The ISO14971 regulation directly involves Risk management. A few of the requirements are to have risks identified and documented, a risk management plan, and risk control. These can be in the form of documents, policies, and procedures that the company must follow to ensure quality product is delivered to the customer and that employees are safe in producing them.

In my company we have many documents that are part of the Quality Management System. They are also reviewed each time a new product or process is implemented for due diligence within the organization. We recently have been moving to update our risk management plans to make them easier to use.