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> What is ISO 15189?

What is ISO 15189?

This standard is used for accreditation of clinical lab competence. It was published in 2003 and has become a widely accepted standard. It enables labs to establish proficient operational procedures, meet client expectations and improve service.

This standard makes a significant template for evaluating the technical ability of medical labs and management of their service and staff.

ISO 15189 is a specific standard, as opposed to a generic certification standard. This means that an organization implementing benefits from a guideline for orientation with a more technical approach. Moreover, this standard also helps greatly in understanding how the prerequisites of ISO 9001:2000 – Quality Management - can be applied to clinical lab activities.

What are the benefits of this certification?

The benefits include both lab and business benefits. An organization implementing this standard will benefit from having a basis for most other quality systems for labs such as Good Lab Practices and improved national and international reputation and image of the lab. Moreover, the organizations will be continuously improving data quality and lab effectiveness, achieving customer satisfaction via introduction of quality management system (a part of the 15189 Certification UAE), periodically carrying out quality control checks by which system is always maintained, calibrating and tracing all test equipment to national standards to ascertain and maintain the accuracy of results, and participating in Inter Lab Comparison program to determine the quality level compared to other accredited labs.

Who is it applicable to?

This standard is developed particularly for medical labs.

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