Evidence for the positive impact of ISO 9001 and ISO 15189 quality systems on laboratory performance – evaluation of EQA results (June 2018)
ISO 9001 and ISO 15189 have been established as continuative models for quality systems beyond national laws, mandatory standards and guidelines of expert associations regarding analytical and organisational performance of medical laboratories and transfusion services.
The report reviewed more than 52,000 EQA results over a 19 year period, and the absence or presence of a laboratory quality management system showed different error rates. Laboratories with ISO 9001 or ISO 15189 certification/accreditation had 0.7% incorrect results, while this rate was doubled without such quality systems (1.4%, p = 0.0002). Statistically significant error reductions were seen upon ISO 9001/ISO 15189 implementation (1.3% before vs. 0.7% after; p = 0.0468). Transfusion services had fewer errors (0.9%) compared to hospital and independent laboratories (both 1.2%).
The report therefore concludes that the Implementation and maintenance of quality systems according to ISO 9001 or ISO 15189 as well as laboratory specialisation result in better analytical performance as can be seen in immunohaematology EQA results.
A copy of the paper can be accessed here (payment required).
Authors: Christoph Buchta*, Wim Coucke, Wolfgang R. Mayr, Mathias M. Müller, Reinhard Oeser,
Christian R. Schweiger and Günther F. Körmöczi (June 2018)