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) and DSTU ISO/TS 22003:2019 (ISO/TS 22003:2013, IDT) in the following scope (Certificate):
- 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 22000:2018 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).
Certificate of Accreditation in accordance with the requirements of DSTU EN ISO/IEC 17065:2019 (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).
