第1页共28页编号：时间：2021年x月x日书山有路勤为径，学海无涯苦作舟页码：第1页共28页立仰國際驗證機構編譯ISO9001/2000ISREONInternationalCertification第2页共28页第1页共28页编号：时间：2021年x月x日书山有路勤为径，学海无涯苦作舟页码：第2页共28页Index:1Scope1.1General1.2Application2Normativereference3Termsanddefinitions4Qualitymanagementsystem4.1Generalrequirements4.2Documentationrequirements4.2.1General4.2.2Qualitymanual4.2.3Controlofdocuments5Managementresponsibility5.1Managementcommitment5.2Customerfocus5.3Qualitypolicy5.4Planning5.4.1Qualityobjectives5.4.2Qualitymanagementsystemplanning5.5Responsibility,authorityandcommunication5.5.1Responsibilityandauthority5.5.2Managementrepresentative5.5.3Internalcommunication5.6Managementreview5.6.1General5.6.2Reviewinput5.6.3Reviewoutput6Resourcemanagement6.1Provisionofresources6.2Humanresources6.2.1General6.2.2Competence,awarenessandtraining6.3Infrastructure6.4Workenvironment7Productrealization7.1Planningofproductrealization7.2Customer-relatedprocesses7.2.1Determinationofrequirementsrelatedtotheproduct7.2.2Reviewofrequirementsrelatedtotheproduct7.2.3Customercommunication7.3Designanddevelopment7.3.1Designanddevelopment目錄：1範圍1.1通則1.2應用2引用標準3名詞與定義4品質管理系統4.1一般要求4.2文件化要求4.2.1通則4.2.2品質手冊4.2.3文件管制5.管理責任5.1管理承諾5.2顧客為重5.3品質政策5.4規劃5.4.1品質目標5.4.2品質管理系統規劃5.5責任、授權戌溝通5.5.1責任與授權5.5.2管理代表5.5.3內部溝通5.6管理審查5.6.1通則5.6.2管理審查的輸入5.6.3管理審查的輸出6資源管理6.1資源提供6.2人力資源6.2.1通則6.2.2資格、認知與訓6.3基礎設施6.4工作環境7產品實現7.1產品實現的規劃7.2顧客相關的過程7.2.1決定產品相關的需求7.2.2產品相關需求的審查7.2.3客戶溝通7.3設計與開發第3页共28页第2页共28页编号：时间：2021年x月x日书山有路勤为径，学海无涯苦作舟页码：第3页共28页planning7.3.2Designanddevelopmentinputs7.3.3Designanddevelopmentoutputs7.3.4Designanddevelopmentreview7.3.5Designanddevelopmentverification7.3.6Designanddevelopmentvalidation7.3.7Controlofdesignanddevelopmentchanges7.4Purchasing7.4.1Purchasingprocess7.4.2Purchasinginformation7.4.3Verificationofpurchasedproduct7.5Productionandserviceprovision7.5.1Controlofproductionandserviceprovision7.5.2Validationofprocessesforproductionandserviceprovision7.5.3Identificationandtraceability7.5.4Customerproperty7.5.5Preservationofproduct7.6Controlofmonitoringandmeasuringdevices8Measurement,analysisandimprovement8.1General8.2Monitoringandmeasurement8.2.1Customersatisfaction8.2.2Internalaudit8.2.3Monitoringandmeasurementofprocesses8.2.4Monitoringandmeasurementofproduct8.3Controlofnonconformingproduct8.4Analysisofdata8.5Improvement8.5.1Continualimprovement8.5.2Correctiveaction8.5.3PreventiveactionQualitymanagementsystems–Requirements1Scope1.1GeneralThisInternationalStandardspecifiesrequirementsfor7.3.1設計與開發的規劃7.3.2設計與開發的輸入7.3.3設計與開發的輸出7.3.4設計與開發的審查7.3.5設計與開發的驗證7.3.6設計與開發的確認7.3.7設計與開發變更的管制7.4採購7.4.1採購過程7.4.2採購資訊7.4.3採購品驗證7.5生產及服務提供7.5.1生產及服務提供之管制7.5.2生產與服務提供過程的確認7.5.3鑑別與追溯7.5.4客戶財產7.5.5產品保存7.6量測與監控設備的管制8.量測、分析與改善8.1通則8.2監控與量測8.2.1客戶滿意8.2.2內部稽核8.2.3過程的監控與量測8.2.4產品的監控與量測8.3不合格品管制8.4資料分析8.5改善8.5.1持續改善8.5.2矯正措施8.5.3預防措施第4页共28页第3页共28页编号：时间：2021年x月x日...
