In order to guarantee the highest reliability of our products, our company has obtained the ISO 9002 certificate. It was the first certificate received by a medical equipment producer in Poland.
After a three-year period of maintenance and improvement of Quality Management System according to ISO 90002 certificate, EMTEL obtained the ISO 9001 certificate in May 2001. This certificate proved that both our production and development departments meet requirements of Quality Management System.
In 2003, we obtained the certificates confirming the fulfillment of European directive 93/42/EEC and standards: EN ISO 9001 and EN ISO 13485. This was a significant step in Quality Management System improvement which resulted in receiving a CE certificate for all our products.
We maintain a high standard of monitors and defibrillators and they consistently meet the requirements of 93/42/EEC directives. This is confirmed by annual audits performed by the TUV NORD Polska, which renew the CE certificate for all products.
In 2019 we decided to maintain the certificatation for the EN ISO 13485 as the proper Quality Management System for the manufacturer of the medical equipment.