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ISO 17025 Proficiency Testing: What You Need to Know

ISO 17025 is an international standard for testing and calibration laboratories. The standard specifies the general requirements for the competence of testing and calibration laboratories. ISO 17025 requires laboratories to participate in proficiency testing as part of their quality management system. Proficiency testing is an essential element of ISO 17025, ensuring laboratories produce accurate and reliable results.

What is Proficiency Testing?

Proficiency testing is a process that evaluates a laboratory’s ability to perform specific tests or measurements accurately and reliably. Proficiency testing involves comparing a laboratory’s results with those of other laboratories. Proficiency testing assesses a laboratory’s technical competence, objectively measuring the laboratory’s quality and reliability.

Why is Proficiency Testing Important?

Proficiency testing is essential for ensuring the accuracy and reliability of laboratory results. Participating in proficiency testing assures customers that laboratory results are accurate and reliable. Proficiency testing also ensures that laboratories maintain their technical competence over time. Regular participation in proficiency testing is a requirement for accreditation under ISO 17025.

How Does Proficiency Testing Work?

Proficiency testing involves the participation of a laboratory in an external quality assurance program. The laboratory receives a sample from an external provider and analyzes the sample using its standard methods. The laboratory then submits the results to the external provider for evaluation. The external provider compares the laboratory’s results with those of other participating laboratories and provides feedback on the laboratory’s performance.

The external provider may use various methods to evaluate laboratory performance. The provider may use statistical methods to evaluate the laboratory’s results or compare the laboratory’s results with those of other participating laboratories. The provider may also provide feedback on the laboratory’s methods, procedures, and equipment.

What Are the Benefits of ISO 17025 Proficiency Testing?

Participating in proficiency testing offers several benefits to laboratories, including:

Improved Accuracy and Reliability of Results

Participating in proficiency testing ensures that laboratories produce accurate and reliable results. Feedback from proficiency testing helps laboratories identify and correct any errors in their methods or procedures, leading to improved accuracy and reliability of results.

Demonstrates Technical Competence

Participating in proficiency testing demonstrates a laboratory’s technical competence to customers and regulators. Proficiency testing provides an objective measure of a laboratory’s quality and reliability, leading to increased customer confidence in the laboratory’s results.

Compliance with Accreditation Requirements

Regular participation in proficiency testing is a requirement for accreditation under ISO 17025. Participating in proficiency testing ensures that laboratories comply with accreditation requirements, leading to increased recognition and acceptance of laboratory results.

Identifies Areas for Improvement

Proficiency testing provides feedback on a laboratory’s methods, procedures, and equipment. Feedback from proficiency testing helps laboratories identify areas for improvement, leading to continuous improvement of laboratory processes.

Conclusion

ISO 17025 proficiency testing is an essential element of laboratory quality management systems. Participating in proficiency testing ensures that laboratories produce accurate and reliable results, demonstrate technical competence, comply with accreditation requirements, and identify areas for improvement. Laboratories should participate in proficiency testing regularly to ensure the accuracy and reliability of their results and maintain their technical competence over time.

Farrukh Mehmood, Pharm-D, M.Phil, RPh

Dr. Farrukh is a Manager of Quality Operations in a renowned Pharmaceutical Industry of Pakistan.

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