Skip to main content Scroll Top

News

Publication of the revision of EA-4/20 Guidance for the assessment of laboratories against EN ISO 15189:2022 Point-of-Care Testing

EA published the revision of the document EA-4/20 Guidance for the assessment of laboratories against EN ISO 15189:2022 Point-of-Care Testing (POCT) on 21 April 2026.

The document has been revised to comply with EN ISO 15189:2022 Medical laboratories — Requirements for quality and competence, since the requirements of EN ISO 22870 Point-of-care testing (POCT) — Requirements for quality and competence are now included, and comply with EA-2/15 M EA Requirements for the Accreditation of Flexible Scopes.

The document is intended for National Accreditation Bodies (NABs) that assess point-of-care testing (POCT) in the field of laboratory medicine and for medical laboratories that are responsible for point-of-care testing.

The scope of this document extends to the following:

a) Medical laboratories including both private institutions and government organizations who provide POCT within the boundaries of their own organization;

b) Medical laboratories that provide POCT to external organizations. Results from POCT remain under the overall responsibility of the medical laboratory (POCT provider).

Download the document here

To go further

Related Posts