MDSAP AS F0010 6 004AO Application Matrix.docx

MDSAP AS F0010 6 004AO Application Matrix.docx

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MDSAPASF00106004AOApplicationMatrix

PleasecompleteandincludewithyourapplicationtoberecognizedasanMDSAPAuditingOrganization.

AuditingOrganizationApplicant:

ISO/IEC17021-1:

2015

IMDRF/MDSAPWG/N3FINAL:

2016（Edition2）

DOCUMENTATION

APPLICANT’SREMARKS

REGULATORYAUTHORITYREMARKS

Criterion

Req.

Manual

（documentnumber）

Procedure

（documentnumber）

Other

（documentnumber）

e.g.Aretheseactivitiesperformedbyyourorganization?

Ifnot,bywhom?

RAuseonly

17021-1:

2015

1.Scope

2.Normativereferences

3.Termsanddefinitions

4.Principles

5.Generalrequirements

5.1Legalandcontractualmatters

Legalentitythatcanbeheldlegallyresponsibleforallitscertificationactivities.

5.1.1

Legallyenforceablearrangementwitheachclientfortheprovisionofcertificationactivitiesforallsiteswiththescopeofcertification.

5.1.2

ResponsibilityandAuthorityforCertificationDecisions

5.1.3

IMDRFN3

5.1Legalandcontractualmatters

LegalentityineligibletobeAOiffoundguiltyofanoffenceagainstnationallawsorregulationsrelatedtomedicaldevices,orrelatingtoanyfraudulentordishonestpractices.

5.1

Organizationalstructure,ownershipandthelegalornaturalpersonsexercisingcontrolovertheAuditingOrganization

5.1.1

Ifpartofalargerorganization,activities,structure,governanceandrelationshipwithAO

5.1.2

IfAOowns（wholeorpart）otherentitiesorhasmultipleoffices;defineanddocumentactivities,rolesandresponsibilities,andthelegalandoperationalrelationshipwiththeAO

5.1.3

LegallyenforceablearrangementswithmanufacturerstoallowRAstoobserveandassessAOauditsandtoaccessthemanufacturer’sdocumentsandrecords

5.1.4

LegallyenforceablearrangementswithmanufacturerstoallowRAstoshareinformation

5.1.5

17021-1:

2015

5.2Managementofimpartiality

Activitiesshallbeperformedimpartially.Commercial,financialorotherpressuresshallnotcompromisetheimpartialityofactivities.

5.2.1

Topmanagementcommitmentto,andapolicyfor;impartiality,themanagementofconflictofinterestandtheobjectivityofcertificationactivities.

5.2.2

Processtoidentify,analyse,evaluate,treat,monitor,anddocumenttherisksrelatedtoconflictofinterests.Risksshallbedocumentedandeliminated,orminimised,toanacceptablelevel.Theriskassessmentprocessshallincludeconsultationwithabalancedrepresentationfromidentifiedpartiesonmattersaffectingimpartiality,opennessandpublicperception.Wherethereareunacceptablethreatstoimpartiality,certificationshallnotbeprovided.

5.2.3

AnAOshallnotcertifyanotherAO’squalitymanagementsystem.

5.2.4

Notofferorprovidemanagementsystemsconsultancy.

5.2.5

Notofferorprovideinternalauditsofcertifiedclients.

5.2.6

NotcertifyingaclientwhentheAOhasarelationshipwithabodythatprovidedmanagementsystemsconsultancy.（SeeN3（ed2）:

Cl5.2.5–3yearperiod）

5.2.7

Notoutsourcingauditstoamanagementsystemconsultancyorganization.

5.2.8

AO’sactivitiesnottobemarketedorlinkedwiththeactivitiesofanorganizationprovidingmanagementsystemsconsultancy.（SeeN3（ed2）:

Cl5.2.6–financialorotherinducements）

5.2.9

Notusepersonnelforaclientwhowasprovidedmanagementsystemconsultancybythosepersonnel.（SeeN3（ed2）:

Cl5.2.5–3yearperiod）

5.2.10

Responsetoanythreatstoimpartialityfromotherpersons,bodiesororganizations.

5.2.11

Personnel,internalandexternal,andcommittees,shallactimpartially.

5.2.12

Requiringpersonnel,internalandexternal,torevealanypotentialconflictofinterest.Notusepersonnelwhenthereareknownthreatstoimpartiality

5.2.13

IMDRFN3

5.2ManagementofImpartiality

Financialandorganizationalindependencefrommanufacturersoranyeconomicoperatororcompetitorwithaninterestinthemanufacturer’sproducts

5.2.1

Organizationstructuredtopromoteandsafeguardindependence,objectivity,andimpartialityofitsactivities.Proceduresandrecordsfortheinvestigationandresolutionofanyconflictofinterest.（SeeN3（ed2）:

Cl6.1.4,MDSAPAUP0028）

5.2.2

Top-levelmanagementandresponsiblepersonnel,includingtheirspousesorchildren,responsibleforcarryingouttheauditsshallnot:

