iso9000實(shí)戰(zhàn)1iso文件要求指南

GuidanceonationrequirementsofISO:ISO/TC176/SC2/N525R2October 1.TwoofthemostimportantobjectivesintheoftheISO9000seriesGuidanceonationrequirementsofISO:ISO/TC176/SC2/N525R2October 1.TwoofthemostimportantobjectivesintheoftheISO9000serieseISO9000todevelopasimplifiedsetoftwillbeequallyapplicabletosmallasasmediumandlargefortheamountandanizations,ationrequiredtobemorerelevanttothedesiredresultsofanization’sISO9001:2008,Qualitymanagementsystems–Requirementshasachievedobjectives,andtheeofthisadditionalguidanceistoentofnewstandardwithspecificregard2008ISO9001ISO9001:2008allowsanizationhewayitchoosesanizationqualitymanagementsystem(QMSThisenableseachdeveloptheminimumamountationneededinordertodemonstrateeffectiveplanning,operationandcontrolofitssesandtheioncontinualimprovementoftheeffectivenessofitsItistISO9001requires(andalwayshasrequired)aedmanagementsystem”,andnota“systemISO9001:2008要求（并且一直如此要求）“”而不是2．Whatisa”?-Definitionsand2．什么叫“文件”?Thefollowingaresomeofthemainobjectivesofindependentofwhetherornotsimplementedaformal1/a)Communicationofa)asatoolforinformationandcommunication.Thetypeandextentofationwilldependonthenatureofanization’sproductsandthedegreeofformalityofa)Communicationofa)asatoolforinformationandcommunication.Thetypeandextentofationwilldependonthenatureofanization’sproductsandthedegreeofformalityofcommunicationsystemsandthelevelofskillsanization,andanizationalb)Evidenceofconformityoftwhatwasplanned,uallybeenc)Knowledgesharingtodisseminateandpreserveanization’s.Atypicalexamplebeatechnicalspecification,whichcanbeusedasabasefordesignanddevelopmentofanewproduct.Alistofcommonlyusedtermsrelatingto(takenfromISO9000:2005ItmustbestressedationispresentedinAnnexAt,accordingtoISOsmaybeinanyformortypeof9000:2005clause3.7.2givesclause4.2medium,andtheationrequirementsdefinitionof“”infollowingAISO9000:2005ISO9001:20084.2ISO9000:20053.7.2prmagneticelectronicoropticalcomputerdisc；mastersampleUsersarealsoreferredtoISO/TR10013:2001,GuidelinesforqualityationforfurtherISO/TR100133．ISOation3．ISO9001：2008ISO9001:2008clause4.1Generalrequirementsrequiresanization,implement,andainaqualitymanagementsystemcontinuallyimproveitseffectivenessinaccordancewiththerequirementsofthisernationalStandard”2/Clause4.2.1Generalexplains tthequalitymanagementsystemshallinclude:ISO9001：20084.2.1edementsofaqualitypolicyandqualityaqualitymanual；edproceduresrequiredbyernationalsneededcontrolofClause4.2.1Generalexplains tthequalitymanagementsystemshallinclude:ISO9001：20084.2.1edementsofaqualitypolicyandqualityaqualitymanual；edproceduresrequiredbyernationalsneededcontrolofbytheanizationtoensuretheeffectiveplanning,operationses,andrecordsrequiredbyernational；ThenotesafterClause4.2makeittwherethestandardspecificallyaedprocedure”,theprocedurehastobeimplementedandained.Italsottheextentoftheationmaydifferfromanizationtoanotherdue4.2條后面有一個(gè)注，清楚說明，凡是標(biāo)準(zhǔn)明確要求“形成文件的程序”，那thesizeanizationandtypeofactivities;thecomplexitythecompetencesesanderactions,andAllstformpartoftheetobecontrolledinaccordanceclause4.2.3ofISOclause001:2008,or,fortheparticularcaseofrecords,accordingISO9001：200.44．