GMP Quality Manual质量手册

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1.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。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.Thedevelopmentofamulti-disciplinarycollaborativeteamstructurethroughoutallactivitiesofthecompany.构建多种学科协作的专业团队和组织架构。5.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,QualitySystemRegulationsforMedicalDevices93/42/EEC,EuropeanMedicalDeviceDirectiveISO9001,ISOQualityManagementSystemsRequirementsENISO13485:2001,ISOQualitySystemsforMedicalDevicesThequalitysystemaddressestheelementsnecessaryforimplementingqualitymanagementincludingtheorganizationalstructure,responsibilities,procedures,processesandresources.TheQualityManualdescribesourqualitysystem.ThecentralobjectiveoftheQualityManualistohelpemployeesmeetallapplicableregulatoryrequirementsandtounderstandthequalitycommitments.InAppendixA,therequirementsof21CFR820,ISO9001andtheMedicalDeviceDirective93/42/EEChavebeencross-referencedtothesectionsofthisQualityManual.Themanualdescribesanoverallprocessapproachofplanningforquality,applicationtoactivities,verification,andimprovement(Deming'sPDCAcycle).Whereapplicable,StandardOperatingProcedures(SOPs)applicabletoeachsectionarecited.TheQualityManualisupdated,reviewedandapprovedevery2years.ThecurrentversionoftheQualityManualisdistributedtoallpersonnel.References:12-0048-SOP,ControlledExternalDocumentFileISO9001,4.2.1,DevelopQualitySystemDocumentsQUALITYSYSTEMDESCRIPTIONScopeThequalitysystemappliestoallourproductsandservices.Wehaveasingle,globalqualitysystemapplicabletoallworldwidelocations.CommitmentOurcommitmenttoqualityisdemonstratedwithacomprehensivesystemthatsatisfiesallapplicableregulatoryrequirements.Assuranceofqualityanditscontinuousimprovementrequiresthesupportoftheentireorganization.Qualityisassuredbyworkinginasystematicmannertoeliminatedefects,errors,andnonconformancethroughproperproductandprocessdesignandimplementation,andfollowingformalizedproceduresandworkinstructions.Employeesareencouragedtobringtomanagement'sattentionanyconcernsregardingqualityachievementandcustomersatisfaction.Weenablesallemployeesbyprovidingthefollowingsupport:Specificjobskilltraining,QualitySystemtraining,Thenecessarytoolsandequipment,Anenvironmentandtheresourcesthatpromotecontinuousimprovement.QualityPlanningThequalityplanningprocessdefinesproductspecifications,meetsthespecificrequirementsforprojectsandcontracts,andensurescustomerneedsandexpectationsaremetorexceeded.Qualityplanningisachievedthroughacombinationofbusinessandproductplanning,projectteams,qualityimprovementplans,reviewofDeviceMasterRecorddocuments,internalandsupplieraudits,andemployeetraining.Thequalitysystemisfullydocumentedtoensurethatqualityplanningisconsistentwithallotherrequirements.References:12-0050-SOP,DesignControlGuideline12-0072-SOP,InspectionandTestRequirements12-0073-SOP,ProcessControlGeneralRequirementsISO9001,4.2.3,ControlQualitySystemDocumentsOrganizationResponsibilityandAuthorityExecutivemanagementisresponsibleforensuringthataneffectiveQualitySystemisestablishedandimplemented.ThesuccessoftheQualitySystemisimpactedthroughcommitment,andthedemonstrationandcommunicationofthatcommitment,byseniorstaff.Theresponsibilityofensuringthatthequalitysystemisestablished,implemented,practiced,andmaintainedlieswiththeDirector,QA/QC,whoisthedesignatedManagementRepresentative.ThedutiesoftheManagementRepresentativeincludethefinaldisposition/determinationofproductsandprocesses,aswellas,developingasetofmeasurementswhichareusedbyseniormanagementtoensurethequalitysystemismeetingorexceedingestablishedrequirements.Functionally,theDirectorofQA/QCreportsdirectlytotheVicePresidentofOperations.Inaddition,the