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1、附件:宁夏回族自治区食品药品监督管理局医疗器械经营企业现场检查评定表二OO八年三月oresourcesmanagementprinciples:firstdeHouonly,bothabilityandpoliticalintegrity,merit,best5,andhumanresourcesmanagementcontent:humanresourcesplanning,andperformanceassessment,andtraining6,andhumanresourcesmanageme
2、ntcoretechnology:performanceassessment,stageassessment:effectivenessstage,andeffectstage,andefficiencystage,andbenefitsstage,andfollowstagelevelsexassessment:joblayerserviceconsciousness,andprofessionallayerprofessionalspirit,andcareerlayerethics,Andaca
3、demiclayerlearningspirit,andcareerlayerthinkingmodeperformanceassessmentelements:named,andsetvalue,andquantitative,andqualitative,andtiming,andSentinelsecondchaptersystemarticleobjectivepeopleiscompanydevelopmentofthis,hasasupportsolidarity,andup,andhas
4、dedicationspiritoftalentteamiscompanysuccessofkey,weiscommittedtocompanyhumancapitalofvalue-added,strengtheningtalentteamofconstruction,effortscreatedfirst-classoftalentgrowthenvironment,constantlyimprovelevelstalentofsolutionproblemofcapacity.Organizat
5、ionalstructurea.organizationchart:-9-说明一、制定依据:依据《医疗器械监督管理条例》、《医疗器械经营企业许可证管理办法》,结合我区实际制定本细则。二、适用范围:本细则适用于医疗器械经营企业的开办审查、变更许可事项审查、换发许可证审查和日常监督检查。三、评定标准:本标准分七部分,共46项,其中有15项为否决项(标注“*”)。1、现场审查时,应逐项进行审查,并依据“审查方法”逐项作出肯定、否定或合理缺项的评定。2、否决项中的“现场检查结果”有一项不符合要求的即判定为不合
6、格。3、除合理缺项外,所有检查验收项目全部符合要求的,判定为合格;否决项全部合格,一般审查项目中有6项以上不符合要求的,判定为不合格;不合格项少于6项的,限期进行整改,整改后仍有1项以上不符合要求的,判定为不合格。4、“现场检查结果”中有1项不合格的,即判定为该审查项目不合格。5、缺项的处理:新开办企业未涉及到该项目或与企业经营范围无关的项目为合理缺项,合理缺项应注明。四、审查结果:现场审查结论分为合格、需要整改、不合格三种结论,需要整改的,企业整改时间不记入行政受理审批时限。oresourcesma
7、nagementprinciples:firstdeHouonly,bothabilityandpoliticalintegrity,merit,best5,andhumanresourcesmanagementcontent:humanresourcesplanning,andperformanceassessment,andtraining6,andhumanresourcesmanagementcoretechnology:performanceassessment,stageassessmen
8、t:effectivenessstage,andeffectstage,andefficiencystage,andbenefitsstage,andfollowstagelevelsexassessment:joblayerserviceconsciousness,andprofessionallayerprofessionalspirit,andcareerlayerethics,Andacademiclayerlearningspirit,andc