State Enterprise "State Expert Center of the Ministry of Health of Ukraine" has successfully passed international ISO certification 9001:2015

State Enterprise "State Expert Center of the Ministry of Health of Ukraine" has successfully passed the audit and received a certificate under the international quality management system EN ISO 9001:2015

Certificate No. 20100223015020 valid until 29.06.2029 certifies that the State Expert Center of the Ministry of Health of Ukraine (hereinafter – the Center) has implemented and uses a quality management system.

Certification of conformity of the Center's quality management system with the requirements of the international standard EN ISO 9001:2015 was carried out by the leading international certification company TÜV AUSTRIA CERT GMbH.

The scope of the enterprise's activity covered by the quality management system is the provision of expert services in the field of preclinical study, clinical trials and state registration of medicinal products (including medical immunobiological preparations); performance of pharmacovigilance; services in the field of standardization of medical care and medical, including pharmaceutical, services.

The State Expert Center of the MoH has had a quality management system in operation since 2014 in accordance with the international standards of the ISO 9001 series. In fact, this is not about creating a new separate management system. The Center integrated quality standards into its activities, using its own existing practical experience of effective management. The introduction of a quality management system in accordance with the international standards of the ISO 9001 series allowed the Center to correctly identify its quality objectives and to determine, at that time, the measures, processes and resources needed to achieve the desired results.

To date, the Center's quality management system continues to improve through the development of a process-based management model; the introduction of electronic document flow; a policy of enhancing the enterprise's financial stability is being pursued; development of the expert environment; improvement of the organizational structure through the effective distribution of powers and functions; improvement of the employee motivation system: ensuring continuous monitoring of management processes: conducting internal audits to identify nonconformities and apply corrective actions. In accordance with the provisions of the international standard ISO 9001:2015, the Center's management ensures, on the basis of allocating resources, defining responsibilities and powers, the performance of activities related to identifying customer requirements, requests and expectations in order to increase their satisfaction.

The main task under martial law remains ensuring the uninterrupted operation of the Center. The prompt and high-quality expert evaluation of materials on medicinal products depends on effective, timely and uninterrupted work, which directly affects the provision of the population with medicinal products and vaccines.

The certificate is an external independent confirmation that our services meet the high international standards of the EN ISO 9001:2015 quality management system. This is the most important step for us, confirming that continuous improvement, the trust of partners and consumers, as well as high quality in everything, are our main benchmarks.