http://qualitymanagementsystem.com/quality-management-software/what-quality-management-software-can-do-for-your-business/ A large part of implementing a quality management system is writing, updating and maintaining business process and systems documentation. Not only is documentation a requirement for formal quality systems such as ISO: 9001 and the FDA, it also defines how each work process is performed to company standards and fits within the entire quality system. Quality documentation also must be revised when changes are made, with the latest revisions accessible to those who do the work.