Certification

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 9001:2008
EN ISO 9001 certification focuses on quality management and represents a standard recognized worldwide.

Medical Device Quality Management System Certification – ISO 13485:2013
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 14001:2004
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.

Certification of compliance with European Council Directive No. 93/42/EHS (“CE” mark).
Medical devices for clinical radiotherapy are designed and manufactured in compliance with the EU directive, which controls the requirements for medical devices. These products are eligible for “CE” marking and launching to markets of EU member states.

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