-bethedesigner,manufacturer,supplier,installer,distributor,importer,purchaser,owner,user,ormaintainer/servicerofthemedicaldeviceswhichtheyassess,northeauthorizedrepresentativeofanyofthoseparties

-beinvolvedinthedesign,manufactureorconstruction,themarketing,installation,useormaintenance/servicingofthosemedicaldevices,orrepresentthepartiesengagedinthoseactivities

-offerorprovideanyservicewhichmayunderminetheconfidenceintheirindependence,impartiality,orobjectivity.Inparticular,theyshallnotofferorprovideconsultancyservicestothemanufacturer,hisauthorizedrepresentative,asupplier,oracommercialcompetitor

-usetheservicesofanyorganizationorindividualthathasprovidedconsultancyservicestothemanufacturer,hisauthorizedrepresentativeorasupplierbeingauditedbytheAuditingOrganization,withinaperiodofthreeyearssincethelastconsultancyserviceswererendered.

5.2.3

Documentationofpersonnelformerlyinvolvedindeviceconsultingandmonitorandresolveanypotentialconflictsofinterest

5.2.4

Threeyearsbetweenconsultancyservicesandassignmentoftasksrelatedtopreviouslyservicedmanufacturers

5.2.5

Notadvertise,committo,guaranteeorimplytheoutcomeofauditsonthebasisoffinancialorotherinducements.

5.2.6

Actionofsubsidiaries,subcontractorsoranyassociatedbodydoesnotaffectindependence,impartiality,objectivity.

5.2.7

Changeofauditteamassignedtoauditamanufactureroverperiodoftime.LAfor<3consecutiveaudits.

5.2.8

FormalcommitmentofpersonneltocomplywiththeAO’sconfidentialityandindependencerules

5.2.9

IfAOispartofalargerorganization,impartialityrequirementsalsoapplytothelargerorganization

5.2.10

Theindividualsinvolvedintheprocessformanagingthreatsonimpartialityshallhaveaccesstoexpert（s）toobtainindependentopinions.（See17021-1:

2015Cl5.2.2）

5.2.11

17021-1:

2015

5.3Liabilityandfinancing

Riskanalysisandarrangementstocoverliabilitiesarisingfromactivitiesandgeographicalareasofoperation.

5.3.1

Evaluationoffinancesandsourcesofincomeanddemonstratecommercial,financialorotherpressuresdonotcompromiseimpartialityinitiallyandonanon-goingbasis.

5.3.2

IMDRFN3

5.3LiabilityandFinancing

LiabilityInsurance–Evidenceofconsiderationofthelevelandgeographicscopeofactivitiesandtheriskprofileofdevicesbeingproducedbythemanufacturersbeingaudited

5.3.1

Financialresources

5.3.2

17021-1:

2015

6.Structuralrequirements

6.1Organizationalstructureandtopmanagement

Documentorganizationalstructure,duties,responsibilities,authoritiesandlinesofauthority.

6.1.1

Activitiestobestructuredandmanagedtosafeguardimpartiality

6.1.2

Identifytopmanagementwithoverallauthorityandresponsibilityforfollowing:

6.1.3

-Operatingpolicydevelopment,processandprocedureestablishment

6.1.3a

-Supervisionoftheimplementationofpolicies,processesandprocedures

6.1.3b

-Ensuringimpartiality

6.1.3c

-Supervisionoffinances

6.1.3d

-Developmentofcertificationservicesandschemes

6.1.3e

-Performanceofauditsandcertificationandcomplaintresponse

6.1.3f

-Certificationdecisions

6.1.3g

-Delegationofauthorities

6.1.3h

-Contractualarrangements

6.1.3i

-Provisionofadequateresources

6.1.3j

Rulesforcommitteesinvolvedincertificationactivities

6.1.4

IMDRFN3

6.1Organizationalstructureandtopmanagement

Personnelcurrentinpracticesandknowledge

6.1.1

Organizationalcapacitytoincludemanagement,administrativesupport,andinfrastructuretoundertakeallcontractedactivities

6.1.2

ParticipationintheMDSAPregulatorycoordinationgroup

6.1.3

ConsiderationandusageofrelevantMDSAPguidanceandbestpracticedocuments

6.1.4

Adoptandadheretoacodeofconductincludingamechanismformonitoringandverification（SeealsoN3（ed2）:

Cl7.1.6）.Violationstobeinvestigatedandactionstaken

6.1.5

Documentedroles,responsibilities,andlinesofreportingforallpersonnel,includingsubcontractors,involvedinauditsanddecisionmaking.

6.1.6

Documentedprocessesandproceduresforindependentreviewofwork

6.1.7

17021-1:

2015

6.2OperationalControl

ProcessforeffectivecontrolofactivitiesbytheAOandrelatedentitiestakingintoaccountriskstheseentitiesmayposetocompetence,consistencyandimpartiality.

6.2.1

Appropriatelevelandmethodsforcontrolofactivitiesun