The most common nonconformities encountered during the assessments of medical laboratories in Hong Kong using ISO 15189 as accreditation criteria

Bella Ho, Eric Ho
2012 Biochemia Medica  
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 diffi cult 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
more » ... 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 diff erence 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 signifi cant nonconformities per laboratory signifi cantly decreased (P = 0.023). Conclusion: Similar nonconformities were reported in the two study periods though the frequency encountered decreased. The signifi cant decrease in number of signifi cant nonconformities encountered in the same group of laboratories in the two periods substantiated that ISO15189 contributed to quality improvement of accredited laboratories.
doi:10.11613/bm.2012.027 fatcat:z37fpvhimrfezgsovfsjaxczui