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

P Pernet, A Szymanowicz, C Oddoze

Annales De Biologie Clinique

|June 28, 2012

Summary

This paper details quality management requirements for point-of-care testing (POCT) under EN ISO 22870, offering a quality policy template, management review guidelines, and an audit questionnaire for enhanced POCT quality.

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Area of Science:

Medical Laboratory Science
Quality Management Systems

Context:

EN ISO 15189 outlines general quality management for medical laboratories.
EN ISO 22870 specifies additional requirements for point-of-care testing (POCT).

Purpose:

To delineate the specific quality management requirements of EN ISO 22870 beyond EN ISO 15189.
To provide practical tools for implementing these POCT-specific requirements.

Summary:

Focuses on quality policy, management reviews, and audits as per EN ISO 22870.
Proposes a quality policy statement template.
Details requirements for POCT management reviews and introduces an audit questionnaire for POCT activities.

Impact:

Facilitates compliance with EN ISO 22870 for POCT services.
Aids in establishing robust quality systems for point-of-care testing.
Supports the consistent delivery of high-quality diagnostic testing outside traditional laboratories.