OpenRegulatory Template

List of CAPAs

ISO 13485:2016 Section	Document Section
8.5.2	(All)
8.5.3	(All)

This list contains all of our Corrective and Preventive Actions (CAPAs).

“Adverse Implications”: Verifying that the corrective / preventive action does not adversely affect the ability to meet applicable regulatory requirements or the safety and performance of the medical device.
“Verification”: Documenting proof of implementation of actions taken.
“Effectiveness”: Review of the effectiveness of corrective / preventive actions taken.
“Root Cause”: Analyzing the underlying cause that led to the event. Different methodologies can be used, e.g. 5 Why’s (asking 5 times Why? in a row) or Ishakawa/Fishbone Diagram (identifying cause categories and sub-causes in a diagram).

Input Category	CAPA ID	Date Created	CAPA Description	Root Cause	Date Root Cause Analysis Completed	Action (Corrective / Preventive)	Date Actions Defined	Potentially Adverse Implications	Verification	Date of Verification	Effectiveness Evaluation	Date Closed
Usability feedback	1	01-01-2022	No contact details provided as part of product information	Missing Test Case for Product Information	02-01-2022	New product release incl. contact details; update test cases	03-01-2022		Release of product version and test case update		Number of future complaints related to this issue; review of technical information by Notified Body for completeness

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