Annexes to COM(2011)770 - Harmonisation of the laws of the Member States relating to making available on the market of lifts and safety components for lifts

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dossier COM(2011)770 - Harmonisation of the laws of the Member States relating to making available on the market of lifts and safety components for ...
document COM(2011)770 EN
date February 26, 2014
Annex XIII, Part A.

(5) OJ L 218, 13.8.2008, p. 30.

(6) OJ L 218, 13.8.2008, p. 82.

(7) OJ L 134, 20.6.1995, p. 37.

(8) OJ L 316, 14.11.2012, p. 12.

(9) Approved by Council Decision 2010/48/EC of 26 November 2009 concerning the conclusion, by the European Community, of the United Nations Convention on the Rights of Persons with Disabilities (OJ L 23, 27.1.2010, p. 35).

(10) OJ L 55, 28.2.2011, p. 13.


ANNEX I

ESSENTIAL HEALTH AND SAFETY REQUIREMENTS

PRELIMINARY REMARKS

1.Obligations under essential health and safety requirements apply only where the corresponding risk exists for the lift or safety component for lifts in question when used as intended by the installer or the manufacturer.

2.The essential health and safety requirements contained in the Directive are imperatives. However, given the present state of the art, the objectives which they lay down may not be attainable. In such cases, and to the greatest extent possible, the lift or safety components for lifts must be designed and constructed in such a way as to approximate to those objectives.

3.The manufacturer and the installer are under an obligation to carry out a risk assessment in order to identify all the risks which apply to their products; they must then design and construct them taking account of the assessment.

1. General

1.1.   Application of Directive 2006/42/EC

Where the relevant risk exists and is not dealt with in this Annex, the essential health and safety requirements of Annex I to Directive 2006/42/EC of the European Parliament and of the Council (1) apply. The essential health and safety requirements of point 1.1.2 of Annex I to Directive 2006/42/EC apply in any event.

1.2.   Carrier

The carrier of each lift must be a car. This car must be designed and constructed to offer the space and strength corresponding to the maximum number of persons and the rated load of the lift set by the installer.

Where the lift is intended for the transport of persons, and where its dimensions permit, the car must be designed and constructed in such a way that its structural features do not obstruct or impede access and use by disabled persons and so as to allow any appropriate adjustments intended to facilitate its use by them.

1.3.   Means of suspension and means of support

The means of suspension and/or support of the car, its attachments and any terminal parts thereof must be selected and designed so as to ensure an adequate level of overall safety and to minimize the risk of the car falling, taking into account the conditions of use, the materials used and the conditions of manufacture.

Where ropes or chains are used to suspend the car, there must be at least two independent cables or chains, each with its own anchorage system. Such ropes and chains must have no joins or splices except where necessary for fixing or forming a loop.

1.4.   Control of loading (including overspeed)

1.4.1.Lifts must be so designed, constructed and installed as to prevent normal starting if the rated load is exceeded.

1.4.2.Lifts must be equipped with an overspeed governor.

These requirements do not apply to lifts in which the design of the drive system prevents overspeed.

1.4.3.Fast lifts must be equipped with a speed-monitoring and speed-limiting device.

1.4.4.Lifts driven by friction pulleys must be designed so as to ensure stability of the traction cables on the pulley.

1.5.   Machinery

1.5.1.All passenger lifts must have their own individual lift machinery. This requirement does not apply to lifts in which the counterweights are replaced by a second car.

1.5.2.The installer must ensure that the lift machinery and the associated devices of a lift are not accessible except for maintenance and in emergencies.

1.6.   Controls

1.6.1.The controls of lifts intended for use by unaccompanied disabled persons must be designed and located accordingly.

1.6.2.The function of the controls must be clearly indicated.

1.6.3.The call circuits of a group of lifts may be shared or interconnected.

1.6.4.Electrical equipment must be so installed and connected that:

(a)there can be no possible confusion with circuits which do not have any direct connection with the lift;

(b)the power supply can be switched while on load;

(c)movements of the lift are dependent on electrical safety devices in a separate electrical safety circuit;

(d)a fault in the electrical installation does not give rise to a dangerous situation.

2. Risks for persons outside the car

2.1.The lift must be designed and constructed to ensure that the space in which the car travels is inaccessible except for maintenance or in emergencies. Before a person enters that space, normal use of the lift must be made impossible.

2.2.The lift must be designed and constructed to prevent the risk of crushing when the car is in one of its extreme positions.

The objective will be achieved by means of free space or refuge beyond the extreme positions.

However, in specific cases, in affording Member States the possibility of giving prior approval, particularly in existing buildings, where this solution is impossible to fulfil, other appropriate means may be provided to avoid this risk.

2.3.The landings at the entrance and exit of the car must be equipped with landing doors of adequate mechanical resistance for the conditions of use envisaged.

An interlocking device must prevent during normal operation:

(a)starting movement of the car, whether or not deliberately activated, unless all landing doors are shut and locked;

(b)the opening of a landing door when the car is still moving and outside a prescribed landing zone.

However, all landing movements with the doors open shall be allowed in specified zones on condition that the levelling speed is controlled.

3. Risks for persons in the car

3.1.Lift cars must be completely enclosed by full-length walls, fitted floors and ceilings included, with the exception of ventilation apertures, and with full-length doors. These doors must be so designed and installed that the car cannot move, except for the landing movements referred to in the third subparagraph of point 2.3, unless the doors are closed, and comes to a halt if the doors are opened.

The doors of the car must remain closed and interlocked if the lift stops between two levels where there is a risk of a fall between the car and the shaft or if there is no shaft.

3.2.In the event of a power cut or failure of components the lift must have devices to prevent free fall or uncontrolled movements of the car.

The device preventing the free fall of the car must be independent of the means of suspension of the car.

This device must be able to stop the car at its rated load and at the maximum speed anticipated by the installer. Any stop occasioned by this device must not cause deceleration harmful to the occupants whatever the load conditions.

3.3.Buffers must be installed between the bottom of the shaft and the floor of the car.

In this case, the free space referred to in point 2.2 must be measured with the buffers totally compressed.

This requirement does not apply to lifts in which the car cannot enter the free space referred to in point 2.2 by reason of the design of the drive system.

3.4.Lifts must be so designed and constructed as to make it impossible for them to be set in motion if the device provided for in point 3.2 is not in an operational position.

4. Other risks

4.1.The landing doors and car doors or the two doors together, where motorized, must be fitted with a device to prevent the risk of crushing when they are moving.

4.2.Landing doors, where they have to contribute to the protection of the building against fire, including those with glass parts, must be suitably resistant to fire in terms of their integrity and their properties with regard to insulation (containment of flames) and the transmission of heat (thermal radiation).

4.3.Counterweights must be so installed as to avoid any risk of colliding with or falling on to the car.

4.4.Lifts must be equipped with means enabling people trapped in the car to be released and evacuated.

4.5.Cars must be fitted with two-way means of communication allowing permanent contact with a rescue service.

4.6.Lifts must be so designed and constructed that, in the event of the temperature in the lift machine exceeding the maximum set by the installer, they can complete movements in progress but refuse new commands.

4.7.Cars must be designed and constructed to ensure sufficient ventilation for passengers, even in the event of a prolonged stoppage.

4.8.The car should be adequately lit whenever in use or whenever a door is opened; there must also be emergency lighting.

4.9.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 so as to function even without the normal power supply. Their period of operation should be long enough to allow normal operation of the rescue procedure.

4.10.The control circuits of lifts which may be used in the event of fire must be designed and manufactured so that lifts may be prevented from stopping at certain levels and allow for priority control of the lift by rescue teams.

5. Marking

5.1.In addition to the minimum particulars required for any machine pursuant to point 1.7.3 of Annex I to Directive 2006/42/EC, each car must bear an easily visible plate clearly showing the rated load in kilograms and the maximum number of passengers which may be carried.

5.2.If the lift is designed to allow people trapped in the car to escape without outside help, the relevant instructions must be clear and visible in the car.

