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ANNEX I
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ESSENTIAL SAFETY AND HEALTH REQUIREMENTS FOR THE CONSTRUCTION AND MANUFACTURE OF LIFTS AND SAFETY COMPONENTS
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PRELIMINARY REMARKS
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1. The obligations laid down by the essential health and safety requirements shall apply only when the relevant risk is present for the lift or safety component associated with the use of this under the conditions of use, the installer of the lift, or the manufacturer of the safety component, fixed conditions.
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The essential health and safety requirements laid down in the directive are essential. However, in the light of the technical stage, it is possible that the objectives set are not achievable. If this is the case, the lift or safety component shall be construed and produced in order to enable these objectives to be pursued as far as possible.
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3. The manufacturer of the safety component and the installer of the lift must carry out a risk analysis with a view to identifying all of the risks associated with their product ; the product must then be constructed and produced in the interests of this ; analysis.
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In accordance with Article 14, the essential requirements of Directive 89 /106/EEC, which have not been included in this Directive, shall apply to lifts.
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1.
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GENERAL NOTES
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1.1.
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Application of Directive 89 /392/EEC as amended by Directives 91 /36 8 / EEC, 93 /44/EEC and 93 /68/EEC
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Where the relevant risk is available but not dealt with in this Annex, the essential health and safety requirements set out in Annex I to Directive 89 /392/EEC shall apply. In any event, the essential requirements of section 1.1.2 of Annex I to Directive 89 /392/EEC shall apply.
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1.2.
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Elevator Chair
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The lift must be designed and constructed in such a way that the area and the carrier capacity correspond to the maximum number of persons and the highest load, as the installer has set for the lift.
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Where the lift is intended to transport persons and its dimensions, the lift must be designed and constructed in such a way that its structure is not for inconvenience or obstacles to the availability and access of disabled persons ; use the lift, so that it is possible to equip it with all necessary devices which may facilitate the use of them by the means of debt.
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1.3.
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Repeating and carrying means
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All the suspension components and / or lifts of the lift must be chosen and constructed in such a way as to ensure a sufficient overall level of safety, and so that the risk of reducing the lift is reduced to a minimum in the light of the conditions of use, the materials used and the conditions of manufacture.
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Where the traction or chains are used as a carrier for the lift, there must be at least two independent two-way or chains, and each rope or chain must be fitted with its own fastening system. Tova and chains shall not be either spliced or collected except where this is necessary in order to be able to be attached or retainted.
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1.4.
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Control of movement (including speed limitation)
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1.4.1.
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The lifts must be so designed and constructed and installed in such a way that the initiation is not possible for so long as the load exceeds the nominal highest rated.
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1.4.2.
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The elevators must be equipped with speed limits.
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However, this does not apply to lifts which, because of the construction of the drift system, will not be able to achieve too much speed.
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1.4.3.
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Rapid lifts must be fitted with a device enabling the speed to be controlled and controlled.
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1.4.4.
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Lifts in the use of the friction rods shall be so constructed as to ensure that the stability of the two-valve stability on the friction board is ensured.
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1.5.
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Elevator Plays
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1.5.1.
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Each person lift must have its own elevator game. This requirement does not apply to lifts where, instead of the counterweight, there is yet another lift chair.
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1.5.2.
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The installer of the lift shall ensure that an elevator's game and its associated devices are not available, except in the case of maintenance and in case of emergency.
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1.6.
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Control devices
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1.6.1.
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The service devices in lifts intended to be used by disabled persons without a whitelighter must be designed and fitted in an appropriate manner.
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1.6.2.
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The function of processing anordings must be clearly specified.
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1.6.3.
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An elevator group's call systems can be common or interconnected.
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1.6.4.
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The electrical equipment must be installed and connected in such a way as to :
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-WHAT?
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any confusion with circuits not belonging to the lift is excluded ;
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-WHAT?
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the energy supply can be switched off to under load,
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-WHAT?
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the movements of the lift are dependent on the electrical safety devices placed in an independent security circuits ;
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-WHAT?
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an electrical installation error does not create a dangerous situation.
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2.
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RISKS FOR PERSONS OUTSIDE THE LIFT
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2.1.
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The lift must be designed and constructed in such a way that access to the lift shaft is impossible, except in the case of maintenance or in case of emergency. Before a person can enter the lift shaft, the normal use of the lift must be made impossible.
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2.2.
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The lift must be designed and constructed in a manner which preclates danger of being squeezing when the lift chair is located in one of its external positions.
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-WHAT?
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This purpose shall be fulfilled by a free space or a safe house outside of each of the extrematic positions.
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-WHAT?
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In specific cases, particularly in existing properties, any other measure may be taken to avoid such danger. The Member States must be given the opportunity to give prior authorisation.
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2.3.
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The opening doors of the lift chair must be fitted with floor doors having a sufficiently large mechanical resistance to the conditions of use of the manufacturer.
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A contraption device shall prevent :
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1.
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that the lift chair may be initiated intentionally or unintentionally if not all floor doors are closed and locked ;
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2.
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the opening of a floor door, while the car is in motion, and if it is not on a floor.
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However, the progress of an open establishment door with a view to bringing the car seat to a level with an establishment threshold, however, is permitted in defined zones if this is carried out at a controlled rate.
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3.
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RISKS TO THE STUDENT BODY
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3.1.
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The lift must be completely closed with whole walls, ceilings and floors, except for ventilation, and equipped with whole doors. The lift doors must be designed and fitted in such a way that the lift chair cannot be moved, except for the transference referred to in the third subparagraph of point 2.3, unless the doors are closed and that it stops if the doors are opened.
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The lift doors shall remain closed and locked in the event of a stop between two floors if there is otherwise a risk of falling between the car chair and the shaft or if there is no harm.
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3.2.
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In the event of an energy failure or a component, the lift must be equipped with devices intended to prevent free fall or uncontrolled upward movements of the lift chair.
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The mechanism for preventing the free fall of the lift shall be independent of the suspension devices of the lift chair.
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This device shall be able to stop the chair at the nominal highest mark and the maximum speed for which the installer of the lift has been determined. The standpoint of this device must not, under any conditions, convene a deceleration that is dangerous to those who are in the chair.
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3.3.
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Buffer devices must be installed between the floor of the lift shaft and the floor of the lift shaft.
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In this case, the free space referred to in point 2.2 shall be measured with the buffer devices in total summary.
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This requirement does not apply to lifts in which the lift chair, due to the design of the driving system, cannot enter the free space referred to in paragraph 2.2.
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3.4.
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The lifts must be designed and manufactured so that they cannot be started unless the device referred to in 3.2 is in a position where it can operate.
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4.
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OTHER RISKS
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4.1.
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If the doors and doors or both of these doors are being moved by mechanical means, they must be equipped with a device which excludes the risk of clamps when they are moved.
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4.2.
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The doors of the doors, including the parts supplied with glass, shall, when they are intended to contribute to the fire of fire, have an appropriate heat-resistant, denoted by the fact that they are all intact and undamaged, as well as in their isolating (fire must not spread) ; thermal transmissible properties (heat radiation).
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4.3.
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Any counterweights must be fitted in such a way as to exclude the possibility of colliding with the lift or downgrading on this one.
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4.4.
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The lifts must be fitted with devices which allow free and assisting persons to be released into the lift chair.
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4.5.
