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.
|Blood regulations||Blood products|
|Food and drug regulations||Stable products|
|Medical devices regulations||Stable products|
|Safety of human cells, tissues and organs for transplantation regulations||Stem cells|
|Food and drug regulations||Mother's milk|
|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.