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3.4 The manufacturer shall undertake to discharge the obligations arising from the quality system as approved and to maintain it in an appropriate and efficient manner.
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 modified 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.
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