What is EN ISO 15859:2016?

EN ISO 15859:2016 is a technical standard that provides guidelines for the evaluation and selection of software tools used in analytical laboratories. It aims to ensure the accuracy, reliability, and comparability of laboratory test results by defining requirements for the software used in analytical processes.

The Importance of EN ISO 15859:2016

The use of software tools in analytical laboratories has become increasingly common in recent years. These tools help automate data processing, improve efficiency, and enhance the quality of test results. However, the reliability and accuracy of these software tools can vary significantly, which may lead to inconsistent test results and potential errors.

EN ISO 15859:2016 addresses this issue by providing a framework for evaluating and selecting software tools based on their performance, functionality, and compatibility with other laboratory equipment and processes. By adhering to this standard, laboratories can ensure that the software tools they use meet the necessary requirements for accurate and reliable analytical testing.

Key Requirements of EN ISO 15859:2016

The standard outlines several key requirements that software tools should meet to comply with EN ISO 15859:2016.

Firstly, the software should be properly validated to demonstrate its fitness for purpose. This involves conducting thorough testing and verification processes to ensure the accuracy and reliability of the software's calculations and algorithms.

Secondly, the software should have a clear and intuitive user interface that allows users to easily navigate and utilize its features. This includes providing comprehensive documentation and training materials to assist users in understanding and utilizing the software effectively.

Furthermore, the software should be compatible with other laboratory instruments and equipment to ensure seamless integration and data exchange. It should also possess adequate security measures to protect sensitive data and prevent unauthorized access.

Benefits of Implementing EN ISO 15859:2016

Implementing EN ISO 15859:2016 brings several benefits to analytical laboratories:

1. Enhanced reliability and accuracy of test results: By using validated software tools that meet the standard's requirements, laboratories can significantly reduce the risk of errors in their analytical processes and obtain more reliable and accurate test results.

2. Improved efficiency and productivity: The streamlined workflows and automation provided by compliant software tools result in increased efficiency and productivity within the laboratory.

3. Facilitated data management and analysis: EN ISO 15859:2016-compliant software ensures consistent data storage, retrieval, and analysis, enabling better decision-making and reporting.

4. Increased confidence and trust: Adhering to EN ISO 15859:2016 demonstrates a commitment to quality and accuracy, enhancing the reputation and credibility of the laboratory among customers, regulatory bodies, and stakeholders.