AUDITS
On February 2019, after 2 days of auditing from the Regulatory Agency of Belarus, Halotech has overcome satisfactorily all the regulatory and quality requirements, for the approval and sale of its products through their official distributor, Cell Diagnostic.
Halotech DNA also overcame the ISO 13485:2016 audit, for the manufacturing of IVD kits through IMQ, thus in full compliance with the Quality Management System and the company has assumed the way of working implementing an integrated risks management, as well as the improvement in the strategic planning of its manufacturing activities. Halotech DNA sustains a great effort to maintain its compliance with the quality system, at the highest level. We have overcome, once again, an audit with the goal of compliance “0 observations”.