6. Instructions

6.1.The safety components for lifts referred to in Annex III must be accompanied by instructions, so the following can be carried out effectively and without danger:

(a)assembly;

(b)connection;

(c)adjustment;

(d)maintenance.

6.2.Each lift must be accompanied by instructions. The instructions shall contain at least the following documents:

(a)instructions containing the plans and diagrams necessary for normal use and relating to maintenance, inspection, repair, periodic checks and the rescue operations referred to in point 4.4;

(b)a logbook in which repairs and, where appropriate, periodic checks can be noted.


(1) OJ L 157, 9.6.2006, p. 24.


ANNEX II

A. CONTENT OF THE EU DECLARATION OF CONFORMITY FOR SAFETY COMPONENTS FOR LIFTS

The EU declaration of conformity for safety components for lifts shall contain the following information:

(a)business name and address of the manufacturer;

(b)where appropriate, business name and address of the authorised representative;

(c)description of the safety component for lifts, details of type or series and serial number (if any); it may, where necessary for the identification of the safety component for lifts, include an image;

(d)safety function of the safety component for lifts, if not obvious from the description;

(e)year of manufacture of the safety component for lifts;

(f)all relevant provisions with which the safety component for lifts complies;

(g)a statement that the safety component for lifts is in conformity with the relevant Union harmonisation legislation;

(h)where appropriate, reference(s) to harmonised standard(s) used;

(i)where appropriate, the name, address and identification number of the notified body which carried out the EU-type examination of safety components for lifts set out in Annex IV, Part A and Annex VI, and the reference of the EU-type examination certificate issued by that notified body;

(j)where appropriate, the name, address and identification number of the notified body which carried out the conformity to type with random checking for safety components for lifts set out in Annex IX;

(k)where appropriate, the name, address and identification number of the notified body which approved the quality system operated by the manufacturer in accordance with the conformity assessment procedure set out in Annex VI or VII;

(l)the name and function of the person empowered to sign the declaration on behalf of the manufacturer or his authorised representative;

(m)place and date of signature;

(n)signature.

B. CONTENT OF THE EU DECLARATION OF CONFORMITY FOR LIFTS

The EU declaration of conformity for lifts shall be drafted in the same language as the instructions referred to in Annex I, point 6.2 and contain the following information:

(a)business name and address of the installer;

(b)where appropriate, business name and address of the authorised representative;

(c)description of the lift, details of the type or series, serial number and address where the lift is installed;

(d)year of installation of the lift;

(e)all relevant provisions to which the lift conforms;

(f)a statement that the lift is in conformity with the relevant Union harmonisation legislation;

(g)where appropriate, reference(s) to harmonised standard(s) used;

(h)where appropriate, the name, address and identification number of the notified body which carried out the EU-type examination of lifts set out in Annex IV, Part B and the reference of the EU-type examination certificate issued by that notified body;

(i)where appropriate, the name, address and identification number of the notified body which carried out the unit verification for lifts set out in Annex VIII;

(j)where appropriate, the name, address and identification number of the notified body which carried out the final inspection for lifts set out in Annex V;

(k)where appropriate, the name, address, and identification number of the notified body which approved the quality assurance system operated by the installer in accordance with the conformity assessment procedure set out in Annex X, XI or XII;

(l)the name and function of the person empowered to sign the declaration on behalf of the installer or his authorised representative;

(m)place and date of signature;

(n)signature.


ANNEX III

LIST OF SAFETY COMPONENTS FOR LIFTS

1.Devices for locking landing doors.

2.Devices to prevent falls referred to in point 3.2 of Annex I to prevent the car from falling or uncontrolled movements.

3.Overspeed limitation devices.

4.
(a)Energy-accumulating buffers:

(i)non-linear, or

(ii)with damping of the return movement.

(b)Energy-dissipating buffers.

5.Safety devices fitted to jacks of hydraulic power circuits where these are used as devices to prevent falls.

6.Electric safety devices in the form of safety circuits containing electronic components.


ANNEX IV

EU-TYPE EXAMINATION FOR LIFTS AND SAFETY COMPONENTS FOR LIFTS

(module B)

A. EU-type examination of safety components for lifts

1.EU-type examination is the part of a conformity assessment procedure in which a notified body examines the technical design of a safety component for lifts and verifies and attests that the technical design of the safety component for lifts satisfies the applicable essential health and safety requirements of Annex I and will enable a lift in which it is correctly incorporated to satisfy those requirements.

2.The application for EU-type examination shall be lodged by the manufacturer, or his authorised representative, with a single notified body of his choice.

The application shall include:

(a)the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well and the place of manufacture of the safety components for lifts;

(b)a written declaration that the same application has not been lodged with any other notified body;

(c)the technical documentation;

(d)a representative specimen of the safety component for lifts or details of the place where it can be examined. The notified body may request further specimens if needed for carrying out the test programme;

(e)the supporting evidence for the adequacy of the technical design solution. This supporting evidence shall mention any documents, including other relevant technical specifications, that have been used, in particular where the relevant harmonised standards have not been applied in full. The supporting evidence shall include, where necessary, the results of tests carried out in accordance with other relevant technical specifications by the appropriate laboratory of the manufacturer, or by another testing laboratory on his behalf and under his responsibility.

3.The technical documentation shall make it possible to assess whether the safety component for lifts meets the conditions referred to in point 1 and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the safety component for lifts.

The technical documentation shall contain, where applicable, the following:

(a)a description of the safety component for lifts, including its area of use (in particular possible limits on speed, load and power) and conditions (in particular explosive environments and exposure to the elements);

(b)design and manufacturing drawings and diagrams;

(c)explanations necessary for the understanding of those drawings and diagrams and the operation of the safety component for lifts;

(d)a list of the harmonised standards applied in full or in part the references of which have been published in the Official Journal of the European Union and, where those harmonised standards have not been applied, descriptions of the solutions adopted to enable the safety component for lifts to meet the conditions referred to in point 1, including a list of other relevant technical specifications applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied;

(e)results of design calculations performed by or for the manufacturer;

(f)test reports;

(g)a copy of the instructions for the safety components for lifts;

(h)steps taken at the manufacturing stage to ensure that series-produced safety components for lifts conform to the safety component for lifts examined.

4.The notified body shall:

(a)examine the technical documentation and the supporting evidence to assess the adequacy of the technical design of the safety component for lifts;

(b)agree with the applicant on a location where the examinations and tests will be carried out;

(c)verify that the representative specimen(s) has(have) been manufactured in conformity with the technical documentation, and identify the elements which have been designed in accordance with the applicable provisions of the relevant harmonised standards, as well as the elements which have been designed in accordance with other relevant technical specifications;

(d)carry out appropriate examinations and tests, or have them carried out, to check whether, where the manufacturer has chosen to apply the specifications of the relevant harmonised standards, these have been applied correctly;

(e)carry out appropriate examinations and tests, or have them carried out, to check whether, where the specifications of the relevant harmonised standards have not been applied, the solutions adopted by the manufacturer applying other relevant technical specifications enable the safety component for lifts to meet the conditions referred to in point 1.

The notified body shall draw up an evaluation report that records the examinations, verifications and tests carried out and their outcome. Without prejudice to its obligations vis-à-vis the notifying authorities, the notified body shall release the content of that report, in full or in part, only with the agreement of the manufacturer.

5.Where the type of the safety component for lifts meets the conditions referred to in point 1, the notified body shall issue an EU-type examination certificate to the manufacturer. That certificate shall contain the name and address of the manufacturer the conclusions of the EU-type examination, any conditions of validity of the certificate and the particulars necessary to identify the approved type.

The EU-type examination certificate may have one or more annexes attached.

The EU-type examination certificate and its annexes shall contain all relevant information to allow the conformity of manufactured safety components for lifts with the examined type to be evaluated and to allow for in-service control.

Where the type of the safety component for lifts does not satisfy the conditions referred to in point 1, the notified body shall refuse to issue an EU-type examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.

