3. Quality system

The manufacturer shall lodge an application for assessment of the quality system with the notified body of his choice for the measuring instruments concerned. The application shall include: the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well; all relevant information for the instrument category envisaged; the documentation concerning the quality system; a written declaration that the same application has not been lodged with any other notified body. The quality system shall ensure compliance of the measuring instruments with the requirements of this Directive that apply to them. 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. This 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 and/or normative documents 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 measuring instruments will be met, applying other relevant technical specifications; the design control and design verification techniques, processes and systematic actions that will be used when designing the measuring instruments pertaining to the instrument category 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, qualification reports on the personnel concerned; the means of monitoring the achievement of the required design and product quality and the effective operation of the quality system. The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2. It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant harmonised standard. In addition to experience in quality management systems, the auditing team shall have at least one member experienced as an assessor in the relevant instrument field and instrument technology concerned, and knowledge of the applicable requirements of this Directive. The audit shall include an assessment visit to the manufacturer’s premises. The manufacturer or his authorised representative shall be notified of the decision. The notification shall contain the conclusions of the audit and the reasoned assessment decision. The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient. The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system. The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a re-assessment is necessary. It shall notify the manufacturer or his authorised representative of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision. Each notified body shall inform its notifying authority of quality system approvals issued or withdrawn, and shall periodically or upon request, make available to its notifying authority the list of quality system approvals refused, suspended or otherwise restricted.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.