Synergene Biotechnology group underwent its ISO 17025 accreditation pre-assessment on 30 March.

The Synergene Biotechnology Group, whose corporate headquarters are located in Malta, is seeking to be ISO accredited within the next few months. Mr Jonathan Farrugia, Synergene’s Quality Manager, said “Achieving this accreditation will make Synergene the only ISO accredited molecular diagnostic laboratory in Malta and only the second lab to be accredited locally, the other being in the field of water testing”.

Synergene has been implementing a Quality system in line with the requirements of MSA IEC ISO 17025:2001. The quality system is made up of a Quality Manual detailing all clauses of ISO 17025, polices and procedures which document and are ancillary to the Quality System.

“The implementation phase is a multi-faceted one involving staff and management alike. It starts from the moment sample/s arrive at the lab and is ongoing even after a test report is issued for that particular sample,” Mr Farrugia said.

On 30 March, Synergene underwent an ISO pre-assessment in collaboration with NAB-MSA. The purpose of the pre-assessment was to verify the level of implementation of a Quality system as well as to iron out any outstanding issues between the company and the regulator prior to full assessment.

The conclusion of the pre-assessment confirmed that Synergene’s plans for the full assessment can proceed in the very near future.

Mr Andrew Alexander, Sales and Marketing Manager for Synergene, added “ISO accreditation will place Synergene in an excellent position to compete in international markets. Discussions are presently under way for large UK forensics contracts that are pending ISO accreditation”.