ISO9000标准英文版.docx
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ISO9000标准英文版.docx
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ISO9000标准英文版
ISO9000:
2000(E)
Qualitymanagementsystems–Fundamentalsandvocabulary
1Scope
ThisInternationalStandarddescribesfundamentalsofqualitymanagementsystems,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.
2Fundamentalsofqualitymanagementsystems
2.1Rationaleforqualitymanagementsystems
Qualitymanagementsystemscanassistorganizationsinenhancingcustomersatisfaction.
Customersrequireproductswithcharacteristicsthatsatisfytheirneedsandexpectations.Theseneedsandexpectationsareexpressedinproductspecificationsandcollectivelyreferredtoascustomerrequirements.Customerrequirementsmaybespecifiedcontractuallybythecustomerormaybedeterminedbytheorganizationitself.Ineithercase,thecustomerultimatelydeterminestheacceptabilityoftheproduct.Becausecustomerneedsandexpectationsarechanging,andbecauseofcompetitivepressuresandtechnicaladvances,organizationsaredriventoimprovecontinuallytheirproductsandprocesses.
Thequalitymanagementsystemapproachencouragesorganizationstoanalysecustomerrequirements,definetheprocessesthatcontributetotheachievementofaproductwhichisacceptabletothecustomer,andkeeptheseprocessesundercontrol.Aqualitymanagementsystemcanprovidetheframeworkforcontinualimprovementtoincreasetheprobabilityofenhancingcustomersatisfactionandthesatisfactionofotherinterestedparties.Itprovidesconfidencetotheorganizationanditscustomersthatitisabletoprovideproductsthatconsistentlyfulfillrequirements.
2.2Requirementsofqualitymanagementsystemsandrequirementsforproducts
TheISO9000familydistinguishesbetweenrequirementsforqualitymanagementsystemsandrequirementsforproducts.
RequirementsforqualitymanagementsystemsarespecifiedinISO9001.Requirementsforqualitymanagementsystemsaregenericandapplicabletoorganizationsinanyindustryoreconomicsectorregardlessoftheofferedproductcategory.ISO9001itselfdoesnotestablishrequirementsforproducts.
Requirementsforproductscanbespecifiedbycustomersorbytheorganizationinanticipationofcustomerrequirements,orbyregulation.Therequirementsforproductsandinsomecasesassociatedprocessescanbecontainedin,forexample,technicalspecifications,productstandards,processstandards,contractualagreementsandregulatoryrequirements.
2.3Qualitymanagementsystemsapproach
Anapproachtodevelopingandimplementingaqualitymanagementsystemconsistsofseveralstepsincludingthefollowing:
a)determiningtheneedsandexpectationsofcustomersandinterestedparties;
b)establishingthequalitypolicyandqualityobjectivesoftheorganization;
c)determiningtheprocessesandresponsibilitiesnecessarytoattainthequalityobjectives;
d)determiningandprovidingtheresources
e)establishingmethodstomeasuretheeffectivenessandefficiencyofeachprocess;
f)applyingthesemeasurestodeterminetheeffectivenessandefficiencyofeachprocess;
g)determiningmeansofpreventingnonconformitiesandeliminatingtheircauses;
h)establishingandapplyingaprocessforcontinualimprovementofthequalitymanagementsystem.
Suchanapproachisalsoapplicabletomaintainingandimprovingandexistingqualitymanagementsystem.
Anorganizationthatadoptstheaboveapproachcreatesconfidenceinthecapabilityofitsprocessesandthequalityofitsproducts,andprovidesabasisforcontinualimprovement.Thiscanleadtoincreasedsatisfactionofcustomersandotherinterestedpartiesandtothesuccessoftheorganization.
2.4Theprocessapproach
Anyactivity,orsetofactivities,thatusesresourcestotransforminputstooutputscanbeconsideredasaprocess.
Fororganizationstofunctioneffectively,theyhavetoidentifyandmanagenumerousinterrelatedandinteractingprocesses.Often,theoutputfromoneprocesswilldirectlyformtheinputintothenextprocess.Thesystematicidentificationandmanagementoftheprocessesemployedwithinanorganizationandparticularlytheinteractionsbetweensuchprocessesisreferredtoasthe“processapproach.”
TheintentofthisInternationalStandardistoencouragetheadoptionoftheprocessapproachtomanageanorganization.
