Accreditation and Regulations
Héma-Québec adheres to the highest standards to provide the Québec population with safe, high-quality biological products of human origin.
It is committed to offering and maintaining the highest level of expertise in its field, using cutting-edge methods and technologies. It provides its clients with products and analytical services of the highest possible quality within the required time frames.
It complies with rigorous quality and safety standards and holds licenses and certifications from various regulatory agencies that conduct periodic inspections and audits.
| Organization | Regulatory framework | Scope |
| Health Canada | Blood regulations | Blood products |
| Health Canada | Food and drug regulations | Stable products |
| Health Canada | 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 |
International Standards for Hematopoietic Cellular Therapy Product Collection, Processing and Administration | Regulation | Stem cells |
| Health Canada | Safety of human cells, tissues and organs for transplantation regulations | Stem cells Human tissues |
American Association or Tissue Banks | Regulation | Human tissues |
| Canadian Food Inspection Agency | Food and drug regulations | Mother's milk |
| Bureau de normalisation du Québec (BNQ) | ISO 15189 Medical laboratories | Analysis laboratory |
American Society for Histocompatibility and Immunogenetics | Regulation | Analysis laboratory |
| Public Health Agency of Canada | Human pathogens and toxins regulations | Analysis 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, which are reflected in the previous table.
ISBT 128 standards for consistent labelling of blood, blood components and laboratory samples.
NMDP (National Marrow Donor Program) for the distribution of cord blood units in the United States.
ISO 15189 standards for medical biology analyses (immunohematology, platelet immunology, and HLA typing) performed by laboratories in Montreal and Quebec City.
- Montreal Reference Laboratory:
See ISO 15189 accreditation for Montreal See the ISO 15189 certificate for Montreal
- Quebec Reference Laboratory:
See ISO 15189 accreditation for Quebec See the ISO 15189 certificate for Quebec