ISO9001(2000)(ppt 22).ppt

9000國際標準,概述,何謂ISO?INTERNATIONALORGANIZATIONFORSTANDARDIZATION,國際標準組織,ISONAME?,ThenameISOwasactuallyborrowedfromtheGreekword:ISOSISO9000:InternationalQualityManagementandQualityAssuranceStandards,ISO9000的精神說=寫=做,“Discipline”“守法”,ISO9001Principles,Saywhatyoudo.(Mission,responsibilities,goals,processsteps,processorworkdescription,etc.)Dowhatyousay.(Performtothepointtoobtaindesiredresults;documentandimplementprocessesandrecordtheresults.)Proveit,showevidence.(Showthedocumentedprocessesandrecordedresults.),ISO9000系列,品質管理及品質保證國際標準,ISO9000系列,簡介：ISO標準中，有關品質管理及品質保證之制度均在ISO9000系列中規定。擬訂者：ISO9000系列，係由ISO技術委員會(ISO/TC176)品質保證組所擬訂。,ISO9000系列之淵源,MIL-Q-9858A美軍品保標準,AQAP(1958)北大西洋公約組織的品保標準,英國國防部標準,BS5750(1979)英國國家標準,ISO9000系列(1987)(1994,2000revised),ISO9001:1994vs.ISO9001:2000,ISO9001:1994-QualityAssuranceISO9001:2000-QualitySystem,ISO9000:2000FAMILY,ISO8402+ISO9000-1(1994)ISO9000:2000(Fundamental&Vocabulary)ISO9001:2000QualityManagementSystems-RequirementsISO9004:2000Qualitymanagementsystems-GuidelinesforperformanceimprovementsISO10011-1/ISO10011-2/ISO10011-3(Q)ISO14010/ISO14011/ISO14012(E),ISO19011:2000,0.3RelationshipwithISO9004a)ISO9001:specifiesrequirementforaqualitymanagementsystemthatcanbeusedforinternalapplicationbyorganizations,orforcertification,orforcontractualpurposes.Itfocusesontheeffectivenessofthequalitymanagementsysteminmeetingcustomerrequirements.b)ISO9004:givesguidanceonawiderrangeofobjectivesofaqualitymanagementsystemthandoesISO9001,particularlyforthecontinualimprovementofanorganizationsoverallperformanceandefficiency,aswellasitseffectiveness.ISO9004isrecommendedasaguidefororganizationswhosetopmanagementwishestomovebeyondtherequirementsofISO9001,inpursuitofcontinualimprovementofperformance.However,itisnotintendedforcertificationorforcontractualpurposes.,全世界46萬廠商通過ISO9000認證英國28.2%,歐洲30.3%,亞洲19.4%,ISO9000系列之品質標準架構(2000),選擇及運用之指導綱要/相關名詞定義,品管所需之品質系統要素,品質保證模式,ISO9000,ISO9004,ISO9001,非合約狀況下之品管指導綱領,合約狀況之外部品質保證,為何要推行ISO9000品保制度,潮流與趨勢:各國工廠品保制度標準已漸改採ISO9000品保模式。CEMARK:其統一品質管理與品質保證標準乃採自ISO9000系列。買方要求:通過ISO9000之認證成為購買者選擇供應廠商之要求。,ISO9001幫助我們國際化標準化文件化,品保功能稽核(2000),1stParty：自己公司進行品保功能稽核2ndParty：買賣雙方3rdParty：驗證團體,1ST,材料廠協力廠/分包商,1ST,顧客CUSTOMER(2000),Organization(2000),工廠,1ST,2ND,2ND,3RDPARTY,供貨,供貨,(Supplier)(2000),ISO9001:2000之品質系統要求,0.0簡介1.0範圍2.0引用標準3.0名詞與定義4.0品質管理系統5.0管理責任6.0資源管理7.0產品實現8.0量測、分析與改善,Customer,Customer,Requirements,Satisfaction,Qualitymanagementsystemcontinualimprovement(kpi),5.0Managementresponsibility,6.0Resourcemanagement,8.0Measurement,analysis&improvement,7.0Productand/orservicerealization,Input,Output,Productand/orservice,Qualitymanagementsystem,ISO9001:2000,Valueadding,Information,0.2PDCAa)Plan:establishtheobjectivesandprocessesnecessarytodeliverresultsinaccordancewithcustomerrequirementsandtheorganizationspolicies.b)Do:implementtheprocesses.c)Check:monitorandmeasureprocessesandproductagainstpolicies,objectivesandrequirementsfortheproductandreporttheresultsd)Act:takeactionstocontinuallyimproveprocessperformance.,KPI:(1)Machineshutdown#(2)IPdppm(3)OAY%(4)PPH,Process,Input,Output,PC:1.1.W/OSummary1.2.MPS1.3.DailyScheduleW/H:2.1.工單發料單2.2.MaterialENG:3.1.設備/治具維護3.2.SOP3.3.PMP3.4.ECN3.5.PilotRunSc