1. What documentation is required in addition to procedures, instructions and forms?

Documents such as procedures, instructions and forms are generally well identified in the quality management system (QMS) (see Identifying and implementing document requirements [FIC 0389] ). The question nevertheless arises as to how to identify procedures, instructions and forms not explicitly required by the standard. For this, the process approach enables everyone to position themselves within a global activity and to understand the usefulness of documentation ( cf. Implementing the process approach