QSR820质量手册英文版

O-DR

QMRev.F

QualityManual

CONFIDENTIAL

CN0781

Effective:October22,2013

Page1of17

TableofContents

Topic

SeePage

1.0

Purpose

3

2.0

Scope

3

3.0

Companybackgroundandhistory

3

4.0

SubpartA-GeneralProvisions

3

4.1Sec.820.5Qualitysystem

3

5.0

SubpartB-QualitySystemRequirements

4

5.1 820.20Managementresponsibility

4

5.1.1Qualitypolicy

4

5.1.2 Organization

4

5.1.3 Managementreview

5

5.1.4Qualityplanning

5

5.1.5Qualitysystemprocedures

6

5.2 820.22Qualityaudit

7

5.3 820.25Personnel

7

6.0

SubpartC-DesignControls

7

6.1 820.30DesignControls

7

7.0

SubpartD-DocumentControls

8

7.1 820.40DocumentControls

8

8.0

SubpartE-PurchasingControls

8

8.1 820.50Purchasingcontrols

8

9.0

SubpartF-IdentificationandTraceability

8

9.1 820.60Identification

8

9.2 820.65Traceability

9

10.0

SubpartG-ProductionandProcessControls

9

10.1 820.70Productionandprocesscontrols

9

10.2 820.72Inspection,measuring,andtestequipment

9

10.3 820.75Processvalidation

10

11.0

SubpartH-AcceptaneeActivities

10

11.1 820.80Receiving,in-process,andfinisheddeviceacceptanee

10

11.2 820.86Acceptaneestatus

11

12.0

SubpartI —NonconformingProduct

11

12.1 820.90Nonconformingproduct

11

13.0

SubpartJ-CorrectiveandPreventativeAction

11

13.1 820.100Correctiveandpreventativeaction

11

14.0

SubpartK-LabelingandPackagingControl

12

14.1 820.120Devicelabeling

12

14.2 820.120Devicepackaging

12

OLDR

QMRev.F

QualityManual

CONFIDENTIAL

CN0781

Effective:October22,2013

Page2of17

TableofContents(Continued)

Topic

SeePage

15.0SubpartL

-Handling,Storage,Distribution,andInstallation

12

15.1

820.140Handling

12

15.2

820.150Storage

12

15.3

820.160Distribution

12

15.4

820.170Installation

12

16.0SubpartM-Records

13

16.1

820.180Generalrequirements

13

16.2

820.181Devicemasterrecord

13

16.3

820.184Devicehistoryrecord

13

16.4

820.186Qualitysystemrecord

13

16.5

820.198Complaintfiles

13

17.0SubpartN

—Servicing

15

17.1

820.200Servicing

15

18.0SubpartO-StatisticalTechniques

15

18.1

820.50Statisticaltechniques

15

19.0Additionalregulatoryrequirements

15

19.1Non-USRegulatoryRequirements

15

20.0 Exclusions/Non-applicability

15

ManagementProcess

16

QMSDiagram

18

QMRev.F

QualityManual

CONFIDENTIAL

CN0781

Effective:October22,2013

Page3of17

1.0 Purpose

Thisqualitymanual(QM)definesLDRSpinepolicy.

2.0 Scope

Thefollowing' Regulations 'and'Standards'areLDRiSabtequahtysystem:

Applicable'Regulations'

Wheretheterm'Regulations 'isusedtpith efeegulation(s)listedbelow:

? 21CFRPart820:FoodandDrugAdministrationQualitySystemRegulations(QSR)

Applicable Standards

Standardsisuse(quareeysttenthsiandard(s)listed

Wheretheterm' Standard'or

below:

ISO13485(7/2003):Medicaldevices-Qualitymanagementsystems-Requirementsforregulatorypurposes

ApplicableDocuments

1.LIST4-01LIST,Masterlistofqualitysystemdocuments

3.0Companybackgroundandhistory

LDRSpinewasfoundedin2004tofocusonUSsalesanddistributionofmedicaldevices(manufacturedbyLDRMedical)totreatspinal

disorders,andtoobtainregulatoryapprovalsforLDRMedicalproductsintheUSmarket.Productsincludespinalimplants,instrume

ntsandsterilizationtrays.LDRSpinemayalsodistributedevicesforothercompaniesinthespinalmarket.

