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 latest (2012) version of ISO 15189, a few key words were dropped from an important sentence about measurement uncertainty. In previous versions, uncertainty was required "where relevant and possible." In the new version, laboratories don't have a choice. They must calculate measurenment uncertainty, even when irrelevant and impractical. The only certainty now about measurement uncertainty is that ISO has made it a commandment. Thou shalt MU!
Uncertainty is an ISO-driven metrological concept. For years, while it has been popular in Europe, uncertainty has been discussed in the US, but never implemented. Now that CLSI has issued its C51A guideline, uncertainty is now official in the US, too. The C51 guideline is worth exploring in detail, for those who seek metrological orthodoxy in their testing processes.
October 2007
Looking beyond the terminology of Trueness and Uncertainty, Dr. Westgard examines the intended uses and customers of these terms. If we spend our time fighting about Metrological definitions, are we serving the patient?
October 2007
Trueness. Uncertainty. Accuracy. Precision. Why are there so many definitions for the same terms? Dr. Westgard traces the history of metric concepts in the clinical laboratory. See when and where ISO, IFCC, and CLSI began introducing new terminology into the lab.