Division 3.4
United Kingdom
The manufacturer must undertake to fulfil the obligations arising out of the quality system as approved and maintain it at an adequate and efficient level.
The manufacturer or his authorized representative must keep the notified body that has approved the quality system informed of any proposed change in the quality system.
The notified body must assess the changes proposed and decide whether the altered quality system will still satisfy the requirements referred to in 3.2 or whether reassessment is required.
It must notify the manufacturer of its decision. The notification must contain the conclusions of the examination and the substantiated assessment decision.