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iso 13485 training

ISO 13485 is the ISO standard that specifies requirements for a comprehensive quality management system for manufacturers of medical devices. ISO 13485:2016 was published by ISO on January 1, 2016. Any firm involved in the design, production, installation, or servicing of medical equipment can benefit from ISO 13485 training courses to better understand and apply quality management requirements.<br><br>

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iso 13485 training

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  1. ISO13485Certification WhatisISO13485? ISO13485isaqualitymanagementsystemstandardthatisspecifictothemedical deviceindustry.Ithelpsmanufacturerscreateproductsthataresafeandeffectivefor patients.ToreceiveISO13485certification,acompanymustdemonstratethatithasa comprehensivequalitymanagementsysteminplace.Thissystemincludesprocesses forthedesign,development,production,installation,andservicingofmedicaldevices. Importance ISO13485certificationisofutmostimportanceformedicaldevicecompanies.Ithelps toensurethatproductsaresafeandreliableforpatients.Byobtainingthiscertification, companiesdemonstratetheircommitmenttoqualityandpatientsafety.Thecertification alsohelpscompaniestomeetregulatoryrequirementsindifferentcountries.Itisa globallyrecognizedstandardthatcanhelpcompaniestoexpandtheirbusinessintonew markets.Inaddition,itcanhelpcompaniestoimprovetheiroperationsandachieve betterperformance. Benefits ●Itdemonstratesthatyourmedicaldevicemanufacturingprocessesarecompliant withtherigorousqualitymanagementsystemrequirementsofISO13485. ●Itconfirmsthatyourorganizationhasthenecessaryresourcesandsystemsin placetoproducesafeandeffectivemedicaldevices. ●Itprovidesaframeworkforthecontinualimprovementofyourmedicaldevice manufacturingprocesses. ●Itdemonstratesyourcommitmenttoqualityandpatientsafety. ●Itdemonstratesthatyouareareliablesupplierofmedicaldevices. ●Itenhancesyourcompany'simageandreputationinthemedicaldeviceindustry. WhichOrganizationsCanApply? ISO13485isdesignedfororganizationsthatdesign,develop,manufacture,install,or servicemedicaldevices.Thisincludesmedicaldevicemanufacturers,suppliersof medicaldevicecomponentsandaccessories,andcontractmanufacturers.Itdoesnot applytocompaniesthatonlydistributemedicaldevices. HowtoGetISO13485Certified? Thefirststepistoassessyourorganization'sreadinessforcertification.Thisinvolves completinganISO13485GapAnalysistoidentifyanyareaswhereyourquality

  2. managementsystemneedsimprovement.Onceyouhaveaddressedthesegaps,youmanagementsystemneedsimprovement.Onceyouhaveaddressedthesegaps,you canapplyforcertification. Thecertificationprocessinvolvessubmittingacompletedapplicationandsupporting documentationtoanaccreditedcertificationbody.Thebodywillthenevaluateyour organizationagainsttherequirementsofISO13485.Ifyoumeettheserequirements, thebodywillawardyoucertification. Conclusion iso13485trainingisagloballyrecognizedstandardthathelpsmedicaldevice companiestoimprovetheiroperationsandachievebetterperformance.Itconfirmsthat yourorganizationhasthenecessaryresourcesandsystemsinplacetoproducesafe andeffectivemedicaldevices.Toreceivethecertification,acompanymust demonstratethatithasacomprehensivequalitymanagementsysteminplace,and shouldmeetallthenecessarycertificationrequirements.

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