Licences and certifications

Héma-Québec makes every effort to provide the Québec population with safe, top-quality biological products of human origin. It complies with rigorous quality and safety standards and holds licences and certifications from various regulatory agencies that conduct periodic inspections and audits.

OrganizationPurposeScope

Health Canada

Blood regulationsBlood products

Health Canada

Food and drug regulationsStable products

Health Canada

Medical devices regulationsStable products

NetCord-FACT

International Standards for Cord Blood Collection, Banking and Release for Administration
RegulationStem cells

WMDA

World Marrow Donor Association
RegulationStem cells

Health Canada

Safety of human cells, tissues and organs for transplantation regulationsStem cells
Human tissues

AATB

American Association or Tissue Banks
RegulationHuman tissues

Canadian Food Inspection Agency

Food and drug regulationsMother's milk

Bureau de normalisation du Québec (BNQ)

ISO 15189
Medical laboratories
Reference laboratory

ASHI

American Society for Histocompatibility and Immunogenetics
RegulationReference laboratory

Public Health Agency of Canada

Human pathogens and toxins regulationsLaboratories

Héma-Québec also strictly complies with other standards that do not require inspections by regulatory agencies, including:

  • CSA (Canadian Standards Association) standards for blood products, human tissues and stem cells: Z902, Z900.1, Z900.2.2, Z900.2.4, Z900.1 and Z900.2.5.

    Note that some regulations refer to mandatory sections of the CSA standards, and those are reflected in the licences in the previous table.
  • Standard ISBT 128 for consistent labelling of blood and blood components.