What is ISO 11065:2018?

ISO 11065:2018 is a standard that provides guidelines for the determination of the performance characteristics of quantitative analytical methods. It aims to establish a common approach and ensure the accuracy, precision, linearity, detection limit, and quantification limit of such methods.

In-depth Understanding of ISO 11065:2018

The standard covers a wide range of analytical methods used in various industries, including pharmaceuticals, environmental monitoring, food safety, and forensic analysis. ISO 11065:2018 specifies the requirements for validation studies, determining measurement uncertainty, establishing calibration hierarchy, and verifying method suitability.

One of the key aspects emphasized in ISO 11065:2018 is the need for a rigorous validation process. This involves evaluating the method's accuracy by comparing the results obtained from the method with a known reference or an alternative method. The precision assessment evaluates the method's repeatability and intermediate precision.

Application of ISO 11065:2018

The application of ISO 11065:2018 ensures reliable and accurate analytical results. It offers guidance on specific factors affecting performance, such as sample handling, storage conditions, and instrument calibration. By following the standard, laboratories can optimize their analytical procedures, minimize errors, and improve overall quality assurance.

Moreover, ISO 11065:2018 promotes traceability by requiring laboratories to establish a calibration hierarchy. This includes utilizing certified reference materials (CRMs) whenever possible, performing regular equipment calibration, and implementing internal quality control measures. Traceability ensures comparability and reliability of results across different laboratories.

Conclusion

ISO 11065:2018 is a crucial standard that ensures reliable and accurate quantitative analytical methods. It provides guidelines for the validation, performance assessment, and measurement uncertainty determination of these methods. Adhering to this standard helps laboratories achieve consistent results, improve overall quality control, and enhance customer confidence.