ISO15189 - The Four Components of a Quality Management System

Medical laboratories are a critical part of the healthcare system. A patient’s diagnosis and treatment are often based on test results, and an incorrect test result could lead to a misdiagnosis — which could have potentially fatal consequences. This is why accurate test results are critical — each and every time a test is conducted. In order to improve the accuracy of results, medical labs around the world have begun adopting ISO 15189: Medical laboratories—particular requirements for quality and competence. The standard requires medical labs to implement a quality management system. This requires them to document all their processes and procedures to ensure lab technologists always understand and follow the correct method when conducting a test.

This white paper provides an overview of the four main components of a quality management system:

1. Management Responsibility
2. Resource Management
3. Service Realization
4. Measurement, Analysis & Improvement

Download free white paper here (registration needed):
ISO 15189 Medical Laboratories: Understanding the Four Components of a Quality Management System

Source: Dark Daily