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1、ISO9000-FrequentlyAskedQuestions(FAQs)ThislistofFrequentlyAskedQuestions(FAQs)hasbeenupdatedafterpublicationoftheISO9000:2000familyofInternationalStandards.InputhasbeenobtainedfromexpertsandusersoftheISO9000standards,expressedduringseminarsandpresentationsaroundtheworld.Thelistwillbereviewedandupdat
2、edonaregularbasistomaintainitsaccuracy,andtoincludenewquestionswhereappropriate.Itisintendedthatthislistwillalsoprovideagoodsourceofinformationfornewusersofthestandards.Whywerethestandardsrevised?Themajorreasonsfortheyear2000revisionsofthestandardsinclude: emphasizingtheneedtomonitorcustomersatisfac
3、tion, meetingtheneedformoreuser-friendlydocuments, assuringconsistencybetweenqualitymanagementsystemrequirementsandguidelines, promotingtheuseofgenericqualitymanagementprinciplesbyorganizations,andenhancementoftheircompatibilitywithISO14001.Inaddition,theyear2000revisionoftheISO9000standardsgivesuse
4、rstheopportunitytofurtherincreasevaluetotheiractivitiesandtoimprovetheirperformancecontinuallybyfocusingonthemajorprocesseswithintheorganization.Extensivesurveyshavebeenperformedonaworldwidebasistounderstandtheneedsofallusersofthequalitymanagementsystemstandards.Thenewrevisionstakeintoaccountpreviou
5、sexperiencewithqualitymanagementsystemstandards(1987and1994editions)andemerginginsightsintogenericmanagementsystems.Theyresultinacloseralignmentofqualitymanagementsystemswiththeneedsoforganizationsandbetterreflectthewayorganizationsruntheirbusinessactivities.ISOsrulesofprocedure(theISO/IECDirectives
6、)alsospecifythatstandardsbeperiodicallyrevisedtoensurethatthosestandardsarecurrentandsatisfytheneedsoftheglobalcommunity.FAQOOlfMarch2001Whoisresponsibleforrevisingthestandards?TherevisionprocessistheresponsibilityofISOTechnicalCommittee(TC)176andisconductedonthebasisofconsensusamongqualityandindust
7、ryexpertsnominatedbyIS。Memberbodies,andrepresentingallinterestedpartiesFAQ002,March2001Willtheyear2000revisionaffectmyorganizationscurrentqualitysystemregistration/certification?Yes.ThestrategyadoptedbyyourorganizationtomeettherequirementsofISO9001:2000shouldincludeanappropriatetimingforupgradingyou
8、rorganizationsregistration/certification.Itisexpectedthattheprocessofupgradingregistration/certificationwillbeasmoothtransitionthatisincorporatedintotheapplicableRegistrationorCertificationBodysregularauditroutine.TheIntemationalACCTeditrtionForum(IAFhasalreadyestablishedasetofguidelinesforCertifica
9、tionBodies/Registrarstofollow,andthisincludesatransitionperiodofuptothreeyearsafterthe15thofDecember2000.Youareadvisedtocontactyourregistration/certificationbodytonegotiateasuitabletransitiontimeframefortheassessmentofyourownorganization.FAQ003,March2001Howmuchisthetransitiontothenewstandardsgoingto
10、cost?OneofthegoalsofISO/TC176istoproducestandardsthatwillminimizeanypotentialcostsduringasmoothtransition.Anyadditionalcostsmaybeconsideredasavalue-addedinvestment.ThecostofimplementinganynecessarychangesinordertomeetthenewrequirementsofISO9001:2000willvaryfromoneorganizationtoanother,dependingonvar
11、iousfactorssuchastheactualstateofimplementationofthequalitymanagementsystem,thesizeandcomplexityoftheorganization,theattitudeandcommitmentofthetopmanagement,etc.Itisexpectedthatthebenefitstoallorganizationswilloutweigheventualcostsassociatedwiththetransition.Regardingthecostsofupgradingthecertificat
12、ion,theIntemationalACcTeditatiOnFonJms(IAF)guidelinesprovidefortheincorporationofauditstothenewstandardintosurveillancevisitsforexisting(1994)certifications,whereverpossible.FAQ004,March2001Wherecanmyorganizationobtaincopiesoftherevisedstandards?CopiesoftherevisedstandardsmaybepurchasedfromNationalS
