In accordance with our mission all activities are performed in compliance with ISO 9001 quality management standard. First time we got its certificate in 1998 from SGS Yarsley International Certification Services certification body.
We had a renewel audit concerning ISO 9001 and a certification audit concerning ISO 14001 which was successful.
Our Quality Policy is available here.
In addition the production of in vivo pharmaceuticals is performed in compliance with requirements of GMP (Good Manufacturing Practice) which is regulated in Hungary by 44/2005 (X.19.) order of Health Ministry, and its realisation is regularly inspected by Directorate General of National Institute of Pharmacy.
All our products, as well as their production, storage and delivery meet the strictest security requirements. Prevention of radioactive pollution of the environment is guaranteed by a multilevel safety system. Our Environmental Policy is available here.
All in vitro diagnostic products have CE compliance mark required by 8/2003 (III.13.) order of Ministry of Health, Social and Family affairs. PSA kits and kits for Down syndrome risk assessment have certification required by this order.
Immunoassay Business Line has certified quality management system according to ISO13485 (certificate) standard for design, production and distribution of radioactive immunoassay kits. We have certification for manufacture of Fe-59 Core Reagent.
All certificates were issued by National Institute for Quality- and Organizational Development in Healthcare and Medicines / Directorate of Device Testing and Clinical Engineering.
Your comments about this site (www.izotop.hu) are welcome here: email@example.com