ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
Annex A (normative): Additional requirements for point-of-care testing – ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence

ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence A.2: POCT governance

What does A.2 require?

Final accountability rests with the organization's governing body for making sure there are processes that watch over the accuracy and quality of POCT performed anywhere in the organization. Every site that uses laboratory-supported POCT shall have a service agreement with the laboratory that sets out and communicates who is responsible for what and who has which authority, carries clinical approval (and financial approval where relevant), and is held with the POCT areas; a health professional body such as a medical advisory committee may administer these agreements.

Maintained by Gerard BlokdykControl text last updated

Other controls in Annex A (normative): Additional requirements for point-of-care testing – ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence

Query this from an agent

The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.