Paragraph 1: The EC quality assurance system

The “EC quality assurance system” is the procedure whereby a notified body certifies that the manufacturer has taken all necessary measures to ensure that the manufacturing process, including final inspection and testing of the personal protective equipment, guarantees the homogeneity of its production and the conformity of each item of personal protective equipment submitted to this procedure with the model which was the subject of the EC type-examination certificate and…

For each model of personal protective equipment manufactured, a notified body chosen by the manufacturer shall take an adequate sample of the personal protective equipment at random intervals, at least once a year. Under its responsibility, it shall examine the sample and perform the appropriate tests defined by the standards referred to in 6° of Article L. 4311-7 or necessary to ensure that the samples of personal protective equipment comply…

Where the report provided for in Article R. 4313-58 concludes that there is a lack of homogeneity of production or that the samples of personal protective equipment examined do not conform to the model described in the EC type-examination certificate and the applicable technical rules, the notified body shall take the appropriate measures in the light of the defects found and shall inform the Minister responsible for labour. The period…

The measures referred to in article R. 4313-59 may consist of an increase in the frequency of sampling, a request for modification of the manufacturing processes including final inspection, a request for recall or scrapping of defective batches. The financial cost of implementing these measures is borne by the manufacturer. If these measures do not appear to be sufficient or are not complied with, the safeguard procedure provided for in…

The possibilities for complaint provided for in Article R. 4313-35 are applicable to the decisions of the notified body provided for in this paragraph.