A robust document control management process lies at the heart of a quality management system (QMS); almost every aspect of auditing and compliance verification is determined through the scrutiny of documented evidence. As the saying goes: “If it’s not documented, it didn’t happen.”
Change management is the process responsible for controlling the lifecycle of all changes within a QMS system. It is a formal process used to ensure there is a standardized method and procedures in place to drive efficient and prompt handling of all changes while effectively communicating the changes to the impacted areas prior to implementation.