Influence of the ISO 7101-2023 standard on the medical system

Abstract

The ISO 7101-2023 standard is a new regulatory document adopted globally to improve quality, safety, and efficiency in healthcare systems. This article analyzes the changes that will occur as a result of the implementation of ISO 7101-2023 in the field of medicine, in particular, the integration of digital technologies (AI, telemedicine), patient data management systems, safety and quality control criteria. The integration of ISO 7101:2023 with previously widely used international standards, such as ISO 9001, ISO 13485 and others, and its role in controlling system control in integrated health and safety control are undergoing in-depth analysis. In this process, special attention is paid to ensuring legal and regulatory requirements in clinical practice, the stability and provision of patient needs, as well as the provision of modern innovative technologies and quality management.
In addition, the article provides for the updating of new software in the updated healthcare system of the ISO 71011: ISO 22023 standard, updates, disease control, ensuring the openness of clinical processes, ensuring safety, disease recovery, health improvement. As the author, based on this standard, healthcare problems arise, for which existing and future problems are also analyzed. The article substantiates that the ISO 7101:2023 standard is a new stage in supporting quality management, correction, and innovative development of the medical system.