ISO13485内部审核检查表英文版.docx
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ISO13485内部审核检查表英文版.docx
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ISO13485内部审核检查表英文版
ISO13485:
2016PlannerandDeltaChecklist
Instructions:
1.HighlightedareasaretobecompletedbytheClientOrganizationpriortotheoff-sitereview,oron-siteGapAnalysisorUpgradeAudit,andsubmittedtotheNSF-ISRLeadAuditorforreview.
2.TheAnnexA-ISO13485:
2016vs.ISO13485:
2003ComparisonTablehasbeenprovidedattheendofthisdocumentforinformationandreferencepurposesonly.
3.CompletionbytheClientOrganizationshouldincludethefinalstatementofreadinessforUpgradebytheTopManagementoftheClientOrganization.
4.Thecolumnsfor“PlannedCompletionDate”andResponsibility”maybeusedbytheClientOrganizationtodeveloptheirplanforupgradingtheirQMStotherequirementsofISO13485:
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:
ISO13485:
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
Updatesrequired:
•Clauses6,7and8;
•Medicaldevicefile;
•Controlsrelatedtodocumentandrecordamendment,securityandintegrity
Clause5–ManagementResponsibility
•Increasedfocusonregulatoryrequirements;
•Documentedproceduresformanagementreview;documentedplannedintervals
Evidenceof:
Clause6.2–Humanresources
Updatesrequired:
•Documentedprocessesforcompetence,awarenessandtraining
•Riskbasedtrainingeffectiveness
Evidenceof:
Clause6.3–Infrastructure
Updatesrequired:
•Processesforpreventingproductmix-up;
•Informationsystemsinfrastructure;
•Maintenanceintervalsforproductionormonitoringequipment.
Evidenceof:
Clause6.4–Workenvironment
Updatesrequired:
•Documentationrequirementsforworkenvironment;
•Contaminationcontrolsforsterilemedicaldevices.
Evidenceof:
Clause7.1–Planningofproductrealization
Updatesrequired;
•Processesforriskmanagement;
•Requirementsforstorage,handling,distributionandtraceability.
Evidenceof:
Clause7.2–Customerrelatedprocesses
Updatesrequired:
•Requirementandavailabilityforanyusertraining;
•Documentedprocessesforcommunicatingwithstakeholders,includingregulatoryauthorities.
Clause7.3–Designanddevelopment
Updatesrequired:
•Traceabilityofdesigninputstooutputs;
•Requiredresources,includingcompetenceofpersonnelinvolvedindesignprojects;
•Additionaldetailsanddocumentationforverificationandvalidationplans,includingstatisticaltechniques,sampling
rationaleandrepresentativeproductandrecords;
•Documentedproceduresfordesigntransferanddesignchange;
•Designanddevelopmentfiles.
Clause7.4–Purchasing
Updatesrequired:
•Increasedfocusonsuppliermonitoringandrisk;
•Documentedagreementsforpriornotificationofchangestosuppliedproduct;
•Linkagebetweenverificationofpurchasedproductandchangecontrol.
Evidenceof:
Clause7.5–Produc
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