Implementing ISO 9000 Quality Management System.docx
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Implementing ISO 9000 Quality Management System.docx
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ImplementingISO9000QualityManagementSystem
ImplementingISO9000QualityManagementSystem
ImplementationofISO9000affectstheentireorganizationrightfromthestart.If
pursuedwithtotaldedication,itresultsin'culturaltransition'toanatmosphereof
continuousimprovement.
TheprocessofimplementingISO9000dependson:
Thesophisticationofyourexistingqualityprogram,
Thesizeofyourorganization,and
Thecomplexityofyourprocess.
The14essentialsteps,brieflydescribedbelow,aretobefollowedthroughinorderto
implementISO9000qualitymanagementsystemsuccessfully.
Step1:
Topmanagementcommitment
Step2:
Establishimplementationteam
Step3.StartISO9000awarenessprograms
Step4:
ProvideTraining
Step5.Conductinitialstatussurvey
Step6:
Createadocumentedimplementationplan
Step7.Developqualitymanagementsystemdocumentation
Step8:
Documentcontrol
Step9.Implementation
Step10.Internalqualityaudit
Step11.Managementreview
Step12.Pre-assessmentaudit
Step13.Certificationandregistration
Step14:
ContinualImprovement
Step1:
TopManagementCommitment
Thetopmanagement(managingdirectororchiefexecutive)shoulddemonstratea
commitmentandadeterminationtoimplementanISO9000qualitymanagement
systemintheorganization.Withouttopmanagementcommitment,noqualityinitiative
cansucceed.Topmanagementmustbeconvincedthatregistrationandcertification
willenabletheorganizationtodemonstratetoitscustomersavisiblecommitmentto
quality.Itshouldrealizethataqualitymanagementsystemwouldimproveoverall
businessefficiencybyeliminationofwastefulduplicationinmanagementsystem.
Thetopmanagementshouldprovideevidenceofitscommitmenttothedevelopment
andimplementationofthequalitymanagementsystemandcontinuallyimproveits
effectivenessby:
Communicatingtotheorganizationtheimportanceofmeetingcustomeraswellas
statutoryandregulatoryrequirements,
Definingtheorganization'squalitypolicyandmakethisknowntoeveryemployee,
Ensuringthatqualityobjectivesareestablishedatalllevelsandfunctions,
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Ensuringtheavailabilityofresourcesrequiredforthedevelopmentand
implementationofthequalitymanagementsystem,
Appointingamanagementrepresentativetocoordinatequalitymanagement
systemactivities,and
Conductingmanagementreview.
Thetopmanagementshouldalsoconsideractionssuchas:
Leadingtheorganizationbyexample,
Participatinginimprovementprojects,
Creatinganenvironmentthatencouragestheinvolvementofpeople.
Thistypeoftopmanagementcommitmentmaybedrivenby:
Directmarketplacepressure:
requirementsofcrucialcustomersorparent
conglomerates.
Indirectmarketplacepressure:
increasedqualitylevelsandvisibilityamong
competitors.
Growthambitions:
desiretoexploitmarketopportunities.
Personalbeliefinthevalueofqualityasagoalandqualitymanagementsystems
asameansofreachingthatgoal.
Thetopmanagementshouldidentifythegoalstobeachievedthroughthequality
managementsystem.Typicalgoalsmaybe:
Bemoreefficientandprofitable
Produceproductsandservicesthatconsistentlymeetcustomers'needsand
expectations
Achievecustomerssatisfaction
Increasemarketshare
Improvecommunicationsandmoraleintheorganization
Reducecostsandliabilities
Increaseconfidenceintheproductionsystem
Step2.EstablishImplementationTeam
ISO9000isimplementedbypeople.Thefirstphaseofimplementationcallsforthe
commitmentoftopmanagement-theCEOandperhapsahandfulofotherkeypeople.
ThenextstepistoestablishimplementationteamandappointaManagement
Representative(MR)asitscoordinatortoplanandoverseeimplementation.Its
membersshouldincluderepresentativesofallfunctionsoftheorganization-
Marketing,Designanddevelopment,Planning,Production,Qualitycontrol,etc.
Inthecontextofthestandard,theMRisthepersonwithintheOrganizationwhoacts
asinterfacebetweenorganizationmanagementandtheISO9000registrar.Hisrole
is,infact,muchbroaderthanthat.TheMRshouldalsoactastheorganization’s
"qualitymanagementsystemchampion,"andmustbeapersonwith:
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TotalbackingfromtheCEO,
GenuineandpassionatecommitmenttoqualityingeneralandtheISO9000quality
managementsysteminparticular,
Thedignity-resultingfromrank,seniority,orboth-toinfluencemanagersand
othersofalllevelsandfunctions,
DetailedknowledgeofqualitymethodsingeneralandISO9000inparticular.
ThemembersoftheimplementationteamshouldalsobetrainedonISO9000quality
managementsystemsbyaprofessionaltrainingorganization.
