Qs93中英版.docx
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Qs93中英版.docx
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Qs93中英版
QS-90003rdEdition
QualitySystemRequirements
Introduction
Goal
ThegoalforQualitySystemRequirementsQS-9000isthedevelopmentoffundamentalqualitysystemsthatprovideforcontinuousimprovement,emphasizingdefectpreventionandthereductionofvariationandwasteonthesupplierchain.
目的
QS-9000品質系統要求其目的乃於供應體系中發展品質系統的基礎,以提供持續改善,強調預防不良,減低變異與浪費.
Purpose
QS-9000definesthefundamentalqualitysystemexpectationsofChrysler,Ford,GeneralMotors,TruckManufacturersandothersubscribingcompaniesforinternalandexternalsupplierofproductionandservicepartsandmaterials.ThesecompaniesarecommittedtoworkingwithThesuppliertoensurecustomersatisfactionbeginningwithconformancetoqualityrequirements,andcontinuingwithreductionofvariationandwastetobenefitthefinalcustomer,thesupplybase,andthemselves.
意圖
QS-9000定義Chrysler,Ford,GM,卡車製造廠及其他採用本要求的公司對其內部外部提供量產及服務性材料與零件的供應商所建立品質系統基礎的期望.上述公司承諾與其供應商合作以確保顧客的滿意始於品質要求的符合,與持續減低變異與浪費,止於最終顧客,供應體系,及上述公司均有所獲益.
Approach
QS-9000isaharmonizationofChrysler'sSupplierQualityAssuranceManual,Ford'sQ-101QualitySystemStandard,andGeneralMotors'NAOTargetforExcellence,withinputfromtheTruckManufacturers.ISO9001:
1994Section4hasbeenadoptedasthefoundationforQS-9000andisprintedinSectionIinitalictype.Interpretationsandsupplementalqualitysystemrequirementshavebeenharmonizedandareprintedinnormaltype.Whileothercompaniesmayadoptthisdocument,Chrysler,Ford,andGeneralMotorsretainfullcontroloverthecontentexceptforISO9001:
1994,ofwhichcopyrightremainswiththeInternationalOrganizationforStandardization.
Theword"shall"indicatesmandatoryrequirements.Theword"should"indicatesamandatoryrequirementwithsomeflexibilityallowedincompliancemethodology.Thesupplierchoosingotherapproachestosatisfya"should"mustbeabletoshowthattheirapproachmeetstheintentofQS-9000.AllQS-9000requirementsshallbeaddressedinthequalitysystemdocumentation,butnotnecessarilybyindividualprocedures.
Where"typical","example",or"e.g."areused,anysuggestionsgivenareforguidanceonly.
Thereferencesto"thisInternationalStandard"intheISOtextof4.1.2.3,.4.1.3,4.2.1,4.2.2,4.5.1,andNote17(4.11.1)shallbeunderstoodforthepurposesofQS-9000torefertoQS-9000requirements,andnotjustISO9001orISO9002requirements.
Paragraphsmarked"NOTE"areforguidanceinunderstandingorclarifyingtheassociatedrequirement.Theword,"should,"appearinginaNOTEisforguidanceonly.
TheGlossarycontainsinformationwhichshouldbeusedforpurposesofcompliance/registrationtoQS-9000.WhereinconsistentterminologyexistsbetweenQS-9000andISO8402(orothersimilardocuments,e.g.,ISOA-3),QS-9000takesprecedenceforQS-9000registration.
方式
QS-9000是調和Chrysler的SupplierQualityAssurance,Ford的Q-101QualitySystemStandard,及北美GM的TargetforExcellence等各項要求,加上卡車製造廠的意見,並採用ISO9001:
1994第四段而構成QS-9000的基礎,而以斜體字表示於第一章.有關品質系統要求的詮釋及額外要求則被統合後以正楷字表示.至於其他公司採用本文件時,除卻ISO9001:
1994部份,Chrysler,Ford與GM仍全權掌握所有內容,而ISO9001:
1994則歸屬於國際標準組織.
本文中"SHALL"字眼指強制性要求."SHOULD"亦指強制性要求但在執行方式容許較大的彈性.供應商選擇其它方式以滿足"SHOULD"要求時,必須展示其作法符合QS-9000的意圖.所有QS-9000的要求皆須被品質系統文件所包含,但無需逐一制定程序書.
當文中使用"typical","example",或"e.g."時,其所提示的內容僅作為參考指引.
