MDSAP Audit Procedures and Forms

MDSAP AU P0002

• MDSAP AU P0002.005 Audit Approach (PDF - 1.3MB)
  (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 F0019.2.010 NC Grading and Exchange Form
• MDSAP AU G0019.3.007 Medical Device Regulatory Audit Report Form Guidelines
• MDSAP AU G0019.4.004 Guidelines NC Grading Exchange Form

MDSAP AU P0026

• MDSAP AU P0026.003 Certificate Document Requirements
• MDSAP G0026.1.004 Surveillance Audit Confirmation Notification Process

MDSAP AU P0027

• MDSAP AU P0027.005 Post Audit Activities and Timeline Policy

MDSAP AU P0028

• MDSAP AU P0028.003 Threat to Impartiality

MDSAP AU P0029

• MDSAP AU P0029 004 Initial Manufacturer Audit_Mfg Withdrawal Notification

MDSAP AU P0033

• MDSAP AU P0033.001 REPs User Account Management

MDSAP AU P0036

• MDSAP AU P0036.001 Remote Auditing Pilot Program