Quality & certifications

The quality of the products that reach your lab is built twice: by CABRU's certified ISO 9001 quality management system, and by the certified quality systems of the manufacturers we select and represent in Italy.

CABRU's quality system

CABRU s.a.s. operates a quality management system certified to the UNI EN ISO 9001:2015 standard. The system governs supplier selection and qualification, order management, product storage and delivery, and the handling of non-conformities and complaints, and is subject to periodic surveillance audits by the certification body.

The quality of the manufacturers we represent

We don't choose a manufacturer for its catalogue alone: we also assess its quality system. All the manufacturers we represent operate a certified quality management system. Most are ISO 9001 certified; the manufacturers specialised in in-vitro diagnostics are ISO 13485 certified, the quality standard specific to medical devices.

• Cayman ChemicalISO 9001:2015ISO 13485ISO 17025ISO 17034
• A&A BiotechnologyISO 13485:2016
• Affinity BiologicalsISO 13485:2016FDA QSR
• BioatlasISO 9001
• BioMedica DiagnosticsISO 13485 MDSAPIVDR
• BioVendorISO 9001ISO 13485ISO 14001
• Candor Bioscience / Medix BiochemicaISO 9001:2015ISO 13485:2016
• CondalabISO 9001ISO 13485ISO 11133
• Enzyme Research LaboratoriesISO 9001:2015
• ExBioISO 9001:2015ISO 13485cGMP
• FineTestISO 9001:2015
• G BiosciencesISO 9001:2015ISO 13485:2016cGMP
• LDN — Labor Diagnostika NordISO 9001ISO 13485
• MagBio GenomicsISO 9001:2015ISO 13485:2016
• ReliaTechISO 9001:2015
• RovalabISO 9001:2015
• SolabiaISO 9001ISO 14001

Standards taken from each manufacturer's own quality statements. ISO 13485 certifications identify the manufacturers in the diagnostics sector. The “Candor Medix Biochemica” card combines two companies: Candor Bioscience (ISO 9001:2015 and ISO 13485:2016) and Medix Biochemica (ISO 13485). For Solabia, the standards are those of the Limoges plant that produces the BSA, certified ISO 9001 and ISO 14001 when it belonged to Seqens. For the other manufacturers, the current certificate is available on the manufacturer's official website.

What it means for your lab

• Products that come from manufacturers with certified quality systems, selected also for their reliability.
• Batch traceability and technical documentation (e.g. certificates of analysis) available on request.
• Storage and transport compliant with the manufacturer's instructions, cold chain included where required.
• A single point of contact overseeing the whole process, from enquiry to delivery, under CABRU's quality system.
• Structured handling of orders, non-conformities and complaints.