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ISO 20364:2026

Healthcare organization management — Pandemic response — Requirements for surging diagnostic demand

Standard Details

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.

General Information

Status : Published
Standard Type: Main
Document No: ISO 20364:2026
Document Year: 2026
Pages: 15
Edition: 1
  • Section Volume:
  • ISO/TC 304. Healthcare organization management
  • ICS:
  • 11.020.01 Quality and environmental management in health care *Including quality and environmental management in health care technology *Health care management systems, see 03.100.70 *IT applications in health care technology, see 35.240.80

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ISO 20364:2026
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