What is ISO 15823:2018?

ISO 15823:2018 is a widely recognized technical standard that provides guidelines and requirements for the validation of analytical methods used in various industries, including pharmaceuticals, environmental testing, food and beverages, and many others. This standard plays a crucial role in ensuring the accuracy and reliability of the analytical results obtained from different testing procedures.

The Importance of ISO 15823:2018

ISO 15823:2018 serves as a benchmark for laboratories and organizations involved in analytical testing. It outlines the essential criteria that need to be met to achieve reliable and consistent results. By conforming to this standard, laboratories can enhance their credibility and gain trust from clients and regulatory bodies.

ISO 15823:2018 also helps to minimize variations in test results by providing clear methodologies and protocols. This ensures that different laboratories, using diverse analytical methods, obtain comparable results, allowing for better data interpretation and decision-making processes.

Main Components of ISO 15823:2018

ISO 15823:2018 consists of several key components that aid in the implementation and practice of the standard:

1. Scope: This section defines the intended application areas of the standard, the principle of the validation process, and the limitations of the methods described.

2. Normative references: Here, other related standards and guidelines that should be followed are mentioned to ensure comprehensive compliance.

3. Terms and definitions: This component provides an extensive list of terminologies used throughout the standard, helping to clarify any potential confusion or ambiguity.

4. General requirements: These requirements focus on the validation process, including method development, selection of validation characteristics, and the acceptance criteria for the selected method.

5. Validation protocol: This section outlines the steps involved in the validation process, including experimental design, sample preparation, calibration, and data analysis.

6. Reporting: Here, guidelines are provided for documenting and reporting the validation results, ensuring transparency and traceability of the entire process.

Conclusion

ISO 15823:2018 is a comprehensive standard that provides the necessary guidance for accurate and reliable analytical method validation. By following this standard, laboratories can ensure consistency in their test results, gain the trust of clients and regulatory bodies, and contribute to overall quality assurance in analytical testing.