(Superseding IS 17723 : 2021/ISO 22870 : 2016)

Revised Standard from Last Update.

NATIONAL FOREWORD

This Indian Standard (Third Revision) which is an identical adoption of ISO 15189 : 2022 ‘Medical Laboratories - Requirements for Quality and Competence’ issued by the International Organization for Standardization (ISO), was adopted by the Bureau of Indian Standards on the recommendation of theHospital Planning Sectional Committee and approval of the Medical Equipment and Hospital Planning Division Council.

This standard was first published in 2005 based on ISO 15189 : 2003 and was subsequently revised in 2010 and 2014 to align its requirements with ISO 15189 : 2007 and ISO 15189 : 2012 respectively. This revision has been undertaken to align with ISO 15189 : 2022.

This standard also gives the requirements for quality and competence for point-of-care testing (POCT), which were earlier given in ISO 22870 : 2016. With the publication of this standard, IS 17723 : 2021 ‘Point-of-care testing (POCT) Requirements for quality and competence’ which was an identical adoption of ISO 22870 : 2016 stands withdrawn.