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.
Organization | Purpose | Scope |
Blood regulations | Blood products | |
Food and drug regulations | Stable products | |
Medical devices regulations | Stable products | |
International Standards for Cord Blood Collection, Banking and Release for Administration | Regulation | Stem cells |
World Marrow Donor Association | Regulation | Stem cells |
Safety of human cells, tissues and organs for transplantation regulations | Stem cells Human tissues | |
American Association or Tissue Banks | Regulation | Human tissues |
Food and drug regulations | Mother's milk | |
ISO 15189 Medical laboratories | Reference laboratory | |
American Society for Histocompatibility and Immunogenetics | Regulation | Reference laboratory |
Human pathogens and toxins regulations | Laboratories |
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.