[Guidelines for documentation management mastery according to the EN ISO 22870].
This article proposes to organize the documentation system of point-of-care testing (POCT) to meet the requirements of EN ISO 22870. In a first part, we propose provisions to improve the control of documents circulating outside the laboratory and aimed at non-laboratory staff. Then we review POCT-related records and we propose an organization facilitating their audit. In the last part, a model of POCT quality plan is proposed : in addition to the quality manual, this document defines the specific measures taken in order to ensure the control of POCT.
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Pernet
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Szymanowicz
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Goudable
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Guimont