QUALITYSYSTEMREQUIREMENTS品质系统要求 QualityProgram品质纲要 ManagementResponsibility管理职责 QualityPolicies,Procedures,andWorkInstructions品质方针、流程、作业指导书 QualityManagementPlan品质管理计划 InternalAuditProgram内部稽核计划 OTPVAuditsOTPV稽核 Training培训 CONTRACTREVIEW合同评审 DESIGNCONTROL设计变更 DesignDevelopmentandPlanning设计规划 DesignInput设计输入 DesignOutput设计输出 DesignReview设计评审 DesignVerification设计验证 DesignValidation设计确认 DesignChanges设计变更 DOCUMENTCONTROL文件控制 RedLineDrawings/ProceduralDocumentation“红线描述”文件 SUPPLIERQUALITYCONTROL供应商供货品质控制 DefinedQualityandTechnicalRequirements确定品质、技术要求 Sub-tierSupplierApprovals分工方承认 Sub-tierSupplierAudits分工方稽核 FirstArticleInspections首样检验 Records记录 PRODUCTIDENTIFICATIONANDLOTTRACEABILITY产品标示与批量的可追溯性 PROCESSCONTROL制程控制 ProcessQualification制程条件 QualityMetrics品质方针 ContinuousImprovementProgram持续改善计划 INSPECTIONANDTESTING检验与检测 Source/ingInspectionandTests供货/进料检验与测试 In-ProcessInspectionandTesting制程检验与测试 FinalInspectionandTesting最终检验与测试 ShippingInspection(OBATesting/Inspection)出货检验(开箱检验/测试) ReliabilityTesting可靠性测试 InspectionandTestingRecords检验与测试记录 CALIBRATION校验 CalibrationProcedures校验流程 RecallList召回名录 CalibrationRecords校验记录 OutofTolerance(Calibration)Notices校验通知单 INSPECTIONANDTESTSTATUS检验与测试状态 CONTROLOFNONCONFORMINGPRODUCT不合格品控制 ReviewandDispositionofNonconformingProducts不合格品评审与处理 CorrectiveActionProcess改善流程 HANDLING,STORAGE,PACKAGING,ANDDELIVERY处理、存储、包装与运输 Handling处理 Storage存储 Packaging包装 Delivery运输 QUALITYRECORDS品质记录 DELIVERABLES运输 QualityManagementPlan品质改善计划 Sub-tierSupplierManagementPlans分工方品质改善计划 InternalAuditProgramPlan内部稽核计划 DEFINITIONS定义 plywiththequalityprogramrequirementssetforth
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