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(module E)U.K.
The manufacturer of the safety component or his authorized representative established in the Community must affix the CE marking to each safety component and draw up an EC declaration of conformity. The CE marking must be accompanied by the identification number of the notified body responsible for surveillance as specified in Section 4.
The application must include:
all relevant information for the safety components envisaged,
the documentation on the quality assurance system,
the technical documentation of the approved safety components and a copy of the EC type-examination certificates.
All the elements, requirements and provisions adopted by the manufacturer of the safety components must be documented in a systematic and orderly manner in the form of written measures, procedures and instructions. This quality assurance system documentation must ensure a common understanding of the quality programmes, plans, manuals and records.
It must contain in particular an adequate description of:
the quality objectives;
the organizational structure, responsibilities and powers of the management with regard to safety component quality;
the examinations and tests that will be carried out after manufacture;
the means to verify the effective operation of the quality assurance system;
quality records, such as inspection reports and test data, calibration data, reports on the qualifications of the personnel concerned, etc.
The auditing team must have at least one member with experience of assessment in the lift technology concerned. The assessment procedure must include a visit to the premises of the safety component manufacturer.
The decision must be notified to the manufacturer of the safety components. The notification must contain the conclusions of the examination and the reasoned assessment decision.
The manufacturer of the safety components or his authorized representative established in the Community must keep the notified body which 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 still satisfies the requirements referred to in Section 3.2 or whether a reassessment is required.
It must notify its decision to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision.
the quality assurance system documentation,
the technical documentation,
the quality records, such as inspection reports and test data, calibration data, reports on the qualifications of the personnel concerned, etc.
At the time of such visits, the notified body may carry out tests or have them carried out in order to check the proper functioning of the quality assurance system where necessary; it must provide the manufacturer of the safety components with a visit report and, if a test has been carried out, with a test report.
the documentation referred to in the third indent of the second paragraph 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 and in Sections 4.3 and 4.4.
This harmonized standard will be EN 29003, supplemented where necessary to take account of the specific features of safety components.