ISO原始條文中,於4.1.2.3,4.1.3,4.2.1,4.2.2,4.5.1,及備註17(4.11.1)敘述之"本國際標準",在本QS-9000要求的應用上,乃指QS-9000,而非僅限於ISO9001或ISO9002.的要求.
"NOTE"備註欄是針對相關要求的澄清或瞭解的指引,而出現在備註中的"should"亦僅為指引.
詞彙部份的內容也需被使用以符合/登錄QS-9000,當QS-9000及ISO8402(或類似文件,如ISOA-3)其中的術語解釋不一致時,針對QS-9000的登錄,則QS-9000的解釋具優先性.
Applicability
QS-9000appliestoallinternalandexternalsuppliersitesof:
a)productionmaterials,b)productionorserviceparts,orc)heattreating,painting,platingorotherfinishingservicesdirectlytoOEMcustomerssubscribingtothisdocument.
QS-9000appliestoprovidersof:
1)semiconductorsinconjunctionwiththeSemiconductorSupplementissuedbyChrysler,FordandDelcoElectronics;2)toolingandequipmentinconjunctionwiththeToolingandEquipment(TE)SupplementissuedbyChrysler,FordandGeneralMotors.AvailabilityofthirdpartyregistrationtotheTESupplementwillbeannouncedbyChrysler,Fordand/orGeneralMotorsasappropriate.
"Site"(seeGlossary)isdefinedasalocationatwhichvalue-addedproductionprocessesoccur(seeGlossary).Remotelocations,e.g.engineering,purchasing,internaloff-sitewarehouses,shallbeauditedastheysupportasite.RemotelocationscannotobtainindependentQS-9000registration.Remotelocationsshallbeincludedintheinitialauditandthenbeincludedinthenormalsurveillanceplanandataregularfrequency.Remotelocationswheredesignfunctionsisperformedshallundergosurveillanceauditsatleastoncewithineachconsecutive12-monthperiod.
Servicepartsandmaterialsapplicabilitydoesnotincludeaftermarket(seeGlossary)partsorsupplier.
IfindoubtregardingQS-9000applicability,contactyourcustomer.
Onlythosesuppliersmeetingthe"Applicability"definitionarerequiredtoachievecompliance/registration.Any"site"mayelecttopursuethirdpartyregistration;however,such"sites"shallhavedemonstratedcapabilitytocomplywithallQS-9000requirementsasevidencedbyrecords(see4.16)exceptforcustomerapprovalofthePPAPPartSubmissionWarrant.Only4.19:
Servicing(and4.4:
DesignControlforISO9002)maybedeterminedasnotapplicablebythecertificationbody/registrar.Commercial/independentlaboratoryfacilitiescannotberegisteredtoQS-9000.
ThisdocumentsupersedesalleditionsofChrysler'sSupplierQualityAssuranceManual,Ford'sQ-101QualitySystemStandard,GeneralMotors'NAOTargetsforExcellence,GeneralMotors'EuropeGeneralQualityStandardforPurchasedMaterialsandtheTruckManufacturers'qualitysystemmanualsdatedpriorto1995.
Implementation
Chrysler,Ford,GeneralMotors,theTruckManufacturersandtheothersubscribingcompaniesrequirethatsuppliersestablish,document,andimplementeffectivequalitysystemsbasedonQS-9000inaccordancewithtimingrequirementsestablishedbytheircustomers.AllrequirementsofQS-9000aretobeincorporatedinthesupplier'squalitysystemanddescribedinthesupplier'squalitymanual(seeGlossary).QS-9000isaninputdocumentfordevelopmentofaqualitymanual.SeetheQualitySystemDocumentationProgressiononpage6foranillustrationofthetypicallevelsofdocumentation.
適用
QS-9000適用於下列所有直接交貨給採用本文件OEM顧客的內部外部供應商其場所:
a)量產材料,b)量產或服務零件,c)熱處理,噴漆,電鍍或其他表面處理.
QS-9000適用於下列廠商:
1)半導體業,合併應用Chrysler,Ford及DelcoElectronics所發行的半導體補充要求;2)工模具及設備業,合併應用Chrysler,Ford及GM所發行的工模具及設備(TE)補充要求.對於TE補充要求的第三者登錄將由Chrysler,Ford及GM於適當時機宣佈.
