We are very pleased to announce the fully positive result for the certification audit as per requirements of the International Standard ISO 13485: 2016 “Medical devices — Quality management systems — Requirements for regulatory purposes”.
The audit was provided by the well-known and internationally recognized Certification and Notified Body BSI (British Standards Institution) in the Bomi Group Russia facility.
This audit was successfully passed as a result of the constant effort and great work of the Russian team, and underlines our commitment to bring high-quality standards to the Russian Healthcare Industry and increases the quality level of the services.
Teresa Perry, Global Quality and Accreditation Manager, BS comments: “Successfully certified organizations can demonstrate the effective interconnectivity of their processes. It is essential to be able to demonstrate how outputs from complaints, for example, feed into management review, improvement processes, Technical Documentation and risk management updates, to name a few.”
This represents a crucial step in Bomi Group’s growth strategy in Russia. Less than a year ago the new warehouse was inaugurated close to Sheremetyevo Airport, in Industrial park Sherizon-Nord (Moscow Region). With a total area of 3,400 m² with ambient temperature and +2+8°C dedicated rooms, the Sheremetyevo Warehouse is a crucial junction for the transport network, considering its strategic position close to Moscow, and close to MKAD and A-107/M11 highways, and thanks also to our extensive distribution network of Bomi Health Carrier we are able to offer better quality and speed of transport service in the regions and Moscow Distribution area and rest of the country.
Therefore, we would like to thank our valuable Clients for their confidence and loyalty and express our gratitude for their continuous support at the time of the preparation for this certification audit and during the audit itself!