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ISOISO 13485:200313485:2003 RichardRichard RushRush QualityQuality ManagementManagement ConsultingConsulting
ISOISO 13485:200313485:2003
RichardRichard RushRush
QualityQuality ManagementManagement ConsultingConsulting
www.qualitymanagementconsulting.com
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ManagementManagement ConsultingConsulting
ObjectivesObjectives DiscussDiscuss EuropeanEuropean regulatoryregulatory schemescheme
ObjectivesObjectives
DiscussDiscuss EuropeanEuropean regulatoryregulatory schemescheme
Background/historyBackground/history ofof ISOISO 1348513485
CompareCompare andand contrastcontrast 90019001 andand 1348513485
IdentifyIdentify implementationimplementation challengeschallenges forfor
ISOISO 1348513485
AnswerAnswer youryour questionsquestions
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TheThe EuropeanEuropean RegulatoryRegulatory SchemeScheme MedicalMedical DeviceDevice DirectiveDirective isis thethe
TheThe EuropeanEuropean RegulatoryRegulatory SchemeScheme
MedicalMedical DeviceDevice DirectiveDirective isis thethe EuropeanEuropean
parliamentparliament’’ss legallegal objectivesobjectives whichwhich areare agreedagreed toto
andand transposedtransposed intointo nationalnational law.law.
TheThe DirectivesDirectives harmonizeharmonize controlscontrols onon productproduct
designdesign andand safetysafety requirementsrequirements throughoutthroughout
Europe.Europe.
YouYou cancan downloaddownload directivesdirectives freefree ofof chargecharge fromfrom
thethe EuropeanEuropean UnionUnion website.website.
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TheThe EuropeanEuropean RegulatoryRegulatory SchemeScheme CompetentCompetent AuthorityAuthority –– thethe
TheThe EuropeanEuropean RegulatoryRegulatory SchemeScheme
CompetentCompetent AuthorityAuthority –– thethe administrativeadministrative
agencyagency withinwithin aa EuropeanEuropean countrycountry asas
designateddesignated inin thatthat countrycountry’’ss nationalnational lawlaw
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TheThe EuropeanEuropean RegulatoryRegulatory SchemeScheme NotifiedNotified BodyBody –– aa
TheThe EuropeanEuropean RegulatoryRegulatory SchemeScheme
NotifiedNotified BodyBody –– aa governmentgovernment--sanctionedsanctioned
agencyagency inin aa membermember statestate ofof thethe EuropeanEuropean
UnionUnion thatthat carriescarries outout conformityconformity assessmentassessment
proceduresprocedures forfor medicalmedical devices.devices.
TheThe NotifiedNotified BodyBody providesprovides servicesservices forfor
conformityconformity assessmentassessment ofof thethe qualityquality systemsystem andand
toto thethe essentialessential requirementsrequirements listedlisted inin thethe
medicalmedical devicedevice directive.directive.
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TheThe EuropeanEuropean RegulatoryRegulatory SchemeScheme TheThe NotifiedNotified BodyBody maymay bebe utilizedutilized
TheThe EuropeanEuropean RegulatoryRegulatory SchemeScheme
TheThe NotifiedNotified BodyBody maymay bebe utilizedutilized toto certifycertify thethe
qualityquality systemsystem toto ISOISO 1348513485
TheThe NotifiedNotified BodyBody maymay bebe requiredrequired toto reviewreview
TechnicalTechnical FileFile documentation,documentation, toto assureassure
conformanceconformance withwith ““essentialessential requirementsrequirements”” fromfrom
thethe directivesdirectives
Ultimately,Ultimately, thethe notifiednotified bodybody certifiescertifies thethe
applicationapplication ofof thethe CECE MarkMark forfor classclass 22 andand 33
devicesdevices
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TheThe EuropeanEuropean RegulatoryRegulatory SchemeScheme TheThe NotifiedNotified BodyBody isis regulatedregulated
TheThe EuropeanEuropean RegulatoryRegulatory SchemeScheme
TheThe NotifiedNotified BodyBody isis regulatedregulated andand
overseenoverseen byby thethe CompetentCompetent AuthorityAuthority
DecisionsDecisions mademade byby thethe notifiednotified bodybody areare
recognizedrecognized byby allall EuropeanEuropean countriescountries
CertainCertain requirementsrequirements maymay bebe additionallyadditionally
placedplaced byby otherother countriescountries (e.g.,(e.g., nationalnational
languagelanguage requirementsrequirements forfor labels,labels,
