Biomedical Laboratory techniques

Quality control in biomedical services aims to ensure the reliability, safety, and effectiveness of activities carried out in clinical laboratories, biotechnology, and medical device production. Understanding the fundamental principles of quality, assurance, and control involves distinguishing between Quality Assurance activities, focused on prevention and the definition of procedures and standards, and Quality Control activities, aimed at verifying results and ensuring product or service conformity. The application of regulations and standards such as ISO 9001 and ISO 13485, together with European MDR and IVDR regulations, guarantees compliance with national and international requirements. Statistical process control, control charts, and process capability analysis are essential tools for monitoring quality and identifying significant deviations. The qualification of equipment and facilities, validation of methods and processes, calibration, and traceability ensure reproducibility and reliability of results. Finally, the management of nonconformities through root cause analysis, implementation of corrective and preventive actions, and internal and external audits promotes continuous improvement of the quality system and the maintenance of high standards in biomedical services.