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The lift must be fitted with a two-way means of communication, which will allow for all time to be connected with a particular alarm centre.
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4.6.
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The lifts must be designed and manufactured so that, by exceeding the highest temperature of the lift installer, they may terminate the movements in progress but not perform any new operations ; control orders.
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4.7.
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The lift chairs must be designed and constructed so as to provide adequate ventilation to passengers, even in the case of long-term standings.
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4.8.
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The lift must be provided with sufficient illumination when used, or when a door is opened ; it must also be equipped with emergency lighting.
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4.9.
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The means of communication referred to in point 4.5 and the emergency lighting referred to in point 4.8 must be designed and constructed in such a way as to operate at a power outage. They must be able to function during the period that normally takes before help reaches its way.
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4.10.
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The operating system in elevators which can be used in the event of fire must be so designed and constructed that it can be fought from certain floors and provide the right of the rescue card to the service.
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5.
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LABELLING
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5.1.
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In addition to the minimum declarations made by any machine in accordance with section 1.7.3 of Annex I to Directive 89 /392/EEC, the lift must be provided with a clear sign on which the label of the label in kilograms and the maximum number of passengers is clearly marked ; specified.
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5.2.
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If the apparatus is designed so that persons who are stuck in the lift chair can enter without outside help, the lift must be clearly and visibly specified in the lift and visible.
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6.
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USAGE VIEW
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6.1.
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The safety components referred to in Annex IV must be accompanied by an instruction manual in an official language of the installer of the lift, or a different Community language approved by this person, so that :
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-WHAT?
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mounting
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-WHAT?
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connection
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-WHAT?
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adjustment
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-WHAT?
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maintenance
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can be done in an efficient and dangerous manner.
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6.2.
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Each lift shall be provided with documentation drawn up in one or more Community languages which may be established in accordance with the Treaty of the Member State in which the lift is installed. This dossier shall include at least :
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an instruction manual with the plans and diagrams necessary for normal use as well as for maintenance, inspection, repair, periodic verification and the rescue efforts referred to in Section 4.4 ;
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a service book, in which repairs and, where appropriate, periodic verifications may be indicated.
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ANNEX II
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A.
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Contents of the EC declaration of conformity for safety components (12)
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The EC declaration of conformity must include the following information :
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-WHAT?
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name and address of the manufacturer of safety components (13) ;
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where appropriate, the name and address of his authorised representative established within the Community (3) ;
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-WHAT?
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description of the safety component, type and serial number and, where appropriate, serial number,
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-WHAT?
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the safety feature of the safety component, if this is not clear from the description,
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-WHAT?
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the manufacturing year of the safety component ;
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-WHAT?
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all relevant provisions satisfying the safety component,
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where appropriate, reference to the harmonized standards used,
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-WHAT?
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where appropriate, the name, address and identification number of the notified body which has carried out the EC type-examination in accordance with Article 8 (2) ; paragraph 1 (a) (a), i) and (ii),
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-WHAT?
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where appropriate, a reference to the EC type-examination certificate issued by the notified body,
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-WHAT?
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where appropriate, the name, address and identification number of the notified body which carried out the production control in accordance with Article 8 (3) ; paragraph 1 (a) (a), (ii)
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-WHAT?
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where appropriate, the name, address and identification number of the notified body which has checked the quality assurance system used by the manufacturer in accordance with Article 8 (2) ; paragraph 1 (a) (a), (iii)
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-WHAT?
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identification of the signatory authorised to oblige the manufacturer of safety components, or his authorised representative established within the Community.
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B.
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Contents of the EC declaration of conformity for installed elevators (14)
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The EC declaration of conformity must include the following information :
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-WHAT?
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name and address of the installer of an installer (15) ;
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-WHAT?
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description of the lift, the type and serial number, serial number and address of the place where the lift is installed ;
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-WHAT?
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the installer of the lift,
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-WHAT?
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all relevant provisions which the lift satisfies ;
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-WHAT?
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where appropriate, reference to the harmonized standards used,
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-WHAT?
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where appropriate, the name, address and identification number of the notified body which has carried out the EC type-examination of the lift model in accordance with Article 8 (1). 2, no. i) and (ii),
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-WHAT?
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where appropriate, a reference to the EC type-examination certificate,
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-WHAT?
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where appropriate, the name, address and identification number of the notified body which has carried out the EC verification of the lift in accordance with Article 8 (3) ; 2, no. (iv)
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-WHAT?
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where appropriate, the name, address and identification number of the notified body which has carried out the final checks on the lift in accordance with Article 8 (1). 2, no. i), (ii), (iii), first indent,
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-WHAT?
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where appropriate, the name, address and identification number of the notified body responsible for checking the quality system, the installer of the lift, has been applied in accordance with Article 8 (1). 2, second and third indenus in paragraph 1. (i), (ii) and (iii) and Article 8 (1). 2, no. (v)
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identification of the signatory to which the lift installer is required.
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ANNEX III
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CE-CONFORMITY MARKING
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The CE conformity marking shall consist of the initials ' CE ` in accordance with the following model :
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If the CE marking is reduced or enlarged, the size of the model as indicated above must be complied with.
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The various components of the CE marking must, as far as possible, be of the same height, and this must be at least 5 mm above. This minimum size may be exempted from small safety components.
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The CE marking shall be followed by the identification number of the notified body in connection with :
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-WHAT?
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the procedures referred to in Article 8 (1) paragraph 1 (a) (a), (ii) or (iii)
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-WHAT?
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the procedures referred to in Article 8 (1) 2.
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ANNEX IV
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LIST OF SAFETY COMPONENTS REFERRED TO IN ARTICLE 1 (1) AND ARTICLE 8 (1)
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1.
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Facility for locking of floor doors.
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2.
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Regulations (cf. section 3.2 of Annex I) for the hurdle of the free fall of the lift or uncontrolled upward movements.
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3.
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Speed limiters.
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4.
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a)
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Energy-accumulating buffers
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either non-linear species ;
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-WHAT?
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or with the damping of the return cover.
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b)
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Energy-absorbing buffers.
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5.
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Safety devices on hydraulic cylinders in hydraulic systems when used as devices for preventing fall.
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6.
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Electrical safety devices in the form of safety-breakers in which electronic components are used.
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ANNEX V
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EF TYPE-EXAMINATION
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(module B)
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A.
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EC type-examination of safety components
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1.
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The EC type-examination is the procedure whereby a notified body ascertains and certifies that a representative copy of a safety component will give the lift on which it is properly installed, the possibility of complying with the relevant provisions of this Directive.
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2.
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The application for EC type-examination shall be lodged by the manufacturer or his authorized representative established within the Community to a notified body of his choice.
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The request shall contain :
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-WHAT?
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the name and address of the manufacturer of the safety component and the name and address of the manufacturer ' s representative, where the device is lodged by it and the location of the safety components ;
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-WHAT?
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a written declaration that the same request has not been lodged with other notified bodies ;
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-WHAT?
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technical documentation,
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-WHAT?
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a representative sample of the safety component or an indication of the place where it can be investigated. The notified body may, with justification, request other copies.
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3.
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The technical documentation must enable the conformity of the safety component and its ability to give the lift on which it is correctly installed, the possibility of complying with the provisions of the Directive.
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The technical documentation must, to the extent necessary for the assessment of the conformity, contain the following information :
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-WHAT?
