Article R4313-50 of the French Labour Code
November 3, 2023
The manufacturer undertakes to fulfil all the conditions necessary for the approved quality system to remain effective.
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.
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…
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is a Registered Trademark of
PETROFF LAW FIRM (SELARL LEGASTRAT)
182, rue de Rivoli
75001, Paris France
RCS Paris n°814433470
Paris Bar Registration n° (Toque) C2396
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is a Registered Trademark of
PETROFF LAW FIRM (SELARL LEGASTRAT)
182, rue de Rivoli
75001, Paris France
RCS Paris n°814433470
Paris Bar Registration n° (Toque) C2396
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