Division 3.3
United Kingdom
The notified body must assess the quality system to determine whether it satisfies the requirements referred to in section 3.2. It must presume conformity with those requirements in respect of quality systems that implement the relevant harmonized standard. The auditing team must have at least one member with experience of assessing the relevant product technology. The assessment procedure includes an inspection visit to the manufacturer's premises.
The decision is notified to the manufacturer. The notification must contain the conclusions of the examination and the duly substantiated assessment decision.