ISO 13485 Audit Management Software Evaluation Checklist
Systematically evaluate and compare ISO 13485 audit management software solutions using this structured checklist.
Evaluator Name
*
First Name
Last Name
Evaluator Email Address
*
example@example.com
Organization Name
*
Software Name
*
Software Version/Release
Vendor/Supplier Name
Core ISO 13485 Compliance Features
*
Rows
Available
Not Available
Needs Improvement
Document Control
1
2
3
Audit Trail
4
5
6
CAPA Management
7
8
9
Risk Management
10
11
12
Training Management
13
14
15
Supplier Management
16
17
18
How would you rate the usability of the software?
*
1
2
3
4
5
Does the software integrate with other quality management systems?
*
Yes
No
Partial/With Limitations
How would you rate the vendor's technical support and documentation?
*
1
2
3
4
5
Overall, how well does the software support ISO 13485 audit processes?
*
Poor
1
2
3
4
5
6
7
8
9
Excellent
10
1 is Poor, 10 is Excellent
Additional comments or recommendations
Submit Evaluation
Should be Empty: