About ISO 15189:2012

ISO 15189:2012 is an international standard for quality management and competence in medical laboratories. It specifies the requirements for a laboratory’s quality and competency to ensure accurate and reliable results for patient care. The certification is essential for laboratories involved in diagnostic testing, medical research, and other health-related services.

The standard focuses on aspects like personnel qualifications, laboratory environment, equipment calibration, and effective process management. It emphasizes the need for strong quality control systems, regular assessments, and adherence to ethical practices. Laboratories must demonstrate continuous improvement and maintain compliance with regulatory requirements.

Achieving ISO 15189:2012 certification enhances the credibility of a medical laboratory, promoting trust with healthcare providers and patients. It ensures that laboratories meet high standards of accuracy, safety, and efficiency, helping improve patient outcomes and streamline healthcare services.