What is ISO 15189:2012 Certification?
ISO 15189:2012 certification is an international standard specifying requirements for quality and competence in medical laboratories. It ensures laboratories meet stringent criteria for testing, calibration, and quality assurance, enhancing reliability and confidence in laboratory results.
Key Features and Benefits of ISO 15189:2012 Certification:
Quality Management System: Establishes a framework for quality management tailored to medical laboratory operations.
Quality Control Measures: Includes protocols for internal quality control and proficiency testing to monitor and improve testing accuracy.
Risk Management: Implements measures to reduce risks to patient safety and testing precision.
Continual Improvement: Promotes continual improvement in laboratory processes and quality management systems.
Stakeholder Confidence: Instills trust in the laboratory's testing reliability for patients, providers, regulators, and insurers.
Professional Development: Encourages continuous training to enhance laboratory staff skills and expertise.
