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sertifikasi iso 13485

Memiliki dua dekade pengalaman audit Sertifikasi ISO membantu mencapai sertifikasi lebih cepat.

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sertifikasi iso 13485

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  1. ISO13485Certification • WhatisISO13485? • ISO13485isaqualitymanagementsystemstandardthatisspecifictothemedicaldeviceindustry.Ithelpsmanufacturerscreateproductsthataresafeandeffectiveforpatients.ToreceiveISO13485certification,acompanymustdemonstratethatithasacomprehensivequalitymanagementsysteminplace.Thissystemincludesprocessesforthedesign,development,production,installation,andservicingofmedicaldevices. • Importance • ISO13485certificationisofutmostimportanceformedicaldevicecompanies.Ithelpstoensurethatproductsaresafeandreliableforpatients.Byobtainingthiscertification,companiesdemonstratetheircommitmenttoqualityandpatientsafety.Thecertificationalsohelpscompaniestomeetregulatoryrequirementsindifferentcountries.Itisagloballyrecognizedstandardthatcanhelpcompaniestoexpandtheirbusinessintonewmarkets.Inaddition,itcanhelpcompaniestoimprovetheiroperationsandachievebetterperformance. • Benefits • ItdemonstratesthatyourmedicaldevicemanufacturingprocessesarecompliantwiththerigorousqualitymanagementsystemrequirementsofISO13485. • Itconfirmsthatyourorganizationhasthenecessaryresourcesandsystemsinplacetoproducesafeandeffectivemedicaldevices. • Itprovidesaframeworkforthecontinualimprovementofyourmedicaldevicemanufacturingprocesses. • Itdemonstratesyourcommitmenttoqualityandpatientsafety. • Itdemonstratesthatyouareareliablesupplierofmedicaldevices. • Itenhancesyourcompany'simageandreputationinthemedicaldeviceindustry. • WhichOrganizationsCanApply? • ISO13485isdesignedfororganizationsthatdesign,develop,manufacture,install,orservicemedicaldevices.Thisincludesmedicaldevicemanufacturers,suppliersofmedicaldevicecomponentsandaccessories,andcontractmanufacturers.Itdoesnotapplytocompaniesthatonlydistributemedicaldevices. • HowtoGetISO13485Certified?

  2. Thefirststepistoassessyourorganization'sreadinessforcertification.ThisinvolvescompletinganISO13485GapAnalysistoidentifyanyareaswhereyourqualitymanagementsystemneedsimprovement.Onceyouhaveaddressedthesegaps,youcanapplyforcertification.Thefirststepistoassessyourorganization'sreadinessforcertification.ThisinvolvescompletinganISO13485GapAnalysistoidentifyanyareaswhereyourqualitymanagementsystemneedsimprovement.Onceyouhaveaddressedthesegaps,youcanapplyforcertification. Thecertificationprocessinvolvessubmittingacompletedapplicationandsupportingdocumentationtoanaccreditedcertificationbody.ThebodywillthenevaluateyourorganizationagainsttherequirementsofISO13485.Ifyoumeettheserequirements,thebodywillawardyoucertification. Conclusion ISO13485certificationisagloballyrecognizedstandardthathelpsmedicaldevicecompaniestoimprovetheiroperationsandachievebetterperformance.Itconfirmsthatyourorganizationhasthenecessaryresourcesandsystemsinplacetoproducesafeandeffectivemedicaldevices.Toreceivethecertification,acompanymustdemonstratethatithasacomprehensivequalitymanagementsysteminplace,andshouldmeetallthenecessarycertificationrequirements. Readmore:sertifikasi iso 13485

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