Division 5.2

The manufacturer must authorise the notified body to carry out all the necessary inspections and supply it with all relevant information, in particular:

• the documentation on the quality system,

• the data stipulated in the part of the quality system relating to design, such as the results of analyses, calculation, tests, etc.,

• the data stipulated in the part of the quality system relating to manufacture, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.