LDRSpinefunctionsasadistributorandinitialimporterofmedicaldevices,andistheUSAgentforLDRMedical.LDRSpinemayalsodesignanddevelopmedicaldevicesfordistributionintheUS.

LDRSpineislocatedat:

13785ResearchBoulevard,Suite200

Austin,Texas78750

LDRSpineistheUSentityoftheglobalLDRbrand.Themajorityofdesign,development,andmanufacturingfunctionsareperformedbyLDRMedicalwhichislocatedinTroyes,Franee.WhileLDRSpinehasimplementedaqualitysystemtoaddresstheactivitiesintheUS(specificallycontrolanddistribution),manyqualitysystemfunctionsaretheresponsibilityof,andaddressedbyLDRMedical.

4.0SubpartA-GeneralProvisions

Sec.820.5Qualitysystem

LDRSpinehasimplementedandmaintainsaqualitysystem.Thesystemshallbemaintainedanditseffectivenessmonitored

inaccordaneewiththe ' Regulations

'StandardsLDR.Spinehas:

Identifiedtheprocessesneededforthequalitysystemandtheirapplicationthroughouttheorganization

Determinedthesequeneeandinteractionoftheseprocesses

Determinedcriteria andmethodsneededtoen surethat boththe operationandcontrol ofthese processesareeffective

Ensuredtheavailability ofresourcesandinformation necessary tosupporttheoperationandmonitori ngofthese

processes

Monitored,measuredandanalyzedtheseprocesses

Implementedactionsn ecessarytoachieveplanned resultsand maintain theeffectivenessofthese processes

QMRev.F

QualityManual

CONFIDENTIAL

CN0781

Effective:October22,2013

Page4of17

LDRSpineshallensurecontroloverprocessesthatareoutsourcedthatmayaffectproductconformitywithrequirements.Control

ofsuchprocessesisidentifiedwithinthequalitysystem.

ThemanagementofLDRSpineiscommittedtosuccessfullyimplementinganeffectivequalitysystem.Thisshallbeaccomplishedby:

?Communicatingtheimportaneeofmeetingcustomerrequirements

?Communicatingtheimportaneeofmeetingtherequirementsspecifiedinthe

'Regulations 'and'Standards'

?Establishingaqualitypolicyandcommunicatingtheimportaneeofthequalitypolicy

?Establishingqualityobjectives

?Performingmanagementreviews

?Ensuringtheavailabilityofresources

5.0SubpartB-QualitySystemRequirements

820.20Managementresponsibility

Qualitypolicy

ThequalitypolicyisthedefiningstatementofthecommitmenttoLDRSpine(includingmanagementwithexecutiveresponsibility)tomeetitscustomerrequirementsandtocomplywithallregulatoryrequirements.LDRSpinehasestablishedthefollowingqualitypolicy:

LDRSpineshallprovidesafeandeffectivedevicesthatimprovethequalityofspinecareandmeetcustomer®ulatoryrequirements

Managementwithexecutiveresponsibilityshallensurethatthequalitypolicyisunderstood,implemented,andmaintainedatalllevelsoftheorganization.

Organization

LDRSpinehasestablishedandmaintainsanadequateorganizationstructuretoensurethatdevicesaredesig

ned,produced,accepted,anddistributedinaccordaneewiththeregulatoryrequirements.

Responsibilityandauthority

TheorganizationalstructureofLDRSpineiscontainedintheorganizationalchart.Thechart,alongwithjobdescriptions,defineanddocumenttheresponsibility,authority,andtheinterrelationofpersonnelwhomanage,perfor