4. Surveillance under the responsibility of the notified body

Directive 2014/68/EU of the European Parliament and of the Council of 15 May 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of pressure equipment (recast) Text with EEA relevance · European Union

The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system. The manufacturer shall, for assessment purposes, allow the notified body access to the design, manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular: the quality system documentation, the quality records provided for by the design part of the quality system, such as results of analyses, calculations, tests, etc., the quality records provided for by the manufacturing part of the quality system, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc. The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report. The frequency of periodic audits shall be such that a full reassessment is carried out every three years. In addition, the notified body may pay unexpected visits to the manufacturer. The need for such additional visits, and the frequency thereof, will be determined on the basis of a visit control system operated by the notified body. In particular, the following factors shall be considered in the visit control system: the category of the equipment, the results of previous surveillance visits, the need to follow up corrective action(s), special conditions linked to the approval of the system, where applicable, significant changes in manufacturing organisation, policy or techniques. During such visits, the notified body may, if necessary, carry out product tests, or have them carried out, in order to check the proper functioning of the quality system. It shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-02 · Text as adopted (Official Journal); later amendments are not incorporated in this text.