质量管理系统–根本性和词汇量(1)

ISO9000:2000(E)1ISO9000:2000(E)Qualitymanagementsystems–Fundamentalsandvocabulary1ScopeThisInternationalStandarddescribesfundamentalsofqualitymanagementsystems,whichformthesubjectoftheISO9000family,anddefinesrelatedterms.ThisInternationalStandardisapplicabletothefollowing:a)organizationsseekingadvantagethroughtheimplementationofaqualitymanagementsystem;b)organizationsseekingconfidencefromtheirsuppliersthattheirproductrequirementswillbesatisfied;c)usersoftheproducts;d)thoseconcernedwithamutualunderstandingoftheterminologyusedinqualitymanagement(e.g.suppliers,customers,regulators);e)thoseinternalorexternaltotheorganizationwhoassessthequalitymanagementsystemoraudititforconformitywiththerequirementsofISO9001(e.g.auditors,regulators,certification/registrationbodies);f)thoseinternalorexternaltotheorganizationwhogiveadviceortrainingonthequalitymanagementsystemappropriatetothatorganization;g)developersofrelatedstandards.2Fundamentalsofqualitymanagementsystems2.1RationaleforqualitymanagementsystemsQualitymanagementsystemscanassistorganizationsinenhancingcustomersatisfaction.Customersrequireproductswithcharacteristicsthatsatisfytheirneedsandexpectations.Theseneedsandexpectationsareexpressedinproductspecificationsandcollectivelyreferredtoascustomerrequirements.Customerrequirementsmaybespecifiedcontractuallybythecustomerormaybedeterminedbytheorganizationitself.Ineithercase,thecustomerultimatelydeterminestheacceptabilityoftheproduct.Becausecustomerneedsandexpectationsarechanging,andbecauseofcompetitivepressuresandtechnicaladvances,organizationsaredriventoimprovecontinuallytheirproductsandprocesses.Thequalitymanagementsystemapproachencouragesorganizationstoanalysecustomerrequirements,definetheprocessesthatcontributetotheachievementofaproductwhichisacceptabletothecustomer,andkeeptheseprocessesundercontrol.Aqualitymanagementsystemcanprovidetheframeworkforcontinualimprovementtoincreasetheprobabilityofenhancingcustomersatisfactionandthesatisfactionofotherinterestedparties.Itprovidesconfidencetotheorganizationanditscustomersthatitisabletoprovideproductsthatconsistentlyfulfillrequirements.2.2RequirementsofqualitymanagementsystemsandrequirementsforproductsTheISO9000familydistinguishesbetweenrequirementsforqualitymanagementsystemsandrequirementsforproducts.RequirementsforqualitymanagementsystemsarespecifiedinISO9001.Requirementsforqualitymanagementsystemsaregenericandapplicabletoorganizationsinanyindustryoreconomicsectorregardlessoftheofferedproductcategory.ISO9001itselfdoesnotestablishrequirementsforproducts.Requirementsforproductscanbespecifiedbycustomersorbytheorganizationinanticipationofcustomerrequirements,orbyregulation.Therequirementsforproductsandinsomecasesassociatedprocessescanbecontainedin,forexample,technicalspecifications,productstandards,processstandards,contractualagreementsandregulatoryrequirements.2.3QualitymanagementsystemsapproachISO9000:2000(E)2Anapproachtodevelopingandimplementingaqualitymanagementsystemconsistsofseveralstepsincludingthefollowing:a)determiningtheneedsandexpectationsofcustomersandinterestedparties;b)establishingthequalitypolicyandqualityobjectivesoftheorganization;c)determiningtheprocessesandresponsibilitiesnecessarytoattainthequalityobjectives;d)determiningandprovidingtheresourcese)establishingmethodstomeasuretheeffectivenessandefficiencyofeachprocess;f)applyingthesemeasurestodeterminetheeffectivenessandefficiencyofeachprocess;g)determiningmeansofpreventingnonconformitiesandeliminatingtheircauses;h)establishingandapplyingaprocessforcontinualimprovementofthequalitymanagementsystem.Suchanapproachisalsoapplicabletomaintainingandimprovingandexistingqualitymanagementsystem.Anorganizationthatadoptstheaboveapproachcreatesconfidenceinthecapabilityofitsprocessesandthequalityofitsproducts,andprovidesabasisforcontinualimprovement.Thiscanleadtoincreasedsatisfactionofcustomersandotherinterestedpartiesandtothesuccessoftheorganization.2.4TheprocessapproachAnyactivity,orsetofactivities,thatusesresourcestotransforminputstooutputscanbeconsideredasaprocess.Fororganizationstofunctioneffectively,theyhavetoidentifyandmanagenumerousinterrelatedandinteractingprocesses.Often,theoutputfromoneprocesswilldirectlyformtheinputintothenextprocess.Thesystematicidentificationandmanagementoftheprocessesemployedwithinanorganizationandparticularlytheinteractionsbetweensuchprocessesisreferredtoasthe“processapproach.”TheintentofthisInternationalStandardistoencouragetheadoptionoftheprocessapproachtomanageanorganization.Figure1illustratestheprocess-basedqualitymanagementsystemdescribedtheISO9000familystandards.Thisillustrationshowsthatinterestedpartiesplayasignificantroleinprovidinginputstotheorganization.Monitoringthesatisfactionofinterestedpartiesrequirestheevaluationofinformationrelatingtotheperceptionofinterestedpartiesastotheextenttowhichtheirneedsandexpectationshavebeenmet.ThemodelshowninFigure1doesnotshowprocessesatadetailedlevel.2.5QualitypolicyandqualityobjectivesQualitypolicyandqualityobjectivesareestablishedtoprovideafoc