3.3. It must contain in particular an adequate description of:U.K.
— the quality objectives and the organisational structure, responsibilities and powers of the management with regard to design and product quality
— the technical documentation to be drawn up for each product, containing at least the information indicated in point 3.1 for the technical documentations mentioned there
— the design control and design verification techniques, processes and systematic actions that will be used when designing the products pertaining to the equipment category covered
— the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used
— the examinations and test that will be carried out before, during and after manufacture, and the frequency with which they will be carried out
— the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned etc.
— the means to monitor the achievement of the required design and product quality and the effective operation of the quality assurance system.