ISO 15189

The Need for International Standards

ISO 15189 quality standards provide an effective quality management and technical competence framework that enables medical laboratories to meet international standards for patient care and laboratory responsibility.

While the standard is based on ISO 9001, it is a unique certification that takes into consideration the specific requirements of the medical environment and the importance of the medical laboratory to patient care.

Up till the 1980's, although medical laboratories were becoming more sophisticated, with automated analysis equipment being used, quality controls were non-standardized. With every country having its own accreditation, there was no international process for testing proficiency.

By the 1990's, equipment and customer relations software had become advanced enough that an international code was needed that would apply to all markets. It was not until 2003 that the first ISO 15189 standard was introduced. At the time, it was very similar to the ISO 9001 standard that is adopted by establishments in many industries.



Laboratoires St. Elie's Commitment to Assured Quality

By 2013, ISO 15189 was adopted by laboratories in over 60 countries, but Lebanon was not one of them. Laboratoires St. Elie was the first to do so in 2014, after spending three years preparing for it. While other laboratories are satisfied with their differing internal control methods, our laboratory provides internationally certifiable quality management.

Our system not only ensures the integrity of our results but is insistent on servicing our customers with the utmost care. Even the smallest incidents are reported, corrected and improved upon without delay; and every measure is taken to provide a comfortable environment for those who visit our lab. Our monthly training programs take into account every aspect of our business: from updating technicians on scientific methods to revising customer service training for receptionists and administrators depending on the evolving needs of our visitors.

Our commitment to ISO 15198 is also a commitment to you. We don't just claim to care about your needs, but are audited yearly to ensure that we keep to our word. You may find out more about our services on this site or contact us directly for professional support; but we equally hope you will pay us a visit to see the customer-focused difference that cannot be expressed here.