Guidelines for point-of-care testing quality management according to ISO 22870

P. Pernet; A. Szymanowicz; C. Oddoze; A. Vassault; V. Annaix; A. Gruson; M. Boisson

doi:10.1684/abc.2012.0680



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Guidelines for point-of-care testing quality management according to ISO 22870
Annales de Biologie Clinique. Volume 70, Number 1, 185-206, Hors série n°1, Février 2012 - Recommandations pour l’Accréditation des laboratoires de biologie médicale - Volume 2, Qualité et accréditation en biologie médicale. Biologie délocalisée
Résumé PDF
Author(s) : P. Pernet, A. Szymanowicz, C. Oddoze, A. Vassault, V. Annaix, A. Gruson, M. Boisson
Summary : In this paper, we focus on the additional requirements of EN ISO 22870 compared to those described in Chapter 4: Quality Management of EN ISO 15189. They concern the quality policy, the management reviews and the audits. Thus, we propose a template of quality policy statement, and specific requirements for conducting management review of POCT are given. Finally, a questionnaire for performing an audit of POCT activities is proposed. The composition and activities of the multidisciplinary group for the supervision of POCT activities, which is also a specific requirement of EN ISO 22870, is discussed in another article of this volume.
Keywords : accreditation, point-of-care testing, ISO 22870, quality policy, management review, audit