The notified body shall keep a copy of the EU-type examination certificate, its annexes and additions, as well as the technical documentation and the evaluation report, for 15 years from the date of issue of that certificate.

6.The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved type may no longer meet the conditions referred to in point 1 and shall determine whether such changes require further investigation. If so, the notified body shall inform the manufacturer accordingly.

7.The manufacturer shall inform the notified body that holds the technical documentation relating to the EU-type examination certificate of any modification to the approved type that may affect the conformity of the safety component for lifts with the conditions referred to in point 1 or the conditions of validity of the EU-type examination certificate.

The notified body shall examine the modification and inform the applicant whether the EU-type examination certificate remains valid or whether further examinations, verifications or tests are needed. As appropriate, the notified body shall issue an addition to the original EU-type examination certificate or ask for a new application for an EU-type examination to be submitted.

8.Each notified body shall inform its notifying authority concerning the EU-type examination certificates and any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of such certificates and any additions thereto refused, suspended or otherwise restricted.

Each notified body shall inform the other notified bodies concerning the EU-type examination certificates and any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning such certificates and/or additions thereto which it has issued.

9.The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU-type examination certificates and additions thereto. On request, the Commission and the Member States may obtain a copy of the technical documentation and of the report on the examinations, verifications and tests carried out by the notified body.

10.The manufacturer shall keep with the technical documentation a copy of EU-type examination certificates, its annexes and additions at the disposal of the national authorities for 10 years after the safety component for lifts has been placed on the market.

11.Authorised representative

The manufacturer’s authorised representative may lodge the application referred to in point 2 and fulfil the obligations set out in points 7 and 10, provided that they are specified in the mandate.

B. EU-type examination of lifts

1.EU-type examination of lifts is the part of a conformity assessment procedure in which a notified body examines the technical design of a model lift, or a lift for which there is no provision for an extension or variant, and verifies and attests that the technical design of the model lift or the lift meets the applicable essential health and safety requirements set out in Annex I.

EU-type examination of a lift includes an examination of a representative specimen of a complete lift.

2.The application for EU-type examination shall be lodged by the installer or his authorised representative with a single notified body of his choice.

The application shall include:

(a)the name and address of the installer; and, if the application is lodged by the authorised representative, his name and address as well;

(b)a written declaration that the same application has not been lodged with any other notified body;

(c)the technical documentation;

(d)details of the place where the specimen lift can be examined. The specimen lift submitted for examination shall include the terminal parts and be capable of serving at least three levels (top, middle and bottom);

(e)the supporting evidence for the adequacy of the technical design solution. This supporting evidence shall mention any documents, including other relevant technical specifications that have been used, in particular where the relevant harmonised standards have not been applied in full. The supporting evidence shall include, where necessary, the results of tests carried out in accordance with other relevant technical specifications by the appropriate laboratory of the installer, or by another testing laboratory on his behalf and under his responsibility.

3.The technical documentation shall make it possible to assess the conformity of the lift with the applicable essential health and safety requirements set out in Annex I.

The technical documentation shall contain, where applicable, the following:

(a)a description of the model lift indicating clearly all the permitted variations of the model lift;

(b)design and manufacturing drawings and diagrams;

(c)explanations necessary for the understanding of those drawings and diagrams and of the operation of the lift;

(d)a list of the essential health and safety requirements taken into consideration;

(e)a list of the harmonised standards applied in full or in part the references of which have been published in the Official Journal of the European Union and, where those harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential health and safety requirements of the Directive, including a list of other relevant technical specifications applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied;

(f)a copy of the EU declarations of conformity of the safety components for lifts incorporated in the lift;

(g)results of design calculations performed by or for the installer;

(h)test reports;

(i)a copy of the instructions referred to in point 6.2 of Annex I;

(j)steps taken at the installation stage to ensure that the series-produced lift conforms to the essential health and safety requirements set out in Annex I.

4.The notified body shall:

(a)examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the model lift or of the lift for which there is no provision for an extension or variant;

(b)agree with the installer on a location where the examinations and tests will be carried out;

(c)examine the specimen lift to check that it has been manufactured in accordance with the technical documentation, and identify the elements which have been designed in accordance with the applicable provisions of the relevant harmonised standards, as well as the elements which have been designed in accordance with other relevant technical specifications;

(d)carry out appropriate examinations and tests, or have them carried out, to check whether, where the installer has chosen to apply the specifications of the relevant harmonised standards, these have been applied correctly;

(e)carry out appropriate examinations and tests, or have them carried out, to check whether, where the specifications of the relevant harmonised standards have not been applied, the solutions adopted by the installer applying other relevant technical specifications meet the corresponding essential health and safety requirements of this Directive.

5.The notified body shall draw up an evaluation report that records the examinations, verifications and tests carried out and their outcome. Without prejudice to its obligations vis-à-vis the notifying authorities, the notified body shall release the content of that report, in full or in part, only with the agreement of the installer.

6.Where the type meets the essential health and safety requirements set out in Annex I applicable to the lift concerned, the notified body shall issue an EU-type examination certificate to the installer. That certificate shall contain the name and address of the installer, the conclusions of the EU-type examination, any conditions of validity of the certificate and the particulars necessary to identify the approved type.

The EU-type examination certificate may have one or more annexes attached.

The EU-type examination certificate and its annexes shall contain all the information necessary to enable the conformity of lifts with the approved type to be assessed during the final inspection.

Where the type does not comply with the essential health and safety requirements set out in Annex I, the notified body shall refuse to issue an EU-type examination certificate and shall inform the installer accordingly, giving detailed reasons for its refusal.

The notified body shall keep a copy of the EU-type examination certificate, its annexes and additions, as well as the technical documentation and the evaluation report for 15 years from the date of issue of that certificate.

7.The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved type may no longer comply with the essential health and safety requirements set out in Annex I, and shall determine whether such changes require further investigation. If so, the notified body shall inform the installer accordingly.

8.The installer shall inform the notified body of any modifications to the approved type, including variations not specified in the original technical documentation, that may affect the conformity of the lift with the essential health and safety requirements set out in Annex I or the conditions of validity of the EU-type examination certificate.

The notified body shall examine the modification and inform the installer whether the EU-type examination certificate remains valid or whether further examinations, verifications or tests are needed. As appropriate the notified body shall issue an addition to the original EU-type examination certificate or ask for a new application for an EU-type examination to be submitted.

9.Each notified body shall inform its notifying authority concerning the EU-type examination certificates and any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of such certificates and any additions thereto refused, suspended or otherwise restricted.

Each notified body shall inform the other notified bodies concerning the EU-type examination certificates and any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning such certificates and additions thereto which it has issued.

10.The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU-type examination certificates and additions thereto. On request, the Commission and the Member States may obtain a copy of the technical documentation and of the report on the examinations, verifications and tests carried out by the notified body.

11.The installer shall keep with the technical documentation a copy of the EU-type examination certificate, including its annexes and additions, at the disposal of the national authorities for 10 years after the lift has been placed on the market.

12.Authorised representative

The installer’s authorised representative may lodge the application referred to in point 2 and fulfil the obligations set out in points 8 and 11, provided that they are specified in the mandate.


ANNEX V

FINAL INSPECTION FOR LIFTS

1. Final inspection is the part of a conformity assessment procedure whereby a notified body ascertains and certifies that a lift subject to an EU-type examination certificate or designed and manufactured according to an approved quality system satisfies the essential health and safety requirements set out in Annex I.

2. Obligations of the installer

The installer shall take all measures necessary to ensure that the lift being installed complies with the applicable essential health and safety requirements set out in Annex I and with one of the following:

(a)an approved type described in an EU-type examination certificate;

(b)a lift designed and manufactured in accordance with a quality system pursuant to Annex XI and the EU design examination certificate if the design is not wholly in accordance with the harmonised standards.

3. Final inspection

A notified body chosen by the installer shall carry out the final inspection of the lift about to be placed on the market in order to check the conformity of the lift with the applicable essential health and safety requirements set out in Annex I.

