I have observed the evolution of medical laboratory quality management standards from Guide 25 to ISO/IEC 17025 and finally to ISO 15189. Despite advancements, significant gaps remain between these standards’ expectations and their practical application.
A major issue is the confusing language and terminology in ISO 15189, leading to misinterpretation among medical professionals. The standard’s focus on competence is crucial, yet it lacks clarity, specificity, and evidence-based recommendations, hindering its effectiveness.
We must revise our standard-writing methodology to ensure quality and competence. Current standards suffer from ambiguity, redundancy, and impracticality. It’s essential to create clear, specific standards based on validated, implementable practices, emphasizing best practices and maintaining high quality despite resource limitations. The standard should be user-friendly, motivating, and practical, with clear requirements and objective evidence criteria to minimize discrepancies during assessments. Incorporating a robust feedback mechanism will ensure continuous improvement and relevance.
My detailed review of ISO 15189:2022 highlights these deficiencies and calls for an urgent revision. I encourage you to download my review and raise your voice to the ISO Technical Committee TC 212, your national standard body, ILAC, regional cooperation, and your country’s accreditation board. Together, we can advocate for a global quality standard that truly serves the needs of medical laboratories and ensures excellence in healthcare.
Download the ISO 15189:2022 deficiency analysis and review from the following link:
https://blog.quality-pathshala.com/Exposing_Deficiencies_in_ISO_151892022.pdf
About the Author
Dr. Sambhu Chakraborty is a distinguished consultant in quality accreditation for laboratories andhospitals. With a leadership portfolio that includes directorial roles in two laboratory organizations and a consulting firm, as well as chairman of International Organization of Laboratories ( An ILAC stakeholder organisation), Dr. Chakraborty is a respected voice in the field. For further engagement or inquiries, Dr. Chakraborty can be contacted through email at info@sambhuchakraborty.com and contact information are available on his websites, https://www.quality-pathshala.com and https://www.sambhuchakraborty.com , or via WhatsApp at +919830051583.