A practical guide to ISO 15189 in laboratory medicine

ISO 15189 - the standard for the medical laboratory -- Defining and managing quality in the medical laboratory -- Organisation and management responsibility -- Quality management system -- Personnel -- Accommodation and environmental conditions, includin occupational health and safety -- Laboratory equipment, reagents, consumable (IVD) and external services -- Pre-examinatuion and post-examination process -- Examination processes and ensuring the quality of examination results -- Evaluation and continual improvement.

Includes bibliographical references and index.

Written by Dr David Burnett OBE, former Consultant Clinical Biochemist at the St Albans & Hemel Hempstead NHS Trust, this book is primarily intended as a practical guide for laboratory professionals wishing to implement the International Standard, ISO 15189:2012 Medical laboratories – Requirements for quality and competence in their laboratories, but will also be useful to peer review assessors or full time assessors working for accreditation bodies.