3.1.The installer shall lodge an application for final inspection with a single notified body of his choice and shall provide to the notified body the following documents:

(a)the plan of the complete lift;

(b)the plans and diagrams necessary for final inspection, in particular control circuit diagrams;

(c)a copy of the instructions referred to in Annex I, point 6.2;

(d)a written declaration that the same application has not been lodged with any other notified body.

The notified body may not require detailed plans or precise information not necessary for verifying the conformity of the lift.

The appropriate examinations and tests set out in the relevant harmonised standard(s) or equivalent tests shall be carried out in order to check the conformity of the lift with the applicable essential health and safety requirements set out in Annex I.

3.2.The examinations shall include at least one of the following:

(a)examination of the documents referred to in point 3.1 to check that the lift conforms with the approved type described in the EU-type examination certificate pursuant to Annex IV, Part B;

(b)examination of the documents referred to in point 3.1 to check that the lift conforms with the lift designed and manufactured in accordance with an approved quality system pursuant to Annex XI and if the design is not wholly in accordance with the harmonised standards, with the EU design examination certificate.

3.3.The tests of the lift shall include at least the following:

(a)operation of the lift both empty and at maximum load to ensure correct installation and operation of the safety devices (end stops, locking devices, etc.);

(b)operation of the lift at both maximum load and empty to ensure the correct functioning of the safety devices in the event of loss of power;

(c)static test with a load equal to 1,25 times the rated load.

The rated load shall be that referred to in Annex I, point 5.

After these tests, the notified body shall check that no distortion or deterioration which could impair the use of the lift has occurred.

4. If the lift satisfies the essential health and safety requirements set out in Annex I, the notified body shall affix or have affixed its identification number adjacent to the CE marking in accordance with Articles 18 and 19 and shall issue a final inspection certificate which mentions the examinations and tests carried out.

The notified body shall fill in the corresponding pages in the logbook referred to in Annex I, point 6.2.

If the notified body refuses to issue the final inspection certificate, it shall state the detailed reasons for refusal and indicate the necessary corrective measures to be taken. Where the installer again applies for final inspection, he shall apply to the same notified body.

5. CE marking and EU declaration of conformity

5.1.The installer shall affix the CE marking in the car of each lift which satisfies the essential health and safety requirements of this Directive, and, under the responsibility of the notified body referred to in point 3.1, the latter’s identification number adjacent to the CE marking in the car of each lift.

5.2.The installer shall draw up a written EU declaration of conformity for each lift and keep a copy of the EU declaration of conformity and the final inspection certificate at the disposal of the national authorities for 10 years after the placing on the market of the lift. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.

6. The Commission and the Member States may obtain a copy of the final inspection certificate on request.

7. Authorised representative

The installer’s obligations set out in points 3.1 and 5 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.


ANNEX VI

CONFORMITY TO TYPE BASED ON PRODUCT QUALITY ASSURANCE FOR SAFETY COMPONENTS FOR LIFTS

(module E)

1. Conformity to type based on product quality assurance for safety components for lifts is the part of the conformity assessment procedure whereby a notified body assesses the quality system of a manufacturer in order to ensure that the safety components for lifts are manufactured and monitored in conformity with the type described in the EU-type examination certificate, satisfy the applicable requirements of Annex I and will enable a lift to which they are correctly incorporated to satisfy those requirements.

2. Obligations of the manufacturer

The manufacturer shall operate an approved quality system for final inspection and testing of the safety components for lifts as specified in point 3, and shall be subject to surveillance as specified in point 4.

3. Quality system

3.1.The manufacturer shall lodge an application for assessment of his quality system for the safety components for lifts concerned with a single notified body of his choice.

The application shall include:

(a)the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well;

(b)a written declaration that the same application has not been lodged with any other notified body;

(c)the address of the premises where final inspection and testing of the safety components for lifts are carried out;

(d)all relevant information on the safety components for lifts to be manufactured;

(e)the documentation concerning the quality system;

(f)the technical documentation of the approved safety components for lifts and a copy of the EU-type examination certificate.

3.2.Under the quality system, each safety component for lifts shall be inspected and appropriate tests as set out in the relevant harmonised standards or equivalent tests shall be carried out in order to ensure that it meets the conditions referred to in point 1. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records.

It shall contain in particular an adequate description of:

(a)the quality objectives;

(b)the organizational structure, responsibilities and powers of the management with regard to product quality;

(c)the examinations and tests that will be carried out after manufacture;

(d)the means of monitoring the effective operation of the quality system; and

(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 shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2. It shall presume conformity with those requirements in respect of the elements of the quality systems that comply with the corresponding specifications of the relevant harmonised standard.

In addition to experience in quality management systems, the auditing team shall have at least one member with experience of assessment in the lift technology concerned and knowledge of the essential health and safety requirements set out in Annex I.

The audit shall include an assessment visit to the manufacturer’s premises.

The auditing team shall review the technical documentation referred to in point 3.1(f), in order to verify the manufacturer’s ability to identify the relevant requirements of this Directive and to carry out the necessary examinations with a view to ensuring compliance of the safety components for lifts with those requirements.

The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned assessment decision.

3.4.The manufacturer shall undertake to fulfil the obligations arising from the quality system as approved and to maintain it so that it remains adequate and efficient.

3.5.The manufacturer or his authorised representative shall keep the notified body which has approved the quality system informed of any intended changes of the quality system.

The notified body shall assess the modifications proposed and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary.

It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

4. Surveillance under the responsibility of the notified body

4.1.The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

4.2.The manufacturer shall for assessment purposes allow the notified body access to the premises where final inspection, testing and storage are carried out and provide it with all necessary information, in particular:

(a)the quality system documentation;

(b)the technical documentation;

(c)the quality records, such as inspection reports and test data, calibration data, reports on the qualifications of the personnel concerned.

4.3.The notified body shall periodically carry out audits to ensure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report.

4.4.Additionally, the notified body may pay unexpected visits to the manufacturer’s premises where final inspection and testing of safety components for lifts are carried out.

At the time of such visits, the notified body may, where necessary, carry out tests or have them carried out in order to check the proper functioning of the quality system. It shall provide the manufacturer, with a visit report and, if a test has been carried out, with a test report.

5. CE marking and EU declaration of conformity

5.1.The manufacturer shall affix the CE marking, and, under the responsibility of the notified body referred to in point 3.1, the latter’s identification number to each individual safety component for lifts that meets the conditions referred to in point 1.

5.2.The manufacturer shall draw up a written EU declaration of conformity for each safety component for lifts and keep a copy of it at the disposal of the national authorities for 10 years after the safety component for lifts has been placed on the market. The EU declaration of conformity shall identify the safety component for lifts for which it has been drawn up.

6. The manufacturer shall for a period ending 10 years after the safety component for lifts has been placed on the market, keep at the disposal of the national authorities:

(a)the technical documentation referred to in point 3.1(f);

(b)the documentation referred to in point 3.1(e);

(c)the information relating to the change referred to in point 3.5;

(d)the decisions and reports from the notified body which are referred to in the third paragraph of point 3.5 and in points 4.3 and 4.4.

7. Each notified body shall inform its notifying authority of quality system approval decision(s) issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of approval decisions refused, suspended or otherwise restricted.

Each notified body shall inform the other notified bodies of quality system approval decision(s) which it has refused, suspended or withdrawn and, upon request, of approval decision(s) which it has issued.

On request, the notified body shall provide the Commission and the Member States with a copy of quality system approval decision(s) issued.

8. Authorised representative

The manufacturer’s obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.


ANNEX VII

CONFORMITY BASED ON FULL QUALITY ASSURANCE FOR SAFETY COMPONENTS FOR LIFTS

(module H)

1. Conformity based on full quality assurance for safety components for lifts is the conformity assessment procedure whereby a notified body assesses the quality system of a manufacturer to ensure that the safety components for lifts are designed, manufactured, inspected and tested in order to satisfy the applicable requirements of Annex I and to enable a lift to which they are correctly incorporated to satisfy those requirements.

