I agree with the posts above. The ISO standard provides the flexibility needed to accommodate the needs of the companies but still providing the necessary regulation to process output. But from the FDA side, it provides the monitoring through the whole lifecycle of the product to provide a consistent quality. Although they are both similar, they are different in the approach of driving a product into the market.

https://www.fda.gov/downloads/drugs/guidances/ucm070336.pdf
http://www.iso9001help.co.uk/752.html