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Accreditation of medical laboratories according to ISO 15189 standard

By: | Tags: , | Comments: 0 | June 3rd, 2019

Accreditation, globally, has become a generally accepted way of managing quality and confirming the technical capability of medical laboratories. International Standard ISO 15189 defines the requirements that a medical laboratory must fulfill in terms of quality systems and competence, and the fulfillment of these requirements is verified by a National Accreditation Body (NAB). Accreditation per this standard applies to all medical laboratories for biological, microbiological, immunological, chemical, immunohematological, hematological, biophysical, cytological, pathological and other examinations of human material. Such laboratory examinations are carried out for the purpose of providing information for diagnosis, prevention and treatment of diseases or for the assessment of human health.

Medical laboratories are critical to patient safety by having in mind that laboratory results directly affect the patient’s diagnosis and therefore the quality of patient health care.

Laboratories (test, calibration and medical) may have a quality management system according to ISO 9001 Quality Management System – Requirements, as a general standard for organization management of any type and size. However, in order to provide evidence of testing quality in the medical laboratory, it is necessary to implement a lab management standard ISO 15189 Medical Laboratory – Quality and Competence Requirements.

Accreditation of medical laboratories according to the international standard, ISO 15189 demonstrates the quality and trust of the users and patients with the services provided by medical laboratories. The aim of the laboratory is not only to obtain accurate test results but also to conduct patient examinations within a defined time frame, using appropriate laboratory management procedures, respecting ethical principles, confidentiality and patient safety.

Medical laboratories can use ISO 15189 stadnard in developing their own quality management systems and assessing their competences. Furthermore, the standard can also be used to assess or recognize the competence of medical laboratories by users of laboratory services, regulatory bodies and accreditation bodies.

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Akreditacija medicinskih laboratorija prema ISO 15189

Akreditacija je postala opće prihvaćen način za upravljanje kvalitetom i potvrdu tehničke osposobljenosti medicinskih laboratorija u svijetu. Međunarodni standard ISO 15189 definiše zahtjeve, koje mora ispuniti medicinska laboratorija u pogledu sistema kvaliteta i kompetentnosti, a ispunjenost ovih zahtjeva provjerava nacionalno akreditaciono tijelo. Akreditacija po ovom standardu se primjenjuje se na sve medicinske laboratorije za biološka, mikrobiološka, imunološka, hemijska, imunohematološka, hematološka, biofizikalna, citološka, patološka i druga ispitivanja humanog materijala. Ispitivanja u ovim laboratorijima se provode u svrhu pružanja informacija za dijagnozu, prevenciju i liječenje bolesti ili za procjenu zdravlja ljudi.

Medicinske laboratorije su ključne za sigurnost pacijenta, uzimajući u obzir da laboratorijski rezultati direktno utiču na postavljenu dijagnozu, a samim tim i na kvalitet zaštite zdravlja pacijenta.

Laboratorije (ispitne, kalibracione, medicinske), mogu imati uveden sistem upravljanja kvalitetom prema standardu ISO 9001 Sistem upravljanja kvalitetom – Zahtjevi, kao opšti standard za upravljanje organizacijom bilo kojeg tipa i veličine. Međutim, kako bi obezbjedili dokaze o kvalitetu razultata ispitivanja u medicinskom laboratoriju, neophodno je implementirati poseban standard ISO 15189 Medicinski laboratoriji – Zahtjevi za kvalitet i kompetentnost.

Akreditacija medicinskih laboratorija prema međunarodnom standardu, ISO 15189 demonstrira kvalitet i povjerenje korisnika ili pacijenta uslugama, koju pružaju medicinske laboratorije. Cilj rada laboratorija nije samo u dobivanju tačnih rezultata ispitivanja, nego provođenja ispitivanja na pacijentu u definisanom vremenskom okviru, korištenjem odgovarajućih procedura upravljanja radom laboratorije, poštujući etička načela, povjerljivost i sigurnost pacijenta.

Medicinske laboratorije mogu koristiti ISO 15189 standard u razvoju vlastitih sistema upravljanja kvalitetom i ocjeni kompetentnosti rada. Također, može se primijeniti za potvrdu ili prepoznavanje kompetentnosti medicinskih laboratorija od strane korisnika usluga laboratorije, regulatornih tijela i tijela za akreditiranje.

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