The increase of competitiveness level and international recognition of the absolute products quality is one of the main targets and values for Kievguma LLC. To reach it our enterprise conducts quality management system certification and international audits on a regular basis. Thus, on October 28 Maria Kalogirou, an auditor from TUV Austria Hellas certification authority, visited Kievguma to check compliance of the medical products quality system with EN ISO 13485: 2016 standard requirements.

The check-up was conducted in a form of a supervisory audit to confirm our received certificate. Our enterprise was able to demonstrate to the auditor the proper compliance with the standards at all the stages of design, working out and production of medical goods. So this audit was a true success for us.

It wasn’t our first audit from TUV Austria Hellas. Every time visiting Kievguma Ms Kalogirou gives us high marks and stresses our achievements. The experienced auditor gave us some precious pieces of advice which will help us to improve the processes of our quality management system according to the European requirements. 

TÜV Austria certificate for EN ISO 13485 standard is the guarantee of high product quality. It gives more opportunities for the company to enter the International market. Thus, a lot of European and CIS countries give the significant advantages to the companies with EN ISO 13485 certification. Still, the most important thing is that successful certification is the advantage of Kievguma products over the products of many our competitors.