GuidanceonClause4.2ofISO4.ISO9001：20084.2ThefollowingcommentsendedtoassistusersofISO9001:2008understandingtheentoftheationrequirementsofISO9001：2008edementsofaqualitypolicyanda)Requirementsforthequalitypolicyaredefinedinclause5.3ofISO9001:2008.TheedqualitypolicyhastobecontrolledaccordingtotherequirementsclauseISO9001：20085.33/4.2.3tarerevisingtheirqualitypolicyfortime,orinordermeettheamendedrequirementsinISO9001:2008,shouldpayparticularattentiontoclause4.2.3(c),(d)and(gISO9001：2008的補(bǔ)充解釋而對(duì)他們的質(zhì)量方針進(jìn)行評(píng)審的組織，特別4.2.3tarerevisingtheirqualitypolicyfortime,orinordermeettheamendedrequirementsinISO9001:2008,shouldpayparticularattentiontoclause4.2.3(c),(d)and(gISO9001：2008的補(bǔ)充解釋而對(duì)他們的質(zhì)量方針進(jìn)行評(píng)審的組織，特別要注意滿足第4.2.3條c）d）和g）這Requirementsforqualityobjectivesaredefinedinclause5.4.1ofISOedqualityobjectivesarealsosubjecttorequirementsofclause.3b)Qualityb)Clause4.2.2ofISO9001:2008specifiestheminimumcontentforaqualityTheformatandstructureofthemanualisafor anization,anddependon anization’ssize,cultureandcomplexity. anizationschoosetousethequalitymanualforotherpuringtheQMS.estofISO9001：2008第4.2.2條規(guī)定了質(zhì)量手冊(cè)最低限度的內(nèi)容。質(zhì)量手冊(cè)的格式和結(jié)構(gòu)由A anizationmayfinditappropriatetoincludethedescriptionoftirewithinasinglemanual,includingalltheedproceduresrequiredbyLarge,multi-anizationsmayneedseveralmanualsattheglobal,orregionallevel,andamorecomplexhierarchyThequalitymanualisarequirementsofclause4.2.3.stobecontrolledinaccordancewith大型 4.2.3復(fù)edc) procedures”forthefollowingsixactivities: ISO9001：2008特別規(guī)定組織要有以下六個(gè)活動(dòng)的“形成文件的程序ControlControlofs文件控制ernalaudit8.3Controlofproduct8.5.2Correctiveaction4/8.5.3Preventiveactionedetobecontrolledinaccordancewithrequirementsofclause4.2.3 anizationsmayfinditconvenienttocombinetheprocedurefor oaed(forexample,8.5.3Preventiveactionedetobecontrolledinaccordancewithrequirementsofclause4.2.3 anizationsmayfinditconvenienttocombinetheprocedurefor oaed(forexample,correctiveactionandagivenactivitybyusingpreventiveaction).Othersmaychoosenedprocedure(forernalauditsreanizations(particularlylargerses)mayrequireadditionalanizations,orthosewithmorecomplexedprocedures(particularlythosetoproductrealizationses)toimplementaneffective（特別是那些與產(chǎn)品實(shí)現(xiàn)有關(guān)的過程）anizationsmayrequireadditionalprocedures,butthesizeand/orcultureanizationcouldenablethesetobeeffectivelyimplementedwithouted.However,inordertodemonstratecompliancewithISOanizationhastobeabletoprovideobjectiveevidence(nottitsQMShasbeeneffectivelyISO9001：2008要求，組織還是要能夠sneededbyanizationtoensuretheeffectiveplanning,andcontrolofitsd)Inorderfor anizationtodemonstratetheeffectiveionofitsQMS,itedmaybesarytosnHowever,thesspecificallymentionedinISO9001:2008要開發(fā)和編寫其他文件。但是，ISO9001：2008中僅僅特別提到的那些文件是：Qualitypolicy(clause4.2.1.a)質(zhì)量方針（Qualityobjectives(clause4.2.1.a)質(zhì)量目標(biāo)（Qualitymanualclause4.2.1.b)質(zhì)量手冊(cè)（ThereareseveralrequirementsofISO9001:2008whereanizationcouldvaluetoitsQMSanddemonstrateconformitybythepreparationofeventhoughthestandarddoesnotspecificallyrequirethem.Examplesmayinclude:ISO9001：2008標(biāo)準(zhǔn)有一些要求，凡是組織能夠通過編寫其他文件來為其質(zhì)量管理體-smaps, sflowchartsand/orsdescriptions和/-anizationcharts5/Workand/ortestinstructions工作和/-sernalcommunicationsProductionschedules-rlistsTestandinspectionplansQualityplansAllsetobecontrolledinaccordancewiththerequirementsclause4.2.3and/or4.2.4,as4.2.3和/Workand/ortestinstructions工作和/-sernalcommunicationsProductionschedules-rlistsTestandinspectionplansQualityplansAllsetobecontrolledinaccordancewiththerequirementsclause4.2.3and/or4.2.4,as4.2.3和/4.2.4e)：ExamplesofrecordsspecificallyrequiredbyISO9001:2008arepresentedinAnnexISO9001：2008Banizationsarefreetodevelopothertmaybeneededtoconformityoftheirses,productsandqualitymanagement組織可 。Requirementsforthecontrolofrecordsaredifferentfromthoseforandallrecordsetobecontrolledaccordingtothoseofclause4.2.4of都必須按照對(duì)4.2.4anizationspreparingtoimplementa5thesofimplementingaQMS,andwishtotherequirementsofISO9001:2008,thefollowingcommentsmaybe 執(zhí)行質(zhì)量管理體系過程中的各個(gè)組織，以及希望滿足ISO9001：2008要thesofimplementingeyettoimplementQMS,ISO9001:2008emphasizesasapproach.This對(duì)于正在實(shí)施過程中或者尚未實(shí)施質(zhì)量管理體系的組織，ISO9001：2008強(qiáng)調(diào)采用過-Identifyingthepro sesnemanagementsystem;saryfortheeffective ionofthe-understandingeractionsnthese理解這些過程之間的相互作用-ingthe sestotheextentsarytoretheiroperationandcontrol.