http://www.legislation.gov.uk/eudr/1994/25/annex/XVI/division/4/2008-12-11Directive 94/25/EC of the European Parliament and of the Council of 16 June 1994 on the approximation of the laws, regulations and administrative provisions of the Member States relating to recreational craft (repealed)Directive 94/25/EC of the European Parliament and of the Council (repealed)Directive 94/25/EC of the European Parliament and of the Council of 16 June 1994 on the approximation of the laws, regulations and administrative provisions of the Member States relating to recreational craft (repealed)2020-12-12King's Printer of Acts of Parliamenthttps://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01994L0025-20081211texttext/xmlen2008-12-11 ANNEX XVI <Addition ChangeId="O001001M030" CommentaryRef="c000006">PRODUCT QUALITY ASSURANCE (MODULE E)</Addition> 4.

Surveillance under the responsibility of the notified body

4.1.

The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

4.2.

The manufacturer must allow the notified body entrance for inspection purposes to the locations of inspection, testing and storage and shall provide it with all necessary information, in particular:

the quality system documentation, the technical documentation, the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.

4.3.

The notified body must periodically carry out audits to ensure that the manufacturer maintains and applies the quality system and must provide an audit report to the manufacturer.

4.4.

Additionally, the notified body may pay unexpected visits to the manufacturer. At the time of such visits, the notified body may carry out tests or have them carried out in order to check the proper functioning of the quality system where necessary; it must provide the manufacturer with a visit report and, if a test has been carried out, with a test report.

Inserted by Directive 2003/44/EC of the European Parliament and of the Council of 16 June 2003 amending Directive 94/25/EC on the approximation of the laws, regulations and administrative provisions of the Member States relating to recreational craft (Text with EEA relevance).
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<Addition ChangeId="O001001M030" CommentaryRef="c000006">The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.</Addition>
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<Addition ChangeId="O001001M030" CommentaryRef="c000006">The manufacturer must allow the notified body entrance for inspection purposes to the locations of inspection, testing and storage and shall provide it with all necessary information, in particular:</Addition>
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<Addition ChangeId="O001001M030" CommentaryRef="c000006">the quality system documentation,</Addition>
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<Addition ChangeId="O001001M030" CommentaryRef="c000006">the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.</Addition>
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Inserted by
<Citation Class="EuropeanUnionDirective" Year="2003" Number="44" URI="http://www.legislation.gov.uk/id/eudr/2003/44" Title="Directive 2003/44/EC of the European Parliament and of the Council of 16 June 2003 amending Directive 94/25/EC on the approximation of the laws, regulations and administrative provisions of the Member States relating to recreational craft (Text with EEA relevance)">Directive 2003/44/EC of the European Parliament and of the Council of 16 June 2003 amending Directive 94/25/EC on the approximation of the laws, regulations and administrative provisions of the Member States relating to recreational craft (Text with EEA relevance)</Citation>
.
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