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Showing 2341–2350 of 49269 articles for “Art. 635 2-5°”
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.
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 document…
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 t…
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…
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…
The reference headcount is the average headcount for the calendar year preceding the year in which approval is granted. It is calculated in accordance with article L. 1111-2 and rounded to the nearest…
In order to receive the job creation premium, the approved company must: 1° Provide the State representative with information on the company's workforce and development, the content and transmission d…
When a medical biology laboratory established in another Member State of the European Union or party to the Agreement on the European Economic Area carries out the analytical phase of medical biology…
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