ISO 20364:2026

Description

This document outlines requirements for healthcare organizations to deliver diagnostic tests timely and accurately in a pandemic by leveraging innovative approaches to overcome the limitations of laboratory capacity as follows:

• mitigation of threats encountered in providing diagnostic services during a pandemic;
• consideration for quality assurance of diagnostic service provision in a pandemic context;
• possible response measures to the surge in diagnostic demand.

This document does not cover the specific procedures involved in providing pandemic-response medical tests, such as the specimen collection protocols in the specimen collection units or screening stations (e.g. walk-through or drive-through), experimental procedures and the quality management systems of medical laboratories. Furthermore, this document does not address the pandemic responses related to the medical treatment of infected patients in care units (e.g. emergency unit and in-patient unit) and the transferring of confirmed patients within the healthcare organization during a pandemic.