"Site"場所的定義(參閱詞彙)是指具附加價值生產製程發生的地點(參閱詞彙),諸如工程,採購,內部離線庫房等遠距地點,乃支援"Site"的運作,皆應被稽核,但這些遠距地點無法取得獨立的QS-9000登錄.初次評鑑及定期追查計畫都應包括各個遠距地點,如果遠距地點是屬於設計功能者,則每12個月期間應最少執行定期追查乙次.
服務零件及材料其適用性並不包括後修市場(參閱詞彙)零件或供應商.
如對QS-9000的用性有所疑問時,請聯絡您的顧客.
只有那些契合本段"適用"定義的供應商被要求達成QS-9000的符合/登錄.任一"site"場所都可選擇進行第三者登錄,而這樣的場所應有品質記錄(參閱4.16)為佐證以展示具備能力滿足所有QS-9000的要求,但記錄中的PPAP零件送樣申請書除外.只有4.19的服務或是ISO9002系統中的4.4設計管制可經認證團體認定為不適用.商業/獨立的實驗設施無法取得QS-9000登錄.
本文件取代1995之前下列廠商公佈的各項標準:
Chrysler的SupplierQualityAssuranceManual,Ford的Q-101QualitySystemStandard,北美GM的TargetforExcellence,歐洲GM的GeneralQualityStandardforPurchasedMaterials及卡車製造廠的品質系統手冊.
應用
Chrysler,Ford,GM,卡車製造廠及其他採用本文件的公司要求各供應商依據其顧客的時間表建立執行一個基於QS-9000的有效品質系統,並將其書面化.供應商的品質系統應結合QS-9000的所有要求並將其書於供應商的品質手冊(參閱詞彙).QS-9000於供應商發展其品質手冊時為其依據文件之一.參閱第六頁的品質系統文件發展圖以瞭解文件的典型階層.
ConformancetoQS-9000willbeevaluatedusingtheprocessdescribedinAppendixA.Eachcustomerwillcontinuetodevelopuniquesupplierratings.
ThirdpartyregistrationtoQS-9000willbeacceptedandwillberequiredbysomecustomers(refertoSectionII:
Customer-SpecificRequirements).VerificationofconformancetoISO9001(orISO9002forsuppliersthatarenotresponsibleforthedesignofanyproductsuppliertoanycustomersubscribingtothisdocument)isanecessaryconditionforregistrationtoQS-9000.RegistrationtoISO9001,however,maynotbesufficientforthecompaniesusingQS-9000,sincethisdocumentcontainsadditionalrequirementsforthesecompanies.SubcontractorthirdpartyregistrationtoQS-9000isnotrequiredbyChrysler,FordorGeneralMotorsatthistime.
SuppliersandsubcontractorsshalldeployQS-9000asappropriate.AnycompanymayrequireQS-9000registrationofitssuppliers,regardlessofthecompany'spositioninthesupplychain,e.g.Tier2andbelow.
使用附錄A所描述的過程以評估品質系統對QS-9000的符合性.每一顧客將持續發展其獨特的評分制度.
有些顧客會接受及要求QS-9000的第三者登錄(參閱第二章的顧客特定要求).登錄為QS-9000時亦須驗證符合ISO9001(或是ISO9002,如供應商無須對任何採用本文件的顧客其任何產品負設計責任者).但是登錄為ISO9001的供應商並不意味就足以引用QS-9000,因為QS-9000尚包含其他額外要求.目前Chrysler,Ford或GM並不要求分包商進行QS-9000的第三者登錄.
供應商與其分包商應適當展開QS-9000,任何公司都可要求其供應商取得QS-9000登錄,而不論該公司在整個供應體系的位階,亦即二階廠商及更下階廠商.
Thethirdregistrationscopemustincludeallproductsandservicesbeingsuppliedtooneormoreofthecompaniessubscribingtothisdocument,unlessspecificallywaivedbythecustomer.
ThetermQS-9000isacopyrightprotectedpropertyofChrysler,FordandGeneralMotors.Onlythosethirdpartycertificationbodies/registrarsqualifiedforQS-9000byaChrysler,FordandGeneralMotorsrecognizedaccreditationbodyarepermittedtoissuearegistrationcertificatewiththetermQS-9000.
TherelatedQS-9000manualsareavailablefromAIAG,GarwinContinuousorFAPM(seeForewordforphonenumbers).Therelatedmanuals(withlatesteditionnumberanddateattimeofpublication)areshownbelow.Fordocumentcontrolpurposes,usetheeditionnumber/dates."Printingdates"donotrepresentrevisionstothesedocumentsexceptforPPAPSecondEdition.
QualitySystemAssessment
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