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a general description of the safety component, including the scope (in particular any restrictions on speed, load, energy), and conditions (in particular explosive atmospherance, adverse weather conditions),
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-WHAT?
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design drawings or diagrams and manufacturing drawings or diagrams ;
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-WHAT?
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relevant essential requirements and the ways in which these requirements have been met (e.g. harmonised standards),
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-WHAT?
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where appropriate, the results of the tests or calculations carried out by the manufacturer or by the manufacturer ;
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-WHAT?
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a copy of the installation instructions for the safety components,
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-WHAT?
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the measures which will be taken at the manufacturing stage to ensure that the series of safety components is in accordance with the safety component tested.
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4.
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The notified body must :
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-WHAT?
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examine the technical documentation, in order to assess whether it is capable of meeting the objectives pursued ;
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-WHAT?
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examine the safety component to check whether it corresponds to the technical documentation ;
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-WHAT?
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carry out or carry out the appropriate checks and tests to verify whether the solutions of the safety component manufacturer are in accordance with the requirements of the Directive and make it possible for the safety component to be able to comply with the requirements of the Directive ; its function when it is fitted correctly on an elevator.
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5.
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If the representative copy of the safety component of the Directive is to be provided, the notified body must issue an EC type-examination certificate to the applicant. The certificate must include the name and address of the manufacturer of the safety component, the results of the checks, the conditions of validity of the certificate and the necessary data for identification of the approved type.
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The Commission, the Member States and the other notified bodies may have a copy of the certificate and, on a reasoned request, a copy of the technical documentation and the reports for the studies carried out, calculations or tests. If the notified body must issue a EC type-examination certificate to the manufacturer, it shall provide a detailed account of the reasons for this. A procedure shall be established.
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6.
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The manufacturer of the safety component or its authorised representative established within the Community must inform the notified body of any, including minor, amendments which he has made or intends to perform of the approved security component, including new ; editions which are not specified in the initial technical documentation (cf. point 3, first indent). The notified body must examine these modifications and inform the manufacturer or his representative, whether the EC type-examination certificate remains valid (16).
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7.
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Each notified body must communicate to the Member States the relevant information concerning :
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-WHAT?
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EC type-examination certificates issued by the EC type-examination,
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-WHAT?
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the withdrawn EC type-examination certificates.
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In addition, all notified bodies must communicate to the other notified bodies the relevant information relating to the EC type-examination certificates of the EC type-examination.
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8.
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The EC type-examination certificate, dossiers and correspondence relating to EC type-examination procedures shall be drawn up in an official language of the Member State in which the notified body is established or in a language approved by that body.
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9.
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The manufacturer of the safety component or its authorised representative established within the Community must also keep, in addition to the technical documentation, a copy of the EC type-examination certificates and any addendum to these for a period of 10 years from the safety component Date of manufacture.
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Where neither the manufacturer of a safety component nor his representative is established in the Community, the obligation to present the technical documentation shall be the responsibility of the person responsible for the placing on the market of the safety component in the Community.
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B.
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EC type-examination of the lift
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1.
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The EC type-examination procedure is the procedure whereby a notified body ascertains and certify that an elevator model or an elevator for which no other versions have been foreseen comply with the provisions of this Directive.
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2.
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The request for EC type-examination of the lift shall be submitted by the installer of the lift to a notified body of his choice.
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The request must contain
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-WHAT?
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the name and address of the lift installer,
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-WHAT?
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a written declaration that the same request has not been lodged with other notified bodies ;
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-WHAT?
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technical documentation,
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-WHAT?
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Indication of the place where the lift model can be examined. This shall include the connectivity and the equipment for at least three levels (the upper, the bottom and the intermediate).
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3.
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The technical documentation must enable the assessment of the lift to be assessed in accordance with the provisions of the Directive and to understand its design and its function.
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The technical documentation must, to the extent necessary for the assessment of the conformity, contain the following information :
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-WHAT?
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a general description of the lift model. The technical documentation must clearly specify all of the change options that are in connection with the model of the lift submitted for testing (see. Article 1 (1). 4)
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-WHAT?
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design drawings or diagrams and manufacturing drawings or diagrams ;
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-WHAT?
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relevant essential requirements and the ways in which these requirements have been met (e.g. harmonised standards),
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-WHAT?
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a copy of the EC declaration of conformity for the safety components used in the manufacture of the lift ;
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-WHAT?
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where appropriate, the results of the tests or calculations carried out by the manufacturer or by the manufacturer ;
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-WHAT?
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a copy of the lift instruction for the lift,
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-WHAT?
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the measures which will be taken at the installation to ensure that the serial-producing lift is in accordance with the provisions of the Directive.
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4.
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The notified body must :
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-WHAT?
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examine the technical documentation, in order to assess whether it is capable of meeting the objectives pursued ;
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-WHAT?
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examine the model of the lift in order to check whether it corresponds to the technical documentation,
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-WHAT?
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carry out or carry out the appropriate checks and tests to verify whether the installer of the installer is in accordance with the requirements of the Directive and allows the lift to be able to meet them.
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5.
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If the model of the lift is to be provided to the Directive, the notified body must issue a EC type-examination certificate to the applicant. The certificate must include the name and address of the lift installer, the results of the checks, the conditions of validity of the certificate and the necessary data for identification of the approved type.
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The Commission, the Member States and the other notified bodies may have a copy of the certificate and, on a reasoned request, a copy of the technical documentation and the reports for the studies carried out, calculations or tests.
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If the notified body must issue a EC type-examination certificate to the manufacturer, it shall provide a detailed account of the reasons for this. A procedure shall be established.
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6.
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The installer of the installer shall inform the notified body of any, including minor, amendments which he has carried out or intends to make of the approved lift, including new editions which are not specified in the initial technical documentation (see. point 3, first indent). The notified body must examine these amendments and shall inform the installer whether the EC type-examination certificate remains valid (17).
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7.
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Each notified body must communicate to the Member States the relevant information concerning :
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-WHAT?
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EC type-examination certificates issued by the EC type-examination,
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-WHAT?
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the withdrawn EC type-examination certificates.
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In addition, all notified bodies must communicate to the other notified bodies the relevant information relating to the EC type-examination certificates of the EC type-examination.
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8.
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The EC type-examination certificate, dossiers and correspondence relating to EC type-examination procedures shall be drawn up in an official language of the Member State in which the notified body is established or in a language approved by that body.
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9.
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In addition to the technical documentation, the installer must also keep a copy of the EC type-examination certificates and any addendum to these for a period of 10 years from the date of manufacture of the lift conforming to it, the lift model.
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_____
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ANNEX WE
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FINAL CHECKS
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1.
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The final inspection is the procedure whereby the installer of the lift satisfies the conditions laid down in paragraph 2 and declares that the lift that is placed on the market meets the requirements of the Directive ; the installer of the lift must affix the CE marking to each of them ; the lift chair and draw up a declaration of conformity of the EC.
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2.
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The installer of the lift shall take all necessary measures to ensure that the lift placed on the market is in conformity with the model of the lift described in the EC type-examination certificate and with the essential health and safety requirements which : apply to it.
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3.
