Biron’s medical laboratory obtains ISO 15189 certification

This internationally recognized standard specifies the competence and quality requirements for laboratory services, from collecting samples to interpreting results. It requires a rigorous approach to managing the quality of laboratory activities and all aspects of laboratory operations, including the safety of staff and ethical conduct.

Until now, the medical laboratory had to comply with the standards of Accreditation Canada, which conducted assessments every four years. It will now undergo a much more demanding audit process with assessments every two years.

The ISO 15189 standard specifies requirements for managing activities, as well as technical requirements for staff, laboratory equipment, processes, data and results. It includes 520 required elements divided into three major processes:

1. Management is aimed at analyzing and improving overall operations through the establishment of governance and a quality control system. For example, the laboratory must put in place a mechanism to report and document any organizational or technical problems that arise.
2. Core business refers to the actual performance of the tests. The standard covers all aspects of the pre-analytical (sampling), analytical (laboratory analysis) and post-analytical (reporting) phases.
3. Support includes access to the human and material resources needed for our activities. For example, staff training, use of equipment and management of the computer system are all points that are assessed.

Quality standards at Biron’s laboratory have always been high. With the ISO 15189 standard, application of the rules must be even more stringent.

“Various elements have an impact on the validity of a laboratory result, such as the integrity of the tube in which the sample is taken, compliance of the reagents used, transport conditions, storage life of the sample and calibration of the laboratory equipment. All of these elements must be clearly established, validated, complied with and controlled,” says Marie-France Marcotte, Director of Quality and Compliance at Biron Health Group.

At all times Biron must be able to demonstrate, with supporting evidence, that these elements comply with the standard. Writing what you do and doing what you write is the key!