What is ISO-TS 119642019

Introduction

ISO-TS 11964-2:2019 is a technical specification developed by the International Organization for Standardization (ISO) that provides guidelines and best practices for the implementation of data quality in analytical laboratories. It focuses on data management, data integrity, and data validation processes, ensuring accurate and reliable results in scientific analysis.

Data Quality in Analytical Laboratories

Data quality plays a vital role in analytical laboratories as it directly impacts the reliability and accuracy of analytical results. ISO-TS 11964-2:2019 addresses key aspects of data quality to ensure consistent and trustworthy outcomes.

Data Management

Data management is crucial for maintaining data integrity and traceability. ISO-TS 11964-2:2019 emphasizes the need for clear documentation of procedures, including data collection, storage, and processing. Laboratory personnel should follow standardized protocols to ensure data consistency throughout the analysis process.

Laboratories must establish proper data backup systems to prevent data loss and adopt appropriate security measures to protect sensitive data. This includes restricting access to authorized personnel, implementing user authentication protocols, and regularly monitoring and auditing data management systems.

Data Integrity

Data integrity refers to the accuracy, completeness, and reliability of data. ISO-TS 11964-2:2019 highlights the importance of maintaining data integrity through comprehensive data verification and validation procedures.

Laboratories should implement robust quality control measures to identify and mitigate potential errors or anomalies in data. This includes conducting regular calibration of instruments, performing method validation studies, and establishing clear acceptance criteria for analytical results.

Furthermore, data audits should be conducted periodically to verify the accuracy and consistency of stored data. Any discrepancies should be thoroughly investigated and documented, ensuring traceability and transparency in the analytical process.

Data Validation

Data validation is a critical step in ensuring the reliability and usability of analytical results. ISO-TS 11964-2:2019 provides guidelines for the validation of analytical methods, including assessing method performance, establishing detection limits, and evaluating measurement uncertainty.

Laboratories must develop comprehensive validation protocols that encompass all relevant parameters, such as accuracy, precision, specificity, and robustness. The validation process should be meticulously documented, providing a clear audit trail and facilitating the reproducibility of results.

Periodic revalidation is necessary to ensure ongoing method suitability and reliability. Changes in equipment, environmental conditions, or laboratory personnel may necessitate revalidation to maintain data quality and integrity.

In conclusion, ISO-TS 11964-2:2019 provides an essential framework for ensuring data quality in analytical laboratories. By implementing the guidelines and best practices outlined in this technical specification, laboratories can enhance the accuracy, reliability, and traceability of their analytical results, ultimately facilitating scientific advancements and informed decision-making.