ISO13485内部审核检查表英文版Word文件下载.docx

ISO13485内部审核检查表英文版Word文件下载.docx

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2016.

5.AllotherareasoftheChecklistarerequiredtobecompletedbytheNSF-ISRLeadAuditortoconfirmtheeffectiveimplementationoftheClientOrganization’sISO13485:

2016QualityManagementSystem.

6.TheLeadAuditorshallsigntheappropriatesectionsattheendoftheChecklisttoindicate:

whethertheClientOrganizationisReady/NotReadyforUpgradeAudit（Off-sitereview）,ANDthefinalapprovaloftheQMSinmeetingtherequirementsofISO13485:

2016（duringtheon-siteUpgradeAudit）

7.ThischecklistshallbesubmittedbytheNSF-ISRLeadAuditorasoneoftherecordsoftheISO13485:

2016UpgradefortheClientOrganization.

OrganizationName:

OrganizationAddress:

NumberofPersonnel:

1stShift 

:

2ndShift 

3rdShift 

Temp./Part-time 

Otherlocationsincludedinthisregistration:

ManagementContact:

NameandRevisionStatusofQMSdocumentation:

FRSNumber:

Off-siteReviewDate（DeskAudit）:

AuditDates（on-site）:

LeadAuditor/AuditTeam:

ScopeofRegistration:

2016ClausesthatareNotApplicabletothescopeoftheQMS:

ReferenceISO13485:

2016（E）Medicaldevices—Qualitymanagementsystems—

Requirementsforregulatorypurposes:

Scope,Section1

TheintervalbetweentheclientDeltaReviewandtheUpgradeAuditshouldnotexceed90days.

NOTE:

PleaseensurethatyourOrganization’sregisteredISO13485:

2003QMSremainscompliantwiththatversionoftheStandarduntiltheTransitiontoISO13485:

2016iscompleteandverifiedbytheNSF-ISRLeadAuditor.

Question/Requirement

LevelofCompletion

0=NotStarted

10=Completed&

Implemented

QMSProcessRelatedtoRequirement

（ProcessName）

PlannedCompletionDate

Responsibility

ReferenceDocument

（Name/Rev.Level）

OR

Records

NSF-ISRLeadAuditorReviewComments

QMSDocumentation

Clause4.1–Generalrequirements

Updatesrequired:

•Documentation

•Increasedregulatoryandriskbasedapproach;

•Outsourcedprocesses;

•Changemanagement;

•Validationofsoftware.

ALL

Clause4.2–Documentationrequirements

•Clauses6,7and8;

•Medicaldevicefile;

•Controlsrelatedtodocumentandrecordamendment,securityandintegrity

Clause5–ManagementResponsibility

•Increasedfocusonregulatoryrequirements;

•Documentedproceduresformanagementreview;

documentedplannedintervals

Evidenceof:

Clause6.2–Humanresources

•Documentedprocessesforcompetence,awarenessandtraining

•Riskbasedtrainingeffectiveness

Clause6.3–Infrastructure

•Processesforpreventingproductmix-up;

•Informationsystemsinfrastructure;

•Maintenanceintervalsforproductionormonitoringequipment.

Evidenceof:

Clause6.4–Workenvironment

•Documentationrequirementsforworkenvironment;

•Contaminationcontrolsforsterilemedicaldevices.

Clause7.1–Planningofproductrealization

Updatesrequired;

•Processesforriskmanagement;

•Requirementsforstorage,handling,distributionandtraceability.

Clause7.2–Customerrelatedprocesses

Updatesrequired:

•Requirementandavailabilityforanyusertraining;

•Documentedprocessesforcommunicatingwithstakeholders,includingregulatoryauthorities.

Clause7.3–Designanddevelopment

•Traceabilityofdesigninputstooutputs;

•Requiredresources,includingcompetenceofpersonnelinvolvedindesignprojects;

•Additionaldetailsanddocumentationforverificationandvalidationplans,includingstatisticaltechniques,sampling

rationaleandrepresentativeproductandrecords;

•Documentedproceduresfordesigntransferanddesignchange;

•Designanddevelopmentfiles.

Clause7.4–Purchasing

•Increasedfocusonsuppliermonitoringandrisk;

•Documentedagreementsforpriornotificationofchangestosuppliedproduct;

•Linkagebetweenverificationofpurchasedproductandchangecontrol.

Clause7.5–Produc