Medical Device School – Most important issues on your CAPA (ISO 13485)
The CAPA system is an important pillar of your Quality Management System (ISO 13485 or FDA QSR) and we have identified a lot of issues that companies are doing with it.
CAPA means Corrective Action Preventive Action and is used when an issue is identified. But there are many parameters to do a good CAPA and there are also some good practices to avoid to show the wrong one to an auditor.
Let us know if you were in the same situation and what you have done to correct it.
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