[Guidelines for documentation management mastery according to the EN ISO 22870]

Ann Biol Clin (Paris). 2012 Feb:70 Spec No 1:207-31. doi: 10.1684/abc.2012.0681.
[Article in French]

Abstract

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.

Publication types

  • English Abstract