(This isn't necessarily a ISO 9001:2015-specific question, but it is certainly relevant to the 2015 revision as well as prior revisions.) My organization has struggled with the question of whether the ISO 9001 standard requires all documented information to be controlled. We chose to parse of the language of the ISO 9001 standard to carve out the possibility that some documented information could be managed (potentially rather loosely) outside of our main Document Control procedure. We defined criteria that determines the scope of processes included the QMS. And then we stated that we considered a written procedure to be "required by the quality management system" for each of these processes (see the first sentence of 7.5.3), while other documents are optional and therefore may optionally be controlled. This means that work instructions, training materials, etc. may optionally be controlled, but it is not required. But is this putting too much of a spin on the language of the ISO 9001? Does the mere existence of a document imply that it is "necessary for the effectiveness of the quality management system" (see 7.5.1.b)? That certainly seems to be the clear message in http://www.iso.org/iso/documented_information.pdf (section 4b): "Where it exists, all such documented information, is also subject to the requirements clause 7.5." (And then again, does ISO guidance not incorporated into the standard represent requirements or interpretation of requirements?) Thoughts?