Laboratory quality regulations and accreditation standards in Canada.
OBJECTIVE
To review the current status of laboratory quality regulations and accreditation standards in Canada.


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.
Division of Clinical Biochemistry, DPLM, The Hospital For Sick Children, Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, Ontario, Canada.
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D000068:Accreditation / Q000331:legislation & jurisprudence* / Q000592:standards*; D002170:Canada; D033161:Government Regulation; D007391:International Cooperation; D007753:Laboratories / Q000331:legislation & jurisprudence* / Q000592:standards*; D011786:Quality Control