Step3.StartISO9000AwarenessPrograms
ISO9000awarenessprogramsshouldbeconductedtocommunicatetothe
employeestheaimoftheISO9000qualitymanagementsystem;theadvantageit
offerstoemployees,customersandtheorganization;howitwillwork;andtheirroles
andresponsibilitieswithinthesystem.Suppliersofmaterialsandcomponentsshould
alsoparticipateintheseprograms.
Theawarenessprogramshouldemphasizethebenefitsthattheorganizationexpects
torealizethroughitsISO9000qualitymanagementsystem.Theprogramshouldalso
stressthehigherlevelsofparticipationandself-directionthatthequalitymanagement
systemrenderstoemployees.Suchafocuswillgofartoenlistemployeesupportand
commitment.
Theprogramscouldberuneitherbytheimplementationteamorbyexpertshiredto
talktodifferentlevelsofemployees.
Step4.ProvideTraining
SincetheISO9000qualitymanagementsystemaffectsalltheareasandallpersonnel
intheorganization,trainingprogramsshouldbestructuredfordifferentcategoriesof
employees-seniormanagers,middle-levelmanagers,supervisorsandworkers.The
ISO9000implementationplanshouldmakeprovisionforthistraining.Thetraining
shouldcoverthebasicconceptsofqualitymanagementsystemsandthestandardand
theiroverallimpactonthestrategicgoalsoftheorganization,thechangedprocesses,
andthelikelyworkcultureimplicationsofthesystem.Inaddition,initialtrainingmay
alsobenecessaryonwritingqualitymanuals,proceduresandworkinstruction;
auditingprinciples;techniquesoflaboratorymanagement;calibration;testing
procedures,etc.
Whenin-housecapacitytocarryoutsuchtrainingisnotavailable,itmaybenecessary
toparticipateinexternaltrainingcoursesrunbyprofessionaltrainingorganizations.
Alternatively,anexternaltraininginstitutioncouldbeinvitedtoconductin-house
trainingcourses.
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Step5.ConductInitialStatusSurvey
ISO9000doesnotrequireduplicationofeffortorredundantsystem.ThegoalofISO
9000istocreateaqualitymanagementsystemthatconformstothestandard.This
doesnotprecludeincorporating,adapting,andaddingontoqualityprogramsalreadyin
place.Sothenextstepintheimplementationprocessistocomparetheorganization’s
existingqualitymanagementsystem,ifthereisone--withtherequirementsofthe
standard(ISO9001:
2000).
Forthispurpose,anorganizationflowchartshowinghowinformationactuallyflows
(notwhatshouldbedone)fromorderplacementbythecustomertodeliverytothis
customershouldbedrawnup.Fromthisover-allflowchart,aflowchartofactivitiesin
eachdepartmentshouldbeprepared.
Withtheaidoftheflowcharts,arecordofexistingqualitymanagementsystemshould
beestablished.Asignificantnumberofwrittenproceduresmayalreadybeinplace.
Unlesstheyareverymuchoutofdate,thesedocumentsshouldnotbediscarded.
Rather,theyshouldbeincorporatedintothenewqualitymanagementsystem.
Documentsrequiringmodificationorelaborationshouldbeidentifiedandlisted.This
exerciseissometimesreferredtoas"gapanalysis''.Duringthesereviewprocesses,
wideconsultationwithexecutivesandrepresentativesofvariousunionsand
associationswithintheorganizationisrequiredtoenlisttheiractivecooperation.
Inthereviewprocess,documentsshouldbecollected,studiedandregisteredfor
furtheruse,possiblyaftertheyhavebeenrevised.Beforedevelopingnewquality
managementsystemdocumentation,youneedtoconsiderwithwhichquality
requirementsordepartmentyoushouldstart.Thebestistoselectanareawhere
processesarefairlywellorganized,runningeffectivelyandfunctioningsatisfactorily.
Thebasicapproachistodetermineandrecordhowaprocessiscurrentlycarriedout.
Wecandothisbyidentifyingthepeopleinvolvedandobtaininginformationfromthem
duringindividualinterviews.Unfortunately,itoftenhappensthatdifferentpeoplewill
givedifferent,contradictingversionsofaprocess.Eachonemayrefertooral
instructionsthatarenotaccurateorclear.Thisiswhythefactsareoftennot
describedcorrectlythefirsttimearound,andhavetoberevisedseveraltimes.
Onceithasbeenagreedhowtodescribethecurrentprocess,thisprocesshastobe
adapted,supplementedandimplementedaccordingtotherequirementsofthequality
standard(ISO9001:
2000).Thisrequiresorganizationalarrangements,thedrawing
upofadditionaldocumentsandpossibleremovalofexistingdocumentation(e.g.
procedures,inspection/testplans,inspection/testinstructions)andrecords(e.g.
inspection/testreports,inspection/testcertificates).
Inintroducingaqualitymanagementsystem,theemphasisisontheimprovementof
theexistingprocessesorthere-organizationofprocesses.
Ingeneral,thestepstofollowarethefollowing:
Ascertainandestablishthefollowing:
Whatisthepresento
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