On April 21, the Accreditation Body of Serbia (ATS) participated in the CLAQ 365 symposium (Laboratory Accreditation and Quality Systems), which was held at the Mona Plaza Hotel in Belgrade. This was the 1st symposium related to the accreditation of medical laboratories and the new version of the ISO 15189:2022 standard. The symposium was accredited as international and many experts from abroad and from our country took part in it. Five more nationally accredited symposia are planned to be held.
This year's meeting was opened by Mr. Ph.D. Sanja Stanković, director of the Center for Medical Biochemistry, Clinical Center of Serbia, and the main organizer of this event.
The acting director of the Accreditation Body of Serbia, Dragan Pušara, M.Sc., addressed the attendees and spoke about the activities on the development of the accreditation scheme for medical laboratories according to the ISO 15189 standard.
On this occasion, he reminded those present that in 2008, ATS started activities on the development of this new scheme, so that the first accreditation according to the SRPS EN ISO 15189:2009 standard was granted on 26.06.2009, to the Clinical Center of Serbia for the following fields: biochemical, immunochemical, hematological and biological tests of human clinical samples.
ATS has so far accredited 15 medical laboratories according to the SRPS EN ISO 15189:2014 standard. In addition to the ISO 15189 standard for medical laboratories, the SRPS EN ISO 22870 Point-of-care testing (POCT) standard.
- Requirements for quality and competence are also related. ATS can boast of having issued the first scope of accreditation in the field of point-of-care testing on 20.07.2022 to the University Clinical Center, the Center for Medical Biochemistry, for on-site point-of-care testing (POCT) according to SRPS EN ISO 15189 and SRPS EN ISO 22870. The Center for Medical Biochemistry, with its great team, was the first to introduce POCT and extend its scope of work to these very important point-of-care testing.
Dragan Pušara, M.Sc., pointed out that ATS is facing a new challenge - the transition to accreditation according to the new edition of the standard (SRPS EN ISO 15189:2023). The transition period for the application of the new edition of the standard is three years from the date of its publication, which is 05.12.2025, by which time all medical laboratories must switch to this new edition of the standard. One of the novelties in the current edition of the ISO 15189:2022 standard is that the requirements for point-of-care testing (POCT) according to ISO 22870:2016 have been implemented in this new edition of ISO 15189 so that after the transition period, the accreditation of medical laboratories according to ISO 15189:2012 and POCT accreditation according to ISO 22870:2016 with ISO 15189:2012 will no longer be recognized.
Also, the Acting Director of ATS pointed out that the ATS is extending its scope of activity to include a new scheme/type of accreditation of conformity assessment bodies according to the standard SRPS EN ISO 20387:2021 Biotechnology - Biobanking - General requirements for biobanking, with the aim that in the near future carry out biobanking accreditation, whereby ATS will equally keep pace with developed EU countries where this new field is also in its infancy.
Then the participants of the symposium were addressed by experts from abroad, Dr. Aliki Stathopoulou, who spoke on the topic of laboratory accreditation and its impact on point-of-care testing and the health system.
Dr. Jelena Seferović, in front of the Clinical Center of Serbia, said that laboratory accreditation supports clinical examinations.
Those present were also addressed by a B.Sc. pharmacist, spec. of medical biochemistry, Tatjana Vodnik, who spoke about the requirements of the new standard SRPS EN ISO 15189:2023 Medical laboratories - requirements for quality and competence, including examinations with the patient Point-of-Care Testing (POCT), from the perspective of an expert who comes before the Center for Medical Biochemistry, Clinical Center of Serbia.
And with the requirements for resources specified by the new edition of the standard, the attendees were introduced by Assoc. Vladan Ćosić, Ph.D., employed at the University Clinical Center of Niš.
ATS representatives also addressed the participants:
Ljiljana Markićević, assistant director for development and quality, spoke about the requirements of the new standard SRPS EN ISO 15189:2023 Medical laboratories - requirements for quality and competence including tests with the patient Point-of-Care Testing (POCT), from the aspect of accreditation.
We remind you once again that the transition to accreditation according to the new edition of the standard is until 05.12.2025.
Milica Jovčić, assistant director for the accreditation process, in addition to presenting information of importance for medical laboratories, also gave an overview of the International Organization for Standardization (IOS). This independent, non-governmental, international organization has a total of 168 members, 816 committees, and 24,736 standards.
On this occasion, she emphasized the importance of ISO standards in the field of healthcare, which enable individuals and the community to receive the quality of healthcare they deserve. By applying these standards, organizations prove their commitment to the principles of quality, transparency, responsibility, and safety.
Jelena Stojanović, head of the department for testing laboratories, spoke about the key steps in the accreditation process, which includes the following steps:
- Submitting and considering the application for accreditation;
- Preliminary visit;
- Preparation for assessment;
- Documentary review;
- Decision-making on accreditation.
ATS will continue to support such professional gatherings in the future and strive to participate in the organization of such events with its competence, which is primarily reflected in its professional staff.