Quality and Certifications

QUALITY MILESTONES FOR TEMA SINERGIE

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.

“Design, manufacturing, 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 aftersales assistance of devices and systems for radiation therapy and nuclear medicine.”

In January 2013 the quality system was certified UNI EN ISO 13485 for medical devices, renewed in June 2018 with the new edition ISO 13485:2016, in the following application field:

“Design, manufacturing and after-sales assistance of devices for the containment, handling and monitoring of sterile radioactive substances. Marketing and after-sales assistance of 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.

MEDICAL DEVICES CERTIFICATION

In December 2008, Tema Sinergie obtained the certification for the first automatic dose drawing station “Micro DDSA” as a Class 1 medical device according to Specification 93/42 CE.

Later, in 2009, the Rad Inject infusion pump was certified as Class 2b medical device too.

These products are registered onto the medical devices register of the Italian National Health Department as required by the “Modifiche ed integrazioni al decreto 20 febbraio 2007 recante Nuove modalità per gli adempimenti previsti per la registrazione dei dispositivi impiantabili attivi nonché per l’iscrizione nel Repertorio dei dispositivi medici” decree released on December 21st 2009.

© 2018 TEMA SINERGIE S.p.A
Fiscal Code n. 00970310397
Business Register of Ravenna n. 00970310397  |  R.E.A. 111877
Capital Stock € 2.000.000,00 paid-up