Regulations

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 CanadaBlood regulationsBlood products
Health CanadaFood and drug regulationsStable products
Health CanadaMedical 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 CanadaSafety of human cells, tissues and organs for transplantation regulationsStem cells
Human tissues

AATB

American Association or Tissue Banks

RegulationHuman tissues
Canadian Food Inspection AgencyFood 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 CanadaHuman 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.

  • NMDP (National Marrow Donor Program) for the distribution of cord blood units in the United States.