Abstract: The report overviews the context, conditions and approaches to quality management 
in Europe and Bulgaria. The importance for nation-wide healthcare quality assurance policies 
is well recognised and there are a number of laws and regulations, shared responsibilities with 
regards to quality implementation aims, expert committees and national quality coordinators 
in various medical spheres. Main approaches to quality management in Bulgaria are discussed 
such as registration and licensing of physicians and healthcare establishments, certification, 
continuous medical education and qualification, accreditation, registration of pharmaceutical 
products, medical equipment and blood products, followed by drafting and development of 
standards/instructions for practice and auditing/inspection follow-ups. The active 
participation of professional organizations in developing GMP requirements is appreciated. 
The draft of National Health Strategy 2021-2030 and patient safety as integral part of health 
policy with regards to quality improvement is discussed. The work of European and Bulgarian 
inspectorates and supervision institutions is analysed and proposals for amendments in quality 
managements legislation are made.
Conclusion: Quality assurance, safety, medical errors and sentinel events suggest serious 
issues system-wide and not only from medical, but also from financial, legal, ethical and 
societal standpoint. This is a quality indicator in healthcare that requires attention to be 
focused not only on medical errors as such, but on improvement of all aspects of healthcare 
delivery.
Key words: quality, quality management, safety, supervision, medical services

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