Objectives: To review the current status of laboratory quality regulations and accreditation standards in Canada.
Design and methods: The review is written based on information collected by survey questionnaires, a comprehensive review of available websites, and personal communications.
Results: Accreditation of medical laboratories in Canada is regulated by provincial health authorities. Out of the ten provinces of Canada, five have provincial accreditation bodies, while in the other five provinces, medical laboratories are accredited by Canadian Counsel on Health Service Accreditation (CCHSA). Each of these accreditation bodies has developed their own standards, implementing the International Organization for Standardization (ISO) documents to variable extent. Canadian Coalition for Quality in Laboratory Medicine (CCQLM) has recently been incorporated to provide a national structure for harmonizing quality management in medical laboratories across Canada.
Conclusions: Although provincially regulated, implementation of ISO in accreditation standards and coalition of accreditation bodies have been promoting the harmonization of quality regulations in Canada.