"Quality Management"

New ISO 15189 Book Published to Help Clinical Lab Managers

‘A Practical Guide to ISO 15189 in Laboratory Medicine’ was authored by clinical chemist David Burnett, Ph.D.

THERE IS NOW A COMPREHENSIVE GUIDE for lab executives and lab managers interested in learning more about ISO 15189:2012, the latest version of the quality management system (QMS) for medical laboratories.

It is a book titled: “A Practical Guide to ISO 15189 in Laboratory Medicine” and was published last fall by a division of the Association of Clinical Biochemistry and Laboratory Medicine in the United Kingdom.

The book is devoted to the latest update of the QMS, known as ISO 15189: 2012 Medical Laboratories. It was written by David Burnett, OBE, Ph.D., FRCPath of the United Kingdom. He is known to many active members of the American Association of Clinical Chemistry for his long service as a Consultant Clinical Biochemist to the St. Albans and Hemel Hempstead NHs Trust in England, prior to his recent retirement.

Burnett has produced an information-packed book of 372 pages. It is likely to be considered the definitive guide to ISO 15189: 2012 and will be a comprehensive resource for lab managers wanting to better understand how to earn accreditation to ISO 15189 and then sustain the benefits that it can produce for the medical laboratory.

Here in the United States, few lab managers understand the role that ISO— the International Organization for Standardization—has in establishing standards for quality that make it easier for companies and organizations across the globe to get international acceptance for their different products and services. More than 164 countries participate in ISO’s Central Secretariat.

Insights into ISO 15189

In his book, Burnett provides a clear description of ISO, along with how ISO 15189 was created and is updated. He provides clarity on the organization of the various sections of ISO 15189 and how they work together as a comprehensive quality management system within a medical laboratory organization.

It is likely that lab managers and pathologists embarked on the journey to earn ISO 15189 accreditation in their laboratory will find Burnett’s book to be a necessary complement to the ISO 15189 standards. His book explains each of the requirements in the standards, providing context and examples.

Burnett is uniquely qualified to author this book. He served on the ISO Technical Committee 2012–Working Group 1 that produced the third version of ISO 15189 that was issued in 2012. This provided him with direct understanding about the revisions and updates that were incorporated into ISO 15189: 2012.

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