Paragraph 3.4 Full quality assuranceF1

The manufacturer must undertake to fulfil the obligations arising out of the quality system as approved and to uphold it so that it remains adequate and efficient.

• The manufacturer or his authorised representative must keep the notified body that has approved the quality system informed of any intended updating of the quality system.

• The notified body must evaluate the modifications proposed and decide whether the amended quality system will still satisfy the requirements referred to in point 3.2 or whether a reassessment is required.

• It must notify its decision to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision.