Certifikace
The UJP PRAHA a.s. company, with regard to its activities and in accordance with the requirements of the so-called "atomic law" and other regulations, holds a number of important certificates and permits.

We manage all the activities and processes needed for the implementation of our products to ensure stable and expected results and satisfy all interested parties. We achieve this goal with an integrated quality and environment management system. We express our attitude towards and relationship with our customers and interested parties in our Company Policy. Our compliance with the above-mentioned principles is always reviewed by an independent party, state authority or certification body.

Due to its activity and in compliance with the requirements of Act No. 18/1997 Coll. On the Peaceful Utilization of Nuclear Energy and Ionizing Radiation (the Atomic Act) and other regulations, UJP PRAHA is the holder of many important certificates and licences.

System certification

Management system certification – ISO 9001:2015
EN ISO 9001 certification focuses on quality management and represents a standard recognized worldwide.

Medical Device Quality Management System Certification – ISO 13485:2016
The quality systems certification of manufacturers of medical equipment is based on the EN ISO 9001 standard, which is complemented with specific requirements for individual categories of medical devices.

Management systems certification – ISO 14001:2015
This standard is focused on environmental protection and prevention of pollution. It does not specify any strict requirements for the environmental behaviour of the company but emphasizes the observance of legislative requirements concerning the environment in particular.

Product certification

  • Type approvals of packages for the transport of radionuclides, type B(U) and type IP
    The State Office for Nuclear Safety issues the Type Approval Certificate separately for each product type. Altogether, it concerns approximately 40 off-the-shelf types.
  • Compliance with EU legislation
    Medical devices for radiotherapy have been designed and manufactured in compliance with European Council Directive No. 93/42/ECC (MDD) and are in the process of transitioning to EU Regulation 2017/745 (MDR). These products are subject to the transition period as stated in EU Regulation 2023/607.
  • The national certifications of medical equipment permitting it to be launched in markets in countries outside the EU, such as Russia, Belarus, Ukraine and Kazakhstan.

Authorization according to the atomic act

  • Licence to manufacture and handle ionizing radiation sources
  • Licence to handle nuclear materials
  • Licence to handle radioactive waste
  • Licence to transport nuclear materials

Personnel certification

  • Special professional competence in the management of works with ionizing radiation sources
  • International quality manager certificate, also for medical devices (EOQ and MDD)
  • International welding technologist certificate
  • Certificate of “visual inspection of a weld surface” qualification examination
  • Certificates for specific activities of non-destructive testing (NDT) according to the requirements of the Std-201 APC:2011 standard
  • Certificate in the field of non-destructive testing (NDT) according to the requirements of the Std-201 APC:2011 standard
  • Qualification in the field of non-destructive testing of metal materials, welds, etc.

The activity of our company is subject to the inspection of the appropriate authorities

  • State Office for Nuclear Safety, from the point of view of nuclear safety and radiation protection
  • Czech Environmental Inspectorate, from the point of view of the Act on Water and Act on Ambient Air Protection
  • Municipality of the Capital of Prague, from the point of view of the Act on Waste
  • Labour Inspection, from the point of view of safety at work and labour relations