This analysis highlights the need for standardized audits and regulations in embryology laboratories, suggesting a self-regulatory approach.
An embryology laboratory audit effectively implements the medical care quality management system (internal and external audit), on the other hand, an external audit can also be carried out as a part of the organization’s accreditation. Currently, there are national audit standards, an audit criteria, and requirements for persons operating in ART laboratories. A traditional audit of an IVF laboratory can only cover certain aspects of the laboratory’s activities, and is extremely dependent on the personal and professional qualities of the auditor himself. The work raises questions about the necessity to create a national self-regulatory audit organization, develop standards for conducting an audit of an embryology laboratory, and requirements for auditors.
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N.V. Leonov (2025) studied this question.
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