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The installer shall operate an approved quality system for the design, manufacture, assembly, installation, final inspection and testing of the lifts as specified in point 3, and shall be subject to surveillance as specified in point 4. The adequacy of the technical design of the lifts shall have been examined in accordance with point 3.3.
The application shall include:
the name and address of the installer, and, if the application is lodged by the authorised representative, his name and address as well;
all relevant information on the lifts to be installed, in particular information which makes for an understanding of the relationship between the design and operation of the lift;
the documentation on the quality system;
the technical documentation described in point 3 of Annex IV, Part B;
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 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, including other relevant technical specifications that will be used to ensure that the applicable essential health and safety requirements set out in Annex I will be met;
the design control and design verification techniques, processes and systematic actions that will be used when designing the lifts;
the examinations and tests that will be carried out on acceptance of the supplies of materials, components and sub-assemblies;
the corresponding assembly, installation, quality control and quality assurance techniques, processes and systematic actions that will be used;
the examinations and tests that will be carried out before (inspection of installation conditions: shaft, housing of machinery, etc.), during and after installation (including at least the tests laid down in point 3.3 of Annex V);
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.
The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved design may no longer comply with the essential health and safety requirements set out in Annex I, and shall determine whether such changes require further investigation. If so, the notified body shall inform the installer accordingly.
Each notified body shall inform the other notified bodies of the EU design examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, of the certificates and/or additions thereto which it has issued.
The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU design examination certificates and/or additions thereto. On request, the Commission and the Member States may obtain a copy of the technical documentation and of the results of the examinations carried out by the notified body.
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.
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 installer’s premises and a visit to an installation site.
The auditing team shall review the technical documentation referred to in point 3.1(d), to verify the installer’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 lift with those requirements.
The decision shall be notified to the installer or, where appropriate, to his authorised representative. The notification shall contain the conclusions of the assessment and the reasoned assessment decision.
The installer shall keep the notified body that has approved the quality system informed of any intended change to the 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 its decision to the installer or, where appropriate, to his authorised representative. The notification shall contain the conclusions of the assessment and the reasoned assessment decision.
The notified body shall affix, or cause to be affixed, its identification number adjacent to the CE marking in accordance with Articles 18 and 19.
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 quality records provided for in the part of the quality system concerning acceptance of supplies and installation, 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(c);
the technical documentation referred to in point 3.1(d);
the information relating to the changes referred to in the second paragraph of point 3.5;
the decisions and reports from the notified body which are referred to in the fourth 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 decision(s) which it has refused, suspended or withdrawn, and, upon request, of approval decisions which it has 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.
On request, the notified body shall provide the Commission and the Member States with a copy of quality system approval decision(s) issued.
The installer’s obligations set out in points 3.1, 3.3.3, 3.3.5, 5 and 7 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.