Tools, Technologies and Training for Healthcare Laboratories


Basic Quality Management Systems

 Westgard QC is proud to announce the publication of a new book, Basic Quality Management Systems.

Basic Quality Management Systems

essentials for implementing quality management in the medical laboratory

Basic Quality Management Systems

2014, 290 pages, 9" by 6" paperback
ISBN 1-886958-28-9
ISBN-13 978-1-886958-28-9
List price: $80.00

Download the Preface, Table of Contents, Index and Chapter Excerpts of this book.

Order the book now online.

[Special discount: Save 15% off the cost of the book with the coupon code SAVEMYQSYSTEM.
The fine print: Online store only, cannot be combined with other offers. One coupon per order, per customer. Expires March 30th, 2015.]

For medical laboratories in the US, it's become clear that CLIA compliance is no longer enough to assure the quality of testing. For laboratories that want to thrive and prosper - and beat out their competition - something more robust is required.

For laboratories around the rest of the world, ISO 15189 is the de facto standard for quality, often directly referenced as the regulatory basis for the laboratory. Yet despite the availability of the ISO 15189 standard, the provisions are not well understood, and practical implementation is often a mystery. Rather than contract expensive consultants, now laboratories can start with a smaller step: an overview of the different aspects and provisions of the standard.

What's a laboratory to do?

In this vital new manual, Dr. James O. Westgard, sorts through all the ISO standards, CLSI guidelines, WHO and CDC recommendations, as well as the trends and fads, distilling Quality Management Systems into something less fuzzy and more concrete. With practical step-by-step directions, laboratories can begin their QMS journey immediately

What's in Basic Quality Management Systems?

  • 17 Chapters
  • Index
  • Discussion of all ISO 15189, CLIA General Laboratory System Regulations, WHO/CDC/CLSI guidelins
  • Practical guide to the CLSI guidelines, ISO standards, CLIA Final Rules as well as Accreditation Requirements
  • Demonstration of Two laboratories that implemented ISO 15189 QMS
  • Compliance is no longer enough

What topics are covered?

  • Deming's "Plan-Do-Check-Act" cycle - the fundamental building block for developing scientific quality managment processes
  • Three-stage implementation model focusing on management requirements, technical requirements, and inspection/accreditation
  • Application of a Six Sigma Quality Management System, using the powerful tools and concepts from the Six Sigma movement to accelerate QMS implementation
  • Introduction of Westgard Sigma Rules™ as a simpler approach for matching the QC needed to the performance of the method
  • Introduction of Sigma Proficiency Assessment Charts as a Quality Monitor for External Quality Assessment and Proficiency Testing programs, enabling the estimation of measurement uncertainty
  • Examples of real-world laboratories that have implemented ISO 15189 QMS both in the US and abroad

So  do I really need to understand Quality Management Systems?

Rather than making an uncoordinated set of attempts to assure quality, the Quality Management System unifies, systematizes, and standardizes Quality in the medical laboratory. It heightens Quality Management to the level of organizational culture. It ingrains the correct practices into the entire staff. While this seems like a tall order, Dr. Westgard shows practical ways to implement indicators, checklists, and benchmarks to achieve this level of quality.