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!
September 2007
Total Error. Trueness. Uncertainty. Can these terms coexist? Under ISO, will defining an allowable error for a test become unacceptable? Will the embrace of ISO accreditation mandate the rejection of all non-ISO-conforming terminology and concepts?
The debate - and the future - is uncertain.
February 2007
We need some truthful guidance about Trueness, Uncertainty and Quality. This year's regulations feature new terminology that adheres to ISO conventions. As we leave behind our familiar concepts of precision, bias, and total error, are we gaining anything? Are we just changing names, or are we changing our goals, too?
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)