Lab Processes and Procedures / Laboratory Quality Control

ISO 15189 Medical laboratories: understanding a quality management system

ISO 15189 Medical Laboratories: Quality Management SystemMedical laboratories are a critical part of the healthcare system. A patient’s diagnosis and treatment are often based on test results, and an incorrect laboratory test result could lead to a misdiagnosis, which has potentially fatal consequences. This is why accurate results are critical every single time a test is conducted.

To improve the accuracy of results, medical laboratories worldwide are adopting ISO 15189: Medical laboratories— particular requirements for quality and competence.  The standard requires laboratories to implement a quality management system,  examine all of their processes and procedures, document them, relay them to employees, and evaluate their effectiveness.

A newly-published white paper, “ISO 15189 Medical Laboratories: Understanding the Four Components of a Quality Management System,” provides a useful road map to help laboratories implement the internationally recognized standard.  A chapter is devoted to each of the four components, as well as the Deming Cycle which organizations can use to achieve continual improvement of their quality management system.

Ultimately, the White Paper will help employees understand what procedures to follow and how to implement quality indicators.  This in turn will help employees find weak points in their processes so they can improve them.  More importantly, clinical laboratories and anatomic pathology groups can address pre- and post-analytical processes where the majority of errors occur.

By adopting ISO 15189, top-level management will be able to take ownership of their quality management system by setting up the policies that guide it. A case study profiles a laboratory that successfully implemented ISO 15189 and the Deming Cycle.

Gregory J. Flynn, BSc, MD, FRCPC, co-author of the White Paper, is chief executive officer, Institute for Quality Management in Healthcare (IQMH), and managing director, Quality Management Program—Laboratory Services (QMP–LS).  Julie Coffey, MLT, ART, CQA, CMQ/OE (ASQ), co-author, is a staff technologist and quality manager from the Ontario Laboratory Accreditation division of QMP–LS, a partner of IQMH.

This White Paper, “ISO 15189 Medical Laboratories: Understanding the Four Components of a Quality Management System” is available as a free PDF download.  It is part of the Dark Daily Resource Center which has a growing library of White Papers and other information resources tailored specifically for the needs of laboratory administrators, lab managers, pathologists, and lab industry consultants.



About Randox

Headquartered in the United Kingdom, Randox Laboratories Ltd. is a market leader within the in vitro diagnostics industry, manufacturing high quality diagnostic products for laboratories worldwide. Our extensive product portfolio offers complete solutions within the fields of clinical chemistry, cardiology, forensic toxicology, veterinary, drug residues, life sciences, oncology, molecular diagnostics and internal and external quality control. Our goal is to ‘revolutionise healthcare through continuously improving diagnostic solutions.’ We continue to achieve this year after year due to our commitment and significant re-investment in Research and Development. Our innovative approach to diagnostics allows us to develop revolutionary products, specifically designed to provide more efficient, higher quality and reliable results, ensuring patients receive the right diagnosis at the right time.

One Comment

  1. am so greatful for the information in this website.

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