xmlns:atom="http://www.w3.org/2005/Atom"

SCHEDULE 6Module: Production quality assurance

Quality system

3.3  The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in paragraph 3.2. It shall presume conformity with those requirements in respect of quality systems which implement the relevant harmonized standard. The auditing team shall have at least one member with experience of evaluation in the equipment technology concerned. The evaluation procedure shall include an inspection visit to the manufacturer’s premises. The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the examination and the reasoned assessment decision.