F016 内部审核报告INTERNAL AUDIT REPORT v3

Version3内部审核报告INTERNALAUDITReport审核日期AuditDate(s):参考审核计划RefAuditPlan:审核部门/项目/产品Department/Project/ProductAudited:审核天数LengthofAuditinDays:审核组AuditTeam:1.1.覆盖区域（描述包括在审核中的产品，过程，地点和/或职能区域）AREA(S)COVERED(describeproducts,processes,locationsand/orfunctionalareasincludedintheaudit):不符合项总数TOTALNONCONFORMITIES:建议项总数TOTALCOMMENTS:2.2.总体情况和评价（包括正面和负面的评价，程序和良好规范）GENERALCONDITION&COMMENTS(includepositiveandnegativecomments,proceduresandbestpractices):审核结论等级和复审要求AUDITRESULTSRATINGANDRE-AUDITREQUIREMENTS重大不符合项需采取纠正预防措施/需重审SIGNIFICANTCAPAINDICATED/RE-AUDITRECOMMENDED建议按下面要求的范围和说明进行重审Recommendre-auditwithscope&explanationasbelowSuggestedDateofRe-audit:符合的审核结果SATISFACTORYAUDITRESULTS建议使用已建立的审核频率EstablishedAuditFrequencyRecommended.需要提高NeedsImprovement建议使用已建立的审核频率EstablishedAuditFrequencyRecommended.3.审核范围AuditscopeVersion3检查项目CheckItems管理承诺ManagementCommitment策划Planning资源Resources沟通Communication职责与权力ResponsibilityandAuthority管理评审ManagementReview内部审核InternalAudit文件控制DocumentationControl培训Training设计控制DesignControls客户沟通CustomerCommunication生产和过程控制Production&ProcessControls采购控制PurchasingControls过程确认ProcessValidation监测设备控制ControlofMonitoring/MeasuringDevices标识与可追溯性IdentificationandTraceability标签，包装，操作和分发Labeling,Packaging,Handling&Distribution器械主记录DeviceMasterRecords器械历史记录DeviceHistoryRecords验收活动AcceptanceActivities纠正预防措施CorrectiveandPreventiveAction不合格品控制ControlofNonconformingProduct数据分析AnalysisofDataAUDITED?发现项编号NC#/Comments#注释Remark注：上表用于覆盖所有可用的美国FDA法规，ISO9001:2008,ISO13485:2003和医疗器械生产质量管理规范植入性医疗器械实施细则ChinaGMP2014。Note:TheabovechecklistsweredesignedtocovertheapplicablerequirementsofFDAQSReg,ISO9001:2008,ISO13485:2003andChinaGMP20144.4.不符合项及建议项清单NONCONFORMITY&OBSLIST4.1不符合项Nonconformities编号NC#要求Requirement不符合项描述NonConformityDescriptionCriticalMajorMinor级别ClassificationVersion3CriticalCriticalCriticalCriticalCritical4.2.建议项Comments编号Com#建议项描述COMMENTSDESCRIPTIONCom1审核组审核组Auditor