Services

Applying European approaches and being guided by the impartiality principle in our activity, we offer the following services:

• Assessment of conformity of medical devices to technical regulations – View;
• Certification of management systems to confirm conformity to the requirements of – View:
  • DSTU ISO 9001:2015 Quality management systems. Requirements (ISO 9001:2015, IDT);
    N.B.!
    Institutions delivering secondary and tertiary health care and claiming the highest accreditation category shall have a certificate of conformity of the quality management system to the requirements of the national standard DSTU ISO series 9001. Absence of the certificate may be a basis for denial of assignment of the highest accreditation category to the institution.
    CAB ECOHYNTOX carries out certification of quality management systems of health care institutions, including primary health care institutions, regardless of their ownership form, in accordance with Resolution of the Cabinet of Ministers of Ukraine No. 121 dated 17.12.2012.
  • 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).