Change control

Change control is the planned review of a proposed change so you know the effect on the device, the process, the risk file and the regulatory submissions before you implement it.

ISO 13485 asks for control of design changes, process changes and document changes. MDSAP asks, in several chapters, whether a CAPA-driven change was assessed and whether authorities were notified when the marketed device or the QMS changed. A changed drawing that nobody linked to the risk file is a typical finding.

HAVGATE has change requests and item and bill-of-materials records on the quality side. Document revisions are in document control. Those are separate records from bookkeeping. An invoice does not approve a design change.