Quality system
4.4 In addition, the notified body may pay unexpected visits to the manufacturer. The need for such additional visits, and the frequency thereof, will be determined on the basis of a visit control system operated by the notified body. In particular the following factors must be considered in the visit control system:
the category of the vessel,
the results of previous surveillance visits,
the need to follow up corrective action,
where applicable, special conditions linked to the approval of the system,
significant changes in manufacturing organisation, policy or techniques.
During such visits the notified body may, if necessary, carry out tests, or have them carried out, to verify that the quality system is functioning correctly. The notified body must provide the manufacturer with a visit report and, if a test has taken place, with a test report.