The Radio Equipment and Telecommunications Terminal Equipment Regulations 2000

Full quality assurance

3.2  The quality system must ensure compliance of the products with the requirements of the Directive that apply to them. All the elements, requirements and provisions adoped by the manufacturer must be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation must ensure a common understanding of the quality policies and procedures such as quality programmes, plans, manuals and records.

It must contain in particular an adequate description of :

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

• the technical specifications, including the harmonised standards and technical regulations as well as relevant test specifications that will be applied and, where the standards referred to in Article 5(1) will not be applied in full, the means that will be used to ensure that the essential requirements of the Directive that apply to the products will be met,

• the design control and design verification techniques, processes and systematic actions that will be used when designing the products pertaining to the product 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, as well as the results of the tests carried out before manufacture where appropriate,

• the means by which it is ensured that the test and examination facilities respect the appropriate requirements for the performance of the necessary test,

• 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 system.