As of June 1, 2007 the Laboratory has developed and implemented the quality management system. It has implemented a process approach in accordance with State Standard of Ukraine (DSTU) EN ISO 9001:2018 “Quality management systems. Requirements”.
The quality management system has been certified in accordance with the requirements of State Standard of Ukraine (DSTU)EN ISO 9001:2018 by the Ukrainian Medical Certification Center.
The Laboratory undergoes certification audits by the Ukrainian Medical Certification Center on an annual basis in order to assess the compliance of the quality management system with the requirements of DSTU EN ISO 9001:2018.
As required by DSTU EN ISO 9001:2018 the following documents have been created at the Laboratory:
- quality policy,
- aims of the Laboratory,
- quality manual,
- passport of the Laboratory,
- ïregulation on the Laboratory,
- quality procedures,
- standard operation procedures,
- and other documents.
