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Showing 2361–2370 of 49283 articles for “Art. 815-5 al. 2”
The manufacturer undertakes to fulfil all the conditions necessary for the approved quality system to remain effective.
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…
The notified body checks, by means of surveillance, that the manufacturer duly fulfils the obligations arising out of the approved quality assurance system.
…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 d…
…s 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 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…
…e 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 linke…
…receding the year in which approval is granted. It is calculated in accordance with article L. 1111-2 and rounded to the nearest whole number, excluding employment access contracts.
…e of which are determined by order of the ministers responsible for employment and overseas France; 2° Fulfil its tax and social security obligations, where applicable as part of a payment plan; 3° In…
…editation conditions, the authorisation conditions or the approval conditions referred to in 1° and 2° of Article L. 6221-4 are recognised as equivalent to those laid down for medical biology laborato…
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