Division 3.2 The quality system shall ensure compliance of the products with the type described in the EU-type examination certificate and with the applicable requirements of this Directive.

All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. The quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records.

It shall, in particular, contain an adequate description of:

1. (a)

   the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality,

2. (b)

   the examinations and tests that will be carried out after manufacture,

3. (c)

   the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.,

4. (d)

   the means of monitoring the effective operation of the quality system.