ISO-TS16949trainingforlineleaderrev3

EEMS-CONFIDENTIALJenny/2010ISO/TS16949BasicTrainingEEMS-CONFIDENTIAL课程内容第一章:ISO/TS16949质量管理体系背景第二章:ISO/TS16949质量管理体系要求*条款4.质量管理体系*条款6.资源管理*条款7.产品实现*条款8.测量,分析和改进第三章:质量管理体系过程方法的审核EEMS-CONFIDENTIAL第一章:ISO/TS16949质量管理体系背景EEMS-CONFIDENTIAL质量体系的趋势质量优秀模式如TQM,6SIGMA行业特殊标准如汽车行业(TS16949),航空业(AS9100),电信业(TL9000)等等基础质量体系模式如ISO9001更基础EEMS-CONFIDENTIALISO9000质量管理体系标准•ISO9000:2005–质量管理体系:基础和术语•ISO9001:2008–质量管理体系:要求•ISO9004:2009-质量管理体系:组织持续成功的管理---一种质量管理方法•ISO19011:2002–质量和环境审核指南EEMS-CONFIDENTIALISO9000:2005以过程为导向鼓励组织:--分析顾客的要求--规定过程,以提供满足质量要求的产品--保持这些过程受控股顾客满意帮助组织增强顾客满意持续改进提供:--一个持续改进的框架--信任,证明组织能够持续满足顾客要求EEMS-CONFIDENTIAL以过程为基础的质量管理体系模式EEMS-CONFIDENTIALISO/TS16949•旨在成为国际汽车标准•与顾客特殊要求配套,应用于汽车供应链•要求独立的第三方认证•第一版,1999;第二版,2002;第三版,2009EEMS-CONFIDENTIALISO/TS16949:2009质量管理体系汽车生产和相关服务零件组织应用ISO9001:2008的特别要求•国际汽车推动小组(IATF)和日本汽车制造商协会(JAMA)制定•ISO/TC176质量管理和质量保证技术委员会支持•基于ISO9001(质量管理体系要求),ISO9004(质量管理体系业绩改进指南),AVSQ(意大利),EAQF(法国),QS-9000(美国)和VDA6.1(德国),但并不替代这些要求,取决于顾客的要求•全球主要汽车制造商参与EEMS-CONFIDENTIALISO9001与ISO/TS16949的相互关系EEMS-CONFIDENTIAL第二章:ISO/TS16949质量管理体系要求EEMS-CONFIDENTIALISO9001:2008的内容(ISO/TS16949:2009)1.范围2.引用标准3.术语(供方组织顾客)4.质量管理体系5.管理职责6.资源管理7.产品实现8.测量,分析和改进EEMS-CONFIDENTIAL4.2.3文件控制DocumentControl•文件控制DocumentControl---确保在正确的时间正确的地点得到正确版本的正确文件.(包括外来文件)Toensurethatrightversionofapplicationdocumentareavailableatrighttimeandrightplace.(Includingexternaldocument)条款4.质量管理体系EEMS-CONFIDENTIAL1.内部文件控制InternaldocumentcontrolEEMS文件控制流程YesIssue/returned/DestroyofreturnedDocuments(SeeNote5)Login/Updatethedocumentmasterlist(SeeNote4)UseAndmaintenance(SeeNote6)IsApprovalpassed?Isthedoc.Modified?Askfortherequirementofnewcreate/update/deregisterofDoc.(SeeNote1)Filloutapplicationform(SeeNote1)EndIsapplicationPass?SendtheDoc.Numberandsoftcopythatcanedited(SeeNote1)NOYESPrepareorupdate(SeeNote2)NOYESApprovalthedocument(SeeNote3)IstheissuedDoc.Lost?YESRaiselostdoc.Form,submittoDCC(SeeNote5)DestroytheobsoleteDocs.(SeeNote5)1.22.13.12.22.32.41.52.5RequirementofDocumentMasterlistofcontroldocuments1.0RelevantDept.2.0DCC3.0ConfirmrespondentNoNo1.11.31.4条款4.质量管理体系EEMS-CONFIDENTIALCompletetheworkinstructionswiththefollowingheadersinrespectiveorder.1.Purpose2.Scope3.EquipmentandMaterials4.ReferenceDocuments5.Requirements6.AppendixUseARIALFontwithSize10andalllettersofDoc.titleshouldbecapitalXNote1:Specifytheresponsibilityforeachinstructionintheflowchart(eg.1.1,1.2,2.1,3.1)Guidelinesfortheflowchartsymbolsasshown:AnactivityoroperationAdecisionmatrixAconnector(Xdenotesanalphabet