This is something that you have to solve in your own organization. In some companies the quality
units are always involved in the changes. Other companies have different levels of change.
Changes that are not initially reviewed by the Quality Unit should be addressed during internal
audits.
Section 13 (change control) expects a formal procedure. And any formal procedure would have to
be approved by the quality unit. This procedure should define what changes need to be approved
by the quality unit and which ones do not need to be approved.
