qs9000中英文版(1)7232.docx

目錄(Contents)：Management Responsibility - Element 4.1管理責任 - 4.1Qualityy Poliicy -44.1.1品質政策 - 4.1.11Organizzationn -4.11.2組織 - 4.1.2Responssibiliity annd Autthoritty 4.11.2.1責任與授權 - 4.1.2.1Resourcces - 4.1.22.2資源 - 4.1.2.22Managemment RRepressentattive - 4.1.2.3管理代表 - 4.1.22.3Organizzationn Inteerfacees - 44.1.2.4組織聯系界面 - 4.11.2.4Informaation to Maanagemment - 4.1.2.5通知管理階層 - 4.11.2.5Managemment RRevieww - 4.1.3管理審查 - 4.1.33Managemment RRevieww - 4.1.3.11管理審查 - 4.1.33.1Businesss Plaan - 44.1.4經營計劃 - 4.1.44Analysiis andd Use of Coompanyy Leveel Datta- 4.1.5公司層級資料的的分析和應用用 - 4.1.5.Customeer Sattisfacction - 4.11.6顧客滿意 - 4.1.66Certifiicatioon Boddy/Reggistraar Nottificaation - 4.11.6.1通知認証團體 - 4.11.6.1Qualityy Systtem - Elemeent 4.2品質系統 - 4.2Generall - 4.2.1概述 - 4.2.1Qualityy Systtem Prroceduures- 4.2.22品質系統程序 - 4.22.2Qualityy Plannning - 4.22.3品質規劃 - 4.2.33Advanceed Prooduct Qualiity Pllanninng - 44.2.3.1先期產品品質規規劃- 4.2.3.11Speciall Charracterristiccs - 44.2.3.2管制特性 - 4.2.33.2Feasibiility Revieews - 4.2.33.3可行性審查 - 4.2.3.3Productt Safeety - 4.2.33.4產品安全性 - 4.2.3.4Processs Faillure MMode aand Efffectss Anallysis (Proccess FFMEAs) - 4.2.3.55制程的失效模式式與效應分析析- 4.22.3.5Mistakee Prooofing - 4.22.3.6錯誤防止 - 4.2.33.6The Conntrol Plan - 4.22.3.7管制計劃 - 4.2.33.7Producttion PPart AApprovval Prrocesss - 4.2.4量產零組件核准准程序 - 4.2.44Generall - 4.2.4.11概述 - 4.2.4.11Subconttractoor Reqquiremments - 4.22.4.2分包商的要求 - 4.22.4.2Engineeering Changge Vallidatiion - 4.2.44.3工程變更的確認認 - 4.2.4.33Continuuous IImprovvementt - 4.2.5持續改善 - 4.2.55Generall - 4.2.5.11概述 - 4.2.5.11Qualityy and Produuctiviity Immproveementss - 4.2.5.22品質和生產力的的改進 -44.2.5.2Techniqques ffor Coontinuuous IImprovvementt - 4.2.5.33持續改善的技術術 - 4.2.5.33Facilitties aand Tooolingg Manaagemennt- 4.2.6設施與工模具管管理 - 44.2.6Facilitties, Equippment, and Proceess Pllanninng Efffectivvenesss - 4.2.6.11設施 、設備及及制程規劃和和效益 - 4.2.66.1Toolingg Manaagemennt - 44.2.6.2工模具管理 - 4.2.6.2Contracct Revview - Elemment 44.3合約審查 - 4.3Generall - 4.3.1概述 - 4.3.1Review - 4.33.2審查 - 4.3.2Amendmeent too a Coontracct - 44.3.合約變更 - 4.3.33Recordss - 4.3.4記錄 - 4.3.4Design Contrrol - Elemeent 4.4設計管制 - 4.4Generall - 4.4.1概述 - 4.4.1Use of Desiggn Datta - 44.4.1.1設計資料的運用用 - 4.4.1.11Design and DDeveloopmentt Plannning - 4.44.2設計與開發規劃劃 - 4.4.2Requireed Skiills - 4.4.2.1所需技能 - 4.4.22.1Organizzationnal annd Tecchnicaal Intterfacces - 4.4.33組織與技術的介介面 - 44.4.3Design Inputt - 4.4.4設計輸入 - 4.4.44Design inputt - Suupplemmentall - 4.4.4.11設計輸入 - 補充 - 44.4.4.1Design Outpuut - 44.4.5設計輸出 - 4.4.55Design Outpuut - SSuppleementaal - 44.4.5.1設計輸出 - 補充 - 44.4.5.1Design Revieew - 44.4.6設計審查 - 4.4.66Design Verifficatiion- 44.4.7設計驗証 - 4.4.77Design Validdationn - 4.4.8設計確認 - 4.4.88Design Validdationn - Suupplemment -4.4.88.1設計確認 - 補充 - 44.4.8.1Design Changges - 4.4.99設計變更- 44.4.9Design Changges - Suppllementtal - 4.4.99.1設計變更 - 補充 - 44.4.9.1Design Changge Imppact - 4.4.9.2設計變更的影響響 - 4.4.9.22Customeer Proototyppe Suppport - 4.44.10顧客原型樣品的的配合 - 4.4.110Confideentiallity - 4.4.11保密性 - 44.4.111Documennt andd Dataa Conttrol - Elemment 44.5文件與資料管制制 - 4.5Generall - 4.5.1概述 - 4.5.1Documennt andd Dataa Apprroval and IIssue- 4.5.2文件與資料之核核准與發行 - 4.55.2Engineeering Speciificattions - 4.55.2.1工程規格 - 4.5.22.1Documennt andd Dataa channges - 4.5.3文件及資料變更更- 4.55.3Purchassing - Elemment 44.6採購 - 4.6Generall - 4.6.1概述 - 4.6.1Approveed Matterialls forr Ongooing PProducction - 4.66.1.1量產中的核准物物料 - 44.6.1.1Governmment, Safetty andd Enviironmeental Regullationns - 44.6.1.2政府，安全與環環境法規 - 4.6.1.2Evaluattion oof Subb-conttractoors - 4.6.22分包商之評估 - 4.66.2Subconttractoor Devvelopmment - 4.6.2.1分包商的開發 - 4.66.2.1Schedulling SSubconntracttors - 4.6.2.2分包商交貨日程程規劃 - 4.6.22.2Purchassing DData - 4.6.3採購資料 - 4.6.33Verificcationn of PPurchaased PProducct - 44.6.4採購產品的驗証証 - 4.6.4Supplieer Verrificaation at Suubconttractoor's PPremisses - ISO4.6.4.11供應商在分包商商處的驗証 - ISOO 4.6.4.1Customeer Verrificaation of Suubconttracteed Prooduct - ISOO6.4.22.2顧客以分包商產產品的驗証 - ISOO 6.4.2.2Controll of CCustommer-Suupplieed Prooduct-Elemeent 4.7顧客提供產品之之管制 - 4.7Customeer Ownned Tooolingg - 4.7.1顧客所有之工模模具 - 44.7.1Productt Idenntificcationn and Elemeent-Ellementt 4.8產品之識別與追追溯性 - 4.8Processs Conttrol-EElemennt 4.99制程管制 - 4.9Cleanliiness of Prremisees - 44.9.b.1生產工場的清潔潔 - 4.9.b.11Continggency Planss-4.9.b.2緊急應變計劃 - 4.99.b.2Designaation of Sppeciall Charracterristiccs-4.99.d.1管制特性的指定定 - 4.9.d.11Preventtive MMainteenancee-4.9.g.1預防保養 - 4.9.gg.1Processs Moniitorinng andd Operrator Instrructioons-4.9.1制程監測和作業業指導書 - 4.9.1Maintaiining Proceess Coontroll-4.9.2制程控制的維持持 - 4.9.2Modifieed Proocess Contrrol Reequireementss-4.9.3制程管制要求的的變更 - 4.9.33Verificcationn of JJob Seetups-4.9.44作業設定的驗証証 - 4.9.4Processs Channges-44.9.5制程變更 - 4.9.55Appearaance IItems-4.9.66外觀項目 - 4.9.66Inspecttion aand Teestingg-Elemment 44.10檢驗與測試 - 4.100Generall-4.100.1概述 - 4.10.1Acceptaance CCriterria foor Atttributte Chaaracteeristiics-4.10.1.1計數值允收準則則 - 4.10.1.1Receiviing Innspecttion aand Teestingg -4.110.2收料檢驗與測試試 - 4.10.2Incominng Prooduct Qualiity -44.10.22.4進料產品的品質質 - 4.10.2.4In-proccess IInspecction and TTestinng-4.110.3制程中之檢驗與與測試 - 4.10.3Final IInspecction and TTestinng -4.10.4最終檢驗與測試試 - 4.10.4Layout Inspeectionn and Functtionall Testting -4.10.4.1全盤尺寸檢驗與與機能測試 - 4.110.4.11Final PProducct Auddit -44.10.44.2最終產品稽核 - 4.110.4.22Inspecttion aand Teest Reecordss -4.110.5檢驗及測試記錄錄 - 4.10.5Supplieer Labboratoory Reequireementss -4.110.6供應商的實驗室室要求 - 4.10.6Laborattory QQualitty Sysstems -4.100.6.1實驗室品質系統統 - 4.10.6.1Laborattory PPersonnnel -4.10.6.2實驗室人員 - 4.100.6.2Laborattory PProducct Ideentifiicatioon andd Testting - 4.100.6.3實驗室被測產品品的識別與測測試 - 44.10.66.3Laborattory PProcesss Conntrol - 4.110.6.44實驗室流程管制制 - 4.10.6.4Laborattory TTestinng andd Caliibratiion Meethodss - 4.10.6.5實驗室測試與校校正的方法 - 4.110.6.55Laborattory SStatissticall Methhods - 4.100.6.6實驗室統計方法法 - 4.10.6.6Accrediited LLaboraatoriees - 44.10.77驗証的實驗室 - 4.110.7Controll of IInspecction, Meassuringg and Test Equippment-Elemeent 4.11檢驗、量測與試試驗設備的管管制 - 44.11Generall-4.111.1概述 - 4.11.1Controll Procceduree- 4.111.2管制程序-4.11.2Calibraation Serviices - 4.111.2.b.1校正服務-4.11.2.b.1Inspecttion, Measuuring, and Test Equippment Recorrds -44.11.33檢驗，量測及與與試驗設備之之記錄 - 4.11.3Measuriing Syystem Analyysis-44.11.44量測系統分析 - 4.111.4Inspecttion aand Teest Sttatus - Eleement 4.12檢驗與測試狀況況 - 4.12Supplemmentall Veriificattion - 4.122.1額外驗証 - 4.12.1Controll of NNonconnformiing Prroductt - Ellementt 4.133不合格品之管制制 - 4.13Generall - 4.13.1概述 - 4.13.1Suspectt Mateerial or Prroductt - 4.13.1.1可疑材料或產品品 - 4.13.1.1Visual Identtificaation - 4.113.1.22視覺識別 - 4.13.1.2Review and DDispossitionn of NNonconnformiing Prroductt - 4.13.2不合格產品之檢檢討與處理 - 4.113.2Priorittized Reducction Planss-4.133.2.1不合格品優先減減量計劃 - 4.13.2.1Controll of RReworkked Prroductt - 4.13.3重工產品之管制制 - 4.13.3Engineeering Approoved PProducct Autthorizzationn - 4.13.4工程認可產品的的授權 - 4.13.4Correcttive aand Prreventtive AActionn - Ellementt 4.144矯正與預防措施施 - 4.14Generall - 4.14.1概述 - 4.14.1Problemm Solvving MMethodds - 44.14.11.1解決問題的方法法 - 4.14.1.1Mistakee Prooofing-4.14.1.2錯誤防止 - 4.14.1.2Correcttive AActionn - 4.14.2矯正措施 - 4.14.2Returneed Prooduct Test/Analyysis - 4.144.2.1退回產品的測試試 /分析 - 44.14.22.1Correcttive AActionn Impaact - 4.14.2.2矯正行動的影響響 - 4.14.2.2Preventtive AActionn-4.144.3預防措施 - 4.14.3Handlinng, Sttoragee, Pacckaginng, Prreservvationn and Delivvery-EElemennt 4.115搬運、儲存、包包裝、保存與與交貨 - 4.15Generall - 4.15.1概述 - 4.15.1Handlinng - 44.15.22搬運 - 4.15.2Storagee - 4.15.3儲存 - 4.15.3Inventoory - 4.15.3.1庫存量 - 44.15.33.1Packagiing-4.15.4包裝 - 4.15.4Customeer Pacckaginng Staandardds-4.115.4.11顧客包裝標準 - 4.115.4.11Labelinng-4.115.4.22標識 - 4.15.4.2Preservvationn-4.155.5防護 - 4.15.5Deliverry-4.115.6交貨 - 4.15.6Supplieer Delliveryy Perfformannce Moonitorring -4.15.6.1供應商交貨績效效監測 - 4.15.6.1Producttion SScheduuling - 4.115.6.22生產排程 - 4.15.6.2Electroonic CCommunnicatiion - 4.15.6.3電子通訊 - 4.15.6.3Shipmennt Nottificaation Systeem - 44.15.66.4交貨通知系統 - 4.115.6.44Controll of QQualitty Reccords- Elemment 44.16品質記錄的管制制 - 4.16Record Retenntion - 4.116.1Internaal Quaality Auditts - EElemennt 4.117內部品質稽核 - 4.117Internaal Auddit Scchedulles-4.17.1稽核計劃排程 - 4.117.1Traininng Eleement 4.18訓練 - 4.18Traininng Efffectivvenesss-4.188.1訓練的有效性 - 4.118.1Serviciing -EElemennt 4.119服務 - 4.19Feedbacck of Inforrmatioon froom Serrvice-4.19.1服務資訊的回饋饋 - 4.19.1Statisttical Technniquess -Eleement 4.20統計技術 - 4.20Identifficatiion off Needd -4.220.1需求的確定 - 4.200.1Proceduure 4.20.2程序 - 4.20.2Selectiion off Stattisticcal Toools-44.20.33統計工具的選擇擇 - 4.20.3Knowleddge off Basiic Staatistiical CConceppts-4.20.4基本統計概念的的知識 - 4.20.4Managemment RResponnsibillity - Elemment 44.1管理責任 - 4.1Qualityy Poliicy -44.1.1 品質政策 - 4.1.11The Suppplierr's maanagemment wwith eexecuttive rresponnsibillity sshall definne andd docuument its ppolicyy for qualiity, iincludding oobjecttives for qqualitty andd its commiitmentt to qqualitty. Thhe quaality policcy shaall bee releevant to thhe suppplierr's orrganizzationnal gooals aand thhe exppectattions and nneeds of itts cusstomerrs. Thhe suppplierr shalll enssure tthat tthis ppolicyy is uundersstood, impllementted annd maiintainned att all levells of the oorganiizatioon.供應商負經管責責任之管理階階層應界定並並明文記載其其對品質所持持之政策，包包含品質目標標與對品質之之承諾。該品品質政策必須須相關於供應應商之組織目目標與顧客需需求與期望，供供應商應確保保該組織內之之所有階層均均了解，實施施與維持此品品質政策。Organizzationn -4.11.2組織 - 4.1.2Responssibiliity annd Autthoritty 4.11.2.1責任與授權 - 4.1.2.1Tile reesponssibiliity, aauthorrity aand thhe intterrellationn of ppersonnnel wwho maanage, perfform aand veerify work affeccting qualiity shhall bbe deffined and ddocumeented, partticulaarly ffor peersonnnel whho neeed thee orgaanizattionall freeedom aand auuthoriity too:a) inittiate actioon to preveent thhe occcurrennce off any noncoonformmity rrelatiing too prodduct, proceess annd quaality systeem;從事影響品質之之管理、執行行與工作人員員均應予以界界事實上和明明文記載其責責任，授權與與相互關系，尤尤其是那些需需要組織賦予予自由度授權權以從事下列列活動人員：a) 發起行動動以預防任何何有關產品、流流程、品質系系統不合格事事情的發生；NOTE:IIt is recommmendeed thaat thee perssonnell respponsibble foor quaality have the aauthorrity tto stoop prooductiion, iif neccessarry to correect quualityy probblems.備注：建議負有有品質責任的的人員，如需需處理品質問問題時，可被被授予停止生生產的權限。b) idenntify and rrecordd any probllems rrelatiing too the produuct, pprocesss andd quallity ssystemm; 鑑定並記錄任任何有關產品品、流程 及品質系統統的問題；c) inittiate, recoommendd or pprovidde sollutionns thrrough desiggnatedd channnels; 循既定管道發發起、建議或或提供解決d) veriify thhe impplemenntatioon of soluttions;驗証解決方案之之執行；e) conttrol ffurtheer proocessiing, ddeliveery orr insttallattion oof nonnconfoormingg prodduct uuntil the ddeficiiency or unnsatissfactoory coonditiion haas beeen corrrecteed.管制不合格產品品被進一步加、交交貨或安裝，直直到缺點或不不滿意情況被被矯正為止。f) reprresentt the needss of tthe cuustomeer in interrnal ffunctiions iin adddressiing QSS-90000 requuiremeents (e.g. selecction of sppeciall charracterristiccs, seettingg quallity oobjecttives, traiining, corrrectivve & pprevenntive actioons, pproducct dessign aand deeveloppment) .在內部組織機能能中代表顧客客的需求以對對應QS-99000的要要求（即管制制特性的選擇擇、設定品質質目標，訓練練，矯正與預預防行動，產產品設計與發發展）。