Book III: Work equipment and means of protection

The notified body shall examine the proposed modifications and decide whether it continues to meet the provisions of Article R. 4313-45. The decision is notified and may be the subject of a complaint under the conditions laid down in Article R. 4313-35.

The manufacturer undertakes to fulfil all the conditions necessary for the approved quality system to remain effective.

The notified body checks, by means of surveillance, that the manufacturer duly fulfils the obligations arising out of the approved quality assurance system.

The manufacturer must allow the notified body access to the locations of design, manufacture, inspection, testing and storage and must provide all necessary information, in particular: 1° the documentation on the quality system; 2° the quality records provided for, on the one hand, in the part of the quality system devoted to design and, on the other hand, in the part devoted to manufacture.

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.