3. Quality system

The manufacturer shall lodge an application for assessment of his quality system for the safety components for lifts concerned with a single notified body of his choice. 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; a written declaration that the same application has not been lodged with any other notified body; the address of the premises where final inspection and testing of the safety components for lifts are carried out; all relevant information on the safety components for lifts to be manufactured; the documentation concerning the quality system; the technical documentation of the approved safety components for lifts and a copy of the EU-type examination certificate. Under the quality system, each safety component for lifts shall be inspected and appropriate tests as set out in the relevant harmonised standards or equivalent tests shall be carried out in order to ensure that it meets the conditions referred to in point 1. 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 contain in particular an adequate description of: the quality objectives; the organizational structure, responsibilities and powers of the management with regard to product quality; the examinations and tests that will be carried out after manufacture; the means of monitoring the effective operation of the quality system; and the quality records, such as inspection reports and test data, calibration data, reports on the qualifications of the personnel concerned, etc. 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 systems 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 with experience of assessment in the lift technology concerned and knowledge of the essential health and safety requirements set out in Annex I. The audit shall include an assessment visit to the manufacturer’s premises. The auditing team shall review the technical documentation referred to in point 3.1(f), in order to verify the manufacturer’s ability to identify the relevant requirements of this Directive and to carry out the necessary examinations with a view to ensuring compliance of the safety components for lifts with those requirements. The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned assessment decision. The manufacturer shall undertake to fulfil the obligations arising from the quality system as approved and to maintain it so that it remains adequate and efficient. The manufacturer or his authorised representative shall keep the notified body which has approved the quality system informed of any intended changes of the quality system. The notified body shall assess the modifications proposed and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary. It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-02 · Text as adopted (Official Journal); later amendments are not incorporated in this text.