ISOQSR

Preparedby:EdKimmelman,ConsultantE:[e-mail]:5Aug.2003PH:1-302-762-0947Page1FAX:[phone]CorrespondencebetweenISO9001:2000andISO13485:2003andtheUSQualitySystemRegulationCorrespondencebetweenISO9001:2000andISO13485:2003andtheUSQualitySystemRegulationPreparedby:EdKimmelman,ConsultantE:[e-mail]:5Aug.2003PH:1-302-762-0947Page2FAX:[phone]ISO/DIS9001:2000ISO13485:2003U.S.QualitySystemRegulation(21CFR820)Comments1Scope1.1GeneralThisInternationalStandardspecifiesrequirementsforaqualitymanagementsystemwhereanorganizationneedstodemonstrateitsabilitytoconsistentlyprovideproductthatmeetscustomerandapplicableregulatoryrequirements,andaimstoenhancecustomersatisfactionthroughtheeffectiveapplicationofthesystem,includingprocessesforcontinualimprovementofthesystemandtheassuranceofconformitytocustomerandapplicableregulatoryrequirements.NOTEInthisInternationalStandard,theterm“product”appliesonlytotheproductintendedfor,orrequiredby,acustomer.1Scope1.1GeneralThisInternationalStandardspecifiesrequirementsforaqualitymanagementsystemwhereanorganizationneedstodemonstrateitsabilitytoprovidemedicaldevicesandrelatedservicesthatconsistentlymeetcustomerrequirementsandregulatoryrequirementsapplicabletomedicaldevicesandrelatedservices.TheprimaryobjectiveofthisInternationalStandardistofacilitateharmonizedmedicaldeviceregulatoryrequirementsforqualitymanagementsystems.Asaresult,itincludessomeparticularrequirementsformedicaldevicesandexcludessomeoftherequirementsofISO9001thatarenotappropriateasregulatoryrequirements.Becauseoftheseexclusions,organizationswhosequalitymanagementsystemsconformtothisInternationalStandardcannotclaimconformitytoISO9001unlesstheirqualitymanagementsystemsconformtoalltherequirementsofISO9001(seeAnnexB)820.1Scope(a)Applicability.(1)Currentgoodmanufacturingpractice(CGMP)requirementsaresetforthinthisqualitysystemregulation.Therequirementsinthispartgovernthemethodsusedin,andthefacilitiesandcontrolsusedfor,thedesign,manufacture,packaging,labeling,storage,installation,andservicingofallfinisheddevicesintendedforhumanuse.TherequirementsinthispartareintendedtoensurethatfinisheddeviceswillbesafeandeffectiveandotherwiseincompliancewiththeFederalFood,Drug,andCosmeticAct(theact).Thispartestablishesbasicrequirementsapplicabletomanufacturersoffinishedmedicaldevices.…(c)Authority.Part820isestablishedandissuedunderauthorityofsections501,502,510,513,514,515,518,519,520,522,701,704,801,803oftheact(21U.S.C.351,352,360,360c,360d,360e,360h,360i,360j,360l,371,374,381,383).Thefailuretocomplywithanyapplicableprovisioninthispartrendersadeviceadulteratedundersection501(h)oftheact.Suchadevice,aswellasanypersonresponsibleforthefailuretocomply,issubjecttoregulatoryaction.(d)Foreignmanufacturers.IfamanufacturerwhooffersdevicesforimportintotheUnitedStatesrefusestopermitorallowthecompletionofaFoodandDrugAdministration(FDA)inspectionoftheforeignfacilityforthepurposeofdeterminingcompliancewiththispart,itThescopesectionsofeachdocumentsetouttheirobjectives.FortheISO/DIS,theobjectiveistoharmonizeregulationaroundtheworld.AsaresultanattemptwasmadebyFDAduringtherevisionoftheGMPs,whilethe1996versionofISO13485wasbeingdeveloped,toincorporatetherequirementsthatwereincludedinthatversionoftheStandard.WhiletheagencycouldnotrevisetheformatoftheregulationtofollowthatoftheStandard,therequirementswereincluded.ThissectionoftheregulationcontainssomeadditionalregulatoryisssuesthatarenotappropriatefortheStandard.CorrespondencebetweenISO9001:2000andISO13485:2003andtheUSQualitySystemRegulationPreparedby:EdKimmelman,ConsultantE:[e-mail]:5Aug.2003PH:1-302-762-0947Page3FAX:[phone]ISO/DIS9001:2000ISO13485:2003U.S.QualitySystemRegulation(21CFR820)Commentsshallappearforpurposesofsection801(a)oftheact,thatthemethodsusedin,andthefacilitiesandcontrolsusedfor,thedesign,manufacture,packaging,labeling,storage,installation,orservicingofanydevicesproducedatsuchfacilitythatareofferedforimportintotheUnitedStatesdonotconformtotherequirementsofsection520(f)oftheactandthispartandthatthedevicesmanufacturedatthatfacilityareadulteratedundersection501(h)oftheact.(e)Exemptionsorvariances.(1)Anypersonwhowishestopetitionforanexemptionorvariancefromanydevicequalitysystemrequirementissubjecttotherequirementsofsection520(f)(2)oftheact.PetitionsforanexemptionorvarianceshallbesubmittedaccordingtotheproceduressetforthinSec.10.30ofthischapter,theFDA'sadministrativeprocedures.GuidanceisavailablefromtheCenterforDevicesandRadiologicalHealth,DivisionofSmallManufacturersAssistance,(HFZ-220),1350PiccardDr.,Rockville,MD20850,U.S.A.,telephone[phone]or1-301-443-6597,FAX[phone].(2)FDAmayinitiateandgrantavariancefromanydevicequalitysystemrequirementwhentheagencydeterminesthatsuchvarianceisinthebestinterestofthepublichealth.Suchvariancewillremainineffectonlysolongasthereremainsapublichealthneedforthedeviceandthedevicewouldnotlikelybemadesufficientlyavailablewithoutthevariance.CorrespondencebetweenISO9001:2000andISO13485:2003andtheUSQualitySyste