Figure1illustratestheprocess-basedqualitymanagementsystemdescribedtheISO9000familystandards.Thisillustrationshowsthatinterestedpartiesplayasignificantroleinprovidinginputstotheorganization.Monitoringthesatisfactionofinterestedpartiesrequirestheevaluationofinformationrelatingtotheperceptionofinterestedpartiesastotheextenttowhichtheirneedsandexpectationshavebeenmet.ThemodelshowninFigure1doesnotshowprocessesatadetailedlevel.
2.5Qualitypolicyandqualityobjectives
Qualitypolicyandqualityobjectivesareestablishedtoprovideafocustodirecttheorganization.Bothdeterminethedesiredresultsandassisttheorganizationtoapplyitsresourcestoachievetheseresults.Thequalitypolicyprovidesaframeworkforestablishingandreviewingqualityobjectives.Thequalityobjectivesneedtobeconsistentwiththequalitypolicyandthecommitmenttocontinualimprovement,andtheirachievementneedstobemeasurable.Theachievementofqualityobjectivescanhaveapositiveimpactonproductquality,operationaleffectivenessandfinancialperformanceandthusonthesatisfactionandconfidenceofinterestedparties.
NOTEStatementsinparenthesesdonotapplytoISO9001.
Figure1–Modelofaprocess-basedqualitymanagementsystem
2.6Roleoftopmanagementwithinthequalitymanagementsystem
Throughleadershipandactions,topmanagementcancreateanenvironmentwherepeoplearefullyinvolvedandinwhichaqualitymanagementsystemcanoperateeffectively.Thequalitymanagementprinciples(see0.2)canbeusedbytopmanagementasthebasisofitsrole,whichisasfollows:
a)toestablishandmaintainthequalitypolicyandqualityobjectivesoftheorganization;
b)topromotethequalitypolicyandqualityobjectivesthroughouttheorganizationtoincreaseawareness,motivationandinvolvement;
c)toensurefocusoncustomerrequirementsthroughouttheorganization;
d)toensurethatappropriateprocessesareimplementedtoenablerequirementsofcustomersandotherinterestedpartiestobefulfilledandqualityobjectivestobeachieved;
e)toensurethataneffectiveandefficientqualitymanagementsystemisestablished,implementedandmaintainedtoachievethesequalityobjectives;
f)toensuretheavailabilityofnecessaryresources;
g)toreviewthequalitymanagementsystemperiodically;
h)todecideonactionsregardingthequalitypolicyandqualityobjectives.
i)todecideonactionsforimprovementofthequalitymanagementsystem.
2.7Documentation
2.7.1Valueofdocumentation
Documentationenablescommunicationofintentandconsistencyofaction.Itsusecontributesfor
a)achievementofconformitytocustomerrequirementsandqualityimprovement,
b)provisionofappropriatetraining.
c)repeatabilityandtraceability,
d)provisionoobjectiveevidence,and
e)evaluationoftheeffectivenessadcontinuingsuitabilityofthequalitymanagementsystem.
Generationofdocumentationshouldnotbeanendinitselfbutshouldbeavalue-addingactivity.
2.7.2Typesofdocumentusedinqualitymanagementsystems
Thefollowingtypesofdocumentareusedinqualitymanagementsystems:
a)documentsthatprovideconsistentinformation,bothinternallyandexternally,abouttheorganization’squalitymanagementsystem;suchdocumentsarereferredtoasqualitymanuals;
b)documentsthatdescribehowthequalitymanagementsystemisappliedtoaspecificproduct,projectorcontract;suchdocumentsarereferredtoasqualityplans;
c)documentsstatingrequirements;suchdocumentsarereferredtoasspecifications;
d)documentsstatingrecommendationsorsuggestions;suchdocumentsarereferredtoasguidelines;
e)documentsthatprovideinformationabouthowtoperformactivitiesandprocessesconsistently;suchdocumentscanincludedocumentedprocedures,workinstructionsanddrawings;
f)documentsthatprovideobjectiveevidenceofactivitiesperformedorresultsachieved;suchdocumentsarereferredtoasrecords.
Eachorganizationdeterminestheextentofdocumentationrequiredadthemediatobeused.Thisdependsonfactorssuchasthetypeandsizeoftheorganization,thecomplexityandinteractionofprocesses,thecomplexityofproducts,customerrequirements,theapplicableregulatoryrequirements,thedemonstratedabilityofpersonnel,andtheextenttowhichitisnecessarytodemonstratefulfillmentofqualitymanagementsystemrequirements.
2.8Evaluatingqualitymanagementsystems
2.8.1Evaluatingprocesseswithinthequalitymanagementsystem
Whenevaluatingqualitymanagementsystems,therearefourbasicquestionsthatshouldbeaskedinrelationtoe
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- ISO9000 标准 英文