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The installer of the installer shall keep a copy of the EC declaration of conformity and of the final inspection certificate referred to in paragraph 6 for 10 years from the date on which the lift was first placed on the market.
|
|
|
4.
|
A notified body, chosen by the installer of the lift, carries out or shall allow the final check of the lift to be placed on the market. Check and appropriate tests, as referred to in the relevant standards referred to in it or in accordance with, shall be carried out. the provisions of Article 5 of the Directive or equivalent tests to check whether the lift meets the relevant requirements of the Directive.
|
|
These checks and tests shall include, inter alia :
|
|
a)
|
an examination of the documentation to verify whether the lift is in conformity with the model of the lift approved in accordance with Annex V, Section B,
|
-WHAT?
|
b)
|
-WHAT?
|
the operation of the lift without load and at maximum load to ensure that the safety devices are installed correctly and operate satisfactorily (stopdevices, locks, etc.),
|
|
|
-WHAT?
|
the operation of the lift at maximum load and without load to ensure that the safety devices operate satisfactorily in the event of a power failure ;
|
|
|
-WHAT?
|
static test with a load corresponding to 1.25 times the label of the label.
|
|
The marker layer shall be the load listed in Annex I (5).
|
|
Following these tests, the notified body must ensure that no deformation or deterioration has not been carried out, which would prevent the use of the lift.
|
|
|
5.
|
The notified body must receive a technical documentation consisting of :
|
|
-WHAT?
|
a general plan above the lift,
|
|
-WHAT?
|
the necessary plans and diagrams to ensure that the final checks may be carried out, e.g. control circuits over the control circuits ;
|
|
-WHAT?
|
a copy of the instructions for use referred to in Annex I, Section 6.2.
|
|
The notified body may not require detailed plans or precise information which is not necessary to verify that the lift to be placed on the market is in accordance with the model of the lift, as described in : EC type-examination declaration.
|
|
|
6.
|
If the lift is to be provided to the lift, the notified body shall affix its identification number or place it on the side of the CE marking, cf. Annex III and draw up a final inspection certificate in which the checks carried out and the tests carried out.
|
|
The notified body must fill in the appropriate pages of the service book referred to in Annex I, Section 6.2.
|
|
If the notified body must issue the final certificate of inspection, it shall provide a detailed justification for this dissenting and the manner in which approval can be achieved. When the installer of the lift is rerequesting final inspection, he must turn to the same notified body.
|
|
|
7.
|
The final inspection certificate, dossiers and correspondence relating to the authorisation procedures shall be made out in an official language of the Member State in which the competent body is established or in a language approved by it.
|
|
_____
|
|
|
|
ANNEX VII
|
|
|
|
MINIMUM CRITERIA TO BE OBSERVED BY THE MEMBER STATES BY THE AUTHORISATION OF BODIES
|
|
|
1.
|
The body, its leader and its staff who shall carry out the work must not be constructor, supplier or manufacturer of the safety components or installer of the lifts which they control, or be any of those persons ; representative. In the same way, the body, its leader and its staff must carry out checks on the quality assurance systems referred to in Article 8 of the Directive neither be a constructor, supplier nor manufacturer of the safety components or installer of the installation ; the lifts which they control, or be any of the representative of these parties. They shall not, either directly or as a representative, participate in the design, manufacture, marketing or maintenance of these safety components or in the installation of these lifts. This does not preclude the possibility of exchanges of technical information between the manufacturer of the safety components or the installer of the lift and the body.
|
|
|
2.
|
The inspection body and staff shall carry out the control of the highest technical integrity and technical competence and be independent of any pressure and incentive, in particular of financial nature, which may affect their assessment or the results of : their checks, in particular by persons or groups of persons who are interested in the results of the checks.
|
|
|
3.
|
The body must have the necessary staff and possess the means necessary to carry out the technical and administrative tasks in carrying out the checks ; it must also have access to the equipment that : are necessary to carry out specific verifications.
|
|
|
4.
|
The staff required to carry out the checks shall have :
|
|
-WHAT?
|
a sound technical and vocational training ;
|
|
-WHAT?
|
sufficient knowledge of the requirements concerning the control it carries out and adequate practical experience of such controls ;
|
|
-WHAT?
|
the ability to draw up attestations, records and reports, which render the results of the checks carried out.
|
|
|
5.
|
The staff required to carry out checks must be guaranteed full independence. The remuneration of each employee must not be dependent on the number of control operations carried out by the person concerned, or the results of the check.
|
|
|
6.
|
The body shall draw up liability insurance unless the liability of civil liability is covered by the State on the basis of national rules of law, or unless the checks are carried out directly by the Member State.
|
|
|
7.
|
The staff of the body shall be subject to professional secrecy in the course of the execution of the work (except for the competent administrative authorities of the State in which it carries out its duties) under the Directive or on any national ; the rule of law issued in accordance with this.
|
|
_____
|
|
|
|
ANNEX VIII
|
|
|
|
QUALITY ASSURANCE OF PRODUCTS
|
|
(module E)
|
|
|
1.
|
The quality assurance of the products is the procedure whereby a manufacturer of safety components satisfying the provisions of point 2 ensures and declares that the safety components are in accordance with the type as described in : The EC type-examination certificate and fulfils the relevant requirements of the Directive and that the safety component will give the lift on which it is properly installed, the possibility of complying with the provisions of the directive.
|
|
The manufacturer of the safety component or its authorised representative established within the Community shall affix the CE marking to each safety component and draw up a EC declaration of conformity. The CE marking must be accompanied by the identification number used by the notified body responsible for the checks referred to in paragraph 4.
|
|
|
2.
|
The manufacturer must operate an approved quality assurance system for final checks on safety component and testing as described in point 3 and shall be subject to the checks referred to in Section 4.
|
|
|
3.
|
Quality management system
|
|
|
3.1.
|
The manufacturer of the safety component shall submit an application for assessment of the quality assurance system for the relevant safety components to a notified body of his choice.
|
|
The application shall include :
|
|
-WHAT?
|
all relevant information on the safety components envisaged,
|
|
-WHAT?
|
the documentation concerning the quality system,
|
|
-WHAT?
|
the technical documentation relating to the approved safety components and a copy of the EC type-examination certificate.
|
|
|
3.2.
|
The quality assurance system shall examine each component safety component and the tests referred to in the relevant standards shall be carried out in accordance with the quality system. Article 5 or equivalent tests to ensure that the product meets the relevant requirements of the Directive.
|
|
All the conditions, requirements and provisions laid down by the manufacturer of safety components shall be documented in a systematic and orderless manner in a written review of the measures, procedures and instructions. This quality assurance system documentation must ensure that quality programmes, plans, manuals and records are interpreted in a similar way.
|
|
In particular, the statement shall contain an adequate description of :
|
|
a)
|
quality objectives,
|
|
b)
|
the organizational structure and responsibilities and powers of the management with regard to the quality of the safety components ;
|
|
c)
|
the examinations and tests that will be carried out after manufacture ;
|
|
d)
|
the means of verification of the effective operation of the quality system,
|
|
(e)
|
the quality records, such as inspection reports and test data, calibration data, reports on the qualifications of the personnel concerned, etc.
|
|
|
3.3.
|
The notified body must assess the quality assurance system to determine whether it satisfies the requirements of point 3.2. The organism must assume that these requirements are met if the quality assurance systems are applying the relevant harmonised standard (18).
|
|
The assessment team shall include at least one member with experience of assessing the level of the lift in question. The assessment procedure shall include a visit to the premises of the safety component manufacturer.