13、tandardsBodies.Manycountriesmayhavetheseavailableinlocal-languageversions(seeISOOnlineforalistingofmemberbody,i.e.nationalstandardsbodies,contactdetails)FAQ005,March2001WherecanIobtaininformationontherevisedstandards?ThereareanumberofsourcesofinformationontherevisionofISO9000qualitymanagementsystems
14、tandards,including,ofcourse,thiswebsite,whichcarriesdetailedinformationontherevisedstandardsandisupdatedonaregularbasis.ISOCentralSecretariatinSwitzerlandisalsomaintainingawebsiteatthatcarriesgeneralinformationontherevisedstandards.YourNationalStandardsBodyshouldbeabletoprovidecopiesoftherevisedstan
15、dardsandregistrarscertificationbodieswillbeabletoprovideguidanceontransitionalregistrationarrangements(seetheISOwebsiteforalistingofthememberbodies,i.e.thenationalstandardsbodies,contactdetails).FAQ006,March2001Wheredoesmyorganizationgoifitneedsclarificationorinterpretationoftherevisedstandards?Thes
16、tartingpointforanyindividualrequestforaninterpretationshouldbewiththeenquirersnationalstandardsbody.ISOcentralsecretariatandTC176cannotacceptdirectrequestsfromindividualsforinterpretationsoftheISO9000standards.Instead,ISO/TC176hasestablishedaWorkingGroupforinterpretation,withaformalproceduretoprovid
17、eanswerstothequestionsthatareforwardedbythenationalstandardbodies.(SeetheISOwebsiteforalistingofthememberbodies,i.e.thenationalstandardsbodies,contactdetails).FAQ007,March2001Willmyorganizationneedafullreassessmentfortherevisedstandards?Thisisprimarilyanissuebetweenyourorganizationandyourregistratio
18、n/certificationbody.ItisexpectedthatconformitytothenewISO9001:2000standardwillbeevaluatedbycertificationbodiesduringregularsurveillancevisits,andthatfullreassessmentwillonlytakeplaceoncecurrentcertificatesexpire.FAQ008,March2001Willmyorganizationhavetochangeitsqualitysystemand,ifso,when?Itisnotthein
19、tentionthatyoushouldhavetochangethewholestructureofyoursystemorre-writeallyourprocedures;however,therevisedstandardsincludesomenewrequirementsandyoushouldconsideraddressingtheminyoursystematanappropriateopportunity.AjointgroupfromtheInternationalAccreditationForum,ISO/TC176andISO/CASCOhaveagreedthat
20、thereshouldbea3yeartransitionperiodduringwhichaccreditedcertificationtothe1994standardsandISO9001:2000maycontinuetocoexist.Thistransitionperiodwillendon15December2003.Bythatdate,allorganizationswishingtoretainaccreditedcertificationwillhavetohavemigratedtheirqualitymanagementsystemtobeingcompliantwi
21、thISO9001:2000.ISO/TC176SC2haspublishedaTransitionPlanningGuidetoassistorganisationsintheirmigration.FAQ09,March2001Willmyorganizationhavetore-writeallitsdocumentation?No.Ifyourcurrentqualitymanagementsystemissuccessfullyimplemented,satisfiestheneedsandobjectivesofyourorganization,reflectsthewayyour
22、organizationworks,addressesallofthenewrequirements,nochangesarerequired.However,ifyourcurrentdocumentedsystemdoesnotaddressallofthenewrequirements,additionaldocumentationmaybenecessary.TheInternationalStandardISO9001:2000hasclarifiedtheneedforrequireddocumentation.Only6documentedproceduresarerequire
23、dbythestandardsforadministrationofthesystem;however,otherdocumentedproceduresmayberequiredbyyourorganizationinordertomanagetheprocesseswhicharenecessaryfortheeffectiveoperationofthequalitymanagementsystem.Thiswillclearlyvarydependingonthesizeoftheorganization,thekindOfactivitiesinwhichitisinvolvedan
24、dtheircomplexity.FAQ010fMarch2001Aretherevisedstandardsmorecompatiblewithnationalqualityawardcriteria?Thequalitymanagementprinciplesarenowthebasisfortherevisedstandards,whicharebetteralignedwiththephilosophyandobjectivesofmostqualityawardprograms.Theseprinciplesare: Customerfocus, 1.eadership, Invol
