QSR820質(zhì)量手冊英文版

O-DRQMRev.FQualityManualCONFIDENTIALCN0781Effective:October22,2013Page1of17TableofContentsTopicSeePage1.0Purpose32.0Scope33.0Companybackgroundandhistory34.0SubpartA-GeneralProvisions34.1Sec.820.5Qualitysystem35.0SubpartB-QualitySystemRequirements45.1 820.20Managementresponsibility45.1.1Qualitypolicy45.1.2 Organization45.1.3 Managementreview55.1.4Qualityplanning55.1.5Qualitysystemprocedures65.2 820.22Qualityaudit75.3 820.25Personnel76.0SubpartC-DesignControls76.1 820.30DesignControls77.0SubpartD-DocumentControls87.1 820.40DocumentControls88.0SubpartE-PurchasingControls88.1 820.50Purchasingcontrols89.0SubpartF-IdentificationandTraceability89.1 820.60Identification89.2 820.65Traceability910.0SubpartG-ProductionandProcessControls910.1 820.70Productionandprocesscontrols910.2 820.72Inspection,measuring,andtestequipment910.3 820.75Processvalidation1011.0SubpartH-AcceptaneeActivities1011.1 820.80Receiving,in-process,andfinisheddeviceacceptanee1011.2 820.86Acceptaneestatus1112.0SubpartI —NonconformingProduct1112.1 820.90Nonconformingproduct1113.0SubpartJ-CorrectiveandPreventativeAction1113.1 820.100Correctiveandpreventativeaction1114.0SubpartK-LabelingandPackagingControl1214.1 820.120Devicelabeling1214.2 820.120Devicepackaging12OLDRQMRev.FQualityManualCONFIDENTIALCN0781Effective:October22,2013Page2of17TableofContents(Continued)TopicSeePage15.0SubpartL-Handling,Storage,Distribution,andInstallation1215.1820.140Handling1215.2820.150Storage1215.3820.160Distribution1215.4820.170Installation1216.0SubpartM-Records1316.1820.180Generalrequirements1316.2820.181Devicemasterrecord1316.3820.184Devicehistoryrecord1316.4820.186Qualitysystemrecord1316.5820.198Complaintfiles1317.0SubpartN—Servicing1517.1820.200Servicing1518.0SubpartO-StatisticalTechniques1518.1820.50Statisticaltechniques1519.0Additionalregulatoryrequirements1519.1Non-USRegulatoryRequirements1520.0 Exclusions/Non-applicability15ManagementProcess16QMSDiagram18QMRev.FQualityManualQMRev.FQualityManualCN0781Effective:October22,2013Page3of171.0 PurposeThisqualitymanual(QM)definesLDRSpinepolicy.2.0 ScopeThefollowing' Regulations 'and'Standards'areLDRiSabtequahtysystem:Applicable'Regulations'Wheretheterm'Regulations 'isusedtpith efeegulation(s)listedbelow:? 21CFRPart820:FoodandDrugAdministrationQualitySystemRegulations(QSR)Applicable StandardsStandardsisuse(quareeysttenthsiandard(s)listedWheretheterm' Standard'orStandardsisuse(quareeysttenthsiandard(s)listedbelow:ISO13485(7/2003):Medicaldevices-Qualitymanagementsystems-RequirementsforregulatorypurposesApplicableDocuments1.LIST4-01LIST,Masterlistofqualitysystemdocuments3.0CompanybackgroundandhistoryLDRSpinewasfoundedin2004tofocusonUSsalesanddistributionofmedicaldevices(manufacturedbyLDRMedical)totreatspinaldisorders,andtoobtainregulatoryapprovalsforLDRMedicalproductsintheUSmarket.Productsincludespinalimplants,instrumentsandsterilizationtrays.LDRSpinemayalsodistributedevicesforothercompaniesinthespinalmarket.LDRSpinefunctionsasadistributorandinitialimporterofmedicaldevices,andistheUSAgentforLDRMedical.LDRSpinemayalsodesignanddevelopmedicaldevicesfordistributionintheUS.LDRSpineislocatedat:13785ResearchBoulevard,Suite200Austin,Texas78750LDRSpineistheUSentityoftheglobalLDRbrand.Themajorityofdesign,development,andmanufacturingfunctionsareperformedbyLDRMedicalwhichislocatedinTroyes,Franee.WhileLDRSpinehasimplementedaqualitysystemtoaddresstheactivitiesintheUS(specificallycontrolanddistribution),manyqualitysystemfunctionsaretheresponsibilityof,andaddressedbyLDRMedical.4.0SubpartA-GeneralProvisionsSec.820.5QualitysystemLDRSpinehasimplementedandmaintainsaqualitysystem.Thesystemshallbemaintainedanditseffectivenessmonitoredinaccordaneewiththe ' Regulations'StandardsLDR.Spinehas:IdentifiedtheprocessesneededforthequalitysystemandtheirapplicationthroughouttheorganizationDeterminedthesequeneeandinteractionoftheseprocessesDeterminedcriteria andmethodsneededtoen surethat boththe operationandcontrol ofthese processesareeffectiveEnsuredtheavailability ofresourcesandinformation necessary tosupporttheoperationandmonitori ngoftheseprocessesMonitored,measuredandanalyzedtheseprocessesImplementedactionsn ecessarytoachieveplanned resultsand maintain theeffectivenessofthese processesQMRev.FQualityManualCONFIDENTIALCN0781Effective:October22,2013Page4of17LDRSpineshallensurecontroloverprocessesthatareoutsourcedthatmayaffectproductconformitywithrequirements.Controlofsuchprocessesisidentifiedwithinthequalitysystem.ThemanagementofLDRSpineiscommittedtosuccessfullyimplementinganeffectivequalitysystem.Thisshallbeaccomplishedby:?Communicatingtheimportaneeofmeetingcustomerrequirements?Communicatingtheimportaneeofmeetingtherequirementsspecifiedinthe'Regulations 'and'Standards'?Establishingaqualitypolicyandcommunicatingtheimportaneeofthequalitypolicy?Establishingqualityobjectives?Performingmanagementreviews?Ensuringtheavailabilityofresources5.0SubpartB-QualitySystemRequirements820.20ManagementresponsibilityQualitypolicyThequalitypolicyisthedefiningstatementofthecommitmenttoLDRSpine(includingmanagementwithexecutiveresponsibility)tomeetitscustomerrequirementsandtocomplywithallregulatoryrequirements.LDRSpinehasestablishedthefollowingqualitypolicy:LDRSpineshallprovidesafeandeffectivedevicesthatimprovethequalityofspinecareandmeetcustomer®ulatoryrequirementsManagementwithexecutiveresponsibilityshallensurethatthequalitypolicyisunderstood,implemented,andmaintainedatalllevelsoftheorganization.OrganizationLDRSpinehasestablishedandmaintainsanadequateorganizationstructuretoensurethatdevicesaredesigned,produced,accepted,anddistributedinaccordaneewiththeregulatoryrequirements.ResponsibilityandauthorityTheorganizationalstructureofLDRSpineiscontainedintheorganizationalchart.Thechart,alongwithjobdescriptions,defineanddocumenttheresponsibility,authority,andtheinterrelationofpersonnelwhomanage,perform,andverifywork