Ukrainian Scientific Institute of Certification

NATALIIA MEKHED

28/01/2019

 

Lead specialist of standardization, certification and quality

Quality manager of the testing laboratory

nataliia.mekhed@uni-cert.ua

 

  • Master’s degree in Biology and Biochemistry – Taras Shevchenko Kyiv State University,
  • Postgraduate Training on the Program “Laboratory genetics” – National Medical Academy of Postgraduate Education. P.L. Shupika Ministry of Health of Ukraine,
  • Postgraduate Training on the Program “Management and Logistics” – NationalAviation University (NAU),
  • More than 12 years’ experience in quality sphere – development, implementation, maintenance and auditing of the Quality Management Systems according to the ISO 9001, ISO 13485, ISO 22000, HACCP, IFS; implementation of ISO/IEC 17025 in the practice of production testing laboratory and its accreditation.
  • Experience in the medical devices conformity assessment sphere- 3 years.
  • Carried out more than 90 audits of quality management systems of domestic and foreign enterprises.
  • Free proficiency in Ukrainian, Russian and English.

Certificates of competence in the field of medical devices conformity assessment: 

  • Lead Auditor on the standard ISO 13485 – Certificate No. UNI-CERT.11-16 dated 19.08.2016 (LLC “UNI-CERT”, Kiev).
  • Lead auditor of quality management systems on the standard ISO 9001: 2008 – Certificate SGS/SSCE/QMSLAC/600270/F/28068 dated 08-12.08.2011 (SGS Ukraine, Odessa).
  • Internal auditor in accordance with ISO/IEC 17025 and ISO 19011 – Certificate No. TCL/2016/02-011 dated 03.02.2016 (Fortius Quality Group, Kyiv).