3.2.

The quality system shall ensure compliance of the radio equipment with the requirements of this Directive that apply to it. 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. That 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 design and product quality; the technical design specifications, including standards, that will be applied and, where the relevant harmonised standards will not be applied in full, the means that will be used to ensure that the essential requirements of this Directive that apply to the radio equipment will be met; the design control and design verification techniques, processes and systematic actions that will be used when designing radio equipment pertaining to the radio equipment type covered; the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used; the examinations and tests 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, reports concerning the qualifications of the personnel, etc.; the means of monitoring the achievement of the required design and product quality and the effective operation of the quality system.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-28 · Text as adopted (Official Journal); later amendments are not incorporated in this text.