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.
Where the notified body concludes that the approved quality assurance system has been applied incorrectly, it may, depending on the seriousness of the defects found: – either request the necessary modifications to the system. – decide to withdraw approval.
In the event of withdrawal of approval of the quality assurance system, manufacture may not continue until the manufacturer has implemented an EC quality assurance system which complies with the provisions of paragraph 1 of this subsection. The safeguard procedure provided for in Chapter IV may also be implemented.
The possibilities of complaint provided for in Article R. 4313-35 are applicable to the decisions of the notified body provided for in this paragraph.
With the exception of those listed in article R. 4313-78, machinery is subject to the conformity assessment procedure with internal control of manufacture. Agricultural or forestry tractors and their separate technical units, systems or components are subject to the EU type-approval or national type-approval procedures defined respectively by Regulation (EU) No 167/2013 of the European Parliament and of the Council of 5 February 2013 on type-approval and market surveillance of…
Where the machine is referred to in Article R. 4313-78 and is manufactured in accordance with the harmonised standards referred to in Article L. 4311-7, and provided that these standards cover all the relevant technical rules, the manufacturer shall apply one of the following procedures: 1° The conformity assessment procedure with internal control of manufacture; 2° The EC type-examination procedure with internal control of manufacture; 3° the full quality assurance…
Where the machine is referred to in Article R. 4313-78 and is not manufactured in accordance with the harmonised standards referred to in Article L. 4311-7 or if the harmonised standards do not cover all the relevant technical rules, the manufacturer shall apply one of the following procedures: 1° The EC type-examination procedure and internal production control; 2° The full quality assurance procedure.
New machines or machines considered as new which are subject either to the procedures defined in article R. 4313-76 or to those defined in article R. 4313-77, are as follows: 1° Circular saws (single- or multiblade) for working with wood and material with similar physical characteristics or for working with meat and material with similar physical characteristics, of the following types : (a) Sawing machinery with one or more fixed…
An assembly of machinery consisting of the assembly of a machine or tractor with interchangeable equipment is not required to satisfy the conformity certification procedure applicable to that assembly if the two constituent parts are compatible with each other and if each of those parts has satisfied the conformity assessment procedure applicable to it.
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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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