2. Obligations of the manufacturer

The manufacturer shall operate an approved quality system for the design, manufacture, final inspection and testing of safety components for lifts as specified in point 3 and shall be subject to surveillance as specified in point 4.

3. Quality system

3.1.The manufacturer shall lodge an application for assessment of his quality system with a single notified body of his choice. The application shall include:

(a)the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well;

(b)the address of the premises where the safety components for lifts are designed, manufactured, inspected and tested;

(c)all relevant information on safety components for lifts to be manufactured;

(d)the technical documentation described in point 3 of Annex IV, Part A for one model of each category of safety component for lifts to be manufactured;

(e)the documentation on the quality system;

(f)a written declaration that the same application has not been lodged with any other notified body.

3.2.The quality system shall ensure compliance of the safety components for lifts with the conditions referred to in point 1. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records.

It shall contain in particular an adequate description of:

(a)the quality objectives and the organizational structure, responsibilities and powers of the management with regard to the design and product quality;

(b)the technical design specifications, including standards that will be applied and, where the relevant harmonised standards will not be applied or not applied in full, the means, including other relevant technical specifications, that will be used to ensure that the conditions referred to in point 1 will be met;

(c)the design control and design verification techniques, processes and systematic actions that will be used when designing the safety components for lifts;

(d)the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used;

(e)the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out;

(f)the quality records, such as inspection reports and test data, calibration data, reports on the qualifications of the personnel concerned;

(g)the means of monitoring the achievement of the required design and product quality and the effective operation of the quality system.

3.3.The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2. It shall presume conformity with those requirements in respect of the elements of the quality systems that comply with the corresponding specifications of the relevant harmonised standard.

In addition to experience in quality management systems, the auditing team shall have at least one member with experience of assessment in the lift technology concerned and knowledge of the essential health and safety requirements set out in Annex I. The audit shall include an assessment visit to the manufacturer’s premises.

The auditing team shall review the technical documentation referred to in point 3.1(d) to verify the manufacturer’s ability to identify the applicable essential health and safety requirements set out in Annex I and to carry out the necessary examinations with a view to ensuring compliance of the safety components for lifts with those requirements.

The decision shall be notified to the manufacturer and, where appropriate, to his authorised representative. The notification shall contain the conclusions of the audit and the reasoned assessment decision.

3.4.The manufacturer shall undertake to fulfil the obligations arising from the quality system as approved and maintain it so that it remains adequate and efficient.

3.5.The manufacturer shall keep the notified body which has approved the quality system informed of any intended change to the quality system.

The notified body shall assess the modifications proposed and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary.

It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the assessment and the reasoned assessment decision.

4. Surveillance under the responsibility of the notified body

4.1.The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

4.2.The manufacturer shall for assessment purposes allow the notified body access to the design, manufacture, inspection and testing, and storage locations, and shall provide it with all necessary information, in particular:

(a)the quality system documentation;

(b)the quality records provided for in the design part of the quality system such as results of analyses, calculations, tests;

(c)the technical documentation for the safety components for lifts manufactured;

(d)the quality records provided for in the manufacturing part of the full quality system, such as inspection reports and test data, calibration data, reports on the qualifications of the personnel concerned.

4.3.The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report.

4.4.Additionally, the notified body may pay unexpected visits to the manufacturer. At the time of such visits, the notified body may, where necessary, carry out tests or have them carried out in order to check the proper functioning of the quality system. It shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.

5. CE marking and EU declaration of conformity

5.1.The manufacturer shall affix the CE marking, and, under the responsibility of the notified body referred to in point 3.1, the latter’s identification number to each individual safety component for lifts that meets the conditions referred to in point 1.

5.2.The manufacturer shall draw up a written EU declaration of conformity for each safety component for lifts and keep a copy of it at the disposal of the national authorities for 10 years after the safety component for lifts has been placed on the market. The EU declaration of conformity shall identify the safety component for lifts for which it has been drawn up.

6. The manufacturer shall, for a period ending 10 years after the safety component for lifts has been placed on the market, keep at the disposal of the national authorities:

(a)the documentation referred to in point 3.1(e);

(b)the technical documentation referred to in point 3.1(d);

(c)the information relating to the change referred to in the first paragraph of point 3.5;

(d)the decisions and reports from the notified body referred to in the third paragraph of point 3.5. and in points 4.3 and 4.4.

7. Each notified body shall inform its notifying authority of quality system approval decision(s) issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of approval decisions refused, suspended or otherwise restricted.

Each notified body shall inform the other notified bodies of quality system approval decisions which it has refused, suspended or withdrawn and, upon request, of approval decisions which it has issued.

On request, the notified body shall provide the Commission and the Member States with a copy of quality system approval decision(s) issued.

The notified body shall keep a copy of the approval decision issued, its annexes and additions, as well as the technical documentation for 15 years from the date of their issue.

8. Authorised representative

The manufacturer’s obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.


ANNEX VIII

CONFORMITY BASED ON UNIT VERIFICATION FOR LIFTS

(module G)

1. Conformity based on unit verification is the conformity assessment procedure whereby a notified body assesses whether a lift complies with the applicable essential health and safety requirements set out in Annex I.

2. Obligations of the installer

2.1.The installer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the lift with the applicable essential health and safety requirements set out in Annex I.

2.2.The installer shall apply to a single notified body of his choice for unit verification.

The application shall contain:

(a)the name and address of the installer, and if the application is lodged by the authorised representative, his name and address as well;

(b)the location where the lift is installed;

(c)a written declaration to the effect that a similar application has not been lodged with another notified body;

(d)the technical documentation.

3. The technical documentation shall allow an assessment of the conformity of the lift with the applicable essential health and safety requirements set out in Annex I.

The technical documentation shall contain at least the following elements:

(a)a description of the lift;

(b)design and manufacturing drawings and diagrams;

(c)explanations necessary for the understanding of those drawings and diagrams and of the operation of the lift;

(d)a list of the essential health and safety requirements taken into consideration;

(e)a list of the harmonised standards applied in full or in part the references of which have been published in the Official Journal of the European Union and, where those harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential health and safety requirements of the Directive, including a list of other relevant technical specifications applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied;

(f)a copy of the EU-type examination certificates of the safety components for lifts incorporated in the lift;

(g)results of design calculations performed by or for the installer;

(h)test reports;

(i)a copy of the instructions referred to in point 6.2 of Annex I.

4. Verification

The notified body chosen by the installer shall examine the technical documentation and the lift and carry out the appropriate tests as set out in the relevant harmonised standard(s), or equivalent tests, to check its conformity with the applicable essential health and safety requirements set out in Annex I. The tests shall include at least the tests referred to in point 3.3 of Annex V.

If the lift meets the essential health and safety requirements set out in Annex I the notified body shall issue a certificate of conformity relating to the tests carried out.

The notified body shall fill in the corresponding pages of the logbook referred to in point 6.2 of Annex I.

If the notified body refuses to issue the certificate of conformity, it shall state in detail its reasons for refusal and indicate the necessary corrective measures to be taken. When the installer reapplies for unit verification he shall apply to the same notified body.

On request, the notified body shall provide the Commission and the Member States with a copy of the certificate of conformity.

5. CE marking and EU declaration of conformity

5.1.The installer shall affix the CE marking in the car of each lift which satisfies the essential health and safety requirements of this Directive, and, under the responsibility of the notified body referred to in point 2.2, the latter’s identification number adjacent to the CE marking in the car of each lift.

5.2.The installer shall draw up a written EU declaration of conformity for each lift and keep a copy of the EU declaration of conformity at the disposal of the national authorities for 10 years after the placing on the market of the lift. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.

6. The installer shall keep with the technical documentation a copy of the certificate of conformity at the disposal of the national authorities for 10 years from the date on which the lift is placed on the market.

7. Authorised representative

The installer’s obligations set out in points 2.2 and 6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.


