On this page, you can find official documents on the scope of accreditation of the Conformity Assessment Boy of the State Enterprise “L. I. Medved’s Research Center of Preventive Toxicology, Food and Chemical Safety of the Ministry of Health of Ukraine” (CAB ECOHYNTOX).
Certificate of Accreditation in accordance with the requirements of DSTU EN ISO/IEC 17021-1:2017 (EN ISO/IEC 17021-1:2015, IDT; ISO/IEC 17021-1:2015, IDT) ТА ISO/TS 22003:2013 in the following area:
- DSTU ISO 9001:2015 Quality management systems. Requirements (ISO 9001:2015, IDT);
- ISO 9001:2015 Quality management systems — Requirements;
- DSTU EN ISO 9001:2018 (EN ISO 9001:2015, IDT; ISO 9001:2015, IDT) Quality management systems. Requirements;
- DSTU EN ISO 13485:2018 (EN ISO 13485:2016, IDT; ISO 13485:2016, IDT) Medical devices. Quality management systems. Requirements for regulatory purposes;
- ISO 13485:2016 «Medical devices — Quality management systems — Requirements for regulatory Purposes;
- ISO 22000:2005 Food Safety management systems-Requirements for any organization in the food chain;
- DSTU ISO 22000:2007 Food Safety management systems-Requirements for any organization in the food chain (ISO 22000:2005, IDT);
- ISO 22000:2018 Food safety management systems — Requirements for any organization in the food chain;
- DSTU ISO 22000:2019 Food safety management systems — Requirements for any organization in the food chain (ISO 22000:2018, IDT).
View the Appendix to the Certificate
Certificate of Accreditation in accordance with the requirements of DSTU EN ISO/IEC 17065:2014 (ISO/IEC 17065:2012) in the following scope:
- Medical Devices;
View the Appendix to the Certificate
Information on Appointment of the State Enterprise “L. I. Medved’s Research Center of Preventive Toxicology, Food and Chemical Safety of the Ministry of Health of Ukraine” as the Conformity Assessment Body for Assessment of Conformity to the Requirements of the Respective Technical Regulations (View the letter of the Ministry of Economic Development and Trade of Ukraine), namely:
- Technical Regulations on Medical Devices (View Order of the Ministry of Economic Development and Trade of Ukraine No. 1196 dated 21.07.2016);
- Technical Regulations on Active Implantable Medical Devices (View Order of the Ministry of Economic Development and Trade of Ukraine No. 1198 dated 21.07.2016);
- Technical Regulations on Medical Devices for In Vitro Diagnostics (View Order of the Ministry of Economic Development and Trade of Ukraine No. 1197 dated 21.07.2016).
