Accreditations & Certifications
“When things don’t work as they should, it often means that standards are absent.”
The ISO 15189 standard is an international quality standard for medical and clinical laboratories. Since 2007 and until its latest version update in 2022, this standard sets the requirements for quality management, technical processes, and competence in medical laboratories. Therefore, the ISO15189:2022 standard promotes confidence and high quality in medical laboratories’ analysis and results generation.
The ISO 15189 standard is based on both ISO 9001 and 17025 standards for quality and process requirements. The ISO 9001 standard refers to quality management requirements and ISO 17025 standard provides requirements for testing and calibration laboratories. However, the ISO 15189:2022 standard is destined for medical laboratories, detailing the examination processes and equipment requirements to comply with the standard and to provide high-quality and reliable results.
The ISO 15189 standard like the ISO 17025 has 5 main requirements. However, there are 5 additional criteria dedicated to medical laboratories:
- Collecting and sharing data on the procedures, sample volumes, and sample containers;
- Implementing ethical practice;
- Cooperating between clinical staff and the medical laboratory which is responsible for providing a quality service to clinicians providing patient samples for testing;
- Giving council on the different ways of testing and various samples that may be needed in laboratories;
- Adding notes and remarques on the analysis results related to the diagnosis and patient care.