Medical Device Quality Management System Audit Checklist Form
Complete this checklist to assess your organization's compliance with medical device quality management requirements.
Audit Date
*
 -
Month
 -
Day
Year
2 digit month, 2 digit day, 4 digit year
Date
Auditor Full Name
*
First Name
Last Name
Department or Process Audited
*
Are all required QMS documents available and up to date?
*
Yes
No
Partially
Is device traceability maintained throughout the process?
*
Yes
No
Not Applicable
Are nonconformance records documented and managed?
*
Yes
No
Partially
Is the CAPA (Corrective and Preventive Action) process effective?
*
Yes
No
Needs Improvement
Is risk management incorporated into product lifecycle activities?
*
Yes
No
Partially
Are training records for relevant personnel up to date?
*
Yes
No
Partially
General Comments or Observations
Submit Audit Checklist
Should be Empty: