What is ISO 13528?

ISO 13528:2022 – Statistical methods for use in proficiency testing by interlaboratory comparison is designed to guide proficiency testing providers on how to analyze and interpret data from interlaboratory comparisons. It outlines validated statistical approaches to ensure test and calibration results are comparable and consistent, thus building trust in laboratory performance and quality systems.

The standard supports proficiency testing schemes which are crucial for assessing the technical competence of laboratories participating in testing and calibration activities.

Why is ISO 13528 important?

ISO 13528 is essential for laboratories seeking to:

  1. Ensure statistical consistency in proficiency testing results.
  2. Comply with ISO/IEC 17043 (Conformity assessment — General requirements for proficiency testing).
  3. Demonstrate technical competence and enhance global recognition.
  4. Improve accuracy and confidence in interlaboratory comparisons.

By aligning with ISO 13528:2022, laboratories can meet regulatory expectations, improve internal quality controls, and offer dependable data to clients or accreditation bodies.

What are the benefits of ISO 13528?

Implementing ISO 13528:2022 brings numerous technical and operational benefits, including:

  1. Standardized Statistical Approaches: Offers consistent methods for data evaluation across different proficiency testing schemes.
  2. Enhanced Laboratory Performance: Supports continuous improvement by identifying outliers and trends in performance.
  3. Compliance and Accreditation Readiness: Helps meet the statistical requirements of ISO/IEC 17025 and ISO/IEC 17043.
  4. Increased Confidence in Results: Assures clients and regulators of the validity and reliability of lab results.
  5. Benchmarking Capability: Enables comparison with peer laboratories, promoting industry best practices.
  6. Error Reduction: Identifies inconsistencies and systematic errors early through robust statistical monitoring.


What kind of businesses can benefit from ISO 13528?

By adopting ISO 13528:2022 through our consulting services, your organization can:

✅ Strengthen internal quality systems with globally accepted statistical techniques.

✅ Boost brand trust by delivering precise and reliable test results.

✅ Improve readiness for audits and accreditation assessments.

✅ Reduce costs associated with errors, retesting, and non-conformities.

✅ Position your laboratory as a high-performing and compliant facility.

✅ Increase market access by showcasing consistent testing capabilities to global clients.

✅ Enable long-term growth through continuous statistical monitoring and improvement.


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