3.4 The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to uphold the system so that it remains adequate and efficient.
The manufacturer or his authorised representative shall inform the notified body which has approved the quality system of any intended updating of the quality system.
The notified body shall evaluate the modifications proposed and decide whether the amended quality system will still satisfy the requirements referred to in paragraph 3.2 or whether a re-assessment is required.
It shall notify its decision to the manufacturer. The notification shall contain the conclusions of the examination and the reasoned assessment decision.