Supplier/Service Qualification Assessment Supplier/Service Provider Name* Supply or Service Description* Reagents Materials Equipment Service Blood Product Software ISBT Number (If Blood Product Supplier) Address* Street Address Address Line 2 City State / Province / Region ZIP / Postal Code AfghanistanAlbaniaAlgeriaAmerican SamoaAndorraAngolaAnguillaAntarcticaAntigua and BarbudaArgentinaArmeniaArubaAustraliaAustriaAzerbaijanBahamasBahrainBangladeshBarbadosBelarusBelgiumBelizeBeninBermudaBhutanBoliviaBonaire, Sint Eustatius and SabaBosnia and HerzegovinaBotswanaBouvet IslandBrazilBritish Indian Ocean TerritoryBrunei DarussalamBulgariaBurkina FasoBurundiCabo VerdeCambodiaCameroonCanadaCayman IslandsCentral African RepublicChadChileChinaChristmas IslandCocos IslandsColombiaComorosCongoCongo, Democratic Republic of theCook IslandsCosta RicaCroatiaCubaCuraçaoCyprusCzechiaCôte d'IvoireDenmarkDjiboutiDominicaDominican RepublicEcuadorEgyptEl SalvadorEquatorial GuineaEritreaEstoniaEswatiniEthiopiaFalkland IslandsFaroe IslandsFijiFinlandFranceFrench GuianaFrench PolynesiaFrench Southern TerritoriesGabonGambiaGeorgiaGermanyGhanaGibraltarGreeceGreenlandGrenadaGuadeloupeGuamGuatemalaGuernseyGuineaGuinea-BissauGuyanaHaitiHeard Island and McDonald IslandsHoly SeeHondurasHong KongHungaryIcelandIndiaIndonesiaIranIraqIrelandIsle of ManIsraelItalyJamaicaJapanJerseyJordanKazakhstanKenyaKiribatiKorea, Democratic People's Republic ofKorea, Republic ofKuwaitKyrgyzstanLao People's Democratic RepublicLatviaLebanonLesothoLiberiaLibyaLiechtensteinLithuaniaLuxembourgMacaoMadagascarMalawiMalaysiaMaldivesMaliMaltaMarshall IslandsMartiniqueMauritaniaMauritiusMayotteMexicoMicronesiaMoldovaMonacoMongoliaMontenegroMontserratMoroccoMozambiqueMyanmarNamibiaNauruNepalNetherlandsNew CaledoniaNew ZealandNicaraguaNigerNigeriaNiueNorfolk IslandNorth MacedoniaNorthern Mariana IslandsNorwayOmanPakistanPalauPalestine, State ofPanamaPapua New GuineaParaguayPeruPhilippinesPitcairnPolandPortugalPuerto RicoQatarRomaniaRussian FederationRwandaRéunionSaint BarthélemySaint Helena, Ascension and Tristan da CunhaSaint Kitts and NevisSaint LuciaSaint MartinSaint Pierre and MiquelonSaint Vincent and the GrenadinesSamoaSan MarinoSao Tome and PrincipeSaudi ArabiaSenegalSerbiaSeychellesSierra LeoneSingaporeSint MaartenSlovakiaSloveniaSolomon IslandsSomaliaSouth AfricaSouth Georgia and the South Sandwich IslandsSouth SudanSpainSri LankaSudanSurinameSvalbard and Jan MayenSwedenSwitzerlandSyria Arab RepublicTaiwanTajikistanTanzania, the United Republic ofThailandTimor-LesteTogoTokelauTongaTrinidad and TobagoTunisiaTurkmenistanTurks and Caicos IslandsTuvaluTürkiyeUS Minor Outlying IslandsUgandaUkraineUnited Arab EmiratesUnited KingdomUnited StatesUruguayUzbekistanVanuatuVenezuelaViet NamVirgin Islands, BritishVirgin Islands, U.S.Wallis and FutunaWestern SaharaYemenZambiaZimbabweÅland Islands Country Phone*FaxContact Email* Tax ID# Website Information Provided By* First Last Title Does your organization have a current, reviewed and approved Quality Policy or Plan? If Yes, please provide a copy.* Yes No N.A. Upload Quality Plan/PolicyAccepted file types: pdf, Max. file size: 2 MB.Is your organization International Organization for Standardization (ISO) certified or are plans for certification in process? If yes, please upload a copy of certificate.* Yes No N.A. ISO CertificateAccepted file types: pdf, Max. file size: 2 MB.Does your organization utilize National Institute Standards and Technology (NIST) certified products to ensure exacting requirements for equipment and process validation? Yes No N.A. Is your organization FDA licensed?* Yes No N.A. FDA License Number Date of Most Recent Inspection MM slash DD slash YYYY Does your organization hold other certifications or licenses in addition to those listed above? If yes, please provide documentation (eg, AABB, CLIA, etc).* Yes No N.A. Upload Other Certifications Drop files here or Select files Accepted file types: pdf, Max. file size: 2 MB. Did the regulatory or accrediting agency(s) note any non-conformity(s) during their most recent on-site inspection(s), e.g. FDA 483 or AABB non-conformity(s), etc.?* Yes No N.A. Was the Corrective and Preventive Action(S) accepted by the regulatory/accrediting agency(s)?* Yes No N.A. If no, please explain Does your organization have minimum job requirements and formalized job-related training programs for each employee job description?* Yes No N.A. Does your organization have a product problem/recall notification protocol and, if asked, could you provide a copy of that policy/procedure in a timely manner?* Yes No N.A. Does your organization have a formal change control process?* Yes No N.A. Does your organization provide Certificates of Analysis with products?* Yes No N.A. Does your organization have an insurance certificate, state or local license, or other required documents to conduct business? If Yes, please provide documentation.* Yes No N.A. Other documents (insurance, license, etc.) Drop files here or Select files Max. file size: 2 MB. Does your organization have a Disaster/Emergency Operations Plan?* Yes No N.A. Will your organization allow CBCO to perform a site visit as deemed appropriate by CBCO?* Yes No N.A.
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