Medical Device Audit Readiness Assessment Form
Evaluate your organization's preparedness for a medical device audit by completing this comprehensive assessment.
Which best describes your organization's current documentation management system?
*
Fully electronic and regularly updated
Partially electronic with some paper records
Primarily paper-based
No formal system in place
How often are internal audits conducted for your medical device processes?
*
Quarterly or more frequently
Bi-annually
Annually
Less than annually or never
Are all required regulatory certifications and registrations up to date?
*
Yes, all are current
Some are pending renewal
Several are expired or missing
Which of the following elements are included in your risk management process? (Select all that apply)
*
Risk identification
Risk assessment and analysis
Risk mitigation actions
Risk review and monitoring
None of the above
Rate your organization's overall audit readiness in the following areas:
*
Rows
Not Ready
Partially Ready
Mostly Ready
Fully Ready
Document Control
1
2
3
4
Training & Competency
5
6
7
8
Supplier Management
9
10
11
12
CAPA (Corrective & Preventive Actions)
13
14
15
16
Equipment Maintenance
17
18
19
20
How confident are you that device traceability can be demonstrated during an audit?
*
1
2
3
4
5
Which best describes your staff training program for medical device compliance?
*
Comprehensive and regularly updated for all staff
Covers most staff but not regularly updated
Limited to key staff only
No formal training program
Do you have a documented procedure for handling nonconformities and corrective actions?
*
Yes, fully documented and implemented
Partially documented
No documented procedure
How frequently are supplier evaluations and audits performed?
*
Annually or more frequently
Every 2-3 years
Less frequently or never
Please provide any additional comments or notes regarding your audit readiness.
Submit Assessment
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