Finagle's Fourth Law: Once a job is messed up, anything done to improve it makes it worse.  

The requirement for corrective action (the CA - CORRECTIVE ACTION from the CAPA) is included within chapter 8.5 – Improvement. Within the most basic requirement, the objective of the corrective action is to:

What a standard The ISO 13485. It's almost fascinating. We can assure you one thing: it requires a lot of work to get the certification even if you are already certified for the ISO 9001 Standard. The ISO 13485 documents control requirements are tougher, traceability is much more complex and not to mention the training requirements.