GMP Quality Manual质量手册

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1、GMPQualityManualThisqualitymanualforGoodManufacturingPracticesisbasedontheISO9001standard,andaddressestherequirementsofFDA'smedicaldeviceregulations.此GMP质量手册是基于ISO9001标准，叙述FAD医用仪器的法规要求。TableofContents目录POLICY方针QUALITYSYSTEMDESCRIPTION质量系统描述QUALITYDEFINITIONS质量定义QUALITYACHIEVEMENT质量目标QUALITYVER

2、IFICATION质量确认QUALITYIMPROVEMENT质量改进ADMINISTRATIVECONTROLS行政控制ComparisonMatrix比对矩阵OrganizationalMatrixforQualitySystemFunctionalResponsibilities质量系统功能图QualitySystemsOrganizationalChart质量系统组织机构图ParentCategory上级分类QualityManuals质量手册POLICY方针QualityPolicy质量方针Wearededicatedtoachievingcustomersatisfac

3、tionthroughanuncompromisingcommitmenttoquality.我们致力于让客户满意，承诺对质量永不妥协。（保证产品质量，让用户满意）Thesehighstandardsarerealizedthroughthefollowingpractices:通过下列实践达到高标准1.Anopendoorpolicythatenablesallpersonneltobringtomanagement'sattentionanyconcernsregardingqualityachievementandcustomersatisfaction.保证产品质量，让用户

4、满意应成为每一员工的工作关注点。2.Personnelperformingtheirworkinamannerthatensuresproductsandservicesmeetallqualityrequirements.员工的操作方式、行为规范要以满足所有质量要求为基本准则。3.Enablingpersonneltocarryouttheirresponsibilitiesbyprovidingthenecessarytraining,resources,andworkenvironment.为员工提供必要的培训、资源及工作环境以保证员工履行其职责。4.Thedevelopme

5、ntofamulti-disciplinarycollaborativeteamstructurethroughoutallactivitiesofthecompany.构建多种学科协作的专业团队和组织架构。1.Theapplicationofhighstandardstobusinessconduct,includingcontactswithcustomers,co-workers,andcollaborators.建立和实施较高的企业营运（包括与与客户、合作商及合作人的联系与合作）操作标准。References:§ISO9001,4.1.1,QualityPolicyManu

6、alObjectives质量目标Wehaveestablishedaqualitysystemthatisdesignedtomeetdomesticandworldwideregulatorystandardsforitsproductsinthemarketplace.Thekeyapplicableregulatorystandardsinclude:§21CFRPart820,QualitySystemRegulationsforMedicalDevices§93/42/EEC,EuropeanMedicalDeviceDirective§ISO9001,ISOQualit

7、yManagementSystemsRequirements§ENISO13485:2001,ISOQualitySystemsforMedicalDevicesThequalitysystemaddressestheelementsnecessaryforimplementingqualitymanagementincludingtheorganizationalstructure,responsibilities,procedures,processesandre