Sch 1B Pt 6 para 5
The manufacturer shall keep the approved body that has approved the quality system informed of any intended change to the quality system. The approved body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in paragraph 5.2 or whether a re-assessment is necessary. It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision.