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SG4N28R4.docx

SG4N28R4

GHTF/SG4/N28R4:

2008

FINALDOCUMENT

Title:

GuidelinesforRegulatoryAuditingof

QualityManagementSystemsofMedical

DeviceManufacturers–

Part1:

GeneralRequirements

AuthoringGroup:

GHTFStudyGroup4

Endorsedby:

TheGlobalHarmonizationTaskForce

Date:

August27,2008

Dr.RolandRotter,GHTFChair

ThedocumenthereinwasproducedbytheGlobalHarmonizationTaskForce,whichiscomprisedofrepresentativesfrommedicaldeviceregulatoryagenciesandtheregulatedindustry.Thedocumentisintendedtoprovidenon-bindingguidanceforuseintheregulationofmedicaldevices,andhasbeensubjecttoconsultationthroughoutitsdevelopment.

Therearenorestrictionsonthereproduction,distributionoruseofthisdocument;however,incorporationofthisdocument,inpartorinwhole,intoanyotherdocument,oritstranslationintolanguagesotherthanEnglish,doesnotconveyorrepresentanendorsementofanykindbytheGlobalHarmonizationTaskForce.

TableofContents

Preface4

1.0Introduction5

2.0Scope5

3.0Purpose5

4.0Rationale6

5.0References6

6.0Definitions6

7.0Generalrequirementsforauditingorganizations10

7.1Legalresponsibility10

7.2Independenceandimpartiality10

7.2.1Managementofimpartiality11

7.3Confidentiality,dueprofessionalcareandcodeofethics11

7.3.1Managementofconfidentiality11

7.4Liabilityandfinancing11

8.0Management12

8.1Structuralrequirements12

8.2Qualitymanagementsystem12

8.3Consistency12

9.0Resources12

9.1Resources12

9.2Auditteamcompetence13

9.2.1Auditteamcompetencecriteria13

9.2.2Auditteamcompetencerecords14

9.2.3Auditorqualifications,trainingandexperience14

9.3Outsourcing15

10.0AuditProcess15

10.1Auditobjectivesandscope15

10.1.1Auditobjectives15

10.1.2Auditscope16

10.2Typesofaudits16

10.2.1Fullaudit16

10.2.2Partialaudit16

10.2.3Surveillanceaudit17

10.2.4Specialaudit17

10.2.5Combinedaudit19

10.2.6Jointaudit19

10.3FlowChart19

10.4Roles,responsibilitiesandauthorities21

10.4.1Auditingorganization21

10.4.2Auditors22

10.4.3Leadauditor23

10.4.4Auditees24

10.4.5Observers25

10.4.6Languagerequirements25

10.5Auditteamcomposition26

10.6Auditactivities26

10.6.1Notification26

10.6.2Preparation27

10.6.3Auditexecution29

10.6.4Auditreport34

10.6.5Auditcompletion35

10.6.6Retentionofauditrecords35

10.7Adequacyofauditdocumentation35

10.8Follow-upactivities36

Preface

ThisdocumentwasproducedbytheGlobalHarmonizationTaskForce,avoluntarygroupofrepresentativesfrommedicaldeviceregulatoryagenciesandtheregulatedindustry.Thedocumentisintendedtoprovidenonbindingguidanceforuseintheregulationofmedicaldevices,andhasbeensubjecttoconsultationthroughoutitsdevelopment.

1.0

Introduction

Thisdocumentgivesguidancetoregulatorsandauditingorganizationsconductingauditsofqualitymanagementsystemsofmedicaldevicemanufacturersbasedontheprocessapproachtoqualitymanagementsystemrequirements（e.g.,ISO13485:

2003and21CFRPart820）.

Theincorporationofqualitymanagementsystemrequirements,basedonISO13485,intoregulationsapplicabletomanufacturersofmedicaldevices,providestheopportunityfordevelopingmechanismsthatwouldleadtoglobalharmonization.Regulatorscanusetheseguidelineswhenintroducingregulatorysystemsformedicaldevices.

Note:

Forthepurposeoftheseguidelines,“audit”meansaregulatoryaudit.

Potentialbenefitsforthepatients/users,regulators,auditingorganizationsorauditeesinclude:

∙ahighdegreeofassurance（alongwithtechnicalevaluation,whererequiredinaddition）thatsafeandeffectivedeviceswillbeavailable

∙independent,reliable,objectiveevaluationofcompliancewithregulatoryrequirementsofthemanufacturer'squalitymanagementsystem

∙ifsatisfactory,resultsareevidence（orpartthereof）ofcompliancewithregulatoryrequirementsnecessarytomarketdevices

Inthisdocumenttheterms“compliance”and“conformity”areusedinterchangeablywhereasinsomejurisdictionstheymayhavedistinctanddifferentmeanings.

Theauditingofamedicaldevicemanufacturer'squalitymanagementsystemmayrepresentonlyonepartoftheconformityassessmentprocedurerequiredbytheapplicableregulations.

2.0Scope

Thisdocumentprovidesguidanceforauditingorganizationsresponsibleforestablishing,planning,carryingout,anddocumentingauditsofmedicaldevicemanufacturers’qualitymanagementsystems.Thedocumentalsocoversrelatedrequirementsonthefollow-upofcorrections,corrective,preventive,orimprovementactions,asapplicable.Inaddition,itdescribesthecompetencecriteriathattheauditteamshouldmeet.

