Procedure

ISO 14971 takes this from ISO 9000, where a procedure can be documented or not. ISO 13485 and the regulations usually ask for documented procedures, so check which one applies before deciding that a practice is enough.

specified way to carry out an activity or a process (3.14) Note 1 to entry: Procedures can be documented or not. [SOURCE: ISO 9000:2015, 3.4.5]

ISO 14971:2019, clause 3.13