Audit procedures and forms

These documents set expectations on auditing organizations (AOs) on how to meet the requirements of the Program. For further information on this approach, click here.

Audit Approach - MDSAP AU P0002

Audit Approach

MDSAP AU P0002

Audit Time Determination Procedure - MDSAP AU P0008

Audit Time Determination Procedure

MDSAP AU P0008

Audit Duration Calculation Form (Audit Model 2017)

MDSAP AU F0008.2

Medical Device Regulatory Audit Reports Policy - MDSAP AU P0019

Medical Device Regulatory Audit Reports Policy

MDSAP AU P0019

NC Grading and Exchange Form

MDSAP AU F0019.2

Medical Device Regulatory Audit Report Form Guidelines

MDSAP AU G0019.3

Medical Device Regulatory Audit Report

MDSAP AU F0019.1

Guidelines NC Grading Exchange Form

MDSAP AU G0019.4

Certificate Document Requirements - MDSAP AU P0026

Certificate Document Requirements

MDSAP AU P0026

Surveillance Audit Confirmation Notification Process

MDSAP AU G0026.1

Post Audit Activities and Timeline Policy - MDSAP AU P0027

Post Audit Activities and Timeline Policy

MDSAP AU P0027

Threat to Impartiality - MDSAP AU P0028

Threat to Impartiality

MDSAP AU P0028

Communication by AOs with RA in MDSAP - MDSAP AU P0029

Communication by AOs with RA on Organizations Participating in MDSAP

MDSAP AU P0029

User Account Management - MDSAP AU P0033

REPs User Account Management

MDSAP AU P0033

REPs User Access Request Form

MDSAP AU F0033.1

Remote / Hybrid Auditing Program - MDSAP AU P0036

Remote / Hybrid Auditing Program

MDSAP AU P0036

Guidelines on the use of GHTF/SG3/N19:2012 - MDSAP AU P0037

Guidelines on the use by MDSAP of document GHTF/SG3/N19:2012 – Nonconformity Grading System for Regulatory Purposes and Information Exchange

MDSAP AU P0037

Nonconformity Assessment Rubric

MDSAP AU F0037.1