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Directive 2014/68/EU of the European Parliament and of the CouncilShow full title

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)

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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 shall, for assessment purposes, allow the notified body access to the manufacture, inspection, testing and storage sites 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, reports concerning the qualifications of the personnel concerned, etc.

4.3.The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and provide the manufacturer with an audit report. The frequency of periodic audits must be such that a full reassessment is carried out every three years.
4.4.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 pressure equipment,

  • the results of previous surveillance visits,

  • the need to follow up corrective actions,

  • 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 verify that the quality system is functioning correctly. The notified body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.

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