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Showing 4811–4820 of 59263 articles for “Art. L 443-6-2 s.”
As soon as the donation is used, the healthcare organisation or institution shall include the data communicated by the third party donors in the data processing provided for in Article L. 2143-4. The…
The officers of the National Council shall organise the election. It shall determine the applicable procedures, in particular those for postal voting, other than those provided for in this title, in a…
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…
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 gu…
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:…
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 th…
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 ma…
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…
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 qualit…
The notified body checks, by means of surveillance, that the manufacturer duly fulfils the obligations arising out of the approved quality assurance system.
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