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  • Title: The most common nonconformities encountered during the assessments of medical laboratories in Hong Kong using ISO 15189 as accreditation criteria.
    Author: Ho B, Ho E.
    Journal: Biochem Med (Zagreb); 2012; 22(2):247-57. PubMed ID: 22838190.
    Abstract:
    INTRODUCTION: ISO 15189 was a new standard published in 2003 for accrediting medical laboratories. We believe that some requirements of the ISO 15189 standard are especially difficult to meet for majority of laboratories. The aim of this article was to present the frequency of nonconformities to requirements of the ISO 15189 accreditation standard, encountered during the assessments of medical laboratories in Hong Kong, during 2004 to 2009. MATERIALS AND METHODS: Nonconformities reported in assessments based on ISO 15189 were analyzed in two periods - from 2004 to 2006 and in 2009. They are categorized according to the ISO 15189 clause numbers. The performance of 27 laboratories initially assessed between 2004 and 2006 was compared to their performance in the second reassessment in 2009. RESULTS: For management requirements, nonconformities were most frequently reported against quality management system, quality and technical records and document control; whereas for technical requirements, they were reported against examination procedures, equipment, and assuring quality of examination procedures. There was no major difference in types of common nonconformities reported in the two study periods. The total number of nonconformities reported in the second reassessment of 27 laboratories in 2009 was almost halved compared to their initial assessments. The number of significant nonconformities per laboratory significantly decreased (P = 0.023). CONCLUSION: Similar nonconformities were reported in the two study periods though the frequency encountered decreased. The significant decrease in number of significant nonconformities encountered in the same group of laboratories in the two periods substantiated that 15015189 contributed to quality improvement of accredited laboratories. UVOD:: ISO 15189 je standard za akreditaciju medicinskih laboratorija objavljen 2003. Smatramo da je kod većine laboratorija nekim zahtjevima standarda ISO15189 posebno teško udovoljiti. Cilj ovog članka bio je iznijeti učestalost pojava nesukladnosti sa zahtjevima akreditacijskog standarda ISO 15189 s kojima smo se susreli tijekom ocjenjivanja sukladnosti medicinskih laboratorija u Hong Kongu tijekom razdoblja od 2004. do 2009. MATERIJALI I METODE:: Nesukladnosti zabilježene prilikom ocjenjivanja suglasnosti sa zahtjevima standarda ISO 15189 analizirane su u dva razdoblja – u razdoblju od 2004. do 2006. godine i 2009. godine. Kategorizirane su prema brojevima zahtjeva standarda ISO 15189. Sukladnosti 27 laboratorija prvotno su ocijenjene u razdoblju između 2004. i 2006. te su ti rezultati uspoređeni s ponovljenim ocjenjivanjem sukladnosti 2009. godine. REZULTATI:: Na području zadovoljavanja zahtjeva koji se odnose na upravljanje, nesukladnosti su najčešće bile zabilježene na području sustava upravljanja kvalitetom, zapisa o kvaliteti i tehničkih zapisa te upravljanja dokumentima, dok su na području tehničkih zahtjeva nesukladnosti zabilježene kod postupaka ispitivanja, laboratorijske opreme i osiguranja kvalitete postupaka ispitivanja. Nije bilo velikih razlika u tipovima nesukladnosti zabilježenih u dva razdoblja ispitivanja. Ukupan broj nesukladnosti zabilježen u drugom ocjenjivanju 27 laboratorija 2009. godine bio je upola manji od ukupnog broja nesukladnosti pri inicijalnom ocjenjivanju sukladnosti. Broj statistički značajnih nesukladnosti po laboratoriju značajno je smanjen (P = 0,023). ZAKLJUČAK:: Slične su nesukladnosti zabilježene u oba razdoblja, no smanjila se njihova učestalost pojavljivanja. Statistički značajno smanjenje broja značajnih nesukladnosti zabilježeno kod iste skupine laboratorija u oba ispitna razdoblja dokazuje da standard ISO 15189 doprinosi poboljšanju kvalitete u akreditiranim laboratorijima.
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