|
|
The decision must be notified to the manufacturer of the safety components. The communication shall contain the results of the checks and the reasoned assessment decision.
|
|
|
3.4.
|
The manufacturer of the safety component undertakes to fulfil its obligations under the quality assurance system as approved and to ensure that it remains appropriate and effective.
|
|
The manufacturer of the safety components or its authorised representative established within the Community must inform the notified body which has approved the quality assurance system informed of any intended change.
|
|
The notified body must assess the proposed changes and decide whether the modified quality system still complies with the requirements referred to in 3.2 or whether a re-evaluation is necessary.
|
|
It shall notify its decision to the manufacturer. The communication shall contain the results of the checks and the reasoned assessment decision.
|
|
|
4.
|
Monitoring under the responsibility of the notified body
|
|
|
4.1.
|
The purpose of the verification is to ensure that the manufacturer of the safety component duly fulfils its obligations under the approved quality assurance system.
|
|
|
4.2.
|
The manufacturer must allow the notified body access to verify the inspection, testing and storage facilities and provide it with all necessary information, including :
|
|
-WHAT?
|
the documentation concerning quality assurance systems,
|
|
-WHAT?
|
technical documentation,
|
|
-WHAT?
|
the quality records, such as inspection reports, test and calibration data, reports on the qualifications of the personnel concerned, etc.
|
|
|
4.3.
|
The notified body must carry out periodic inspection visits to ensure that the manufacturer of the safety components maintains and applies the quality assurance system and must provide a control report to the manufacturer of safety components.
|
|
|
4.4.
|
In addition, the notified body may pay unreported visits to the manufacturer of safety components.
|
|
During such visits, the notified body may, if necessary, perform or perform tests to verify the functioning of the quality assurance system ; it shall issue a visit report and, where appropriate, a test report to : the manufacturer of safety components.
|
|
|
5.
|
The manufacturer must, for a period of 10 years, from the date of manufacture of the safety component, be able to submit to the national authorities :
|
|
-WHAT?
|
the documentation referred to in the third indent of the second subparagraph of 3.1,
|
|
-WHAT?
|
the updating referred to in the second paragraph of point 3.4,
|
|
-WHAT?
|
the decisions and reports from the notified body referred to in points 3.4, last paragraph, and points 4.3 and 4.4.
|
|
|
6.
|
Each notified body must communicate to the other notified bodies the relevant information concerning the quality assurance system approvals issued or withdrawn.
|
|
_____
|
|
|
|
APPENDIX IX
|
|
|
|
FULL QUALITY ASSURANCE
|
|
(module H)
|
|
|
1.
|
Full quality assurance is the procedure whereby a manufacturer of safety components satisfying the provisions of point 2 ensures and declares that safety components comply with the relevant requirements of the Directive and that the safety component will provide : the lift on which it is fitted properly, the possibility of complying with the provisions of the Directive.
|
|
The manufacturer or his authorized representative established within the Community must affix the CE marking to each of the security component and draw up a declaration of EC declaration of conformity. The CE marking must be accompanied by the identification number used by the notified body responsible for the checks referred to in paragraph 4.
|
|
|
2.
|
The manufacturer must operate an approved quality assurance system for design, production, final checking of the safety components and testing as described in point 3 and shall be subject to the checks referred to in Section 4.
|
|
|
3.
|
Quality management system
|
|
|
3.1.
|
The manufacturer must submit an application for assessment of the quality assurance system to a notified body of his choice.
|
|
The application shall include :
|
|
-WHAT?
|
all relevant information on the safety components,
|
|
-WHAT?
|
the documentation concerning the quality assurance system.
|
|
|
3.2.
|
The quality assurance system must ensure that safety components comply with the relevant requirements of the Directive and give the lifts to which they are properly installed, the possibility of complying with those provisions.
|
|
All the conditions, requirements and provisions for which the manufacturer has taken into account shall be documented in a systematic and manageable manner in a written review of precautions, procedures and instructions. This quality assurance system documentation must ensure that quality policy and procedures such as quality programmes, plans, manuals and records are interpreted in the same way.
|
|
In particular, the statement shall contain an adequate description of :
|
|
-WHAT?
|
the quality objectives and the organizational structure, responsibilities and powers of the management with regard to the quality of design and safety components ;
|
|
-WHAT?
|
the technical design specifications, including standards that will be used and, where the standards referred to in Article 5 are not fully applied, how to ensure that the essential requirements of the directive which apply to safety components, will be met
|
|
-WHAT?
|
the design control and verification techniques and processes and systematic actions that will be used in the design of the safety components ;
|
|
-WHAT?
|
the relevant production, quality control and quality assurance techniques, and the systematic practices and measures which will be used ;
|
|
-WHAT?
|
the examinations and tests to be carried out before, during and after production, and the frequency with which it is carried out ;
|
|
-WHAT?
|
the quality records, such as inspection reports and test data, calibration data, qualification reports and so on.
|
|
-WHAT?
|
the means of verification of the achievement of the required design and product 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 of point 3.2. The organism must assume that these requirements are met if the quality assurance systems are applying the relevant harmonised standard (19).
|
|
The assessment team shall include at least one member with experience of assessing the level of the lift in question. The assessment procedure shall include a visit to the manufacturer ' s premises.
|
|
The decision must be notified to the manufacturer of safety components. The communication shall contain the results of the checks and the reasoned assessment decision.
|
|
|
3.4.
|
The manufacturer of safety components undertakes to fulfil its obligations under the quality assurance system as approved and to ensure that it remains appropriate and effective.
|
|
The manufacturer or his authorised representative established within the Community must inform the notified body which has approved the quality assurance system informed of any intended change.
|
|
The notified body must assess the proposed changes and decide whether the modified quality system still complies with the requirements referred to in 3.2 or whether a re-evaluation is necessary.
|
|
It shall notify its decision to the manufacturer. The communication shall contain the results of the checks and the reasoned assessment decision.
|
|
|
4.
|
Monitoring under the responsibility of the notified body
|
|
|
4.1.
|
The purpose of the verification is to ensure that the manufacturer of safety components correctly fulfils its obligations under the approved quality assurance system.
|
|
|
4.2.
|
The manufacturer of the safety components must allow the notified body access to control of the design, production, control and testing and storage facilities and must provide it with all necessary information, including :
|
|
-WHAT?
|
the documentation concerning the quality system,
|
|
-WHAT?
|
the quality records as provided for in the design part of the quality system, such as results of analyses, calculations, tests, etc. ;
|
|
-WHAT?
|
the quality records in accordance with the production part of the quality system, such as inspection reports and test data, calibration data, reports on the qualifications of the personnel concerned, etc.
|
|
|
4.3.
|
The notified body shall make periodic inspection visits to ensure that the manufacturer of the safety components maintains and applies the quality assurance system and must provide a control report to the manufacturer.
|
|
|
4.4.
|
In addition, the notified body may pay unannounced visits to the manufacturer of safety components. During such visits, the notified body may, if necessary, carry out or perform tests to check whether the quality system functions satisfactorily. It shall issue a visit report and, where appropriate, a test report to the manufacturer of safety components.
|
|
|
5.
|
The manufacturer of the safety components or his authorized representative must, for a period of 10 years, from the last manufacturing date of the safety component, be able to submit to the national authorities :
|
|
-WHAT?
|
the documentation referred to in the second indent of the second subparagraph of 3.1,
|
|
-WHAT?
