SG4N28R4.docx
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SG4N28R4.docx
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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.
Copyright©2000bytheGlobalHarmonizationTaskForce
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.
Therearenorestrictionsonthereproduction,distributionoruseofthisdocument;however,incorporationofthisdocument,inpartorinwhole,intoanyotherdocument,oritstranslationintolanguagesotherthanEnglish,doesnotconveyorrepresentanendorsementofanykindbytheGlobalHarmonizationTaskForce.
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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