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The manufacturer shall operate an approved quality system for the design, manufacture, final inspection and testing of safety components for lifts as specified in point 3 and shall be subject to surveillance as specified in point 4.
the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well;
the address of the premises where the safety components for lifts are designed, manufactured, inspected and tested;
all relevant information on safety components for lifts to be manufactured;
the technical documentation described in point 3 of Annex IV, Part A for one model of each category of safety component for lifts to be manufactured;
the documentation on the quality system;
a written declaration that the same application has not been lodged with any other notified body.
It shall contain in particular an adequate description of:
the quality objectives and the organizational structure, responsibilities and powers of the management with regard to the design and product quality;
the technical design specifications, including standards that will be applied and, where the relevant harmonised standards will not be applied or not applied in full, the means, including other relevant technical specifications, that will be used to ensure that the conditions referred to in point 1 will be met;
the design control and design verification techniques, processes and systematic actions that will be used when designing the safety components for lifts;
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 on the qualifications of the personnel concerned;
the means of monitoring the achievement of the required design and product quality and the effective operation of the quality system.
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(d) to verify the manufacturer’s ability to identify the applicable essential health and safety requirements set out in Annex I 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 and, where appropriate, to his authorised representative. The notification shall contain the conclusions of the audit and the reasoned assessment decision.
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 assessment and the reasoned assessment decision.
the quality system documentation;
the quality records provided for in the design part of the quality system such as results of analyses, calculations, tests;
the technical documentation for the safety components for lifts manufactured;
the quality records provided for in the manufacturing part of the full quality system, such as inspection reports and test data, calibration data, reports on the qualifications of the personnel concerned.
the documentation referred to in point 3.1(e);
the technical documentation referred to in point 3.1(d);
the information relating to the change referred to in the first paragraph of point 3.5;
the decisions and reports from the notified body referred to in the third paragraph of point 3.5. and in points 4.3 and 4.4.
Each notified body shall inform the other notified bodies of quality system approval decisions which it has refused, suspended or withdrawn and, upon request, of approval decisions which it has issued.
On request, the notified body shall provide the Commission and the Member States with a copy of quality system approval decision(s) issued.
The notified body shall keep a copy of the approval decision issued, its annexes and additions, as well as the technical documentation for 15 years from the date of their issue.
The manufacturer’s obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.