Paragraph 2 : The EC quality assurance system for supervised production

The EC quality assurance system for production with surveillance is the procedure whereby a manufacturer: 1° has a quality assurance system approved by a notified body of his choice ; 2° entrusts this body with the task of checking, by means of surveillance, that it correctly fulfils the obligations arising from the approved quality assurance system.

In order to be approved, the EC production quality assurance system proposed by the manufacturer must guarantee that each item of personal protective equipment subject to this procedure conforms to the model which was the subject of the EC type-examination certificate and to the technical rules applicable to it.

In order to benefit from an approved quality assurance system, the manufacturer must submit an application for assessment of his system to a notified body of his choice. This application must include: 1° All the information relating to the personal protective equipment envisaged, including the technical file provided for in Article R. 4313-6 relating to the model for which an EC type-examination certificate has been issued; 2° Documentation on the…

The documentation on the quality assurance system shall include in particular a description of: 1° the quality objectives, the organization chart and the distribution of responsibilities within the manufacturer in the fields relating to the quality of personal protective equipment; 2° the examinations, inspections and tests to be carried out by the manufacturer; 3° the means intended to verify the effective operation of the quality assurance system.

The notified body chosen by the manufacturer to assess the quality assurance system shall carry out the necessary checks to determine whether this system is such as to ensure conformity of production with the applicable technical rules. Such conformity is presumed when the manufacturer’s quality assurance system implements the relevant harmonised standards.

In order to assess the quality assurance system, the notified body shall carry out all necessary objective assessments of the elements of this system. In particular, it shall ensure that the system guarantees the conformity of each item of personal protective equipment with the model which has been the subject of an EC type-examination certificate. The body notifies the manufacturer of its decision.

The manufacturer must inform the body which approved his quality assurance system of any proposed changes to that system. The body must examine the proposed modifications and decide whether the quality assurance system continues to meet the provisions of Articles R. 4313-64 to R. 4313-67. The body must notify the manufacturer of its decision concerning the modified quality assurance system.

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 shall allow the notified body access to the premises where the personal protective equipment is inspected, tested and stored and shall provide all necessary information, in particular: 1° The documentation on the quality assurance system, including the quality manuals ; 2° technical documentation.

The notified body must periodically carry out investigations and checks to ensure that the manufacturer maintains and applies the approved quality assurance system. The body may pay unannounced visits to the manufacturer. It provides the manufacturer with a visit report and, where appropriate, an expert report. The notified body’s reports are sent to the manufacturer under the conditions set out in Articles R. 4313-58 and R. 4313-59.