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| 02483cam 2200421zi 4500 |
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| 001 | 9.864231 |
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| 003 | CaOODSP |
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| 005 | 20221107161503 |
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| 006 | m o d f |
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| 007 | cr ||||||||||| |
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| 008 | 181105t20182018oncd #ob f000 0 eng d |
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| 020 | |a9780660283920 |
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| 040 | |aCaOODSP|beng|erda|cCaOODSP |
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| 043 | |an-cn--- |
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| 086 | 1 |aH13-9/30-2018E-PDF |
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| 245 | 00|aGuidance document : |brequirements in the recognition process for Medical Device Single Audit Program (MDSAP) auditing organizations. |
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| 246 | 10|aRequirements in the recognition process for Medical Device Single Audit Program (MDSAP) auditing organizations |
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| 246 | 17|aRequirements in the recognition process for MDSAP auditing organizations |
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| 264 | 1|aOttawa, ON : |bHealth Canada, |c2018. |
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| 264 | 4|c©2018 |
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| 300 | |a1 online resource (11 pages) : |bchart |
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| 336 | |atext|btxt|2rdacontent |
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| 337 | |acomputer|bc|2rdamedia |
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| 338 | |aonline resource|bcr|2rdacarrier |
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| 500 | |aTitle from cover. |
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| 500 | |a"Date adopted 2018-10-30 ; Effective date 2019-01-01." |
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| 500 | |aIssued also in HTML format. |
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| 500 | |aIssued 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). |
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| 504 | |aIncludes bibliographical references. |
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| 520 | |a"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. |
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| 692 | 07|2gccst|aMedical products |
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| 692 | 07|2gccst|aAudit |
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| 692 | 07|2gccst|aProgram development |
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| 710 | 1 |aCanada. |bHealth Canada. |
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| 775 | 08|tLigne directrice : |w(CaOODSP)9.864233 |
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| 856 | 40|qPDF|s622 KB|uhttps://publications.gc.ca/collections/collection_2019/sc-hc/H13-9-30-2018-eng.pdf |
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| 856 | 4 |qHTML|sN/A|uhttps://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 |
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