Division 3.2 The quality system shall ensure compliance of the products with the type described in the EC type-examination certificate and with the applicable requirements of the international instruments.

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:

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

• the examinations and tests that will be carried out after manufacture;

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

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