Abstract
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.
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