ISO134852016内部审核检查表英文版

ISO13485:2016PlannerandDeltaChecklist

Instructions:

HighlightedareasaretobecompletedbytheClientOrganizationpriortotheoff-sitereview,oron-siteGapAnalysisorUpgradeAudit,andsubmittedtotheNSF-ISRLeadAuditorforreview.

TheAnnexA-ISO13485:2016vs.ISO13485:2003ComparisonTable hasbeenprovidedattheendofthisdocumentforinformationandrefereneepurposesonly.

CompletionbytheClientOrganizationshouldincludethefinalstatementofreadinessforUpgradebytheTopManagementoftheClientOrganization.

a ” ”

Thecolumnsfor PlannedCompletionDate andResponsibility maybeusedbytheClientOrganizationtodeveloptheirplanupgradingtheirQMStotherequirementsofISO13485:2016.

sISO13485:2016iality

ANDthefinal

AllotherareasoftheChecklistarerequiredtobecompletedbythe nSf-ISRLeadAuditortoconfirmtheeffectiveimplementationofth eClientOrganization

ManagementSystem.

TheLeadAuditorshallsigntheappropriatesectionsattheendoftheChecklisttoindicate:whethertheClientOrganizationisReady/NotReadyforUpgradeAudit(Off-sitereview),

approvaloftheQMSinmeetingtherequirementsofISO13485:2016(duringtheon-siteUpgradeAudit)

ThischecklistshallbesubmittedbytheNSF-ISRLeadAuditorasoneoftherecordsoftheISO13485:2016UpgradefortheClientOrganization.

OrganizationName:

OrganizationAddress:

NumberofPersonnel:

1stShift:

ndShift:

rdShift:

Temp./Part-time:

Otherlocationsincludedinthisregistration:

ManagementContact:

NameandRevisionStatusofQMSdocumentation:

FRSNumber:

Off-siteReviewDate(DeskAudit):

AuditDates(on-site):

_eadAuditor/AuditTeam:

ScopeofRegistration:

SO13485:2016ClausesthatareNotApplicabletothescopeofthe

QMS:RefereneeISO13485:2016(E)Medicaldevices Qualitymanagement

systems

Requirementsforregulatorypurposes:Scope,Section1

TheintervalbetweentheclientDeltaReviewandtheUpgradeAuditshouldnotexceed90days.

sregisteredISO13485:2003QMSremainscompliantwiththatversionoftheStanda

rduntiltheTransition

NOTE:PleaseensurethatyourOrganization

toISO13485:2016iscompleteandverifiedbytheNSF-ISRLeadAuditor.

Question/Requirement

LevelofCompletion

0=NotStarted

10=Completed&Implemented

QMSProcessRelatedtoRequirement(ProcessName)

Planned

Completion

Date

Responsibility

RefereneeDocument(Name/Rev.Level)

ORRecords

NSF-ISRLeadAuditorReviewComments

QMSDocumentation

Clause4.1 -Generalrequirements

Updatesrequired:

?Documentation

?Increasedregulatoryandriskbasedapproach;

?Outsourcedprocesses;

?Changemanagement;

?Validationofsoftware.

ALL

Clause4.2 -Documentation

requirements

Updatesrequired:

?Clauses6,7and8;

?Medicaldevicefile;

?Controlsrelatedtodocumentand recordamendment,

securityandintegrity

Clause5-ManagementResponsibility

?Increasedfocusonregulatoryrequirements;

?Documentedproceduresformanagementreview;documentedplannedintervals

Evideneeof:Clause6.2 -Human

resources

Updatesrequired:

?Documentedprocessesforcompetenee,awarenessandraining?Riskbasedtrainingeffectiveness

Evideneeof:Clause6.3 -

nfrastructure

Updatesrequired:

?Processesforpreventingproductmix-up;

?Informationsystemsinfrastructure;?Maintenanceintervalsforproductionormonitoringequipment.

Evideneeof:Clause6.4 -Work

environment

Updatesrequired:

?Documentationrequirementsforworkenvironment;

?Contaminationcontrolsforsterile

medicaldevices.

Evideneeof:Clause7.1 -Planning

ofproductrealization

Updatesrequired;

?Processesforriskmanagement;

?Requirementsforstorage,handling,distributionandtraceability.

Evideneeof:Clause7.2 -Customer

relatedprocesses

Updatesrequired:

?Requirementandavailability foranyusertraining;

?Documentedprocessesforcommunicatingwithstakeholders,includingregulatoryauthorities.

Clause7.3~-Designanddevelopment

Updatesrequired:

?Traceabilityofdesigninputstooutputs;

?Requiredresources,includingcompeteneeof

personnelinvolvedindesignprojects;

?Additionaldetailsanddocumentationforverificationandvalidationplans,includingstatisticaltechniques,samplingrationaleandrepresentativeproductandrecords;

?Documentedproceduresfordesigntransferanddesignchange;

?Designanddevelopmentfiles.

Clause7.4 -Purchasing

Updatesrequired:

?Increasedfocusonsuppliermonitoringandrisk;

?Documentedagreementsforpriornotificationofchangestosuppliedproduct;

?Linkagebetweenverificationofpurchasedproductandchangecontrol.

Evideneeof:Clause7.5 -Production

andserviceprovision

Updatesrequired:

?Qualificationofinfrastructure;

?Analysisofservicerecords;

?Documentedproceduresforvalidationincludingstatisticaltechniques,samplingrationale,

revalidation;

?Validationrequirementsforprocessesthatcannot

orarenotsubsequentlymonitored;

?Proceduresforriskbasedsoftwarevalidation;

?Documentedprocedureforproduct

identification/status duringproduction; thismaybe

UniqueDeviceIdentification(uDl),

?Validationofsterilebarriersystems;?

Suitabilityofpackagingsystems;

?Recordingofmeasuringequipmentadjustments.

Evideneeof::Clause8 -

Measurement,analysisandimprovement

Clause8.2-Monitoringandmeasuring

Updatesrequired:

?Linkagesfromcustomerfeedbackintoriskmanagement;

?Documentedprocessesforascertainingwhethercustomerrequirementshavebeenmet;

?Proceduresforcomplainthandling;

?Processesforinformingthirdpartiesof

complaints;

?Plansforinternalauditsatdefinedintervals;

?Processesfortheidentification oftestequipment.

Clause8.3 -Controlofnon

conformingproductUpdatesrequired:

?Processesforcommunicationwithexternalpartiesregardingnonconformingproduct;

?Controlsformanagingconcessions;?Linkagesbetweenreworkandregulatoryrequirements.

Question/Requirement

LevelofCompletion o

二NotStarted10二

Completed&Implemented

QMS

ProcessRelatedtoRequirement(Process

Name)

Planned

Completion

Date

Responsibility

RefereneeDocument(Name/Rev.Level)

ORRecords

NSF-ISRLeadAuditorReviewComments

:Clause8.4~-AnalysisofdataUpdatesrequired:?Sourcesofdataforanalysis,suchasservicerecordsandaudits;

?Proceduresthatcovertheapplicationofstatisticaltechniques;

?Linkagesbetweentheanalysisandimprovementprocesses.

:Clause8.5~-lmprovement

Updatesrequired:

?Actionsaretakenwithoutunduedelay;

?Evaluationofactionsforadverseeffectsonregulatoryrequirementsandproductsafetyandperformanee.

OrganizationconfirmationthattheQMSnowcomplieswithallre