Abstract

General Background: Ensuring the quality and efficiency of healthcare services remains a fundamental priority in modern medical institutions. Specific Background: The integration of international standards, particularly ISO 9001:2015 and ISO 7101:2023, is essential in establishing robust quality management systems. Knowledge Gap: However, limited comparative analyses exist regarding the applicability and effectiveness of these standards within diagnostic and treatment institutions. Aims: This study aims to develop and implement a tailored "Quality Management System in Medical Institutions" based on both ISO 9001:2015 and ISO 7101:2023, assessing its impact on healthcare service quality and operational performance. Results: The system, comprising five principles and 53 specific requirements, was implemented at the ASMI Clinic, resulting in an increase in compliance from 45% to 75% over the course of 2023, with notable improvements in patient safety and staff competencies. Novelty: Unlike generic quality systems, the proposed model is uniquely adapted to the healthcare context, incorporating specialized principles and structured responsibilities. Implications: Despite challenges such as limited resources and employee adaptation, the findings support the strategic value of customized quality management frameworks in enhancing institutional performance and aligning with international best practices.

Highlights:

1. Compares ISO 9001 and 7101 standards in healthcare.

2. Improves service quality and staff performance.

3. Tailored system fits medical regulatory requirements.

Keywords: Healthcare Quality, ISO 9001:2015, ISO 7101:2023, Medical Institutions, Quality Management System

I ntroduction

Achieving sustainable medical success in a demanding and constantly changing environment, providing high-quality and modern medical services is closely related to the quality of management. Based on global and domestic experience, one of the effective modern means of providing high-quality medical care is the implementation and continuous improvement of the quality management system in accordance with the requirements of the international standard ISO 9001. [1]

The International Organization for Standardization (ISO), the World Federation of National Standardization Organizations, defines the basic concepts and principles of quality management. In the ISO 9000:2015 standard, quality is defined as "the degree of compliance of the set of specific properties of the object with the requirements." The 2015 ISO 9001 standard states that tools such as understanding the organizational environment, developing policies and objectives in the field of quality, an action plan for continuous quality improvement, internal audits and preventive actions, risk and knowledge management, and employee competence and awareness allow a medical organization to maintain a high level of quality of medical services. [2-4].

Analysis of foreign literature indicates a growing interest in the quality of medical care, all its aspects, in particular, the terminological definition of the concept of quality in healthcare. [5-15]

As a result of our analysis and analysis, we witnessed the implementation of the international standard ISO 9001:2015 in medical institutions. Therefore, we did not limit ourselves to ISO 9001:2015 alone, but also conducted research on the integration of the international standard ISO 7101:2023, which is recognized and implemented in medical institutions around the world. Table 1 below shows a comparative analysis of the ring standard.

We have developed documents for the implementation of international standards ISO 9001:2015 and ISO 7101:2023 in a number of medical institutions. Information about these documents is reflected in the table below. Documents developed during the implementation of international standards ISO 9001:2015 and ISO 7101:2023.

Methods

In the dissertation work, based on the requirements of international standards ISO 9001:2015 and ISO 7101:2023, a "Quality Management System in Medical Institutions" was developed for treatment and diagnostic institutions. The proposed system consists of 5 principles and 53 requirements.

The proposed "Quality Management in Medical Institutions" system differs from other systems in that its principles are unique and compatible with the healthcare system. The following sequence indicates its requirements.

Figure 1.

Figure 2.

An action plan for the implementation of the "Quality Management System in Medical Institutions" in the "ASMI Clinic" has been developed.

Plan of measures for the implementation of the "Quality Management System in Medical Institutions" at the "Clinic of Andijan State Medical Institute" according to

The champions who achieved high results in accordance with the requirements of the "Quality Management in Medical Institutions" system were identified and presented for incentives. According to the "Quality Management System in Medical Institutions," the requirements, obligations, and duties of those responsible are defined, which are indicated below.

Result and Discussion

Thanks to the improvement of the "Quality Management System in Medical Institutions," factors negatively affecting the quality of medical services have decreased, and the quality of medical services has increased, which can be seen in the example of the "ASMI Clinic." All tasks implemented in the medical institution in January and October 2023 were carried out in accordance with the requirements of the "Quality Management in Medical Institutions" system, and the following indicators were achieved.

Figure 3. Level of implementation of the "Quality Management System in Medical Institutions"

Conclusion

The "Quality Management System in Medical Institutions" was developed based on the standards ISO 9001:2015 and ISO 7101:2023, which significantly improved the quality of medical services after its implementation in the "ASMI Clinic." During 2023, the fulfillment of system requirements increased from 45% to 75%, and positive changes were noted in the field of patient safety and staff qualifications. However, a lack of resources, difficulties for employees in adapting to new requirements, and technical limitations hindered the system's full effectiveness. In the future, it is necessary to increase financial resources, strengthen personnel retraining programs, and implement electronic monitoring systems for further improvement of the Quality Management System in Medical Institutions

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