What is EN ISO 27247:2011?

EN ISO 27247:2011 is a professional technical standard that provides guidelines for the design and implementation of quality management systems specifically tailored for medical laboratories. This standard ensures that medical laboratories meet the highest levels of quality and accuracy in their testing and analysis procedures.

Key Requirements

The EN ISO 27247:2011 standard outlines several key requirements that medical laboratories must adhere to:

Competence and ongoing education of laboratory personnel: The standard emphasizes the importance of having qualified and competent staff who are continuously trained to keep up with the latest advancements in medical testing techniques.

Quality control and proficiency testing: It is essential for laboratories to have rigorous quality control measures in place, ensuring the accuracy and reliability of test results. Proficiency testing is also crucial for maintaining high standards and identifying areas for improvement.

Documented procedures and record keeping: The standard requires medical laboratories to have well-documented procedures for all processes and maintain comprehensive records of all activities. This ensures traceability and accountability.

Benefits of Compliance

Compliance with EN ISO 27247:2011 offers various benefits to medical laboratories:

Improved patient care: By adhering to this standard, laboratories can ensure the reliability and accuracy of test results, leading to better diagnosis and treatment decisions, ultimately improving patient outcomes.

Enhanced reputation: Compliance demonstrates a commitment to quality and competence, which helps build trust among patients, healthcare professionals, and regulatory authorities. A positive reputation can lead to increased referrals and business opportunities.

Operational efficiency: Implementing the standard's guidelines can streamline laboratory processes, reduce errors, and improve overall operational efficiency. This leads to cost savings and quicker turnaround times for test results.

Conclusion

EN ISO 27247:2011 is a critical standard for medical laboratories to ensure the highest levels of quality, accuracy, and patient care. Compliance with this standard not only benefits the laboratory itself but also improves healthcare outcomes and establishes trust in the medical community. By following the requirements outlined in EN ISO 27247:2011, laboratories can continuously improve their processes and demonstrate their commitment to excellence.