(Itmaybeappropriatethesessmaps.Itisemphasized, edsmapsarenot6/requirementofISO9001:2008.)ISO9001：2008的Thesesesthemanagement,resource,productrealizationandtarerelevanttotheeffectiveoperationoftheQMS.shouldbethedrivingforcefordefiningtheamountofmeasurementrequirementofISO9001:2008.)ISO9001：2008的Thesesesthemanagement,resource,productrealizationandtarerelevanttotheeffectiveoperationoftheQMS.shouldbethedrivingforcefordefiningtheamountofmeasurement ysisoftheationneededforthequalitymanagementsystem, oaccountrequirementsofISO9001:2008.ItshouldnotbetdrivesISO9001：2008的要求，分析這些過程，應(yīng)當(dāng)確定驅(qū)動(dòng)質(zhì)量管理體系所需要的文anizationswishingtoadaptanexisting6teaQMSthefollowingcommentsendedinunderstandingthechangesedbythetransitiontoISOtmayberequiredISO9001：2008標(biāo)準(zhǔn)也許有必要：anizationwithanexistingQMSshouldnotneedtorewriteallofitsationinordertomeettherequirementsofISO9001:2008.Thisparticularlytrueif anizationhasstructureditsQMSbasedontheway ationmaybeadequateandcanbesimplyherevisedISO9001：2008的要求而把利用這些修改質(zhì)量手冊(cè)的機(jī)會(huì)，只要把這些文件在手冊(cè)中簡(jiǎn)單加以就可以了。snotuseda shepastwillneedtoparticularattentiontothedefinitionofitsses,theirsequenceanizationmaybeabletocarryoutsomesimplificationand/orconsolidations,inordertosimplifyits組織可以通過這次機(jī)會(huì)對(duì)現(xiàn)有的文件考慮能否加以簡(jiǎn)化，以便簡(jiǎn)化他們的質(zhì)量管理體7．DemonstratingconformitywithISO9001:20087ISO9001：2008anizationswishingtodemonstrateconformitywiththerequirementsof7/9001:2008,fortheesofcertification/registration,contractual,orotheritisimportanttoremembertheneedtoprovideevidenceoftheionofthe9001:2008,fortheesofcertification/registration,contractual,orotheritisimportanttoremembertheneedtoprovideevidenceoftheionoftheanizationsmaybeabletodemonstrateconformitywithouttheneedforextensiveToclaimconformitywithISO9001:2008,theobjectiveevidenceoftheeffectivenessofitsproanizationhastobeabletoprovidesesanditsqualitysystem.Clause3.8.1ofISO9000:2005defines“objectiveevidence”assupportingtheexistenceorvarietyofsomething”andt“objectivemaybeobtainedthroughobservation,measurement,test,orother符合ISO9001：2008體系的有效性。ISO9000：20053.8.1條對(duì)客觀證據(jù)的定義是，“ Objectiveevidencedoesnotprocedures,recordsorother9001:2008.Insomecases,sarilydependontheexistences,exceptwherespecificallymentionedinISOexample,inclause7.1(d)Planningofrealization,andclause8.2.4Monitoringandmeasurementofproduct),itisuptoanizationtodeterminewhatrecordsareneobjectiveevidence.saryinordertoprovide的監(jiān)視和測(cè)量Whereanizationhasnoernalprocedureforaparticularactivity,thisisnotrequiredbythestandard,(forexample,clause5.6ManagementReview),isacceptableforivitytobeconductedusingasabasistherelevantclauseISOhesesituations,ernalandexternalauditsmayusetheofISO9001:2008forconformityassessment（如，條款5.6管理評(píng)審直接利用ISO9001：2008的有關(guān)條款作為基礎(chǔ)來實(shí)施這個(gè)活I(lǐng)SO9001：20088/AnnexTermsandDefinitionsrelatingsThefollowingtermsanddefinitionsAnnexTermsandDefinitionsrelatingsThefollowingtermsanddefinitionsaretakenfromISO9/ISO9000:2005Clauseinformationand pportingspecifiedwaytocarryoutanactivityorapro Procedurescanbe edornot)QualityspecifyingthequalitymanagementsystemofanQualityspecifyingwhichproceduresandasso tedresourshallbeapp dbywhomandwhentoaspecificproject,product, sorcontract ingresultsachievedorprovidingevidenceofactivitiesperformed ingAnnexRecordsrequiredbyISO9001:2008ISO9001:2008要求的10/RecordrequiredManagement6.2.2Education,training,skillsand7.1 ttherealizationpro sesAnnexRecordsrequiredbyISO90