Resourcces - 4.1.22.2資源 - 4.1.2.22The suppplierr shalll ideentifyy resoourcess requuiremeents aand prrovidee adeqquate resouurces, inclludingg the assiggnmentt of ttraineed perrsonneel (seee 4.118) ffor maanagemment, perfoormancce of work and vverifiicatioon acttivitiies inncludiing innternaal quaality auditts. 供應商應鑑定資資源的需求，並並提供適當資資源，包括指指派經訓練的的人員（參閱閱4.18）以以從事管理、執執行工作與包包含內部品質質稽核在內的的各項驗証活活動。Managemment RRepressentattive - 4.1.2.3管理代表 - 4.1.22.3The suppplierr's maanagemment wwith eexecuttive rresponnsibillity sshall appoiint a membeer of the ssuppliier's own mmanageement who, irresspectiive off otheer ressponsiibilitties, shalll havee defiined aauthorrity ffor 供應商負經營責責任之管理階階層應指派供供應商管理階階層其中一員員，明定其授授權且不受其其它職務責任任影響以從事事下列活動a) ensuuring that a quaality systeem is estabblisheed, immplemeented and mmaintaained in acccordiing wiith thhis innternaationaal Staandardd, andd確保品質系統依依本國際標準準建立、實施施與維持，及及b) repoortingg on tthe peerformmance of quualityy systtem too the suppllier'ss manaagemennt forr reviiew annd as a bassis foor impprovemment oof thee quallity ssystemm.將品質系統的運運作成效向供供應商管理階階層報告以供供其審查，並並作為品質系系統改善之依依據。Note 5: the respoonsibiility of a managgementt reprresenttativee may also incluude liiaisonn withh exteernal partiies onn mattters rrelatiing too the suppllier'ss quallity ssystemm. 備注5：管理代代表的責任亦亦可包含就供供應商品質系系統有關事務務與外界團體體的聯系。Organizzationn Inteerfacees - 44.1.2.4組織聯系界面 - 4.11.2.4The suppplierr shalll havve sysstems in pllace tto enssure mmanageement of appproprriate activvitiess duriing coonceptt deveelopmeent thhroughh prodductioon (reefer tto Advvancedd Prodduct QQualitty Plaanningg and Contrrol Pllan reeferennce maanual) . Thhe suppplierr shalll usee a muulti-ddiscipplinarry appproachh for decission-mmakingg and have the aabilitty to commuunicatte neccessarry infformattion aand daata inn the custoomer-pprescrribed formaat.供應商於概念研研發直到生產產等階段，應應建立系統確確保對各項適適當活動的管管理（參考先先期產品品質質規劃和管制制計劃參考手手冊）。供應應商決策時應應採用跨功能能群組討論模模式，且有能能力使用顧客客規定格式溝溝通必要的資資訊和數據。NOTE:TTypicaal funnctionn to bbe inccludedd are:備注：典型的組組織機能包括括：Engineeering/technnical工程/技術Manufaccturinng/Prooductiion制造/生產Industrrial EEngineeeringg工業工程Purchassing/MMateriials MManageement採購/物料管理理Qualityy/Reliiabiliity品質/可靠度Cost Esstimatting成本預估Productt Servvice產品服務Managemment IInformmationn Systtems/DData PProcesssing管理資訊系統/資料處理Packagiing Enngineeering包裝工程Toolingg Engiineeriing/Maaintennance工模具工程 /保養Marketiing annd Salles市場及行銷Subconttractoors, aas neccessarry分包商（必要時時）Informaation to Maanagemment - 4.1.2.5通知管理階層 - 4.11.2.5Managemment wwith rresponnsibillity aand auuthoriity foor corrrectiive acction shalll be pprompttly innformeed of produucts oor proocessees whiich beecome noncoompliaant wiith sppecifiied reequireementss.當產品或制程無無法符合特定定要求時，該該項資訊應迅迅即通知負責責與授權矯正正行動的管理理階層。Managem