英文版最新ISO9001:2015&ISO13485:2016&FDAQSR820全套文件(手册+程序文件)Word格式文档下载.docx
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英文版最新ISO9001:2015&ISO13485:2016&FDAQSR820全套文件(手册+程序文件)Word格式文档下载.docx
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Definitions 2
6.Policy&
Objectives 3
7.Application 4
8.QualityManagementSystem 4
9.ManagementResponsibility 6
10.ResourceManagement 8
11.ProductRealization 8
12.Purchasing 11
13.ProductionControl/ProductIdentification&
Traceability 12
14.ControlofInspection,Measuring,andTestEquipment 13
15.Measurement,Analysis,Improvement 14
Scope
ThismanualdescribestheQualityManagementSystem(QMS)establishedbyandfor
DongguanDaMeiAppliancesLimited.
Theprinciplesandpoliciesonwhichthismanualisbased;
alongwithoperatingprocedures,workinstruc-tions,andothersupportingdocuments;
governallprocessesthataffectqualitythroughouttheorganiza-tion.
2.ApplicableStandards
2.1TheQMSisstructuredandintendedtobeincompliancewiththefollowingstandards.
ISO13485:
2016MedicalDevicesQualityManagementSystemsRequirementsforRegulatoryPurposes21CFRPart820QualitySystemRegulation(ExclusionsandExceptionsnotedbelow.)
2.2NormativeReferences
ISO9000:
2015QualityManagementSystems·
FundamentalsandVocabulary
2016Medicaldevices·
QualityManagementSystems·
GuidanceontheApplicationofISO13485:
2016
3.BusinessProfile
3.1MissionStatement
Todeliverzerodefectstoourinternalandexternalsuppliersandcustomers.
3.2DaMei,withonefacilitylocatedatBlockS,YinyangIndustrialCity,ZhangmutouTown,DongguanCity,GuangdongProvince,China.
3.3TheorganizationalstructureisdescribedbyDongguanDaMeiAppliancesLimitedOrganizationChart.
Responsibility
4.1ThismanualisissuedundertheauthorityofthePresident.
4.2ItistheresponsibilityoftheDirectorofQuality,whoisthedesignatedManagementRepresentative,toensurethattheprinciplesofthismanual,theQualityPolicy,qualityobjectives,customerrequirements,applicableregulatoryrequirements,andqualitymanagementsystemrequirementsarepromoted,com-municatedtoandunderstoodbyallDaMeiemployees.
Definitions
5.1CorrectiveAction
Aprocessimprovementmethodologyaimedatidentifyingandeliminatingthecausesofknownnon-conformitiestopreventtheirrecurrence.Aproblemsolvingprocess.
5.2Customer
1.AbusinessentityandtheindividualsrepresentingitthatspecifyandpurchaseproductsproducedbyDaMei.
2.AbusinessentityconsideringDaMeiasapotentialsupplier.
5.3CustomerComplaint
AcommunicationfromacustomerexpressingdissatisfactionwithproductorserviceoraconcernbasedonobservationsorperceptionsofDaMei;
classifiedasFormalComplaint,InformalComplaint,orCustomerReturn.
5.4CustomerFeedback
CustomerassessmentofDaMei'
sperformanceasitrelatestomeetingcustomerrequirementsand/orexpectations.
5.5Process
Asetofinterrelatedresourcesandactivities;
i.e.people,materials,equipment,environment,methods;
usedtotransformspecificinputsintospecificoutputs.
5.6Product
1.TheendresultofactivitiesperformedandresourcesappliedbyDaMei;
aprocessoutput.
2.Purchasedgoodsandservices.
5.7PreventiveAction
Aprocessimprovementmethodologyaimedatidentifyingandeliminatingpotentialcausesofnoncon-formitiesbeforetheyoccur.
Ariskmanagementprocess.
5.8Qualified
Havingattainedtheknowledge,skills,orotherattributesnecessarytoperformaparticularactivityortaskinaccordancewithspecifiedrequirements.
Objectives
6.1QualityPolicy
Ourgoal,atDaMei,istoprovideproductsandservicesthatcomplywithapplicablerequirementsandexceedourcustomers’expectations.Thiswillbeaccomplishedthroughemployeeinvolvementandongoingeducationtoensurecontinuousimprovementofourprocesses.
Thisqualitypolicyiscommunicatedtoallemployeesaspartoftheirtraining,withtheintentofprovid-ingaclear,commonunderstanding,directlyapplicabletotheirwork.Thequalitypolicyisreviewedatleastonceperyearforcontinuingsuitabilityandadequacy.
6.2QualityObjectives
•OnlyDefect-FreeProductandServicesshipped/providedtocustomers/suppliers
•ContinuousImprovementinDeliveryPerformancethroughtheUtilizationofCapableProcesses
•Maintenance/ContinuationofISO13485Certification
7.Application
7.1TheQMSdescribedinthismanualisapplicableincontractualsituationsentailingthemanufactureofcomponents/devicesinaccordancewithcustomerspecifications.
7.2Exclusions
ParticularRequirementsforSterileMedicalDevicesDaMeidoesnotperformsterilizationofanykind.
RecordmaintenanceofsterilizationprocessparametersisnotapplicabletoDaMei.
