IVDR Quality Management System Audit Checklist
Please complete this checklist to assess compliance with IVDR Quality Management System requirements.
Audit Date
*
 -
Month
 -
Day
Year
2 digit month, 2 digit day, 4 digit year
Date
Auditor Name
*
First Name
Last Name
Department/Area Audited
*
Are documented procedures available and up to date?
*
Yes
No
Partially
Are records properly maintained and accessible?
*
Yes
No
Partially
Personnel training and competency records are complete?
*
Yes
No
Partially
Internal audit findings are documented and addressed?
*
Yes
No
Partially
Assessment of Key IVDR QMS Elements
*
Rows
Compliant
Non-Compliant
Not Applicable
Risk Management
1
2
3
Document Control
4
5
6
Supplier Management
7
8
9
Post-Market Surveillance
10
11
12
Rate overall compliance with IVDR QMS requirements
*
1
2
3
4
5
Additional Comments or Observations
Submit Checklist
Should be Empty: