MDSAP Audit Procedures and Forms
MDSAP AU P0002
- MDSAP AU P0002.004 Audit Model (PDF - 680KB)
(ISO 13485 :2016) - MDSAP AU G0002.1.004 revised 2017-04-17 (PDF - 1.1MB)
(ISO 13485 :2016)
MDSAP AU P0008
- MDSAP AU P0008.007: Audit Time Determination Procedure
- MDSAP AU F0008.2.002 Audit Duration Calculation Form (Audit Model 2017)
MDSAP AU P0019
- MDSAP AU P0019.004 Medical Device Regulatory Audit Reports Policy
- MDSAP AU F0019.1.008 Medical Device Regulatory Audit Report
- MDSAP AU F0019.2.009 NC Grading and Exchange Form
- MDSAP AU P0019.3.006 Medical Device Regulatory Audit Report Form Guidelines
- MDSAP AU G0019.4.003 NC Grading Exchange Form Guidelines
MDSAP AU P0026
- MDSAP AU P0026.002 Certificate Document Requirements
- MDSAP G0026.1.003 Surveillance Audit Confirmation Notification Process
MDSAP AU P0027
MDSAP AU P0028
MDSAP AU P0029
- MDSAP AU P0029 003 Initial Manufacturer Audit_Mfg Withdrawal Notification
- MDSAP AU F0029.1.004(RE) Initial Manufacturer Audit - Manufacturer Withdrawal Notification Form