|
the updating referred to in the second paragraph of point 3.4,
|
|
-WHAT?
|
the decisions and reports from the notified body referred to in points 3.4, last paragraph, and points 4.3 and 4.4.
|
|
Where neither the manufacturer of safety components nor his authorised representative is established in the Community, the obligation to present the technical documentation shall be the responsibility of the person responsible for placing the safety components in the Community.
|
|
|
6.
|
Each notified body must communicate to the other notified bodies the relevant information concerning the quality assurance system approvals issued or withdrawn.
|
|
|
7.
|
The dossiers and correspondence relating to the procedures for full quality assurance shall be made out in an official language of the Member State in which the notified body is established or in a language approved by it.
|
|
_____
|
|
|
|
APPENDIX X
|
|
|
|
DEVICE VERIFICATION
|
|
(module G)
|
|
|
1.
|
The unit verification is the procedure whereby an installer of the lift ensures and declares that the lift which is placed on the market and for which the certificate of conformity referred to in paragraph 4 complies with the requirements of the Directive. The installer of the lift shall affix the CE marking to the lift chair and draw up a declaration of EC declaration of conformity.
|
|
|
2.
|
The installer of the lift shall submit the request for the unit verification to be notified to a notified body of his choice.
|
|
The request shall contain :
|
|
-WHAT?
|
the name and address of the lift installer, and the place where the lift is installed ;
|
|
-WHAT?
|
a written declaration that the same request has not been lodged with other notified bodies ;
|
|
-WHAT?
|
technical documentation.
|
|
|
3.
|
The technical documentation must enable the conformity of the car to be assessed in accordance with the requirements of the Directive and to understand the design, installation and operation of the lift.
|
|
|
3.1.
|
To the extent necessary for the assessment of conformity, the technical documentation must contain the following elements :
|
|
-WHAT?
|
a general description of the lift,
|
|
-WHAT?
|
design drawings or diagrams and manufacturing drawings or diagrams ;
|
|
-WHAT?
|
relevant essential requirements and the ways in which these requirements have been met (e.g. harmonised standards),
|
|
-WHAT?
|
where appropriate, the results of the tests or calculations carried out by the installer or of the installer ;
|
|
-WHAT?
|
a copy of the instructions for the lift,
|
|
-WHAT?
|
a copy of the EC type-examination certificates for the safety components used.
|
|
|
4.
|
The notified body must examine the technical documentation and the lift and carry out the tests as referred to in the relevant standard (s), cf. Article 5 of the Directive or equivalent tests to verify that the lift is in accordance with the relevant requirements of this Directive.
|
|
If the lift is to be provided to the lift, the notified body shall affix its identification number or place it on the side of the CE marking, cf. Annex III, and draw up a certificate of conformity relating to the tests carried out.
|
|
The notified body must fill in the appropriate pages of the service book referred to in Annex I, Section 6.2.
|
|
If the notified body must issue the certificate of conformity, it shall provide a detailed justification for this disceration and shall provide the means by which approval is to be achieved. When the installer of the lift reasks for verification, he must turn to the same notified body.
|
|
|
5.
|
The certificate of conformity, dossiers and correspondence relating to the unit verification procedures shall be drawn up in an official language of the Member State in which the notified body is established or in a language approved by this.
|
|
The installer of the installer shall keep together with the technical documentation a copy of the certificate of conformity for a period of 10 years from the date on which the lift was first placed on the market.
|
|
_____
|
|
|
|
APPENDIX XI
|
|
|
|
CONFORMITY WITH SPOT CHECKS
|
|
(module C)
|
|
|
1.
|
The conformity procedure is the procedure whereby the manufacturer of the safety components or his authorised representative established within the Community ensures and declares that the safety components are in accordance with the type as described in the EC type-approval certificate and meet the requirements of the Directive and that the safety components will give the lift on which they are properly installed, to comply with the essential health and safety requirements of the directive.
|
|
The manufacturer of the safety components or its authorised representative established within the Community shall affix the CE marking to each of the security component and draw up a declaration of EC declaration of conformity.
|
|
|
2.
|
The manufacturer of safety components shall take all measures necessary to ensure that the manufacturing process ensures that the safety components provided are in accordance with the type as described in the EC type-examination certificate and with the relevant requirements of the Directive.
|
|
|
3.
|
The manufacturer of the safety components or its representative must keep a copy of the EC declaration of conformity for a period of 10 years from the date of the safety component of the safety component.
|
|
Where neither the manufacturer of the safety components or his authorised representative is established in the Community, the obligation to present the technical documentation shall be the responsibility of the person responsible for the placing on the market of the safety components in the Community.
|
|
|
4.
|
A notified body of the choice of the safety component manufacturer shall, or may, carry out checks on the safety components with a changing space. The notified body shall, on the spot, replace an appropriate sample for checking the completed safety components and carry out tests as referred to in the appropriate standards referred to in, cf. Whereas Article 5 of the Directive or equivalent tests to verify that production meets the requirements of the Directive comply with the requirements of the Directive, which does not meet the requirements of one or more safety components, the notified body shall take the necessary measures.
|
|
The elements to be taken into consideration for the supervision of the safety components shall be determined by common agreement between all the notified bodies responsible for carrying out this procedure, taking into account the essential elements of safety components ; Characteristics referred to in Annex IV.
|
|
During the manufacturing process, the manufacturer must, under the responsibility of the notified body, be responsible for the identification number of the safety component.
|
|
|
5.
|
The case files and correspondence relating to the procedures for random checks referred to in point 4 shall be drawn up in an official language of the Member State in which the notified body is established or in a language approved by it.
|
|
_____
|
|
|
|
ANNEX XII
|
|
|
|
QUALITY ASSURANCE OF THE LIFT PRODUCTS
|
|
(module E)
|
|
|
1.
|
The quality assurance of the products is the procedure whereby the installer of the lift complies with the provisions of point 2, ensures and declares that the elevators installed are in conformity with the type as described in the EC type-examination certificate and meets the relevant requirements of the Directive.
|
|
|
|
The installer of the lift shall affix the CE marking to each lift and draw up a declaration of EC declaration of conformity. The CE marking must be accompanied by the identification number used by the notified body responsible for the checks referred to in paragraph 4.
|
|
|
2.
|
The installer of the lift shall use an approved quality assurance system for the final checks of the lift and testing as described in point 3 and shall be subject to the checks referred to in Section 4.
|
|
|
3.
|
Quality management system
|
|
|
3.1.
|
The installer of an installer shall submit an application for assessment of the quality assurance system for the lifts for a notified body of his choice.
|
|
The application shall include :
|
|
-WHAT?
|
all relevant information on the elevators envisaged,
|
|
-WHAT?
|
the documentation concerning the quality system,
|
|
-WHAT?
|
the technical documentation relating to the approved lift operators and a copy of the EC type-examination certificate.
|
|
|
3.2.
|
Under the quality system, each lift shall be examined and the tests referred to in the relevant standards shall be carried out in accordance with the quality system. Article 5 or equivalent tests to ensure that the product meets the relevant requirements of the Directive.
|
|
All the conditions, requirements and provisions to which the installer of the lift has been taken into account shall be documented in a systematic and manageable manner in a written review of measures, procedures and instructions. This quality assurance system documentation must ensure that quality programmes, plans, manuals and records are interpreted in a similar way.