reportingreporting adverseadverse events)events)
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TheThe MedicalMedical DeviceDevice QualityQuality SystemSystem StandardStandard FormerlyFormerly ENEN 4600146001
TheThe MedicalMedical DeviceDevice QualityQuality SystemSystem
StandardStandard
FormerlyFormerly ENEN 4600146001
LaterLater ISOISO 13485:199613485:1996
CurrentlyCurrently ISOISO 13485:200313485:2003
FullFull QualityQuality AssuranceAssurance isis oneone routeroute toto aa CECE
MarkMark
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ProcedureProcedure RequirementsRequirements ISOISO 9001:19949001:1994 ISOISO 13485:199613485:1996 ISOISO
ProcedureProcedure RequirementsRequirements
ISOISO 9001:19949001:1994
ISOISO 13485:199613485:1996
ISOISO 9001:20009001:2000
ISOISO 13485:200313485:2003
2121 CFRCFR PartPart 820820 (QSR)(QSR)
1818
1818
66
1717
3636
Source:Source: MedicalMedical ProductProduct OutsourcingOutsourcing MagazineMagazine -- Mar/AprMar/Apr 20042004
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DifferencesDifferences fromfrom ISOISO 9001:20009001:2000 1348513485 doesdoes notnot requirerequire continualcontinual
DifferencesDifferences fromfrom ISOISO 9001:20009001:2000
1348513485 doesdoes notnot requirerequire continualcontinual
improvementimprovement oror customercustomer satisfaction,satisfaction, butbut
ratherrather maintainingmaintaining themthem (4.1)(4.1)
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DifferencesDifferences fromfrom ISOISO 9001:20009001:2000 MedicalMedical devicedevice companiescompanies mustmust
DifferencesDifferences fromfrom ISOISO 9001:20009001:2000
MedicalMedical devicedevice companiescompanies mustmust alsoalso
complycomply withwith locallocal andand nationalnational
requirementsrequirements (4.2)(4.2) andand commitcommit toto
regulatoryregulatory compliancecompliance (5.3)(5.3)
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DifferencesDifferences fromfrom ISOISO 9001:20009001:2000 MoreMore prescriptiveprescriptive requirementsrequirements
DifferencesDifferences fromfrom ISOISO 9001:20009001:2000
MoreMore prescriptiveprescriptive requirementsrequirements forfor
documenteddocumented proceduresprocedures andand recordsrecords
retentionretention
AlignAlign moremore closelyclosely toto FDAFDA’’ss QualityQuality SystemSystem
RegulationRegulation (21(21 CFRCFR 820)820)
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DifferencesDifferences fromfrom ISOISO 9001:20009001:2000 AdditionalAdditional requirementsrequirements forfor
DifferencesDifferences fromfrom ISOISO 9001:20009001:2000
AdditionalAdditional requirementsrequirements forfor sterilesterile andand
implantedimplanted devices,devices, forfor exampleexample
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AdditionalAdditional DocumentationDocumentation ResponsibilitiesResponsibilities andand authoritiesauthorities
AdditionalAdditional DocumentationDocumentation
ResponsibilitiesResponsibilities andand authoritiesauthorities
TrainingTraining proceduresprocedures
Health,Health, cleanliness,cleanliness, andand
clothingclothing
EnvironmentalEnvironmental conditionsconditions
MaintenanceMaintenance
ControlControl ofof contaminatedcontaminated
productsproducts
RiskRisk managementmanagement
CustomerCustomer requirementsrequirements
DesignDesign andand developmentdevelopment
PurchasingPurchasing controlcontrol
LabelingLabeling andand packagingpackaging
InstallationInstallation andand verificationverification
ProcessProcess andand sterilizationsterilization
validationvalidation
IdentificationIdentification
PreservationPreservation ofof productproduct (shelf(shelf
life)life)
FeedbackFeedback andand
AnalysisAnalysis ofof datadata
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ChangesChanges fromfrom ISOISO 13485:199613485:1996 RestructuredRestructured similarsimilar toto ISOISO 90019001
ChangesChanges fromfrom ISOISO 13485:199613485:1996
RestructuredRestructured similarsimilar toto ISOISO 90019001
FollowsFollows thethe processprocess approachapproach
AllowsAllows exclusionsexclusions andand nonnon--applicationapplication forfor
areasareas wherewhere permittedpermitted
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ImplementationImplementation ChallengesChallenges
ImplementationImplementation ChallengesChallenges
