Certification
UJP PRAHA’s products are based on state-of-the-art findings in various branches of science and technology. UJP PRAHA supplies sources of ionizing radiation, medical devices containing radioactivity, and packagings for the transport and storage of radioactive materials. UJP PRAHA experts are engaged in projects aimed at enhancing the safety of large chemical and nuclear facilities and in the development of special materials. All UJP PRAHA’s activities are driven by efforts to ensure safety and protection of human lives and health, property and the environment. We are proud to be able to cope with what legislation refers to as “potentially hazardous” products.
How do we achieve that?
We design our products with a view to imparting them the highest-level service properties while taking into account all the potential risks associated with their use. In doing so we benefit from state-of-the art scientific and technological knowledge, technical standardization, applicable legislation, clinical practice and development tools for risk analysis and assessment as well as other information sources.
The company is well aware of the fact that a sufficient number of specialists and experts capable of fulfilling such tasks constitute the company’s most valuable assets. The company creates teams of professionals and encourages and supports them in enhancing their education, training and skills.
Processes associated with the deployment of the company’s products are managed so as to provide stable and expected results and satisfy all stakeholders. Such efforts are supported by company’s integral quality control and environmental protection system. The company’s attitudes to our customers and stakeholders are expressed in UJP PRAHA’s Company Policy.
Products and processed complying with the above principles are submitted for assessment to independent third parties, authorities, or certification bodies. The principles are intertwined and it is often impossible to discriminate clearly between results of system certification, product certification, and personnel certification. UJP PRAHA earned its first system certificate 10 years ago and since then the system has been upgraded on an ongoing basis.
UJP PRAHA’s most important certifications include:
Management system certification pursuant to the following international standards:
The certificate was obtained from the certification body Det Norske Veritas.
Type approval of Type B(U) packagings
Internationally recognized type approval/licence is obtained from the State Office for Nuclear Safety for each B(U) packaging type manufactured by the UJP PRAHA. So far, this has included roughly 15 standard types supplied by the company.
Type approval of ionizing radiation sources
UJP PRAHA’s products: cobalt irradiator for radiotherapy, X-ray simulator, and blood irradiator have been approved by the State Office for Nuclear Safety as ionizing radiation sources pursuant to the Czech “Atomic Act”.
Clinical assessment
For medical devices, their suitability and fitness for use have been assessed pursuant to the act on clinical assessment of medical products. This assessment was performed by authorized bodies, which issued the respective Clinical Assessment Reports.
Certification of compliance with European Directive 93/42/EEC
Medical devices for clinical radiotherapy are designed and manufactured in compliance with the European Medical Device Directive. Such products qualify for marketing across the European Union and labelling with the CE mark.
UJP PRAHA is the holder of the following licences and certificates:
Ionizing radiation sources manufacturing and management licence
Licence to perform and evaluate materials tests of selected technical equipment in the nuclear power sector and to perform assessments of the integrity and lifetime of nuclear power plant facilities
Nuclear material handling and management licence
Radioactive waste handling and management licence
Nuclear material transport licence
Czech State Office for Nuclear Safety Certificate
of special professional competence for the management of activities involving ionizing radiation sources
International quality manager’s certificate
also for medical devices (EOQ and MDD)
Certificate authorizing the holder to perform materials testing
of selected technical facilities in the nuclear power sector, nuclear power plant equipment integrity and lifetime assessments
The company is subject to the supervisory authority of the following bodies:
- State Office for Nuclear Safety (nuclear safety and radiation protection aspects)
- Czech Environmental Protection Inspectorate (compliance with the provisions of the Clean Water Act and Clean Air Act)
- Prague Municipality (compliance with the provisions of the Act on Wastes)
- Czech Occupational Safety Authority (compliance with occupational safety legislation)