Division 3.3.4 The manufacturer must keep the notified body that has approved the quality system informed of any updating of the quality system in relation to changes brought about by, for example, new technologies and quality concepts.

The notified body must examine the proposed modifications and decide whether the modified quality system complies with the relevant provisions or whether reappraisal is necessary. It must notify the manufacturer of its decision. The notification must include the conclusions of the inspection and the reasoned assessment decision.