ANNEX XIVPRODUCTION QUALITY ASSURANCE
(module D)
1.
Production quality assurance is the procedure whereby the installer of a lift who satisfies the obligations of Section 2 ensures and declares that the lifts satisfy the requirements of the Directive that apply to them. The installer of the lift must affix the CE marking to each lift and draw up a written declaration of conformity. The CE marking must be accompanied by the identification symbol of the notified body responsible for surveillance as specified in Section 4.
2.
The installer of the lift must operate an approved quality assurance system for production, installation, final lift inspection and testing as specified in Section 3 and is subject to surveillance as specified in Section 4.
3.Quality assurance system
3.1.
The installer must lodge an application for assessment of his quality assurance system with a notified body of his choice.
The application must include:
all relevant information for the lifts,
the documentation concerning the quality assurance system,
the technical documentation of the approved type and a copy of the EC type-examination certificate.
3.2.
The quality assurance system must ensure compliance of the lifts with the requirements of the Directive that apply to them.
All the elements, requirements and provisions adopted by the installer of a lift shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. The quality assurance system documentation must permit a consistent interpretation of the quality programmes, plans, manuals and records.
It must contain in particular an adequate description of:
the quality objectives and the organizational structure, responsibilities and powers of the management with regard to the quality of the lifts,
the 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 installation31,
the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.,
the means to monitor the achievement of the required lift quality and the effective operation of the quality assurance system.
3.3.
The notified body must assess the quality assurance system to determine whether it satisfies the requirements referred to in Section 3.2. It presumes conformity with these requirements in respect of quality assurance systems that implement the relevant harmonized standard32.
The auditing team must have at least one member with experience of assessment in the lift technology concerned. The assessment procedure must include an inspection visit to the installer's premises.
The decision must be notified to the installer. The notification must contain the conclusions of the examination and the reasoned assessment decision.
3.4.
The installer must undertake to discharge the obligations arising from the quality assurance system as approved and to ensure that it is maintained in an appropriate and efficient manner.
The installer shall keep the notified body that has approved the quality assurance system informed of any intended updating of the quality assurance system.
The notified body must assess the modifications proposed and decide whether the modified quality assurance system will still satisfy the requirements referred to in Section 3.2 or whether a re-assessment is required.
It must notify its decision to the installer. The notification must contain the conclusions of the examination and the reasoned assessment decision.
4.Surveillance under the responsibility of the notified body
4.1.
The purpose of surveillance is to make sure that the installer duly fulfils the obligations arising out of the approved quality assurance system.
4.2.
The installer must allow the notified body access for inspection purposes to the manufacture, inspection, assembly, installation, testing and storage locations and must provide it with all necessary information, in particular:
the quality assurance system documentation,
the quality records, such as inspection reports and test data, calibration data, reports on the qualifications of the personnel concerned, etc.
4.3.
The notified body must periodically carry out audits to make sure that the installer maintains and applies the quality assurance system and must provide an audit report to the installer.
4.4.
Additionally the notified body may pay unexpected visits to the installer. During such visits the notified body may carry out, or cause to be carried out, tests to verify that the quality assurance system is functioning correctly, if necessary. The notified body must provide the installer with a visit report and, if a test has taken place, with a test report.
5.
The installer must, for a period of 10 years after the last lift has been manufactured, keep at the disposal of the national authorities:
the documentation referred to in the second indent of Section 3.1,
the updating referred to in the second paragraph of Section 3.4,
the decisions and reports from the notified body which are referred to in the final paragraph of Section 3.4, Sections 4.3 and 4.4.
6.
Each notified body must give the other notified bodies the relevant information concerning the quality assurance system approvals issued and withdrawn.
7.
Documentation and correspondence relating to the production quality assurance procedures shall be drawn up in an official language of the Member State in which the notified body is established or in a language acceptable to it.