In November 2021, the Research and Production Center for Radiation Technologies of the Republican State Enterprise INP, with the support of the domestic commodity producer JULDYZ KENAN Co., LTD LLP (www.juldyzkenan.kz), successfully passed the certification audit of the quality management system of the radiation sterilization service for medical products at compliance with the requirements of the international standard ISO 13485: 2016.
The international company LL-C (Certification) Czech Republic a.s., acted as the body for confirming the conformity of management systems. LL-C (Certification) (www.ll-c.ru) company accredited by the Czech Institute of Accreditation, a member of the International Accreditation Forum (IAF). The headquarters of the group is located in Prague, in the Czech Republic, which is a member of the European Union.
The quality management system of the Research and Production Center for Radiation Technologies of the RSE INP has been verified and found to comply with the requirements of the international standard ISO 13485: 2016 for the following certification area: “Electron beam sterilization of medical devices, sterilization on the electron beam accelerator”. As evidenced by the certificate number 760054, valid from December 7, 2021 to December 6, 2024, validity code 5F2566F5-C76.
Quality assurance for healthcare products is vital to meeting regulatory and customer requirements. These issues are covered by the ISO 13485 standard.
Nowadays, the Institute of Nuclear Physics annually renders radiation sterilization services for medical products to 29 Kazakhstani and international companies. The Institute of Nuclear Physics sterilizes over 12 million medical devices annually.