Subsection 3: The full quality assurance system

The notified body carries out periodic audits to ensure that the manufacturer maintains and applies the approved quality system. It provides the manufacturer with an audit report. The frequency of the audits is such that a complete reassessment is carried out every three years.

The notified body makes unannounced visits to the manufacturer, the need for and frequency of which are determined on the basis of the control system managed by the body. The criteria for choosing the body include: 1° The results of previous surveillance visits; 2° The follow-up required for the implementation of corrective measures; 3° Special conditions linked to the approval of the system; 4° Significant changes in the organization of…

The manufacturer must keep at the disposal of the national authorities, for a period of ten years from the last date of manufacture, the elements to be transmitted with any application for assessment of the quality system listed in article R. 4313-44 as well as the decisions and reports provided for in articles R. 4313-48, R. 4313-49, R. 4313-53 and R. 4313-54.

If the body considers that the conditions necessary for approval of the quality system are no longer fulfilled, it will withdraw this approval. This withdrawal prohibits the placing on the market of the machine.