https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/quality-systems-13485/study-guide-gd211-guidance-content-quality-management-system-audit-reports.html
Study Guide GD211: Guidance on the content of quality management system audit reports - Canada.ca
2011 Health Canada study guide for quality management system auditors performing regulatory audits on behalf of Health Canada and other regulators