3.0Purpose

Thepurposesofthisdocumentare:

∙Toharmonizeandtoprovideguidanceonauditingqualitymanagementsystemsofmedicaldevicemanufacturers

∙Tohelptheauditingorganizationdeveloptheirauditingprocedures

∙Toassistauditorsandauditeesinpreparingfor,facilitatingandrespondingtoaudits

4.0Rationale

Thisguidelinepromotesconsistencyinauditingofmedicaldevicemanufacturers’qualitymanagementsystemswhichisimportantinharmonizationandmutualacceptanceofauditresults.

5.0References

GHTF/SG4/N30R20:

2006GuidelinesforRegulatoryAuditingofQualityManagementSystemsofMedicalDeviceManufacturers–Part2:

RegulatoryAuditingStrategy

GHTF/SG4/N33R14:

2007GuidelinesforRegulatoryAuditingofQualityManagementSystemsofMedicalDeviceManufacturers–Part3:

RegulatoryAuditReports

GHTF/SG4（00）3TrainingRequirementsforAuditors

ISO13485:

2003Medicaldevices-Qualitymanagementsystems–Requirementsforregulatorypurposes

ISO17000:

2004Conformityassessment-Vocabularyandgeneralprinciples

ISO/IEC17021:

2006Conformityassessment–Requirementsforbodiesprovidingauditandcertificationofmanagementsystems

ISO19011:

2002Guidelinesforqualityand/orenvironmentalmanagementsystemsauditing

ISO9000:

2005Qualitymanagementsystems–Fundamentalsandvocabulary

6.0Definitions

6.1Audit

Systematic,independent,documentedprocessforobtainingrecords,statementsoffactorotherrelevantinformationandassessingthemobjectivelytodeterminetheextenttowhichspecifiedrequirementsarefulfilled.

ISO17000:

20044.4

Forthepurposeoftheseguidelines,"audit"meansauditoftheauditee’squalitymanagementsystemtodeterminecompliancewiththerelevantregulatoryrequirements.

6.2AuditCriteria

Setofpolicies,procedures,orrequirements.

Note:

Auditcriteriaareusedasareferenceagainstwhichauditevidence（3.9.4）iscompared.

ISO9000:

20053.9.3

6.3AuditEvidence

Records,statementsoffactorotherinformation,whicharerelevanttotheauditcriteriaandverifiable.

Note:

Auditevidencemaybequalitativeand/orquantitativeandisusedtosubstantiateauditobservations.

ISO9000:

20053.9.4

6.4Auditfindings

Resultsoftheevaluationofthecollectedauditevidenceagainstauditcriteria.

Note:

Auditfindingscanindicateeitherconformityornonconformitywithauditcriteriaoropportunitiesforimprovement.

ISO9000:

20053.9.5

6.5Auditlanguage

Thelanguage（s）routinelyusedforthecommunicationorexchangeofinformationbetweenauditee’spersonnelandauditors.

6.6Auditprogram

Setofoneormoreauditsplannedforaspecifictimeframeanddirectedtowardsaspecificpurpose.

Note:

Anauditprogramincludesallactivitiesnecessaryforplanning,organizingandconductingtheaudits.

ISO9000:

20053.9.2

6.7Auditee

Anyorganizationwhosequalitymanagementsystemistobeauditedforcompliancewithrelevantmedicaldeviceregulatoryrequirements.Theorganizationmaybethemanufacturerand/ortheirsupplier（s）.

Note:

ISO9000:

20053.9.8definesauditeeas“organizationbeingaudited”.

6.8Auditingorganization

Abodydesignated,onthebasisofspecificregulations,tocarryoutauditsaccordingtoassignedtasks.

Note:

ISO17000:

20042.5definesthetermconformityassessmentbodyas“bodythatperformsconformityassessmentservices”.

6.9Auditor

Apersonwithrelevantqualificationsandcompetencetoperformauditsorspecifiedpartsofsuchauditsandwhobelongsto,orisauthorizedby,theauditingorganization.

Note:

ISO9000:

20053.9.9definesauditoras“personwiththedemonstratedpersonalattributesandcompetencetoconductanaudit”.

6.10Compliance

Overallconformitytoregulatoryrequirements.

6.11Conformity

Fulfillmentofarequirement.

ISO9000:

20053.6.1

6.12Establish

Establishmeansdefine,document（inwritingorelectronically）,andimplement.

Note:

Thisdefinitiondiffersfromtheusageoftheword“establish”inISO13485:

2003inthattheISO13485:

2003termisnotdefinedandislessprescriptive.

6.13Leadauditor

Anauditorappointedtomanageanaudit

SeeISO9000:

20053.9.10Note1

6.14Manufacturer

Anynaturalorlegalpersonwhodesignsand/ormanufacturesamedicaldevicewiththeintentionofmakingthefinishedmedicaldeviceavailableforuse,underhisname;whetherornotsuchamedicaldeviceisdesignedand/ormanufacturedbythatpersonhimselforonhisbehalfbyathirdparty（ies）.

SG1（PD）/N055R6

Note:

InsomeinternationallyrecognizedStandardsandGuidelinesonauditing,specificresponsibilitie

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