What is EN ISO 27290:2011?

EN ISO 27290:2011 is a technical standard that outlines the requirements for a quality management system in medical laboratories. This standard was published by the International Organization for Standardization (ISO) and the European Committee for Standardization (CEN). It provides guidelines for implementing a quality management system in accordance with international best practices.

The Purpose of EN ISO 27290:2011

The purpose of EN ISO 27290:2011 is to ensure that medical laboratories meet certain standards in their operations. The standard focuses on areas such as management responsibility, resource management, process control, and continual improvement. By implementing this standard, medical laboratories can enhance the quality of their services, improve patient safety, and reduce the risks associated with their activities.

Key Requirements of EN ISO 27290:2011

The standard specifies several key requirements that need to be met by medical laboratories. These include:

Documented Quality Management System: Medical laboratories need to establish and maintain a documented quality management system that complies with the requirements of EN ISO 27290:2011. This system should outline the laboratory's policies, objectives, processes, and procedures.

Competence of Personnel: Laboratories should ensure that their personnel have the necessary qualifications, skills, and training to perform their duties effectively and competently. Competency assessments and ongoing professional development should also be conducted.

Equipment and Facilities: Laboratories must have suitable equipment, facilities, and support services to carry out their testing and calibration activities. These should be regularly maintained, calibrated, and validated to ensure accurate and reliable results.

Process Control: EN ISO 27290:2011 emphasizes the importance of effective process control in medical laboratories. This includes the identification and management of risks, implementation of internal quality control measures, participation in external proficiency testing, and proper handling of samples.

Continual Improvement: Medical laboratories should strive for continual improvement by monitoring their performance, conducting internal audits, and taking corrective and preventive actions when necessary. The standard encourages laboratories to learn from their mistakes and use feedback to drive improvements.

In Conclusion

EN ISO 27290:2011 is a technical standard that provides guidelines for implementing a quality management system in medical laboratories. By adhering to this standard, laboratories can enhance the quality of their services, ensure patient safety, and meet international best practices. It outlines key requirements related to documentation, competence of personnel, equipment and facilities, process control, and continual improvement. Implementing EN ISO 27290:2011 can help medical laboratories deliver reliable and accurate test results and contribute to overall healthcare quality.