)(usedwhencontinuousflowgoesintothenextpage)Note2:FormNumberingSystemAssignaccordingtothedocumentnumbereg.CM-TE-QC-001/01AWhere01–numberofformsA–FormrevisionnumberCompletetheQualityProcedurewiththefollowingheadersinrespectiveorder.1.Purpose2.Scope3.EquipmentandMaterials4.ResponsibilityandReferences5.ProceduresandRequirements6.AppendixUseARIALFontwithSize10andalllettersofDoc.Titleshouldbecapital条款4.质量管理体系EEMS-CONFIDENTIALNote3:TheWorkInstructionsneedtobewritteninEnglish.ForWorkInstructionstobeusedbyoperatorsonthemanufacturingfloorwillrequiretheChineseversiontobeincluded.WorkInstructionsonEquipmentMaintenanceandEquipmentBuyoffaregenerallyexcluded.ThefinaldecisiontohavetheWorkInstructionsinChineseistobedecidedbytherelevantModuleManager.Note4:The“DocumentTitle”contentmustbewrittenusingcapitalfonts(i.e.INPRINTFORM)Note5:FormAlignmentRequirementsa.Forsectionwithboxesforsignature,ensurethattheboxescontain5signaturecolumns,andthecolumnlastverticallineisalignedtothechangedescriptionlastline.Spacethesignatureboxesevenly.Forspacesthatareunfilled,leavethemblank.Anexampleislistedbelow-SignatureNameNAME1NAME2NAME3e.g.BLANKe.g.BLANKDateDesignationNote6:ChangeDescriptionLimitthechangedescriptiontonomorethan10recentrevisionchangedescriptionsummary.Forexample,ifthechangerevisionisat18,therevisionchangedescriptionsummarymustcontainrevision9to18informationonly.Note7:SubmitWItoDCCrequirementOriginatormustsubmittheworkinstructionsthatCompletethesignofftoDCCbefore2daysofeffected.Forexample,iftheeffectivedateis08-Oct-07,originatormustsubmitworkinstructiontoDCCbefore06-Oct-07.条款4.质量管理体系EEMS-CONFIDENTIAL条款4.质量管理体系EEMS-CONFIDENTIAL1.3Anymanuals/references/MSDStobeusedasofficialdocumentsStamponthe1stpageofthedocumentandgettherelevantdepartmentmanagertosign.usingstamp4,noneedsignusingstamp5a.FileMastercopyanddistributereferencecopies.b.Maintaindistributionlist1.11.21.0DCCAdministrativeAssistantControlofReferencedocumentsRemark:AllMSDSmustbesendtoDCCcontrol.条款4.质量管理体系EEMS-CONFIDENTIALTemporaryEngineeringChangeNotification(TECN)TECNrequirementsaredefinedRequestTECN#fromDCCUpdateTECNForminAppendix7SubmitforApprovalApprovalcompleted?ReturntoDCCDCCissueTECNcontrolledcopytorequiredproductionareaUpdateTECNMasterlist&trackforexpiration1.0RequestorDept2.0DCC1.11.21.31.4NoYes1.52.12.2TECNexpired?RequestproductiontoreturnTECNControlCopy,andobsoletecopy,andfileObsoletecopy,file,andupdateTECNmasterlist2.32.4NoYesEEMS-CONFIDENTIALConfidentialDocumentsDefinition-Confidentialdocumentsaredefinedasdocumentscontaini