qs9000中英文版（DOC 46）

Page:1/46目錄(Contents)：ManagementResponsibility-Element4.1管理責任-4.1QualityPolicy-4.1.1品質政策-4.1.1Organization-4.1.2組織-4.1.2ResponsibilityandAuthority4.1.2.1責任與授權-4.1.2.1Resources-4.1.2.2資源-4.1.2.2ManagementRepresentative-4.1.2.3管理代表-4.1.2.3OrganizationInterfaces-4.1.2.4組織聯系界面-4.1.2.4InformationtoManagement-4.1.2.5通知管理階層-4.1.2.5ManagementReview-4.1.3管理審查-4.1.3ManagementReview-4.1.3.1管理審查-4.1.3.1BusinessPlan-4.1.4經營計劃-4.1.4AnalysisandUseofCompanyLevelData-4.1.5公司層級資料的分析和應用-4.1.5.CustomerSatisfaction-4.1.6顧客滿意-4.1.6CertificationBody/RegistrarNotification-4.1.6.1通知認証團體-4.1.6.1QualitySystem-Element4.2品質系統-4.2General-4.2.1概述-4.2.1QualitySystemProcedures-4.2.2品質系統程序-4.2.2QualityPlanning-4.2.3品質規劃-4.2.3AdvancedProductQualityPlanning-4.2.3.1先期產品品質規劃-4.2.3.1SpecialCharacteristics-4.2.3.2管制特性-4.2.3.2FeasibilityReviews-4.2.3.3可行性審查-4.2.3.3ProductSafety-4.2.3.4產品安全性-4.2.3.4ProcessFailureModeandEffectsAnalysis(ProcessFMEAs)-4.2.3.5制程的失效模式與效應分析-4.2.3.5MistakeProofing-4.2.3.6錯誤防止-4.2.3.6TheControlPlan-4.2.3.7管制計劃-4.2.3.7ProductionPartApprovalProcess-4.2.4量產零組件核准程序-4.2.4General-4.2.4.1概述-4.2.4.1SubcontractorRequirements-4.2.4.2分包商的要求-4.2.4.2EngineeringChangeValidation-4.2.4.3工程變更的確認-4.2.4.3ContinuousImprovement-4.2.5持續改善-4.2.5General-4.2.5.1概述-4.2.5.1QualityandProductivityImprovements-4.2.5.2品質和生產力的改進-4.2.5.2TechniquesforContinuousImprovement-4.2.5.3持續改善的技術-4.2.5.3FacilitiesandToolingManagement-4.2.6設施與工模具管理-4.2.6Facilities,Equipment,andProcessPlanningEffectiveness-4.2.6.1設施、設備及制程規劃和效益-4.2.6.1ToolingManagement-4.2.6.2工模具管理-4.2.6.2ContractReview-Element4.3Page:2/46合約審查-4.3General-4.3.1概述-4.3.1Review-4.3.2審查-4.3.2AmendmenttoaContract-4.3.合約變更-4.3.3Records-4.3.4記錄-4.3.4DesignControl-Element4.4設計管制-4.4General-4.4.1概述-4.4.1UseofDesignData-4.4.1.1設計資料的運用-4.4.1.1DesignandDevelopmentPlanning-4.4.2設計與開發規劃-4.4.2RequiredSkills-4.4.2.1所需技能-4.4.2.1OrganizationalandTechnicalInterfaces-4.4.3組織與技術的介面-4.4.3DesignInput-4.4.4設計輸入-4.4.4Designinput-Supplemental-4.4.4.1設計輸入-補充-4.4.4.1DesignOutput-4.4.5設計輸出-4.4.5DesignOutput-Supplemental-4.4.5.1設計輸出-補充-4.4.5.1DesignReview-4.4.6設計審查-4.4.6DesignVerification-4.4.7設計驗証-4.4.7DesignValidation-4.4.8設計確認-4.4.8DesignValidation-Supplement-4.4.8.1設計確認-補充-4.4.8.1DesignChanges-4.4.9設計變更-4.4.9DesignChanges-Supplemental-4.4.9.1設計變更-補充-4.4.9.1DesignChangeImpact-4.4.9.2設計變更的影響-4.4.9.2CustomerPrototypeSupport-4.4.10顧客原型樣品的配合-4.4.10Confidentiality-4.4.11保密性-4.4.11DocumentandDataControl-Element4.5文件與資料管制-4.5General-4.5.1概述-4.5.1DocumentandDataApprovalandIssue