OpenLegislation

Division 3.2 The manufacturer shall, for inspection purposes, allow the notified body access to the places of design, manufacture, inspection, testing and storage, and shall provide it with all necessary information, such as:

United Kingdom

Original text. Later amendments are not shown.

  • the documentation concerning the quality system,

  • the quality records provided for in that part of the quality system concerned with design, such as the results of analyses, calculations, tests, etc.,

  • the quality records provided for in that part of the quality system concerned with manufacture, such as inspection reports and test data, calibration data, reports on the qualifications of the personnel concerned, etc.