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ISO 13485: la certificazione di qualità per dispositivi medici

BOMI GROUP RECONFIRMS ISO 9001:2015 and ISO 13485:2016 CERTIFICATION

THE CERTIFICATION UPGRADE HAS BEEN SUCCESSFULLY COMPLETED AT GROUP LEVEL

Bomi Group, a leader in the Healthcare logistics sector is happy to announce that the entire group has successfully completed the upgrade to ISO 9001:2015 and ISO 13485:2016 certification awarded by the certifying organisation BSI (British Standard Institution) .

Bomi Group has been ISO 9001 since 1993 and ISO 13485 certified since 2006 and operates in a global quality context in which each procedure is subject to a continuous improvement process and in which all validation and control procedures may be driven by clients, are certified by independent agencies and assume a fundamental role in guaranteeing the integrity and traceability of products, their utilisation and marketing.

Bomi Group’s Quality Management System is certified for the warehousing, administration, distribution and transportation – including temperature-controlled transport – of medical equipment, pharmaceutical, food supplements and general healthcare products including the supply of specialises logistics consultancy and ad-hoc procedures such as re-labelling, re-packaging, kit assembly and management services for consignment stock in hospitals.

The following are specifically guaranteed: full knowledge of and adherence to local regulations, compliance with the HACCP (Hazard Analysis and Critical Control Points) system, management of the “Cold Chain” through a validated process incorporating monitoring of product temperatures at each stage of the distribution chain, a transport network that conforms to GDP (Good Distribution Practice) and UDI (Unique Device Identification) systems to guarantee traceability and transparency.

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