Exclusions/nonExclusions/non--application/justificationsapplication/justifications
oftenoften missedmissed
DesignDesign controlcontrol maymay bebe excludedexcluded
ProcessesProcesses thatthat dodo notnot applyapply mustmust bebe justifiedjustified
inin thethe QualityQuality ManualManual
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ImplementationImplementation ChallengesChallenges ProcessProcess approachapproach andand thethe descriptiondescription
ImplementationImplementation ChallengesChallenges
ProcessProcess approachapproach andand thethe descriptiondescription ofof
processesprocesses inin thethe QualityQuality ManualManual isis notnot wellwell
understoodunderstood
NotNot PlanPlan--DoDo--CheckCheck--ActAct
DescribeDescribe keykey businessbusiness activitiesactivities whichwhich addadd
valuevalue
InvolveInvolve inputsinputs andand outputsoutputs thatthat feedfeed toto andand
fromfrom otherother processesprocesses
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ImplementationImplementation ChallengesChallenges AuditsAudits notnot performedperformed usingusing processprocess
ImplementationImplementation ChallengesChallenges
AuditsAudits notnot performedperformed usingusing processprocess modelmodel
AuditorsAuditors notnot wellwell--trainedtrained
BusinessBusiness processesprocesses notnot wellwell--defineddefined
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ImplementationImplementation ChallengesChallenges ObjectivesObjectives tiedtied toto thethe QualityQuality PolicyPolicy
ImplementationImplementation ChallengesChallenges
ObjectivesObjectives tiedtied toto thethe QualityQuality PolicyPolicy havehave
notnot beenbeen determineddetermined
QualityQuality policiespolicies maymay notnot lendlend themselvesthemselves toto
tangibletangible objectivesobjectives
Appropriate,Appropriate, measurablemeasurable andand timetime--basedbased
ImplementationImplementation plansplans
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ImplementationImplementation ChallengesChallenges RiskRisk managementmanagement hashas notnot beenbeen
ImplementationImplementation ChallengesChallenges
RiskRisk managementmanagement hashas notnot beenbeen establishedestablished oror isis
notnot documenteddocumented throughoutthroughout thethe productproduct
realizationrealization processprocess
DesignDesign controlcontrol
SupplierSupplier selectionselection
NonconformancesNonconformances
ECOsECOs
etc.etc.
ISOISO 1497114971 maymay bebe used;used; notnot requiredrequired
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ImplementationImplementation ChallengesChallenges CAPACAPA processprocess isis weakweak RootRoot causecause
ImplementationImplementation ChallengesChallenges
CAPACAPA processprocess isis weakweak
RootRoot causecause analysisanalysis notnot rigorousrigorous
PoorPoor application/understandingapplication/understanding ofof preventivepreventive
actionaction
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ImplementationImplementation ChallengesChallenges FeedbackFeedback processesprocesses areare tootoo limitedlimited
ImplementationImplementation ChallengesChallenges
FeedbackFeedback processesprocesses areare tootoo limitedlimited
ComplaintsComplaints
ReportableReportable eventsevents
CustomerCustomer surveyssurveys
JournalJournal reviewsreviews
InternetInternet searchessearches
MarketMarket researchresearch
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ImplementationImplementation ChallengesChallenges AnalysisAnalysis ofof datadata isis tootoo limitedlimited
ImplementationImplementation ChallengesChallenges
AnalysisAnalysis ofof datadata isis tootoo limitedlimited
ComplaintComplaint ratesrates
AcceptanceAcceptance ratesrates
ProcessProcess controlscontrols
SupplierSupplier performanceperformance
NotNot allall datadata needneed bebe reviewedreviewed inin thethe
managementmanagement reviewreview
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AA UsefulUseful ResourceResource ISO/TRISO/TR 14969:200414969:2004 –– MedicalMedical devicesdevices ––
AA UsefulUseful ResourceResource
ISO/TRISO/TR 14969:200414969:2004 –– MedicalMedical devicesdevices ––
QualityQuality managementmanagement systemssystems –– GuidanceGuidance
onon thethe applicationapplication ofof ISOISO 13485:200313485:2003
ContainsContains thethe fullfull standardstandard andand discussiondiscussion
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