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QMS in medical laboratories

In recent years, the number of medical laboratories in Serbia has increased significantly, and the importance of their work has especially been noticed with the emergence of the COVID-19 pandemic. Precisely for this reason, we draw attention to the benefits that laboratories can have from the implementation of the standard for the quality management system (QMS) and the competence of medical laboratories, SRPS EN ISO 15189:2014. The consistency and accuracy of the test results are directly related to the quality of the laboratory that performs the test. Having accreditation, that is, an internationally agreed level of competence, means that you can trust those results. In addition, a comparison can be made with the results of laboratories abroad, which is the essence of ensuring quality control in medical laboratory testing.

Accreditation of a medical laboratory not only increases the level of trust of patients, but also the credibility of the laboratory, which makes it more competitive in the market of medical services.

The importance of QMS is also widely recognized in Serbia, where 15 medical laboratories have been accredited according to SRPS EN ISO 15189:2014, Medical laboratories - Requirements for quality and competence (list of the laboratories is available on the link: https://bit.ly/3KYrsdL).

It is encouraging that there is an equal number of accredited medical laboratories from the public and private sectors, and that more than half of them have maintained their accreditation for more than a decade. This clearly shows that the importance of continuous application of standards, i.e. accreditation according to SRPS EN ISO 15189:2014, has been observed in practice.

The ISO 15189 standard has been applied internationally since 2003, when the first edition was published. It is currently in the final revision phase, or more precisely, the voting phase of national standards bodies is underway before the adoption of the final draft of ISO/FDIS 15189:2022, which lasts until October 14. The publication of the new ISO 15189 is expected at the beginning of 2023.

The new, fourth edition replaces the third edition (ISO 15189:2012), which has been technically revised. This standard also replaces ISO 22870:2016 (with which SRPS EN ISO 22870:2017, Point-of-care testing (POCT) - Requirements for quality and competence is identical to), and the most important changes are as follows:

– harmonization with ISO/IEC 17025:2017, which has resulted in management requirements now appearing at the end of the document;

– the requirements for point-of-care testing (POCT), previously contained in ISO 22870, are now incorporated into the text of the standard;

– the importance of risk management was emphasized.

ISS is organizing a training dedicated to interpreting the requirements of the SRPS EN ISO 15189:2014 standard, which relate to the quality and competence of medical laboratories. The specificity of this training is reflected in the fact that, in parallel with the interpretation of the valid version of the standard, it points to the novelties brought by ISO/FDIS 15189. This two-day webinar provides the opportunity for participants to acquire new knowledge, thanks to which they will improve and facilitate the application of QMS in their laboratories and prepare for accreditation according to SRPS EN ISO 15189:2014.

More details are available on the link: https://iss.rs/sr_Cyrl/training/course/show/87

Application for the training: https://forms.gle/uKtg8X16Sh2iftFu5