EN ISO 9001:2015 Quality Management System for Health Care Sector in Accordance with PN-EN 15224:2017-02 Standard and Accreditation Standards of the Minister of Health – Comparative Analysis

Abstract The aim The aim of this article is to indicate similarities and differences between EN ISO 9001:2015 quality management system in accordance with PN-EN 15224:2017-02 standard and the accreditation standards of the Minister of Health. Material and methods A comparative analysis of two documents describing requirements of the quality management system EN ISO 9001:2015 in accordance with PN-EN 15224:2017-02 and accreditation standards of the Minister of Health issued by the Quality Monitoring Centre was performed. Results This comparative analysis concerns individual aspects/quality requirements of the PN-EN 15224-02 standard with reference to thematically analogous accreditation standards. According to the following analysis designation of both the PN-EN 15224:2017-02 standard and accreditation for health care sector causes natural, very high convergence and similarity between both systems. For specialist and expert on discussed subject, there is no bigger problem with connecting mutual reference of requirements of individual quality aspects described in the standard and accreditation standards. The PN-EN 15224:2017-02 standard, similarly to accreditation standards, pays particular attention to obligation to manage clinical risk during planning, implementation and control of individual process which becomes the key element of quality management system for clinical activities. In both cases, data related to significant events connected with hospitalization should be analyzed and assessed, and conclusions and observations should be used to conduct improvement projects in important health care areas in accordance with the E. Deming quality improvement methodology (PDCA cycle). However, they can’t be said to be identical. Differences result from the very structure of the documents. Accreditation standards are divided into 15 subject areas, gathering a total of 221 standards. The PN-EN 15224:2017-02 standard, in accordance with the ISO/ IEC Directives, Part 1, Consolidated ISO Supplement, Annex SL, contains common, consistent structure of new revised management system standards. Another difference between discussed systems concerns scope of both documents, the standard has international dimension and the set of standards is definitely national. There are, of course, many more similarities as well as differences, which this article deals with in full. Conclusions Carried out analysis shows clearly that, despite formal differences, there are numerous connections and analogies between requirements of individual quality aspects of the PN-EN 15224:2017-02 standard and requirements of the accreditation standards. Effective implementation of both requirements of the ISO standard in question and accreditation standards can constitute the basis for creating a single, consistent and effective management system for treatment entity as a whole.