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1、附件1：医疗器械生产管理者代表授权书 （以下简称授权人）现代表公司委任为生产管理者代表（以下简称管理者代表），任期自年月日至年月日止。授权人根据《广东省医疗器械生产管理者代表管理办法（试行）》制定本授权书。第一条 管理者代表应树立医疗器械质量意识和责任意识，以实事求是、坚持原则的态度，在履行相关职责时把公众利益放在首位，以保证本企业生产的医疗器械的安全、有效为最高准则。第二条管理者代表职责与权限如下： （一）贯彻执行医疗器械质量管理的法律法规，组织和规范企业医疗器械生产质量管理工作。（二）组织建立、实施和保持本企业医疗器械生产质量管理体系。（三）对下列质量管理活动负责
2、，行使决定权：1．每批次原材料及成品放行的批准；2．质量管理体系文件的批准；3．工艺验证、关键工序和特殊过程参数的批准；4．原材料、半成品及成品质量控制标准的批准；ChapterIGeneralprovisionsarticleIobligationtoclearcreditpre-loaninvestigationrequirements,improvethequalityofpre-loaninvestigation,preventcreditrisks,accordingtotheCBRCcommercialbankcreditduediligenceguidel
3、ines,commercialbankcreditsmallbusinessduediligenceguidelines(trial)andotherregulatoryrequirementsandtheactualsituationoftheBank,thesemeasuresareformulated.Secondpersonmentionedinthesemeasuresreferstoinaccordancewiththerulesofcreditinvestigations,surveysandanalysisofthecreditbusinesspeopl
4、e.ArticlecreditmentionedinthesemeasuresreferstotableprovidedtocustomersbothinsideandoutsideoftheBank'screditbusiness,includingforeigncurrencyloans,tradefinance,bankacceptances,commercialbilldiscounting,guarantees,factoring,credit,loancommitment,guaranteeandothercreditoperations,excluding
5、clientcreditbusiness.Priortothechengdaiinvestigationintothefourtharticlethisreferstocreditbeforethereview,investigatorsbyobtaining,verification,analysisandsecurityaspectsofthesituation,evaluationandrevealsthepossiblecreditrisksandtoproposepreventivemeasures.Articlefifthduediligenceinthes
6、emeasuresreferstothepersoninthepre-loaninvestigationproceduresfulfillingthemostbasicduediligencerequirements.Articlesixthofthemselves,pre-loaninvestigatorsrelativesorotherinterestedpersontoapplyforthecreditbusiness,oneshouldapplyforthewithdrawal.ChapterIIduediligenceduediligenceworkisthe
7、basicrequirementoftheseventharticle:followtheprinciplesoftrue,complete,valid,anddiligenceduediligenceincarryingoutinvestigationduties.Investigatorsshouldbebasedonthecharacteristicsofdifferentvarietiesofcreditbusiness,credit—9—5．不合格品处理的批准；6.风险管理报告的批准；7过程确认方案和过程确认报告的批准。（四）参
