Subsection 3: The full quality assurance system

The full quality assurance procedure is that by which a notified body assesses, approves and monitors the application of the quality system of a machinery manufacturer. To this end, the notified body ensures that all measures have been taken concerning design, manufacture, final inspection and storage.

In order to obtain approval of its quality system, the manufacturer must submit an application for assessment to a body, which must include : 1° The name and address of the manufacturer ; 2° the places of design, manufacture, inspection, testing and storage ; 3° The technical file provided for in Article R. 4313-6 for one model of each machine listed in Article R. 4313-78; 4° Documentation on the quality…

To this end, all the elements, requirements and provisions adopted by the manufacturer are set out in systematic and rational documentation in the form of written measures, procedures and instructions. This documentation includes, in particular, an adequate description of: 1° The quality objectives, the organisational chart and the responsibilities and powers of the management with regard to the design and quality of the machines; 2° The technical solutions adopted to…

When assessing the quality system, the notified body shall consider that the elements of the quality system which comply with the relevant harmonized standard satisfy the corresponding requirements of Article R. 4313-45.

For the assessment of the quality system of a machinery manufacturer, the notified body relies on a team of auditors which includes at least one member experienced in the assessment of machinery technology. This team examines the technical file provided for in Article R. 4313-6. The assessment procedure includes an inspection visit to the manufacturer’s premises.

After assessing the system, the body shall notify its decision to approve or reject the quality system. The notified body’s decision may be the subject of a complaint under the conditions laid down in Article R. 4313-35.

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.