GMP Quality Manual质量手册.docx

编号：时间：2021年x月x日书山有路勤为径，学海无涯苦作舟页码：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QUALITYVERIFICATION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Wearededicatedtoachievingcustomersatisfactionthroughanuncompromisingcommitmenttoquality.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Anopendoorpolicythatenablesallpersonneltobringtomanagement'sattentionanyconcernsregardingqualityachievementandcustomersatisfaction.保证产品质量，让用户满意应成为每一员工的工作关注点。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。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。Thedevelopmentofamulti-disciplinarycollaborativeteamstructurethroughoutallactivitiesofthecompany.构建多种学科协作的专业团队和组织架构。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,QualityPolicyManualObjectives质量目标Wehaveestablishedaqualitysystemthatisdesignedtomeetdomesticandworldwideregulatorystandardsforitsproductsinthemarketplace.Thekeyapplicableregulatorystandardsinclude:21CFRPart820,QualitySystemRegulationsforMedicalDevices93/42/EEC,EuropeanMedicalDeviceDirectiveISO9001,ISOQualityManagementSystemsRequirementsENISO13485:2001,ISOQualitySystemsforMedicalDevicesThequalitysystemaddressestheelementsnecessaryforimplementingqualitymanagementincludingtheorganizationalstructure,responsibilities