-4.5.2文件與資料之核准與發行-4.5.2EngineeringSpecifications-4.5.2.1工程規格-4.5.2.1DocumentandDatachanges-4.5.3文件及資料變更-4.5.3Purchasing-Element4.6採購-4.6General-4.6.1概述-4.6.1ApprovedMaterialsforOngoingProduction-4.6.1.1量產中的核准物料-4.6.1.1Government,SafetyandEnvironmentalRegulations-4.6.1.2政府，安全與環境法規-4.6.1.2EvaluationofSub-contractors-4.6.2分包商之評估-4.6.2SubcontractorDevelopment-4.6.2.1分包商的開發-4.6.2.1SchedulingSubcontractors-4.6.2.2分包商交貨日程規劃-4.6.2.2PurchasingData-4.6.3採購資料-4.6.3VerificationofPurchasedProduct-4.6.4採購產品的驗証-4.6.4SupplierVerificationatSubcontractor'sPremises-ISO4.6.4.1Page:3/46供應商在分包商處的驗証-ISO4.6.4.1CustomerVerificationofSubcontractedProduct-ISO6.4.2.2顧客以分包商產品的驗証-ISO6.4.2.2ControlofCustomer-SuppliedProduct-Element4.7顧客提供產品之管制-4.7CustomerOwnedTooling-4.7.1顧客所有之工模具-4.7.1ProductIdentificationandElement-Element4.8產品之識別與追溯性-4.8ProcessControl-Element4.9制程管制-4.9CleanlinessofPremises-4.9.b.1生產工場的清潔-4.9.b.1ContingencyPlans-4.9.b.2緊急應變計劃-4.9.b.2DesignationofSpecialCharacteristics-4.9.d.1管制特性的指定-4.9.d.1PreventiveMaintenance-4.9.g.1預防保養-4.9.g.1ProcessMonitoringandOperatorInstructions-4.9.1制程監測和作業指導書-4.9.1MaintainingProcessControl-4.9.2制程控制的維持-4.9.2ModifiedProcessControlRequirements-4.9.3制程管制要求的變更-4.9.3VerificationofJobSetups-4.9.4作業設定的驗証-4.9.4ProcessChanges-4.9.5制程變更-4.9.5AppearanceItems-4.9.6外觀項目-4.9.6InspectionandTesting-Element4.10檢驗與測試-4.10General-4.10.1概述-4.10.1AcceptanceCriteriaforAttributeCharacteristics-4.10.1.1計數值允收準則-4.10.1.1ReceivingInspectionandTesting-4.10.2收料檢驗與測試-4.10.2IncomingProductQuality-4.10.2.4進料產品的品質-4.10.2.4In-processInspectionandTesting-4.10.3制程中之檢驗與測試-4.10.3FinalInspectionandTesting-4.10.4最終檢驗與測試-4.10.4LayoutInspectionandFunctionalTesting-4.10.4.1全盤尺寸檢驗與機能測試-4.10.4.1FinalProductAudit-4.10.4.2最終產品稽核-4.10.4.2InspectionandTestRecords-4.10.5檢驗及測試記錄-4.10.5SupplierLaboratoryRequirements-4.10.6供應商的實驗室要求-4.10.6LaboratoryQualitySystems-4.10.6.1實驗室品質系統-4.10.6.1LaboratoryPersonnel-4.10.6.2實驗室人員-4.10.6.2LaboratoryProductIdentificationandTesting-4.10.6.3實驗室被測產品的識別與測試-4.10.6.3LaboratoryProcessControl-4.10.6.4實驗室流程管制-4.10.6.4LaboratoryTestingandCalibrationMethods-4.10.6.5實驗室測試與校正的方法-4.10.6.5LaboratoryStatisticalMethods-4.10.6.6實驗室統計方法-4.10.6.6AccreditedLaboratories-4.10.7驗証的實驗室-4.10.7ControlofInspection,MeasuringandTestEquipment-Element4.11檢驗、量測與試驗設備的管制-4.11General-4.11.1概述-4.11.1ControlProcedure-4.11.2管制程序-4.11.2CalibrationServices-4.11.2.b.1校正服務-4.11.2.b.1Inspection,Measuring,andTestEquipmentRecords-4.11.3Page:4/46檢驗，量測及與試驗設備之記錄-4.11.3MeasuringSystemAnalysis-4.11.4量測系統分析-4.11.4