Quality management system performance under force majeure risk (COVID-19 pandemic)

Aim. To assess the effectiveness of QMS implemented by Research Institute for Complex Issues of Cardiovascular Diseases (NII KPSSZ) in 2020 and determine the impact of force majeure event (COVID-19 pandemic) on the achievement of the goals and objectives of the organization.

Methods. 11 QMS processes of the NII KPSSZ in 2020 were analyzed according to 98 performance criteria. The following general scientific methods were used for the assessment of QMS: analysis, synthesis, structural and systems analysis.

Results. The overall effectiveness of the QMS in 2020 was 83.5%, for the individual processes it varies from 57% to 100%. Achievement of target indicators in accordance with the criteria reflects the effectiveness of risk management in QMS processes. 27 criteria were added (9 of which were reformulated) as a result of the development of the system and the analysis of work experience in unusual circumstances for year 2021. At the end of 2021, QMS will be analyzed according to 117 criteria for the processes effectiveness.

Conclusion. The presented experience of quality management system functioning in 2020 highlights the significant roles of monitoring of the main processes and performance indicators analysis of scientific and medical organization in the ongoing COVID-19 pandemic. Such analysis is a necessary for decision-making because it allows the organization to fulfill the obligations, maintain conditions for increasing stakeholder satisfaction, monitor risks and assess opportunities associated with the environment and objectives of the organization, and ensure compliance with the standard requirements, regulations and legislation.

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