QMS recertification

The company UJP PRAHA a.s. retained a periodic audit at the beginning of May this year as part of its established Integrated Management System. In addition to the certificates ISO 9001:2015 (quality management system), ISO 14001:2015 (environmental management system), ISO 13485:2012 (medical device management system), we again have the EC Certificate – Comprehensive Quality Assurance System, which includes processes for design, production and final inspection / testing of the following product groups:

  • Radiotherapeutic cobalt irradiators
  • X-ray simulators for radiotherapy
  • Radiotherapy systems

The individual processes have been assessed in accordance with Article 11.3 a) of Annex II, with the exception of Part 4 (Module H2) of Medical Device Directive 93/42/EEC, and are in compliance with the applicable requirements. The individual certificates are in Download section.