What is ISO 17025 audit

ISO 17025 is an international standard that sets out the criteria for testing and calibration laboratories. It specifies the requirements to ensure competency, impartiality, and consistent operations in such labs. Compliance with this standard is critical for laboratories to demonstrate their ability to produce reliable and accurate results.

The Purpose of ISO 17025 Audit

An ISO 17025 audit is a systematic examination of a laboratory's quality management system (QMS) and technical competence. The purpose of the audit is to assess whether the laboratory complies with the requirements of the ISO 17025 standard and operates effectively to produce valid and reliable test or calibration results.

Types of ISO 17025 Audit

There are two main types of ISO 17025 audits: internal audits and external audits. Internal audits are conducted by laboratory staff or appointed auditors from within the organization. Their purpose is to verify compliance with the QMS and identify areas for improvement. External audits, on the other hand, are performed by independent accrediting bodies or certification authorities that assess the laboratory's compliance with ISO 17025. These audits are necessary to achieve and maintain accreditation.

Process of ISO 17025 Audit

An ISO 17025 audit typically follows a series of steps. Firstly, the audit team reviews the laboratory's documents, records, and policies to gain an understanding of its quality management system. Then, they conduct interviews with laboratory personnel to assess their competence and understanding of procedures. The audit team also examines the lab's equipment, facilities, and measurement capabilities. They may observe tests or calibrations being performed to ensure adherence to relevant standards. Finally, they compile their findings in an audit report, which includes any non-conformities identified and recommendations for improvement.