英文版最新ISO9001：2015&ISO13485：2016&FDAQSR820全套文件(手册+程序文件)1.docx

英文版最新ISO9001：2015&ISO13485：2016&FDAQSR820全套文件(手册+程序文件)1.docx

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英文版最新

ISO13485:

2016&FDAQSR820

全套文件（手册+程序文件）

-本人辛苦原创

QM-A-01QualityControlManual

TableofContents

1.Purpose&Scope 2

2.ApplicableStandards 2

3.BusinessProfile 2

4.Authority&Responsibility 2

5.Terms&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

1.Purpose&Scope

ThismanualdescribestheQualityManagementSystem（QMS）establishedbyandfor

DongguanDaMeiAppliancesLimited.

Theprinciplesandpoliciesonwhichthismanualisbased;alongwithoperatingprocedures,workinstruc-tions,andothersupportingdocuments;governallprocessesthataffectqualitythroughouttheorganiza-tion.

2.ApplicableStandards

2.1TheQMSisstructuredandintendedtobeincompliancewiththefollowingstandards.

ISO13485:

2016MedicalDevicesQualityManagementSystemsRequirementsforRegulatoryPurposes

21CFRPart820QualitySystemRegulation（ExclusionsandExceptionsnotedbelow.）

2.2NormativeReferences

ISO9000:

2015QualityManagementSystems·FundamentalsandVocabulary

ISO13485:

2016Medicaldevices·QualityManagementSystems·GuidanceontheApplicationofISO13485:

2016

3.BusinessProfile

3.1MissionStatement

Todeliverzerodefectstoourinternalandexternalsuppliersandcustomers.

3.2DaMei,withonefacilitylocatedatBlockS,YinyangIndustrialCity,ZhangmutouTown,DongguanCity,GuangdongProvince,China.

3.3TheorganizationalstructureisdescribedbyDongguanDaMeiAppliancesLimitedOrganizationChart.

4.Authority&Responsibility

4.1ThismanualisissuedundertheauthorityofthePresident.

4.2ItistheresponsibilityoftheDirectorofQuality,whoisthedesignatedManagementRepresentative,toensurethattheprinciplesofthismanual,theQualityPolicy,qualityobjectives,customerrequirements,applicableregulatoryrequirements,andqualitymanagementsystemrequirementsarepromoted,com-municatedtoandunderstoodbyallDaMeiemployees.

5.Terms&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.

6.Policy&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

ParticularRequirementsforSterileMedicalDevices

DaMeidoesnotperformsterilizationofanykind.

RecordmaintenanceofsterilizationprocessparametersisnotapplicabletoDaMei.

8.QualityManagementSystem

8.1