25、vementofpeople, Processapproach, Systemapproachtomanagement, Continualimprovement, Factualapproachtodecisionmaking,and Mutuallybeneficialsupplierrelationships.FAQ011fMarch2001Doestherevisedstandardsaddressfinancialissues?FinancialissuesarenotaddressedintheISO9001:2000standard.TheISO9004:2000guidance
26、standardemphasizesthefinancialresourcesneededfortheimplementationandimprovementofaqualitymanagementsystem.FAQ012,March2001Whatarethebenefitsoftherevisedstandards?Thereareanumberofmajorbenefitswiththerevisedqualitymanagementsystemsstandards.Amongthemare: Applicabilitytoallproductcategories,inallsecto
27、rsandtoallsizesoforganizations Simpletouse,clearinlanguage,readilytranslatable,andeasilyunderstandable Significantreductionintheamountofrequireddocumentation. Connectionofqualitymanagementsystemstoorganizationalprocesses Provisionofanaturalmovetowardsimprovedorganizationalperformance Greaterorientat
28、iontowardcontinualimprovementandcustomersatisfaction CompatibilitywithothermanagementsystemssuchasISO14000 Provisionofaconsistentbasistoaddresstheneedsandinterestsoforganizationsinspecificsectors(e.g.medicaldevices,telecommunications,automotive,etc) Theconceptoftheconsistentpair-ISO9001coveringthere
29、quirementsandISO9004forgoingbeyondtherequirementsinordertofurtherimprovetheperformanceoftheorganization. Considerationoftheneedsofandbenefitstoallinterestedparties.FAQ013,March2001Whatarethemainchangestothestandards?Themainchangesthathavebeenintroducedintheconsistentpairofqualitymanagementsystemstan
30、dardsare: Anewprocess-orientedstructureandamorelogicalsequenceofthecontents Acontinualimprovementprocessasanimportantsteptoenhancethequalitymanagementsystem Increasedemphasisontheroleoftopmanagement,whichincludesitscommitmenttothedevelopmentandimprovementofthequalitymanagementsystem,considerationofl
31、egalandregulatoryrequirements,andestablishmentofmeasurableobjectivesatrelevantfunctionsandlevels. TheconceptofApplicationofthestandardhasbeenintroduced(inclause1.2)asawaytocopewiththewidespectrumOforganizationsandactivities. Arequirementfortheorganizationtomonitorinformationoncustomersatisfactionasa
32、measureofsystemperformance. Significantreductionintheamountofrequireddocumentation. Terminologychanges/improvementsforeasierinterpretation. IncreasedcompatibilitywiththeenvironmentalmanagementsystemstandardISO14001 Specificreferencetoqualitymanagementprinciples. Considerationofthebenefitsandneedsofa
33、llinterestedparties. Additionoftheconceptoforganizationalself-assessmentasadriverforimprovement(ISO9004:2000)FAQ014,March2001WhatnewrequirementshavebeenintroducedintotherevisedISO9001standard?Themainnewrequirementsinclude: Continualimprovement Increasedemphasisontheroleoftopmanagement. Consideration
34、ofstatutoryandregulatoryrequirements. Establishmentofmeasurableobjectivesatrelevantfunctionsandlevels. Monitoringofinformationoncustomersatisfactionasameasureofsystemperformance. Increasedattentiontoresourceavailability. Determinationoftrainingeffectiveness. Measurementsextendedtosystem,processes,an
35、dproduct. AnalysisofcollecteddataontheperformanceofthequalitymanagementsystemFAQ015,March2001WhyhastherequirementformonitoringofcustomersatisfactionbeenincludedinISO9001?Customersatisfactionisrecognizedasoneofthedrivingcriteriaforanyorganization.Inordertoevaluateiftheproductmeetscustomerneedsandexpe
36、ctations,itisnecessarytomonitortheextentofcustomersatisfaction.Improvementscanbemadebytakingactiontoaddressanyidentifiedissuesandconcerns.FAQ016,March2001Willtherevisedstandardsimprovecustomersatisfaction?Thequalitymanagementsystemdescribedintherevisedstandardisbasedonqualitymanagementprinciplesthat
37、includetheprocessapproachandcustomerfocus.Theadoptionoftheseprinciplesshouldprovidecustomerswithahigherlevelofconfidencethatproductswillmeettheirneedsandincreasestheirsatisfaction.FAQ017,March2001Whatisaprocess?Anyactivityoroperation,whichreceivesinputsandconvertsthemtooutputs,canbeconsideredasaproc
