00000nam 2200000zi 4500 9.864231 CaOODSP 20221107161503 m o d f cr ||||||||||| 181105t20182018oncd #ob f000 0 eng d 9780660283920 CaOODSP eng rda CaOODSP n-cn--- H13-9/30-2018E-PDF Guidance document : requirements in the recognition process for Medical Device Single Audit Program (MDSAP) auditing organizations. Requirements in the recognition process for Medical Device Single Audit Program (MDSAP) auditing organizations Requirements in the recognition process for MDSAP auditing organizations Ottawa, ON : Health Canada, 2018. ©2018 1 online resource (11 pages) : chart text txt rdacontent computer c rdamedia online resource cr rdacarrier Title from cover. "Date adopted 2018-10-30 ; Effective date 2019-01-01." Issued also in HTML format. Issued also in French under title: Ligne directrice : exigences du processus de reconnaissance pour les organismes d’audit du Programme d’Audit Unique pour le Matériel Médical (PAUMM). Includes bibliographical references. "The purpose of this document is to outline the requirements that the Therapeutic Products Directorate (TPD) will use in the recognition process for Auditing Organizations. This policy applies to the quality management system (QMS) certification requirements applicable to Class II, III and IV medical devices in the Medical Devices Regulations. For the purposes of this policy, the term ‘Auditing Organization’ has the same meaning as the term ‘registrar’ found in the Medical Devices Regulations"--Introduction, page 5. gccst Medical products gccst Audit gccst Program development Canada. Health Canada. Ligne directrice : (CaOODSP)9.864233 PDF 622 KB https://publications.gc.ca/collections/collection_2019/sc-hc/H13-9-30-2018-eng.pdf HTML N/A https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/quality-systems-13485/requirements-recognition-process-mdsap-auditing-organizations-profile/guidance-document.html Pub.: 180554