BS EN ISO 15195:2019 - Quality Assurance in Healthcare Technology

The BS EN ISO 15195:2019 is a key British Standard that provides essential guidelines for the validation of medical laboratory tests. Specifically aimed at diagnostic laboratories, this standard offers a comprehensive framework for quality assurance, ensuring that laboratories can produce reliable and accurate test results, which are critical for patient diagnosis, treatment, and safety.

Published on February 6, 2019, this standard is identical to both the ISO 15195:2018 and the earlier referenced ISO standards, affirming its international recognition in establishing the protocols for the measurement of uncertainty and calibration of test methods used in medical diagnostics. By adhering to this standard, laboratories can ensure a consistent and dependable approach in validating the performance of in vitro diagnostic devices and test procedures.

The BS EN ISO 15195:2019 also outlines specific criteria related to the performance characteristics that medical laboratories must demonstrate, including accuracy, precision, and analytical sensitivity. This ensures that laboratory results are not only trustworthy but also compliant with regulatory requirements and best practice standards.

Investing in the BS EN ISO 15195:2019 is a vital step for any healthcare institution aiming to enhance its laboratory services. The standard is particularly beneficial for laboratory managers, quality assurance professionals, and medical practitioners involved in diagnosing and treating patients based on laboratory findings. By implementing the protocols defined in this standard, organizations can fortify their reputation for quality and reliability in healthcare technology.

This publication is available for purchase in both PDF and hardcopy formats, priced at £222.00. Ensure your laboratory meets the highest standards of accuracy and reliability - order your copy of the BS EN ISO 15195:2019 today and take a significant step toward excellence in healthcare diagnostics.