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

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