What is EN ISO 27311:2011?

EN ISO 27311:2011 is a technical standard that specifies the requirements for medical laboratories using automated systems for the identification and characterisation of microorganisms. It covers the principles, requirements, and guidance on the use of these systems in laboratory practice.

The Importance of EN ISO 27311:2011

This standard plays a crucial role in ensuring the accuracy, reliability, and comparability of test results in medical laboratories. By providing guidelines for the use of automated systems, it helps professionals to achieve consistent and high-quality outcomes in their microbiology analyses.

Key Guidelines in EN ISO 27311:2011

EN ISO 27311:2011 outlines several important guidelines for medical laboratories. Firstly, it establishes the need for appropriate validation and verification of automated systems. This ensures that the methods used are suitable for the intended purpose and produce reliable results.

Furthermore, the standard emphasizes the importance of quality control measures. Laboratories must regularly monitor the performance of their automated systems, including assessing precision, accuracy, and method comparison.

Implementing EN ISO 27311:2011

To implement EN ISO 27311:2011 effectively, medical laboratories need to carefully select, install, and operate appropriate automated systems. Adequate training should be provided to personnel involved in the testing processes, ensuring they understand the principles and procedures outlined in the standard.

Regular audits and inspections are also necessary to assess compliance with the standard's requirements. These assessments help identify areas for improvement and ensure ongoing adherence to the specified guidelines.

Conclusion

EN ISO 27311:2011 serves as a critical reference for medical laboratories using automated systems in the identification and characterisation of microorganisms. By following its guidelines, professionals can ensure the quality, reliability, and accuracy of their laboratory analyses, ultimately benefiting patient care.