Division 3.2

The quality system shall ensure that the PPE is in conformity with the type described in the F1... type-examination certificate and complies with the applicable requirements of this Regulation.

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.

The quality system documentation 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 corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used;

3. (c)

   the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out;

4. (d)

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

5. (e)

   the means of monitoring the achievement of the required product quality and the effective operation of the quality system.