ANNEX IX

CONFORMITY TO TYPE WITH RANDOM CHECKING FOR SAFETY COMPONENTS FOR LIFTS

(module C 2)

1. Conformity to type with random checking is the part of the conformity assessment procedure whereby a notified body carries out checks on safety components for lifts to ensure that they are in conformity with the approved type as described in the EU type examination certificate and satisfy the applicable requirements of Annex I and will enable a lift in which they are correctly incorporated to satisfy those requirements.

2. Manufacturing

The manufacturer shall take all measures necessary to ensure that the manufacturing process and its monitoring ensure that the manufactured safety components for lifts meet the conditions referred to in point 1.

3. The manufacturer shall lodge an application for random checking with a single notified body of his choice.

The application shall include:

(a)the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well;

(b)a written declaration that the same application has not been lodged with any other notified body;

(c)all relevant information on the safety components for lifts manufactured;

(d)the address of the premises where the sample of the safety components for lifts can be taken.

4. The notified body shall carry out or have carried out checks on safety components for lifts at random intervals. An adequate sample of the final safety components for lifts, taken on site by the notified body, shall be examined and appropriate tests set out in the relevant harmonised standards, and/or equivalent tests set out in other relevant technical specifications, shall be carried out to check whether the safety components for lifts meets the conditions referred to in point 1. In cases where one or more of the safety components for lifts checked do not conform, the notified body shall take appropriate measures.

The points to be taken into account when checking the safety components for lifts will be defined by joint agreement between all the notified bodies responsible for this procedure, taking into consideration the essential characteristics of the safety components for lifts.

The notified body shall issue a certificate of conformity to type with respect to the examinations and tests carried out.

On request, the notified body shall provide the Commission and the Member States with a copy of the certificate of conformity to type.

5. CE marking and EU declaration of conformity

5.1.The manufacturer shall affix the CE marking, and, under the responsibility of the notified body referred to in point 3, the latter’s identification number to each individual safety component for lifts that meets the conditions referred to in point 1.

5.2.The manufacturer shall draw up a written EU declaration of conformity for each safety component for lifts and keep a copy of it at the disposal of the national authorities for 10 years after the safety component for lifts has been placed on the market. The EU declaration of conformity shall identify the safety component for lifts for which it has been drawn up.

6. Authorised representative

The manufacturer’s obligations may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. An authorised representative shall not fulfil the manufacturer’s obligations set out in point 2.


ANNEX X

CONFORMITY TO TYPE BASED ON PRODUCT QUALITY ASSURANCE FOR LIFTS

(module E)

1. Conformity to type based on product quality assurance is the part of the conformity assessment procedure whereby a notified body assesses the product quality system of an installer to ensure that the lifts are in conformity with the approved type as described in the EU-type examination certificate or with a lift designed and manufactured under a full quality system approved in accordance with Annex XI, and satisfy the applicable essential health and safety requirements set out in Annex I.

2. Obligations of the installer

The installer shall operate an approved quality system for final inspection and testing of the lift as specified in point 3, and shall be subject to surveillance as specified in point 4.

3. Quality system

3.1.The installer shall lodge an application for assessment of his quality system for the lifts concerned with a single notified body of his choice.

The application shall include:

(a)the name and address of the installer, and if the application is lodged by the authorised representative, his name and address as well;

(b)all relevant information on the lifts to be installed;

(c)the documentation on the quality system;

(d)the technical documentation of the lifts to be installed;

(e)a written declaration that the same application has not been lodged with any other notified body.

3.2.Under the quality system, each lift shall be examined and appropriate tests as set out in the relevant harmonised standards or equivalent tests shall be carried out in order to ensure its conformity with the applicable essential health and safety requirements set out in Annex I.

All the elements, requirements and provisions adopted by the installer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and quality records.

It shall contain in particular an adequate description of:

(a)the quality objectives;

(b)the organisational structure, responsibilities and powers of the management with regard to product quality;

(c)the examinations and tests that will be carried out before placing on the market, including at least the tests laid down in point 3.3 of Annex V;

(d)the means of monitoring 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.

3.3.The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2. It shall presume conformity with those requirements in respect of the elements of the quality systems that comply with the corresponding specifications of the relevant harmonised standard.

The auditing team shall have at least one member with experience of assessment in the lift technology concerned and knowledge of the essential health and safety requirements set out in Annex I. The audit shall include an assessment visit to the premises of the installer and a visit to the installation site.

The decision shall be notified to the installer. The notification shall contain the conclusions of the audit and the reasoned assessment decision.

3.4.The installer shall undertake to fulfil the obligations arising from the quality system as approved and to maintain it so that it remains adequate and efficient.

3.4.1.The installer shall keep the notified body which has approved the quality system informed of any intended change to the system.

3.4.2.The notified body shall assess the modifications proposed and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary.

It shall notify its decision to the installer or, where appropriate, to his authorised representative. The notification shall contain the conclusions of the assessment and the reasoned assessment decision.

The notified body shall affix, or cause to be affixed, its identification number adjacent to the CE marking in accordance with Articles 18 and 19.

4. Surveillance under the responsibility of the notified body

4.1.The purpose of surveillance is to make sure that the installer duly fulfils the obligations arising out of the approved quality system.

4.2.The installer shall, for assessment purposes, allow the notified body access to the installation, inspection and testing locations, and shall provide it with all necessary information, in particular:

(a)the quality system documentation;

(b)the technical documentation;

(c)the quality records, such as inspection reports and test data, calibration data, reports on the qualifications of the personnel concerned, etc.

4.3.The notified body shall periodically carry out audits to ensure that the installer maintains and applies the quality system and shall provide the installer with an audit report.

4.4.Additionally, the notified body may pay unexpected visits to the lift installation sites.

At the time of such visits, the notified body may, where necessary, carry out tests or have them carried out in order to check the proper functioning of the quality system and of the lift. It shall provide the installer with a visit report and, if tests have been carried out, with a test report.

5. The installer shall, for 10 years after the last lift has been placed on the market, keep at the disposal of the national authorities:

(a)the documentation referred to in point 3.1(c);

(b)the technical documentation referred to in point 3.1(d);

(c)the information relating to the changes referred to in point 3.4.1;

(d)the decisions and reports from the notified body which are referred to in the second paragraph of point 3.4.2 and in points 4.3 and 4.4.

6. Each notified body shall inform its notifying authority of quality system approval decision(s) issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of approval decisions, refused, suspended or otherwise restricted.

Each notified body shall inform the other notified bodies of quality system approval decision(s) which it has refused, suspended or withdrawn and, upon request, of approval decision(s) which it has issued.

On request, the notified body shall provide the Commission and the Member States with a copy of quality system approval decision(s) issued.

7. CE marking and EU declaration of conformity

7.1.The installer shall affix the CE marking in the car of each lift which satisfies the essential health and safety requirements of this Directive, and, under the responsibility of the notified body referred to in point 3.1, the latter’s identification number adjacent to the CE marking in the car of each lift.

7.2.The installer shall draw up a written EU declaration of conformity for each lift and keep a copy of the EU declaration of conformity at the disposal of the national authorities for 10 years after the placing on the market of the lift. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.

8. Authorised representative

The installer’s obligations set out in points 3.1, 3.4.1, 5 and 7 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.


ANNEX XI

CONFORMITY BASED ON FULL QUALITY ASSURANCE PLUS DESIGN EXAMINATION FOR LIFTS

(module H1)

1. Conformity based on full quality assurance plus design examination for lifts is the conformity assessment procedure whereby a notified body assesses the quality system of an installer and, where appropriate, the design of the lifts, to ensure that the lifts satisfy the applicable essential health and safety requirements set out in Annex I.

2. Obligations of the installer

The installer shall operate an approved quality system for the design, manufacture, assembly, installation, final inspection and testing of the lifts as specified in point 3, and shall be subject to surveillance as specified in point 4. The adequacy of the technical design of the lifts shall have been examined in accordance with point 3.3.

3. Quality system

3.1.   The installer shall lodge an application for assessment of his quality system with a single notified body of his choice.

