Accreditations and regulatory certifications
As a precision medicine company, quality systems are the backbone of everything we do. We work with regulatory authorities and accrediting organizations worldwide to ensure that our processes and protocols are up-to-date and consistently meet the highest standards. Our accreditations and regulatory certifications include:
CPSA L0516000
Syantra’s clinical laboratory is certified by the College of Physicians and Surgeons of Alberta (CPSA), the organization that performs medical service approvals for Alberta Health Services. In Canada, laboratory developed tests offered as services are regulated by the provinces, rather than Health Canada.
ISO 13485:2016
Syantra's Quality Management System is ISO 13485:2016 certified. This certification ensures the design, production, installation and servicing of Syantra's medical devices meet applicable regulatory requirements.
COLA 32589
Syantra's clinical laboratory is certified by the Commission on Office Laboratory Accreditation (COLA, ID number: 32589) to allow for processing of samples from the United States. Through this process, Syantra earned recognition from the United States Centers for Medicare and Medicaid Services for meeting regulatory requirements of the Clinical Laboratory Improvement Amendments (CLIA, ID Number: 99D2280227).