The organization plans, performs, monitors and controls production and service provision so as to make sure the product meets its specification. Where appropriate, the controls include: documented procedures and methods for controlling production; qualification of infrastructure; monitoring and measuring of product characteristics and process parameters; having monitoring and measuring equipment available and using it; defined operations for labelling and packaging; and carrying out product release, delivery and activities after delivery. For each medical device or batch, the organization sets up and keeps a record that gives traceability to the degree 7.5.9 requires and shows how many units were made and how many were approved for distribution; the record is verified and approved.
This control maps to 5 controls across 3 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.
Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.
The graph holds this control, the 5 it maps to, and the evidence behind each claim, over MCP and REST.