The application shall include:

(a)the name and address of the installer, and, if the application is lodged by the authorised representative, his name and address as well;

(b)all relevant information on the lifts to be installed, in particular information which makes for an understanding of the relationship between the design and operation of the lift;

(c)the documentation on the quality system;

(d)the technical documentation described in point 3 of Annex IV, Part B;

(e)a written declaration that the same application has not been lodged with any other notified body.

3.2.   The quality system shall ensure compliance of the lifts with the applicable essential health and safety requirements set out in Annex I. All the elements, requirements and provisions adopted by the installer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and quality records.

It shall contain in particular an adequate description of:

(a)the quality objectives and the organisational structure, responsibilities and powers of the management with regard to design and product quality;

(b)the technical design specifications, including standards that will be applied and, where the relevant harmonised standards will not be applied in full, the means, including other relevant technical specifications that will be used to ensure that the applicable essential health and safety requirements set out in Annex I will be met;

(c)the design control and design verification techniques, processes and systematic actions that will be used when designing the lifts;

(d)the examinations and tests that will be carried out on acceptance of the supplies of materials, components and sub-assemblies;

(e)the corresponding assembly, installation, quality control and quality assurance techniques, processes and systematic actions that will be used;

(f)the examinations and tests that will be carried out before (inspection of installation conditions: shaft, housing of machinery, etc.), during and after installation (including at least the tests laid down in point 3.3 of Annex V);

(g)the quality records, such as inspection reports and test data, calibration data, reports on the qualifications of the personnel concerned;

(h)the means of monitoring the achievement of the required design and product quality and the effective operation of the quality system.

3.3.   Design examination

3.3.1.When the design is not entirely in accordance with harmonised standards, the notified body shall ascertain whether the design conforms to the essential health and safety requirements set out in Annex I and, if it does, issue an EU design examination certificate to the installer, stating the limits of the certificate’s validity and giving the details required for identification of the approved design.

3.3.2.Where the design does not satisfy the applicable essential health and safety requirements set out in Annex I, the notified body shall refuse to issue an EU design examination certificate and shall inform the installer accordingly, giving detailed reasons for its refusal.

The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved design may no longer comply with the essential health and safety requirements set out in Annex I, and shall determine whether such changes require further investigation. If so, the notified body shall inform the installer accordingly.

3.3.3.The installer shall keep the notified body that has issued the EU design examination certificate informed of any modification to the approved design that may affect the conformity with the essential health and safety requirements set out in Annex I or the conditions for validity of the certificate. Such modifications shall require additional approval — from the notified body that issued the EU design examination certificate — in the form of an addition to the original EU design examination certificate.

3.3.4.Each notified body shall inform its notifying authority of the EU design examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of EU design examination certificates and/or any additions thereto refused, suspended or otherwise restricted.

Each notified body shall inform the other notified bodies of the EU design examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, of the certificates and/or additions thereto which it has issued.

The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU design examination certificates and/or additions thereto. On request, the Commission and the Member States may obtain a copy of the technical documentation and of the results of the examinations carried out by the notified body.

3.3.5.The installer shall keep a copy of the EU design examination certificate, its annexes and additions together with the technical documentation at the disposal of the national authorities for 10 years after the lift has been placed on the market.

3.4.   Assessment of the quality system

The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2. It shall presume conformity with those requirements in respect of the elements of the quality systems that comply with the corresponding specifications of the relevant harmonised standard.

The auditing team shall have at least one member with experience of assessment in the lift technology concerned and knowledge of the essential health and safety requirements set out in Annex I. The audit shall include an assessment visit to the installer’s premises and a visit to an installation site.

The auditing team shall review the technical documentation referred to in point 3.1(d), to verify the installer’s ability to identify the applicable essential health and safety requirements set out in Annex I and to carry out the necessary examinations with a view to ensuring compliance of the lift with those requirements.

The decision shall be notified to the installer or, where appropriate, to his authorised representative. The notification shall contain the conclusions of the assessment and the reasoned assessment decision.

3.5.   The installer shall undertake to fulfil the obligations arising from the quality system as approved and to maintain it so that it remains adequate and efficient.

The installer shall keep the notified body that has approved the quality system informed of any intended change to the system.

The notified body shall assess the modifications proposed and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary.

It shall notify its decision to the installer or, where appropriate, to his authorised representative. The notification shall contain the conclusions of the assessment and the reasoned assessment decision.

The notified body shall affix, or cause to be affixed, its identification number adjacent to the CE marking in accordance with Articles 18 and 19.

4. Surveillance under the responsibility of the notified body

4.1.The purpose of surveillance is to make sure that the installer duly fulfils the obligations arising out of the approved quality system.

4.2.The installer shall, for assessment purposes, allow the notified body access to the design, manufacture, assembly, installation, inspection, testing and storage locations, and shall provide it with all necessary information, in particular:

(a)the quality system documentation;

(b)the quality records provided for in the design part of the quality system, such as results of analyses, calculations, tests;

(c)the quality records provided for in the part of the quality system concerning acceptance of supplies and installation, such as inspection reports and test data, calibration data, reports on the qualifications of the personnel concerned.

4.3.The notified body shall carry out periodic audits to make sure that the installer maintains and applies the quality system and shall provide the installer with an audit report.

4.4.Additionally, the notified body may pay unexpected visits to the premises of the installer or to the installation site of a lift. At the time of such visits, the notified body may, where necessary, carry out tests or have them carried out in order to check the proper functioning of the quality system. It shall provide the installer with a visit report and, if tests have been carried out, with a test report.

5. The installer shall, keep at the disposal of the national authorities for a period ending 10 years after the lift has been placed on the market:

(a)the documentation referred to in point 3.1(c);

(b)the technical documentation referred to in point 3.1(d);

(c)the information relating to the changes referred to in the second paragraph of point 3.5;

(d)the decisions and reports from the notified body which are referred to in the fourth paragraph of point 3.5 and in points 4.3 and 4.4.

6. Each notified body shall inform its notifying authority of full quality system approval decision(s) issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of approval decisions refused, suspended or otherwise restricted.

Each notified body shall inform the other notified bodies of quality system approval decision(s) which it has refused, suspended or withdrawn, and, upon request, of approval decisions which it has issued.

The notified body shall keep a copy of the approval decision issued, its annexes and additions, as well as the technical documentation for 15 years from the date of their issue.

On request, the notified body shall provide the Commission and the Member States with a copy of quality system approval decision(s) issued.

7. CE marking and EU declaration of conformity

7.1.The installer shall affix the CE marking in the car of each lift which satisfies the essential health and safety requirements of this Directive, and, under the responsibility of the notified body referred to in point 3.1, the latter’s identification number adjacent to the CE marking in the car of each lift.

7.2.The installer shall draw up a written EU declaration of conformity for each lift and keep a copy of the EU declaration of conformity at the disposal of the national authorities for 10 years after the placing on the market of the lift. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.

8. Authorised representative

The installer’s obligations set out in points 3.1, 3.3.3, 3.3.5, 5 and 7 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.


ANNEX XII

CONFORMITY TO TYPE BASED ON PRODUCTION QUALITY ASSURANCE FOR LIFTS

(module D)

1. Conformity to type based on production quality assurance for lifts is the part of the conformity assessment procedure whereby a notified body assesses the production quality system of an installer to ensure that the lifts installed are in conformity with the approved type as described in the EU-type examination certificate or with a lift designed and manufactured under a quality system approved in accordance with Annex XI, and satisfy the applicable essential health and safety requirements set out in Annex I.

2. Obligations of the installer

The installer shall operate an approved quality system for manufacture, assembly, installation, final inspection and testing of the lifts as specified in point 3, and shall be subject to surveillance as specified in point 4.

3. Quality system

3.1.The installer shall lodge an application for assessment of his quality system with a single notified body of his choice.

The application shall include:

(a)the name and address of the installer, and, if the application is lodged by the authorised representative, his name and address as well;

(b)all relevant information for the lifts to be installed;

(c)the documentation on the quality system;

(d)the technical documentation of the lifts to be installed;

(e)a written declaration that the same application has not been lodged with any other notified body.

