Any discussion of CAPA should also look toward the requirements set out in ISO 13485:2016. These cover corrective action under section 8.5.2 and preventive action under section 8.5.3.
ISO is something that is highly recommended as an industry best practice–especially if you are pursuing European, Canadian, or Australian markets.
To become certified, you need a third party ISO registrar to audit your company and agree that you meet the standard. This will be expected for selling outside of the US, but even if you’re sticking to the US market, it’s a good idea. Being able to say that you’re ISO certified carries weight and can be a good marketing tool.
As far as CAPA goes, the requirements from ISO 13485 are very closely aligned with FDA, particularly since the 2016 update. There are no significant differences to report.
