The key points are

1. The standard emphasises the implementation of a Quality Management System (QMS) to ensure consistent and reliable laboratory results.

2. It addresses technical aspects such as personnel qualifications, equipment calibration, and the validation of test methods to maintain accuracy and reliability.

3. ISO 15189 aims to enhance patient care by ensuring that laboratories deliver accurate and timely results, which is essential for diagnosis and treatment.

4. The standard includes requirements for risk management to identify and mitigate potential issues that could impact the quality of laboratory services.

5. Laboratories are encouraged to continuously improve their processes and services through regular audits, feedback, and corrective actions.