Change is formally managed under change control.

Much like all business processes, change must be managed through a change management process.

Change Management

Whichever quality system a company adopts, it must have a change management system in place.

Companies from many industries must document product and/or process requirements, such as written specifications for materials or directions for procedures. These records are subject to change within the product lifecycle.

Companies must also document each change control that applies to these requirements.

Scientific and Technical Development

As a result of scientific and technical development, changes to the legal basic conditions, or business restraints, manufacturers typically must redefine, modify, enhance, or cancel requirements repeatedly in practice.

In turn, this change to previously approved requirements necessitates a review and authorization procedure in order to keep the system in its original state of proven suitability. This is the ultimate mission of the change control.