QSR820质量手册英文版.docx

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CONFIDENTIAL

CN0781
QualityManual
Effective:October22,2013
Page1of17
TableofContents
Topic
SeePage

Purpose
3

Scope
3

Companybackgroundandhistory
3

SubpartA-GeneralProvisions
3


3

SubpartB-QualitySystemRequirements
4


4

4
Organization
4
Managementreview
5

5

6


7


7

SubpartC-DesignControls
7


7

SubpartD-DocumentControls
8


8

SubpartE
-PurchasingControls
8


8

SubpartF
-IdentificationandTraceability
8


8


9

SubpartG
-ProductionandProcessControls
9


9

,measuring,andtestequipment
9


10

SubpartH-AcceptaneeActivities
10

,in-process,andfinisheddeviceacceptanee
10


11

SubpartI
—NonconformingProduct
11


11

SubpartJ-CorrectiveandPreventativeAction
11


11

SubpartK-LabelingandPackagingControl
12


12


12
OL

QualityManual
DR
TableofContents(Continued)
Topic
-Handling,Storage,Distribution,andInstallation




-Records





—Servicing

-StatisticalTechniques


-USRegulatoryRequirements
-applicability
ManagementProcess
QMSDiagram

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CN0781
Effective:October22,2013
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SeePage
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12
12
12
12
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QualityManual

CONFIDENTIAL
CN0781
Effective:October22,2013
Page3of17

Purpose
Thisqualitymanual(QM)definesLDRSpinepolicy.

Scope
'
'
and'Standards'areLDRiSabtequahtysystem:
Thefollowing
Regulations
Applicable'
Regulations'
Wheretheterm
'
Regulations
'
isusedtpith
efeegulation(s)listedbelow:
21CFRPart820:FoodandDrugAdministrationQualitySystemRegulations(QSR)
Applicable'Standards'
Wheretheterm'Standard'or'Standards'isuse(quareeysttenthsiandard(s)listed
below:
?ISO13485(7/2003):Medicaldevices-Qualitymanagementsystems-Requirementsforregulatorypurposes
ApplicableDocuments
-01LIST,Masterlistofqualitysystemdocuments

LDRSpinewasfoundedin2004tofocusonUSsalesanddistributionofmedicaldevices(manufacturedbyLDRMedical)totreatspinaldisorders,,.
LDRSpinefunctionsasadistributorandinitialimporterofmedicaldevices,.
LDRSpineislocatedat:
13785ResearchBoulevard,Suite200
Austin,Texas78750
,development,andmanufacturingfunctionsareperformed
byLDRMedicalwhichislocatedinTroyes,(specificallycontrolanddistribution),manyqualitysystemfunctionsaretheresponsibilityof,andaddressedbyLDRMedical.
-GeneralProvisions



inaccordaneewiththe
'
Regulations
'
:
*
Identifiedtheprocessesneededforthequalitysystemandtheirapplicationthroughouttheorganization
*
Determinedthesequeneeandinteractionoftheseprocesses
*
Determinedcriteria
andmethodsneededtoensurethatboththeoperationandcontrolofthese
processes
areeffective
Ensuredtheavailabilityofresourcesandinformationnecessarytosupporttheoperationandmonitoringoftheseprocesses
Monitored,measuredandanalyzedtheseprocesses
Implementedactionsnecessarytoachieveplannedresultsandmaintaintheeffectivenessoftheseprocesses

QualityManual

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Page4of17

ofsuchprocessesisidentifiedwithinthequalitysystem.
:
Communicatingtheimportaneeofmeetingcustomerrequirements
Communicatingtheimportaneeofmeetingtherequirementsspecifiedinthe
'Regulations'and'Standards'
Establishingaqualitypolicyandcommunicatingtheimportaneeofthequalitypolicy
Establishingqualityobjectives
Performingmanagementreviews
Ensuringtheavailabilityofresources
-QualitySystemRequirements


Qualitypolicy
ThequalitypolicyisthedefiningstatementofthecommitmenttoLDRSpine(includingmanagementwithexecutive
responsibility)
hasestablishedthefollowingqualitypolicy:
LDRSpineshallprovidesafeandeffectivedevices
thatimprovethequalityofspinecareandmeet
customer&regulatoryrequirements
Managementwithexecutiveresponsibilityshallensurethatthequalitypolicyisunderstood,implemented,andmaintainedatalllevelsoftheorganization.
Organization
LDRSpinehasestablishedandmaintainsanadequateorganizationstructuretoensurethatdevicesaredesig
ned,produced,accepted,anddistributedinaccordaneewiththeregulatoryrequirements.
Responsibilityandauthority
,alongwithjob
descriptions,defineanddocumenttheresponsibility,authority,andtheinterrelationofpersonnelwhoman
age,perform,
intheQM,SOPsandotherdocumentation.
Iftheresponsiblepartyisnotavailable,authorizeddeputiesmaysubstitutefortheresponsibleparty.
Itis

addition,
anemployeemaydesignateanotherpersontobeadeputybydocumentingthisfactinwritingandprovidingthe

,adeputymayhavetobetrained(formallyorviaself-training)beforeperformingagivenjob.