What is ISO 11485:2015?

ISO (International Organization for Standardization) 11485:2015 is a technical standard that provides guidance and requirements for the calibration and performance verification of measuring equipment used in medical laboratories. This standard ensures the accuracy, reliability, and traceability of measurements in order to maintain the quality and safety of medical testing.

Importance of ISO 11485:2015

Accurate and reliable measurement is crucial in medical laboratories as it directly affects patient diagnosis, treatment, and overall healthcare outcomes. ISO 11485:2015 plays a vital role in ensuring the quality and integrity of laboratory results and facilitates comparability of measurements worldwide.

This standard establishes a framework for performing calibrations and verifying the performance of measuring equipment, which includes analyzing measurement uncertainty, determining traceability to recognized standards, and conducting systematic testing procedures.

Calibration and Performance Verification

The calibration process defined by ISO 11485:2015 involves comparing the readings of measuring instruments against known references or certified standards. It aims to eliminate or correct any deviations in measurement values and ensure the accuracy and reliability of the equipment.

Performance verification, on the other hand, focuses on assessing the overall performance of measuring equipment. It involves conducting specific tests to evaluate various parameters such as linearity, repeatability, sensitivity, and stability.

Benefits and Compliance

Implementing ISO 11485:2015 brings several benefits to medical laboratories. Firstly, it enhances the credibility and reputation of the laboratory by demonstrating compliance with international standards.

Secondly, adherence to this standard helps reduce measurement errors, leading to precise and consistent laboratory results. This contributes to accurate diagnoses, effective treatments, and better patient care.

Furthermore, ISO 11485:2015 promotes continuous improvement and risk management within laboratory practices. It ensures that laboratories have robust quality assurance systems in place, leading to fewer errors and improved efficiency.

In conclusion, ISO 11485:2015 is a critical standard for the calibration and performance verification of measuring equipment in medical laboratories. By adhering to this standard, laboratories can ensure accurate and reliable measurements, providing better healthcare outcomes for patients.