资源描述：
《美国FDA 医疗器械体系法规QSR820中英文对照 zywen(1).doc》由会员上传分享，免费在线阅读，更多相关内容在行业资料-天天文库。
1、美国FDA医疗器械体系法规QSR820中英文对照SubpartB--QualitySystemRequirements质量体系要求Sec.820.20Managementresponsibility.管理职责(a)Qualitypolicy.质量方针Managementwithexecutiveresponsibilityshallestablishitspolicyandobjectivesfor,andcommitmentto,quality.Managementwithexecutiveresponsibilityshalle
2、nsurethatthequalitypolicyisunderstood,implemented,andmaintainedatalllevelsoftheorganization.具有管理职责的管理者应为质量确定方针和目标,并做出承诺。管理者还应保证质量方针能够在公司各个层级被充分的理解、实施和维护。(b)Organization.组织Eachmanufacturershallestablishandmaintainanadequateorganizationalstructuretoensurethatdevicesarede
3、signedandproducedinaccordancewiththerequirementsofthispart.每个制造商都应当建立一合适的组织结构用以保证设计和生产的器械符合本部分的要求。(1)Responsibilityandauthority.职责和权限Eachmanufacturershallestablishtheappropriateresponsibility,authority,andinterrelationofallpersonnelwhomanage,perform,andassessworkaffect
4、ingquality,andprovidetheindependenceandauthoritynecessarytoperformthesetasks.每个制造商都应当为具体管理、实施、考核影响质量工作的所有人员确立职责、权限和相互关系，并提供必要的独立性和权利来处理这些工作。(2)Resources.资源Eachmanufacturershallprovideadequateresources,includingtheassignmentoftrainedpersonnel,formanagement,performanceof
5、work,andassessmentactivities,includinginternalqualityaudits,tomeettherequirementsofthispart.每个制造商都应当提供充足的资源，包括委派受训过的人员，这些人员用来进行管理、实施相应的工作、并评估相应的活动，这些活动包括为了满足本章节的要求而实施的内部的审计。(3)Managementrepresentative.管理者代表Managementwithexecutiveresponsibilityshallappoint,anddocumentsu
6、chappointmentof,amemberofmanagementwho,irrespectiveofotherresponsibilities,shallhaveestablishedauthorityoverandresponsibilityfor:具有管理职责的管理者应当任命一定数量的管理者，并形成说面的任命文件。这些管理者不管有无其他职责，都至少要具有以下明确的职责和权限：(i)Ensuringthatqualitysystemrequirementsareeffectivelyestablishedandeffecti
7、velymaintainedinaccordancewiththispart;and（i）确保质体系按照本部分的要求得以有效的确定、维护；并且(ii)Reportingontheperformanceofthequalitysystemtomanagementwithexecutiveresponsibilityforreview.(ii)向具有审核管理职责的管理者报告质量体系的运行情况。(c)Managementreview.管理审核（管理评审）Managementwithexecutiveresponsibilityshallr
8、eviewthesuitabilityandeffectivenessofthequalitysystematdefinedintervalsandwithsufficientfrequencyaccordingtoestablish
