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.
The notified body must assess the quality assurance system to determine whether it satisfies the requirements referred to in point 3.2. It shall presume conformity with these requirements in respect of quality assurance systems that implement EN ISO 9001.
The auditing team must have at least one member with experience as an assessor in the equipment technology concerned. The assessment procedure must include an assessment visit to the manufacturer's premises.
The decision must be notified to the manufacturer. The notification must contain the conclusion of the examination and the reasoned assessment decision.