
From June 24 to 27, 2024, KIEVGUMA LLC passed a supervisory audit of certified products – sterile medical products and an audit of the quality system for the production of medical products in accordance with the requirements of the DSTU EN ISO 13485:2018 standard.
During the inspections, the company received valuable recommendations and advice from the auditors of Ukrainian center for medical certification and prognostication LLC, which will help us become even more effective and competitive in the market.
The auditors did not record any critical and significant remarks. The validity of the certificates was extended for another year. The high level of production organization, professionalism of the staff, understanding of their role in the functioning quality system, and other positive aspects were also noted.
All services and production shops that were involved in the audit confirmed the compliance of their functions with the requirements of standards and regulations and demonstrated a high level of competence when communicating with the auditors.
KIEVGUMA continues to constantly improve production processes in compliance with the requirements of all current standards and regulations.
