Tools, Technologies and Training for Healthcare Laboratories

Quality Management - the Gospel according to ISO

In the face of failed CLIA regulations, where do we now turn? We may need to look to standards and practices outside the US. With this in mind, Dr. Westgard introduces a new series of articles about ISO and quality management. Guest authors Dr. Rogerio Rabelo and Dr. Daniel Perigo come to us from Fleury Diagnostics in Brazil, where they have experienced the ISO certification process.

February, 2004

With this update of Westgard Web, we are beginning a new series on quality management - the gospel according to the International Standards Organization, otherwise known as ISO. We’re very pleased to bring you this series from Rogerio Rabelo, M.D, Ph.D, and Daniel Marques Perigo, R.Ph. While we provide many materials on quality management on this website, we have not explored ISO in any depth. We will start to fill that void with this new series. Drs. Rabelo and Perigo start the series with an introduction to the Basics and Perspectives of ISO.

Our intention is to provide an opportunity to learn about ISO from people who have implemented ISO in their own laboratory. Most of us in the US have a long history with laboratory inspection and accreditation, usually by CAP or JCAHO or COLA or CMS. ISO has not been a strong influence in the US, except in industry. However, in the rest of the world, ISO often leads the way to improvements in quality management in industry as well as in laboratories.

I will admit to taking an occasional poke at ISO, particularly the Guide to Uncertainty in Measurements(GUM) which seems to have become an integral part of ISO. While GUM has been accepted in other industries, it presents some real problems when applied in laboratories, as discussed elsewhere on this website.

Reluctantly, I am becoming convinced that international guidelines, external to the US, will be necessary to assure the quality of laboratory testing in the US. I view CLIA as a complete failure, turning laboratory QC into “quality-less compliance.” Any hope for improving laboratory quality is gone with the CLIA Final Rule and the CMS Interpretive Guidelines. The newly announced “equivalent QC” procedures are proof that only the appearance of quality matters, not quality itself.

ISO may offer us another, hopefully, better approach. ISO coupled with professional initiative and responsibility for quality certainly would move laboratories in the right direction. Most anything will be better than the compliance mentality that has resulted from the current US regulatory environment.

I’m pretty much in the same boat as many of you when it comes to ISO. That’s why we solicited this series from Rogerio and Daniel who are responsible for implementing ISO at Fleury Diagnostics in Brazil. I met Rogerio through Liz MacNamara, a long time friend and colleague who mentored Rogerio in post-graduate studies in Montreal. I trust Liz to give me good advice, and likewise, I trust Rogerio and Daniel by association. See About the Authors for more information and background about Rogerio, Daniel, and Fleury Diagnostics.

Let’s learn about ISO and see what’s possible!


James O. Westgard, PhD, is a professor of pathology and laboratory medicine at the University of Wisconsin Medical School, Madison. He also is president of Westgard QC, Inc., (Madison, Wis.) which provides tools, technology, and training for laboratory quality management.