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Medical laboratories (ISO 15189)

ISO 15189 Medical Laboratories — Particular Requirements for Quality and Competence is a standard that sets out requirements for quality and competence in medical laboratories.

It is intended to promote a common approach to quality management in laboratories and to all aspects of laboratory operations, from patient preparation and identification to sample collection and analysis.

SCC accreditation program

This is an assessment service that leads to ISO 15189 accreditation by the Standards Council of Canada (SCC).

The BNQ’s assessment of medical laboratories for ISO 15189 is part of a partnership agreement between the BNQ and the SCC, under the Program for the Accreditation of Laboratories, and it enables laboratories to obtain international recognition.

The Program requirements are found in the SCC’s Accreditation Program Overview, Annex G.

The standards ISO 22870 Point-of-care testing (POCT) — Requirements for quality and competence and CAN/CSA-Z902 Blood and blood components are also included in the Program, for laboratories wishing to be assessed to the requirements of those two standards.

The BNQ has been offering private and public medical laboratories an assessment service for ISO 15189 accreditation since June 2007.