CSA 15189HB:25 ✓ Most Recent

Preface 

This handbook provides guidance and tips on the use of the fourth edition of ISO 15189, Medical laboratories — Requirements for quality and competence, published in 2022. While the Standard can be used as the basis for accreditation, the primary objective of this handbook is to provide management system practitioners with a concise, user-friendly guide to understanding and implementing the requirements of ISO 15189:2022 and to make medical laboratory services better for patients, healthcare professionals, laboratory personnel, and the community. CSA gratefully acknowledges the valuable work of the task force members: Angela Lee, David Mortimer, Dominique Lapointe, Sheila Woodcock, Sindhu Nair, and Susanna Darnel, under the leadership of Robert Rennie and Michael Noble, with contributions from Liz McBride. This task force operated under the jurisdiction of the CSA Z252 technical committee on Medical Laboratory Quality Systems.