ANNEX IVU.K.EC DECLARATION OF CONFORMITY(FULL QUALITY ASSURANCE SYSTEM)

5.SurveillanceU.K.

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:U.K.

• 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.