Biron’s medical laboratory obtains ISO 15189 certification
December 8th, 2022
Following a conformity assessment conducted by the Bureau de normalisation du Québec, Biron Health Group’s medical biology laboratory recently received accreditation for the ISO 15189 standardMedical laboratories - Requirements for quality and competence, from the Standards Council of Canada.
What is the ISO 15189 standard?
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.
More than 500 requirements to meet
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:
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.
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.
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.
A rigorous process
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!
A team effort
Putting in place the elements required for ISO 15189 certification required a year of preparation and the valuable co-operation of colleagues from our network of service centres, the laboratory, human resources, purchasing, the warehouse, information technology, the quality and compliance department and scientific management.
However, the work is far from finished! Maintaining compliance of processes and documentation will require ongoing efforts to ensure the quality and integrity of our analyses. But this challenging exercise paves the way for the continuous improvement of our services, in order to better meet the needs of the population.