Medical Laboratory Accreditation Overview
Accreditation is the evaluation of processes to ensure quality and competence, through conformance to an acknowledged standard. Clients accessing services such as medical laboratory testing, medical specimen procurement, point-of-care testing and diagnostic imaging expect reliability and high quality.
Accreditation elevates the confidence of patients, physicians, nurses, facility administration, government and of all those working in the accredited service. ISO 15189 is the standard of choice for the accreditation of medical diagnostic facilities.
It requires standardized processes and procedures for both quality system and technical requirements. It sets up a no-blame environment that drives continual improvement, reduces risk, establishes an interface with users and ensures the reliability and accuracy of test results.
Accreditation elevates confidence in the system.
Accreditation Canada is a signatory (ISO 15189) to the Mutual Recognition Arrangement (MRA) of the International Laboratory Accreditation Cooperation (ILAC) and its regional Asia Pacific Accreditation Cooperation (APAC). ISO 15189 Plus™ certificates granted under this MRA are recognized world-wide. They provide recognition of competence and underscore the facility’s experience, superior technical competence and reliability. Our signatory status with the APAC MRA is a working arrangement that assists facilitation of international trade and acceptance of testing results. AC Diagnostics accreditation is recognized by ILAC’s 104 signatories in 105 countries.
To achieve this important international status, Accreditation Canada Diagnostics has carefully aligned its accreditation processes with ISO/IEC 17011 Conformity assessment — Requirements for accreditation bodies accrediting conformity assessment bodies, ILAC and APAC policies and guidelines for assessment, assessor qualifications, training and competence. AC Diagnostics undergoes international peer evaluation on a regular basis to maintain its MRA signatory status.
As part of the Mutual Recognition Arrangement, Accreditation Canada recognizes medical testing performed in the accredited laboratories of other economies with signatory status as equivalent. The participation of AC Diagnostics in the APAC MRA means that AC Diagnostics and A2LA (for example) accept reports issued by one another’s laboratories or diagnostic services.
More information and the complete list of signatories can be found at ilac.org and at apac.org.
The AC Diagnostics ISO 15189 Plus™ accreditation requirements are based on ISO 15189:2012 and are augmented with international standards for safety and point-of-care testing, national standards, government regulation and generally accepted principles of good practice.
New! ISO 15189 Plus™ Accreditation