38、ess.Almostallactivitiesandoperationsinvolvedinmakingaproductorprovidingaserviceareprocesses.Fororganizationstofunction,theyhavetodefineandmanagenumerousinter-linkedprocesses.Oftentheoutputfromoneprocesswilldirectlyformtheinputintothenextprocess.Thesystematicidentificationandmanagementofthevariouspro
39、cessesemployedwithinanorganization,andparticularlytheinteractionsbetweensuchprocesses,maybereferredtoastheprocessapproach7tomanagement.Therevisedqualitymanagementsystemstandardsarebasedonjustsuchaprocessapproach,inlinewiththeguidingqualitymanagementprinciples.FAQ018,March2001Whatismeantbycontinualim
40、provement?Continualimprovementrequiresanorganizationtofocusoncontinuallyincreasingtheeffectivenessand/orefficiencyofitsprocesses,tofulfillitspoliciesandobjectives.Continualimprovement(wherecontinualhighlightsthatanimprovementprocessrequiresprogressiveconsolidationsteps)respondstothegrowingneedsandex
41、pectationsofcustomersandensuresadynamicevolutionofthequalitymanagementsystem.FAQ019,March2001Howwilltheimplementationofthenewstandardshelpmyorganizationtoimproveitsefficiency?ISO9001:2000aimsatguaranteeingtheeffectiveness(butnotnecessarytheefficiency)oftheorganization.Forimprovedorganizationaleffici
42、ency,however,thebestresultscanbeobtainedbyusingthenewISO9004:2000inadditiontoISO9001:2000.Theguidingqualitymanagementprinciplesareintendedtoassistanorganizationincontinualimprovement,whichshouldleadtoefficiencythroughouttheorganization.FAQ020,March2001Howwilltherevisedstandardsimprovetheperceptionof
43、ISO9001certification/registration?BydemonstratingtoorganizationsthattheprocessofcertificationbasedonthenewISO9001standardaddsvaluetotheirownbusinessgoals,amarket-wideimprovementintheperceptionofISO9001certificationshouldbedeveloped.Therationalebehindtherevisionprocessplacesgreatemphasisonmakingquali
44、tymanagementsystemsclosertotheprocessesoftheorganizationandoncontinualimprovement.Asaresult,therevisedstandards(ISO9001:2000andISO9004:2000)aredirectedtotheachievementofbusinessresults,includingsatisfactionofcustomersandothers.Thereisconfidencethatmanagementoftheorganizationwillbeabletoadoptthequali
45、tymanagementsystemstandardsnotonlyforcertificationpurposes,butalsoasaprofitableinvestment.FAQ021,March2001Whatwillhappentotheguidelinedocuments(e.g.zISO9000-3zISO9004-2)intheISO9000family?TherevisedISO9001andISO9004qualitymanagementsystemstandardshavebeenpreparedtakingintoaccounttheseandotherguideli
46、nedocumentsoftheformerISO9000family.Therevisedstandardsareintendedtobesufficientlygenericsoastoeliminatetheneedforspecificguidanceontheirapplication.Itisintendedthattheresponsibilityforsomeoftheguidelinestandards(suchasISO9000-3and9000-4)willbetransferredtootherISO/IECTechnicalCommittees.Itispropose
47、dthatstandardssuchasISO9004-2andISO9004-3bewithdrawnandotherdocuments(e.g.ISO10013)maybecometechnicalreportsattheirnextrevisions.ISO10012willremainasaninternationalstandard.ThissituationiscurrentlyunderreviewbyISO/TC176.FAQ022,March2001WhatwillhappentoISO10012-1andISO10012-2?Currentplansaretomaintai
48、nthesemeasurementsystemsstandardsaspartoftheyear2000ISO9000family.Aworkitemhasbeenapprovedforthemergerof10012-1and10012-2intoonestandard.ThenewISO10012standardistargettedforpublicationinearly2002.FAQ023fMarch2001WhathappenedtoISO8402andISO9000-1?ThetermsandvocabularypreviouslyfoundintheISO8402standardareaddressedintheISO9000:2000(QualityManagementSystems:FundamentalsandVocabulary)standard.ThequalitymanagementconceptsinISO9000-1havebeenintegratedintotheISO9000:2000standard.FAQ024,March2001Whichstandardwillmyorganizationberegist