8.QualityManagementSystem
8.1General
8.1.1DaMeihasdeveloped,documented,implemented,andmaintainsitsQMSinaccordancewithISO13485:
2016,and21CFRPart820.
8.1.2DaMeiappliesarisk-basedapproachtothecontrolofappropriateprocessesneededforthequality
managementsystemutilizingthemethodsspecifiedinISO/IEC31010:
2009,Riskmanagement-Riskassessmenttechniques,whichisusedasguidanceonselectionandapplicationofsystematictechniquesforriskassessment.
8.1.3TheQMSisbasedonaprocessapproachtoqualitymanagementandDAMEIappliescontinuousprocessimprovementmethodology,i.e.thePlan-Do-Check-ActCycle(Figure1),toensureitson-goingeffectiveness.
8.1.4Systemprocesses,includingtheirinterrelationshipsandcorrelationtoISO13485:
2016sub-clauses,aredescribedintheappendicesofthismanual.
8.2DocumentControl
8.2.1ThedocumentsystemistieredasshowninFigure2.
8.2.2AlldocumentscomprisingtheQMS;
i.e.thisQualityManual,Procedures,WorkInstructions,Forms;
theircurrentrevisionlevelandfiletypearelistedandcontrolled.
8.2.3QMSdocumentsarecontrolledandrevisedasdescribedinprocedureControlofDocu-ments.
8.2.4RecordsrequiredbytheQMS,ISO13485:
2016,and21CFRPart820aremaintainedinaccordancewithprocedureControlofRecords.
8.3References
QM-COP-01ControlofDocumentsProcedureQM-COP-02ControlofRecordsProcedure
9.ManagementResponsibility
9.1General
9.1.1DaMeimanagementiscommittedtothedevelopmentandimplementationoftheQMSandfullysupportsmaintainingitseffectivenessby:
•communicating,toallfunctionsandlevelswithinDaMei,theimportanceofmeetingcustomer,appli-cableregulatory,andstatutoryrequirements.
•establishinganappropriatequalitypolicyandmeasurableobjectivesandensuringthesearecom-municatedandunderstoodthroughoutthecompany.
•providingaframeworkforreviewofqualityobjectivesandprocesses,includingregularlyscheduledManagementReviewstoensurecontinuingsuitability,adequacy,andeffectivenessoftheQMS.
•ensuringtheintegrityoftheQMSaschangesareplannedandimplemented.
•allocatingsufficientresourcesandprovidingeducationand/ortrainingasrequired.
9.1.2Managementisultimatelyresponsiblefordeterminingandsatisfyingcustomer/productrequire-ments.
9.1.3Roles,responsibilities,authorities,andtheirinterrelationshipsareclearlydefined,documented,andcommunicatedwithinDaMei.Personnelwhomanage,perform,and/orverifyworkaffectingqualityhavethe
authorityandinde-pendencetoperformthesetaskseffectively.
9.2TheDirectorofQualityservesastheManagementRepresentativeand,assuch,isresponsibleandfullyauthorizedtomanagetheQMSandrelatedmattersonanongoingbasis.Rolesandresponsibili-tiesincludethefollowing.
•InterpretsapplicablestandardsandcontinuallyverifiesQMScompliance.
•Ensuresthatrequiredprocessesaredocumented,implemented,andmaintained.
•AdvisesthemanagementteamregardingoperationandeffectivenessoftheQMSandopportuni-tiesforimprovement.
•ServesasliaisontoexternalpartiesregardingmattersrelatingtotheQMS.
•Ensuresthattheprinciplesofthismanual,theQualityPolicy,qualityobjectives,customerrequir-ements,applicableregulatoryrequirements,andQMSrequirementsarepromoted,communicatedtoandunderstoodbyallDaMeiemployees.
9.3IntheeventtheDirectorofQualitycannotserveastheManagementRepresentative,forwhateverreason,theQualityAssuranceManagerservesastheManagementRepresentativeandwillfulfilltherolesandresponsibilitiesoutlinedabove.
9.4ManagementReview
9.4.1ManagementReviewMeetingsareconductedatregularlyplannedintervalstoensurecontinuingsuitability,adequacy,andeffectivenessoftheQMS.
9.4.2Inputtomanagementreviewsmayinclude,butisnotlimitedto,thefollowing.
•QualityPolicy
•QualityObjectives
•Follow-UpItemsFromPreviousManagementReview(s)
•AuditResults
•CustomerInput
•InternalNon-Conformances(NCRs)
•On-timeDeliveryPerformanceData
•SupplierPerformanceData
•TrainingProgramStatus
•InternalCorrective&
PreventiveActionsStatus
•ChangesthatcouldaffecttheQMS
•NeworRevisedRegulatoryRequirements
•ResourceIssues/Requirements
•RecommendationsforImprovement
9.4.3Outputofmanagementreviewsisrecordedandincludestheinputreviewedandanydecisionsandactionsrelatedtothefollowing:
•Improvementsneededtomaintainthesuitability,adequacy,andeffectivenessoftheQMSanditsprocesses
•ImprovementofProduct
•Changesneededtorespondtoneworrevisedregulatoryrequirements
•ResourceNeeds
9.5References
PR-56-001·
ManagementReview
10.ResourceManagement
10.1TheDaMeimanagementteamisresponsibleforidentifying,obtaining,allocating,and/ortrainingappro-priateresourcesto
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