英文版最新ISO9001:2015&ISO13485:2016&FDAQSR820全套文件(手册+程序文件)1Word格式.docx
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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
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
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
ParticularRequirementsforSterileMedicalDevices
DaMeidoesnotperformsterilizationofanykind.
RecordmaintenanceofsterilizationprocessparametersisnotapplicabletoDaMei.
8.QualityManagementSystem
8.1