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Khayrullin I.I.

Pirogov Moscow City Clinical Hospital No. 1;
Russian Medical Academy of Continuous Professional Education

Omelyanovskiy V.V.

Center for Expertise and Quality Control of Medical Care;
Russian Medical Academy of Continuous Professional Education;
Research Financial Institute;
Semashko National Research Institute of Public Health

Gostishchev R.V.

Pirogov Moscow City Clinical Hospital No. 1;
Russian Medical Academy of Continuous Professional Education

Sukhorukikh O.A.

Center for Expertise and Quality Control of Medical Care;
Russian Medical Academy of Continuous Professional Education

Influence of the ISO standard 9001 on performance of medical organizations: a systematic review

Authors:

Khayrullin I.I., Omelyanovskiy V.V., Gostishchev R.V., Sukhorukikh O.A.

More about the authors

Journal: Medical Technologies. Assessment and Choice. 2024;(3): 43‑52

DOI: 10.17116/medtech20244603143

Views: 372

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To cite this article:

Khayrullin II, Omelyanovskiy VV, Gostishchev RV, Sukhorukikh OA. Influence of the ISO standard 9001 on performance of medical organizations: a systematic review. Medical Technologies. Assessment and Choice. 2024;(3):43‑52. (In Russ.)
https://doi.org/10.17116/medtech20244603143

Подписка 2025 (Medical Technologies. Assessment and Choice)
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OBJECTIVE

To access the impact of the ISO 9001 standards on performance of medical organizations.

MATERIAL AND METHODS

A systematic review of studies devoted to the influence of the ISO 9001 standards on performance of medical organizations was performed.

RESULTS

We enrolled 25 studies describing retrospective quasi-experiments (analysis of interrupted time series (n=23) or ex-post-facto studies (n=2)). Both clinical and economic effectiveness of the ISO 9001 standards was demonstrated in most studies. Half of the studies also assessed patient satisfaction, and it increased as well. In some studies, ISO 9001 was a part of improvement program together with the Six Sigma method, patient-oriented organizational technologies, ISO 9004:2001 and IWA 1:2001. It is impossible to distinguish the contribution of the ISO 9001 standard in such cases.

CONCLUSION

Limited evidence suggests that implementation of the ISO 9001 standard can improve performance of healthcare organizations.

Keywords:

quality management system
ISO 9001 standard
quality and safety of medical activities
efficiency of medical activities
quality of medical care
patient satisfaction
quality management
lean technologies
patient-centered care

Authors:

Khayrullin I.I.

Pirogov Moscow City Clinical Hospital No. 1;
Russian Medical Academy of Continuous Professional Education

Omelyanovskiy V.V.

Center for Expertise and Quality Control of Medical Care;
Russian Medical Academy of Continuous Professional Education;
Research Financial Institute;
Semashko National Research Institute of Public Health

Gostishchev R.V.

Pirogov Moscow City Clinical Hospital No. 1;
Russian Medical Academy of Continuous Professional Education

Sukhorukikh O.A.

Center for Expertise and Quality Control of Medical Care;
Russian Medical Academy of Continuous Professional Education

Received:

11.06.2024

Accepted:

08.07.2024

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