|
|
In particular, the statement shall contain an adequate description of :
|
|
a)
|
quality objectives,
|
|
b)
|
the organizational structure and responsibilities and powers of the management with regard to the quality of the lifts ;
|
|
c)
|
the examinations and tests that will be carried out prior to the placing on the market, including at least the tests referred to in Annex VI (4) (b) ;
|
|
d)
|
the means of verification of the effective operation of the quality system,
|
|
(e)
|
the quality records, such as inspection reports and test data, calibration data, reports on the qualifications of the personnel concerned, etc.
|
|
|
3.3.
|
The notified body must assess the quality assurance system to determine whether it satisfies the requirements of point 3.2. The organism must assume that these requirements are met if the quality assurance systems are applying the relevant harmonised standard (20).
|
|
The assessment team shall include at least one member with experience of assessing the level of the lift in question. The assessment procedure must include a visit to the installer of the lift installer and a visit to a construction site.
|
|
The decision must be notified to the lift installer. The notification shall contain the results of the examination and the reasoned assessment decision.
|
|
|
3.4.
|
The installer of the lift shall undertake to fulfil its obligations under the quality assurance system as approved and to ensure that it remains appropriate and effective.
|
|
The installer of the installer shall inform the notified body which has approved the quality assurance system informed of any intended change.
|
|
The notified body must assess the proposed changes and decide whether the modified quality system still complies with the requirements referred to in 3.2 or whether a re-evaluation is necessary.
|
|
It shall inform the installer of the installer of his decision. The communication shall contain the results of the checks and the reasoned assessment decision.
|
|
|
4.
|
Monitoring under the responsibility of the notified body
|
|
|
4.1.
|
The purpose of the verification is to ensure that the installer of the lift is properly fulfilled in accordance with the approved quality assurance system.
|
|
|
4.2.
|
The installer of the installer must allow the notified body access to check the inspection and testing facilities and provide it with all necessary information, including :
|
|
-WHAT?
|
the documentation concerning the quality system,
|
|
-WHAT?
|
technical documentation,
|
|
-WHAT?
|
the quality records, such as inspection reports, test and calibration data, reports on the qualifications of the personnel concerned, etc.
|
|
|
4.3.
|
The notified body must carry out periodic inspections to ensure that the installer of the installer maintains and applies the quality assurance system and must submit a control report to the installer of the lift.
|
|
|
4.4.
|
In addition, the notified body may pay unannounced visits to sites where lift lifts are installed.
|
|
During such visits, the notified body may, if necessary, carry out or perform tests to check whether the quality system and the lift are working satisfactorily ; it shall issue a visit report and, where appropriate, a test report ; for the installer installer.
|
|
|
5.
|
The lift installer must, for a period of 10 years, from the date of the lift, be able to submit to the national authorities :
|
|
-WHAT?
|
the documentation referred to in the third indent of the second subparagraph of 3.1,
|
|
-WHAT?
|
the updating referred to in the second paragraph of point 3.4,
|
|
-WHAT?
|
the decisions and reports from the notified body referred to in points 3.4, last paragraph, and points 4.3 and 4.4.
|
|
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6.
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Each notified body must communicate to the other notified bodies the relevant information concerning the quality assurance system approvals issued or withdrawn.
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_____
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ANNEX XIII
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FULL QUALITY ASSURANCE OF ELEVATORS
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(module H)
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1.
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Full quality assurance is the procedure whereby the installer of the lift who satisfies the provisions of point 2 ensures and declares that the lifts satisfy the requirements of the Directive which apply to it.
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The installer of the lift shall affix the CE marking to each lift and draw up a declaration of EC declaration of conformity. The CE marking must be accompanied by the identification number used by the notified body responsible for the checks referred to in paragraph 4.
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2.
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The installer of the lift shall use an approved quality assurance system for the design, manufacture, assembly, installation and final verification of the lifts and tests as described in point 3, and shall be subject to the checks referred to in section 4.
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3.
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Quality management system
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3.1.
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The installer of an installer shall submit an application for assessment of the quality assurance system to a notified body of his choice.
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The application shall include :
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-WHAT?
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all relevant information concerning the lifts, in particular those making it possible to understand the consistency between the design and functioning of the lift, and to assess conformity with the requirements of the Directive ;
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-WHAT?
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the documentation concerning the quality assurance system.
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3.2.
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The quality assurance system must ensure that the lifts comply with the requirements of the Directive which apply to it.
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All the conditions, requirements and provisions to which the installer of the lift has been taken into account shall be documented in a systematic and manageable manner in a written review of measures, procedures and instructions. The quality system documentation must ensure that the procedures, such as quality programmes, plans, manuals and registers, are interpreted in the same way.
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In particular, the statement shall contain an adequate description of :
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-WHAT?
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the quality objectives and the organizational structure, responsibilities and powers of the management with regard to the quality of design and the quality of the lifts ;
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-WHAT?
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the technical design specifications, including standards that will be used, and, if the standards referred to in Article 5 of this Directive are not fully applied, how to ensure that the essential requirements of the Directive which apply to the lifts, will be met
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-WHAT?
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the design control and verification techniques and processes and systematic actions that will be used in the commissioning of the lift design ;
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-WHAT?
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the examinations and the tests to be carried out on the receipt of the supplies of materials, components and sub-assemmonds ;
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-WHAT?
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the appropriate assembly, installation and quality control techniques, and the systematic practices and measures which will be used ;
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-WHAT?
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the examinations and tests to be carried out before (check on installation conditions : shaft, placement of the lift system, etc.), during and after installation (including at least the tests referred to in Annex VI (4) (b)) ;
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-WHAT?
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the quality records, such as inspection reports and test data, calibration data, reports on the qualifications of the personnel concerned, etc.
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-WHAT?
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the means of verification of the achievement of the required design and installation quality and the effective operation of the quality assurance system.
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3.3.
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Construction Control
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If the design is not entirely consistent with the harmonized standards, the notified body must examine whether the design meets the provisions of the Directive and, if so, shall issue a EC design-examination certificate to : the installer of the lift, specifying the validity of the certificate and the data necessary to identify the approved design.
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3.4.
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Control of the quality assurance system
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The notified body must assess the quality assurance system to determine whether it satisfies the requirements of point 3.2. The organism must assume that these requirements are met if the quality assurance systems are applying the relevant harmonised standard (21).
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The assessment team shall include at least one member with experience of assessing the level of the lift in question. The assessment procedure must include a visit to the installer of the lift installer and a visit to a construction site.
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The decision must be notified to the lift installer. The notification shall contain the results of the examination and the reasoned assessment decision.
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3.5.
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The installer of the lift shall undertake to fulfil its obligations under the quality assurance system as approved and to ensure that it remains appropriate and effective.
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The installer of the installer shall inform the notified body which has approved the quality assurance system informed of any intended change.
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The notified body must assess the proposed changes and decide whether the modified quality system still complies with the requirements referred to in 3.2 or whether a re-evaluation is necessary.
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It shall inform the installer of the decision. The communication shall contain the results of the checks and the reasoned assessment decision.
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4.
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Monitoring under the responsibility of the notified body
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4.1.
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The purpose of the verification is to ensure that the installer of the lift is properly fulfilled in accordance with the approved quality assurance system.
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4.2.
