Tema Sinergie has started its “Quality Path” back in the year 2000, by obtaining the UNI EN ISO 9001 certification by the accredited company CERMET, now KIWA CERMET Italia S.p.A. The system has been upgraded in 2003 to ISO 9001:2000 and in 2009 to ISO 9001:2015, obtained in June 2018, in the following application field:
“Design, manufacturing, placing on the market, installation and after-sales assistance of devices and systems for the protection of the operator and for the containment, handling and monitoring of radioactive and/or sterile substances. Marketing and after-sales assistance of devices for radiation therapy and nuclear medicine.”
In January 2013 the quality system was certified UNI EN ISO 13485 for medical devices, renewed in June 2024 with the new edition ISO 13485:2021, in the following application field:
“Design, manufacturing, placing on the market and after-sales assistance of medical devices and systems for the containment, handling and monitoring of sterile radioactive substances. Marketing and after-sales assistance of medical devices for radiation therapy and nuclear medicine.”
Quality is not an abstract subject to Tema Sinergie: it is instead perceived as a system meant to plan, accomplish and improve the production process managament in order to grant an actual, effective and professional collaboration to the final customer.
The quality management system allows Tema Sinergie to optimize its workflow and avoid waste. Absolute quality is taken as an effective instrument which affects every single field of the company organization and includes a common value, knowledge and procedure system, general principles that are being shared and spread by the company management itself.
KARL100 is a Class I medical device as per MDR 2017/2745 Regulations. The combination with its certified dose calibrator constitutes the KARL100 System.
The RAD-INJECT infusion pump for GAMMA and BETA RADIOPHARMACEUTICAL EMITTERS is certified as a Class IIb medical device according to the 93/42/CE Guidelines.
