheseprocessesinaccordancewiththisstandard.Foranyoutsourcedprocessesthatmayaffectproductconformity,theorganizationshouldensurecontroloverthem.Thecontrolofsuchoutsourcedprocessesshouldbeidentifiedwithinthequalitymanagementsystem.Note:Theprocessesrequiredforthequalitymanagementsystemincludethoserelatedtomanagementactivities,resourceprovision,productrealization,andmeasurement.4.2DocumentationManagementshoulddefinethedocumentationnecessaryfortheestablishment,implementation,andmaintenanceofaneffectiveandefficientqualitymanagementsystem,includingrelevantrecords.Thenatureandscopeofdocumentationshouldmeetcontractual,legal,andregulatoryrequirements,aswellastheneedsandexpectationsofcustomersandotherstakeholders,andshouldbeappropriatefortheorganization.Documentationcanbeinanyformatormediumsuitablefortheorganization'sneeds.Toensurethatdocumentationmeetstheneedsandexpectationsofstakeholders,managementshouldconsider:--Contractualrequirementsfromcustomersandotherstakeholders;--Adoptedinternational,national,regional,andindustrystandards;--Relevantlegalandregulatoryrequirements;--Organizationaldecisions;--Externalinformationsourcesrelatedtoorganizationalcapabilitydevelopment;--Informationrelatedtotheneedsandexpectationsofstakeholders.Managementshouldevaluatetheeffectivenessandefficiencyofdocumentationagainstthefollowingcriteria:--Functionality(e.g.,processingspeed);--Easeofuse;--Requiredresources;--Policiesandobjectives;--Currentandfuturerequirementsrelatedtomanagementknowledge;--Benchmarkingofthedocumentationsystem;--Interfacesusedbytheorganization'scustomers,suppliers,andotherstakeholders.4.2DocumentationRequirements4.2.1GeneralThedocumentationofaqualitymanagementsystemshouldinclude:a)Documentedqualitypolicyandqualityobjectives;b)Qualitymanual;c)Documentedproceduresrequiredbythisstandard;d)Documentsnecessaryfortheeffectiveplanning,operation,andcontrolofprocessestoensureproductconformity;e)Recordsrequiredbythisstandard(see4.2.4).Note1:Wherethisstandardstates"documentedprocedures,"itmeansthattheorganizationmustestablish,document,implement,andmaintainsuchprocedures.Note3:Documentationcanbeinanyformortypeofmedium.4.4.2QualityManualTheorganizationshoulddevelopandmaintainaqualitymanualthatincludes:a)Thescopeofthequalitymanagementsystem,includingdetailsofanyexclusionsandtheirjustification(see1.2);b)Documentedproceduresorreferencestothem;c)Descriptionsoftheinteractionsbetweentheprocessesofthequalitymanagementsystem.4.2.3DocumentControlThedocumentationrequiredforthequalitymanagementsystemshouldbecontrolled.Records,asaspecialtypeofdocument,shouldbecontrolledaccordingtotherequirementsof4.2.4.Proceduresshouldbeestablishedtocontrolthedocumentsinthefollowingaspects:a)Approvalofdocumentspriortoissuetoensuretheiradequacyandsuitability;b)Reviewandupdateofdocumentsasnecessary,withsubsequentre-approval;c)Identificationofchangesandcurrentrevisionstatusofdocuments;d)Availabilityofrelevantversionsofapplicabledocumentsatpointsofuse;e)Maintenanceofdocumentsinalegibleandeasilyidentifiablestate;f)Identificationandcontrolofdistributionofexternaldocuments;g)Preventionofunintendeduseofobsoletedocuments,andappropriateidentificationofanythatareretainedforspecificpurposes.4.2.4RecordControlRecordsshouldbeestablishedandmaintainedtoprovideevidenceofconformitytorequirementsandoftheeffectiveoperationofthequalitymanagementsystem.Recordsshouldbeclear,easilyidentifiable,andretrievable.Proceduresshouldbeestablishedtodefinethecontrolsneededfortheidentification,storage,protection,retrieval,retentiontime,anddispositionofrecords.4.3ApplicationofQualityManagementPrinciplesSuccessfulleadershipandoperationofanorganizationrequireasystematicandtransparentapproachtomanagement.Themanagementguidanceprovidedbythisstandardisbasedoneightqualitymanagementprinciples.Theseprinciplesareintendedfortopmanagementtoleadtheorganizationtowardsperformanceimprovement.Theyareincorporatedintothisstandardandinclude:a)CustomerFocusOrganizationsdependontheircustomers.Therefore,theyshouldunderstandcurrentandfuturecustomerneeds,meetcustomerrequirements,andstrivetoexceedcustomerexpectations.b)Leadershipc)I