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The installer of the installer must allow the notified body access to verify the design, production, installation, inspection and testing, and storage facilities, and must provide it with all necessary information, including :
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-WHAT?
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the documentation concerning the quality system,
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-WHAT?
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the quality records in accordance with the design part of the quality system, such as results of analyses, calculations, tests, etc.
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-WHAT?
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the quality records as provided for in the part of the quality system related to the receipt of supplies and installation, such as inspection reports and test data, calibration data, reports on the qualifications of the personnel concerned, etc.
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4.3.
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The notified body must carry out periodic inspections to ensure that the installer of the installer maintains and applies the quality assurance system and submit a control report to the installer of the lift.
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4.4.
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In addition, the notified body may pay unannounced visits to the installer or in places where lift lifts are installed. During such visits, the notified body may, if necessary, carry out or perform tests to check whether the quality system functions satisfactorily. It shall issue a visit report and, where appropriate, a test report to the installer of the lift.
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5.
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The installer of the installer must, for a period of 10 years, from the date on which the lift was first placed on the market, could submit to the national authorities :
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-WHAT?
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the documentation referred to in the second indent of the second subparagraph of 3.1,
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-WHAT?
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the updating referred to in the second paragraph of the 3.5, second subparagraph,
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-WHAT?
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the decisions and reports from the notified body referred to in 3.5, last paragraph and 4.3 and 4.4.
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If the installer of the lift is not established in the Community, then it shall be the responsibility of the notified body.
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6.
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Each notified body must communicate to the other notified bodies the relevant information concerning the quality assurance system approvals issued or withdrawn.
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7.
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The dossiers and correspondence relating to the procedures for full quality assurance shall be made out in an official language of the Member State in which the notified body is established or in a language approved by it.
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_____
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ANNEX XIV
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QUALITY ASSURANCE OF PRODUCTION
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(module D)
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1.
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Production quality assurance is the procedure whereby the installer of the installer who satisfies the provisions of paragraph 2 ensures and declares that the elevators concerned meet the relevant requirements of the Directive. The installer of the lift shall affix the CE marking to each lift and draw up a written declaration of conformity. The CE marking must be accompanied by the identification number used by the notified body responsible for the checks referred to in paragraph 4.
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2.
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The installer of the lift must use an approved quality assurance system for production, installation, final checking of the lifts and tests as described in point 3, and shall be subject to the checks referred to in Section 4.
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3.
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Quality management system
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3.1.
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The installer of an installer shall submit an application for assessment of the quality assurance system to a notified body of his choice.
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The application shall include :
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-WHAT?
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all relevant information concerning the lifts,
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-WHAT?
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the documentation concerning the quality system,
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-WHAT?
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where applicable, the technical documentation of the approved type and a copy of the EC type-examination certificate.
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3.2.
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The quality assurance system must ensure that the lifts comply with the requirements of the Directive which apply to it.
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All the conditions, requirements and provisions to which the installer of the lift has been taken into account shall be documented in a systematic and manageable manner in a written review of measures, procedures and instructions. This quality assurance system documentation must ensure that the quality programmes, plans, manuals and records are interpreted in a similar way.
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In particular, the statement shall contain an adequate description of :
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-WHAT?
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the quality objectives and the organizational structure, responsibilities and powers of the management with regard to the quality of the lifts ;
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-WHAT?
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manufacturing processes, quality control and security techniques, and the systematic techniques and measures that will be used ;
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-WHAT?
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the examinations and tests to be carried out before, during and after installation (22) ;
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-WHAT?
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the quality records, such as inspection reports and test data, calibration data, reports on the qualifications of the personnel concerned, etc.
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-WHAT?
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the means of monitoring the achievement of the quality of the quality of the elevators and the effective operation of the quality system.
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3.3.
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The notified body must assess the quality assurance system to determine whether it satisfies the requirements of point 3.2. The organism shall assume that these requirements are met if the quality assurance systems use the harmonized standard in the area (23).
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The assessment team shall include at least one member with experience of assessing the level of the lift in question. The assessment procedure must include a visit to the installer of the lift installer.
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The decision must be notified to the lift installer. The notification shall contain the results of the examination and the reasoned assessment decision.
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3.4
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The installer of the lift shall undertake to fulfil its obligations under the quality assurance system as approved and to ensure that it remains appropriate and effective.
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The installer of the installer shall inform the notified body which has approved the quality assurance system informed of any intended change.
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The notified body must assess the proposed changes and decide whether the modified quality system still complies with the requirements referred to in 3.2 or whether a re-evaluation is necessary.
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It shall inform the installer of the decision. The communication shall contain the results of the checks and the reasoned assessment decision.
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4.
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Monitoring under the responsibility of the notified body
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4.1.
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The purpose of EC control is to ensure that the installer of the lift is properly fulfilled in accordance with the approved quality assurance system.
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4.2.
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The installer of the installer must allow the notified body access to check the production, control, installation, testing and storage facilities, and provide it with all necessary information, including :
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-WHAT?
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the documentation concerning the quality system,
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-WHAT?
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the quality records, such as inspection reports, test and calibration data, reports on the qualifications of the personnel concerned, etc.
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4.3.
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The notified body must carry out periodic inspections to ensure that the installer of the installer maintains and applies the quality assurance system ; it emits a control report to the installer of the lift.
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4.4.
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In addition, the notified body may pay unannounced visits to the installer and to the installation site. During such visits, it may, if necessary, carry out or perform tests to check whether the quality assurance system functions satisfactorily. It shall issue a visit report and, where appropriate, a test report to the lift installer.
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5.
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The installer of the installer must, for a period of 10 years from the date of the date of the product, be able to submit to the national authorities :
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-WHAT?
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the documentation referred to in the second indent of the second subparagraph of 3.1,
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-WHAT?
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the updating referred to in the second paragraph of point 3.4,
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-WHAT?
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the decisions and reports from the notified body referred to in points 3.4, fourth subparagraph and 4.3 and 4.4.
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6.
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Each notified body must communicate to the other notified bodies the relevant information concerning the quality assurance system approvals issued or withdrawn.
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7.
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The dossiers and correspondence relating to the quality assurance procedure for production shall be made out in an official language of the Member State in which the notified body is established or in a language approved by it.
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12) This declaration must be written on the machine or printed in printed letters and be drawn up in the same language as the instructions provided for in Annex I, Section 6.1.
13) The company name and full address ; if it is a representative, the manufacturer must also specify the name and address of the safety components.
14) This declaration must be written on a machine or printed in printed letters and be drawn up in the same language as the instructions provided for in Annex I, Section 6.2.
15) Company name and full address.
16) If the notified body must consider it necessary, it may issue a supplement to the original EC type-examination certificate or request that a new request be made.
17) If the notified body must consider it necessary, it may issue a supplement to the original EC type-examination certificate or request that a new request be made.
18) This harmonised standard is EN 29003, if necessary, in order to take account of the specific characteristics that apply to safety components.
19) This harmonised standard is EN 29001, if necessary, in order to take into account the specific characteristics of the safety components.
This harmonised standard is EN 29003, if necessary, in order to take account of the specific characteristics that apply to the lifts.
21) This harmonised standard is EN 29001, if necessary, in order to take account of the specific characteristics that apply to the lifts.
These tests shall include at least the tests referred to in Annex VI (4) (b).
23) This harmonizing standard is EN 29002, where necessary, supplemented to take account of the specific characteristics of the lifts.
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