ISO
Welcome to the Westgard website's ISO section. Here, you will find information on quality management systems in medical laboratories, focusing on ISO 15189 standards, including its 2017 version, and how it relates to ISO lab accreditation. Essays may cover the benefits of achieving 15189 lab accreditation, the requirements for implementing an ISO 15189 quality management system, and the role of ISO for laboratory quality. Some articles might also discuss the connection between ISO 15189 medical laboratories and ISO 17025 calibration requirements, exploring how 15189 calibration services contribute to overall quality.Feel free to explore this category!
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.
The CLSI came out with a recommendation on Validation of User QC for ISO. Dr. Westgard reviews these recommendations, and examines the ISO system as a whole. (Preview)
Do you know the new ISO terms? Dr. Westgard weighs in on the new terminology and suggests there are practical applications for the new uncertainty concepts as well as the old error concepts. He also asks, should we be spending time improving terminology or improving lab performance?
(Preview)
December 2007
After traveling to five continents in 2007, Dr. Westgard gained a new perspective on US healthcare. As our healthcare system fails, the world is watching.