3.2.The quality system shall ensure compliance of the lifts with the applicable essential health and safety requirements set out in Annex I.

All the elements, requirements and provisions adopted by the installer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. The quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records.

It shall contain in particular an adequate description of:

(a)the quality objectives and the organizational structure, responsibilities and powers of the management with regard to the product quality;

(b)the manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used;

(c)the examinations and tests that will be carried out before, during and after installation;

(d)the quality records, such as inspection reports and test data, calibration data, reports on the qualification of the personnel concerned;

(e)the means of monitoring the achievement of the required product quality and the effective operation of the quality system.

3.3.The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2. It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant harmonised standard.

The auditing team shall have at least one member with experience of assessment in the lift technology concerned and knowledge of the essential health and safety requirements set out in Annex I.

The audit shall include an assessment visit to the installer’s premises and a visit to an installation site.

The decision shall be notified to the installer. The notification shall contain the conclusions of the audit and the reasoned assessment decision.

3.4.The installer shall undertake to fulfil the obligations arising from the quality system as approved and to maintain it so that it remains adequate and efficient.

3.4.1.The installer shall keep the notified body that has approved the quality system informed of any intended change to the system.

3.4.2.The notified body shall assess the modifications proposed and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary.

It shall notify its decision to the installer or, where appropriate, to his authorised representative. The notification shall contain the conclusions of the assessment and the reasoned assessment decision.

The notified body shall affix, or cause to be affixed, its identification number adjacent to the CE marking in accordance with Articles 18 and 19.

4. Surveillance under the responsibility of the notified body

4.1.The purpose of surveillance is to make sure that the installer duly fulfils the obligations arising out of the approved quality system.

4.2.The installer shall, for assessment purposes, allow the notified body access to the manufacture, assembly, installation, inspection, testing and storage locations, and shall provide it with all necessary information, in particular:

(a)the quality system documentation;

(b)the technical documentation;

(c)the quality records, such as inspection reports and test data, calibration data, reports on the qualifications of the personnel concerned.

4.3.The notified body shall carry out periodic audits to make sure that the installer maintains and applies the quality system and shall provide the installer with an audit report.

4.4.Additionally, the notified body may pay unexpected visits to the installer. During such visits the notified body may, where necessary carry out tests, or have them carried out, in order to verify that the quality system is functioning correctly. The notified body shall provide the installer with a visit report and, if tests have been carried out, with a test report.

5. The installer shall, keep at the disposal of the national authorities for a period ending 10 years after the lift has been placed on the market:

(a)the documentation referred to in point 3.1(c);

(b)the technical documentation referred to in point 3.1(d);

(c)the information relating to the changes referred to in point 3.4.1;

(d)the decisions and reports from the notified body which are referred to in the second paragraph of point 3.4.2, and in points 4.3 and 4.4.

6. Each notified body shall inform its notifying authority of quality system approval decision(s) issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of approval decisions refused, suspended or otherwise restricted.

Each notified body shall inform the other notified bodies of quality system approval decision(s) which it has refused, suspended or withdrawn, and, upon request, of approval decision(s) which it has issued.

On request, the notified body shall provide the Commission and the Member States with a copy of quality system approval decision(s) issued.

7. CE marking and EU declaration of conformity

7.1.The installer shall affix the CE marking in the car of each lift which satisfies the essential health and safety requirements of this Directive, and, under the responsibility of the notified body referred to in point 3.1, the latter’s identification number adjacent to the CE marking in the car of each lift.

7.2.The installer shall draw up a written EU declaration of conformity for each lift and keep a copy of the EU declaration of conformity at the disposal of the national authorities for 10 years after the placing on the market of the lift. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.

8. Authorised representative

The installer’s obligations set out in points 3.1, 3.4.1, 5 and 7 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.


ANNEX XIII

PART A

Repealed Directive with list of the successive amendments thereto

(referred to in Article 47)

Directive 95/16/EC of the European Parliament and of the Council

(OJ L 213, 7.9.1995, p. 1).
Regulation (EC) No 1882/2003 of the European Parliament and of the Council

(OJ L 284, 31.10.2003, p. 1).
Only point 10 of Annex I
Directive 2006/42/EC of the European Parliament and of the Council

(OJ L 157, 9.6.2006, p. 24).
Only Article 24
Regulation (EU) No 1025/2012 of the European Parliament and of the Council

(OJ L 316, 14.11.2012, p. 12).
Only point (i) of Article 26(1)

PART B

Time limits for transposition into national law and dates of application

(referred to in Article 45)

DirectiveTime limit for transpositionDate of application
95/16/EC1 January 19971 July 1997
2006/42/EC, Article 2429 June 200829 December 2009


ANNEX XIV

CORRELATION TABLE

Directive 95/16/ECThis Directive
Article 1(1)Article 1(1), first subparagraph
—Article 1(1), second subparagraph
Article 1(2), first subparagraphArticle 2(1)
Article 1(2), second subparagraphArticle 1(1)
Article 1(2), third subparagraph
Article 1(3)Article 1(2)
Article 1(4), first indent of first subparagraphArticle 2(6)
Article 1(4), second indent of first subparagraphArticle 2(5)
Article 1(4), fourth indent of first subparagraphArticle 2(7)
Article 1(4), fifth indent of first subparagraphArticle 2(3)
Article 1(4), second subparagraphArticle 16(3)
Article 1(4), third subparagraphArticle 16(4)
Article 1(5)Article 1(3)
—Article 2(1)
Article 2(1), first indentArticle 4(1)
Article 2(1), second indentArticle 4(2)
Article 2(2)Article 6(1)
Article 2(3)Article 6(2)
Article 2(4)Article 3(3)
Article 2(5)Article 3(2)
Article 3, first paragraphArticle 5(1)
Article 3, second paragraphArticle 5(2)
Article 4(1)Article 3(1)
Article 4(2)—
—Articles 7 to 14
Article 5(1)Article 14
Article 6(1) and (2)—
Article 6(3) and (4)Article 42
Article 7(1), first subparagraphArticle 38(1)
Article 7(1), second subparagraphArticle 38(5)
Article 7(2), first subparagraphArticle 39(3)
Article 7(3)
Article 7(4)Article 40(4)
Article 8(1)(a)Article 15
Article 8(1)(b) and (c)—
Article 8(2)Article 16
Article 8(3), first and third indentsArticle 17(2) and Article 19(3)
Article 8(3), second indentArticle 7(3)
Article 8(4)—
Article 8(5)Article 12
Article 9(1)Article 20
Article 9(2)
Article 9(3)Article 30(1)
—
Article 10(1)—
Article 10(2)Article 19(1)
Article 10(3)—
Article 10(4)(a)Article 41(1)(a)
Article 10(4)(b)—
Article 11—
—Article 43
Article 12—
Article 13—
Article 14—
Article 15(1) and (2)—
Article 15(3)Article 45(2)
Article 16Article 46
Article 17Article 49
Annex IAnnex I
Annex II, Part AAnnex II, Part A
Annex II, Part BAnnex II, Part B
Annex IIIArticle 18
Annex IVAnnex III
Annex V, Part AAnnex IV, Part A
Annex V, Part BAnnex IV, Part B
Annex VIAnnex V
Annex VII—
Annex VIIIAnnex VI
Annex IXAnnex VII
Annex XAnnex VIII
Annex XIAnnex IX
Annex XIIAnnex X
Annex XIIIAnnex XI
Annex XIVAnnex XII
—Annex XIII
—Annex XIV


STATEMENT OF THE EUROPEAN PARLIAMENT

The European Parliament considers that only when and in so far as implementing acts in the sense of Regulation (EU) No 182/2011 are discussed in meetings of committees, can the latter be considered as ‘comitology committees’ within the meaning of Annex I to the Framework Agreement on the relations between the European Parliament and the European Commission. Meetings of committees thus fall within the scope of point 15 of the Framework Agreement when and insofar as other issues are discussed.