LIFTS REGULATIONS

SUBSIDIARY LEGISLATION 427.37

LIFTS REGULATIONS

20th April, 2016 *

LEGAL NOTICE 79 of 2016, as amended by Legal Notice 102 of 2019.

(1)

The title of these regulations is the Lifts Regulations

(2) These regulations transpose Directive 2014/33/EU of the

European Parliament and of the Council of 26 February 2014 on the

harmonisation of the laws of the Member States relating to lifts and

safety components for lifts (recast).

(1)

In these regulations, unless the context otherwise

requires

"accreditation" means accreditation as defined in point 10 of

Article 2 of Regulation (EC) No 765/2008;

"authorised representative" means any natural or legal person

established within the Union who has received a written mandate

from an installer or a manufacturer to act on his behalf in relation

to specified tasks;

"carrier" means a part of the lift by which persons and, or goods

are supported in order to be lifted or lowered;

"CE marking" means a marking by which the installer or the

manufacturer indicates that the lift or safety component for lifts are

in conformity with the applicable requirements set out in Union

harmonisation legislation providing for its affixing as set out in

Annex III of the Directive, which is set out in Schedule III;

"conformity assessment" means the process demonstrating

whether the essential health and safety requirements of these

regulations relating to a lift or a safety component for lifts have

been fulfilled;

"conformity assessment body" means a body that performs

conformity assessment activities including calibration, testing,

certification and inspection;

" t h e Di r e c t iv e " m e a ns E u r o p e a n P a r l i a m e nt an d C o un c il

Directive 2014/33/EU on the approximation of the laws of the

Member States relating to lifts;

"distributor" means any natural or legal person in the supply

chain, other than the manufacturer or the importer, who makes a

safety component for lifts available on the market;

"economic operators" means the installer, the manufacturer, the

authorised representative, the importer and the distributor;

"harmonised standard" means harmonised standard as defined in

* See regulation 1(3) of these Regulations as originally promulgated.

point (c) of point 1 of Article 2 of Regulation (EU) No 1025/2012;

"importer" means any natural or legal person established within

the Union who places a safety component for lifts from a third

country on the Union market;

"installer" means the natural or legal person who takes

responsibility for the design, manufacture, installation and placing

on the market of the lift;

"lift" means a lifting appliance serving specific levels, having a

carrier moving along guides which are rigid and inclined at an

angle of more than 15 degrees to the horizontal, or a lifting

appliance moving along a fixed course even where it does not move

along rigid guides;

"making available on the market" means any supply of a safety

component for lifts for distribution or use on the Union market in

the course of a commercial activity, whether in return for payment

or free of charge;

"manufacturer" means any natural or legal person who

manufactures a safety component for lifts or has a safety

component for lifts designed or manufactured, and markets it under

his name or trade mark;

"model lift" means a representative lift whose technical

documentation shows the way in which the essential health and

safety requirements set out in Schedule I will be met for lifts which

conform to the model lift defined by objective parameters and

which uses identical safety components for lifts;

"national accreditation body" means national accreditation body

as defined in point 11 of Article 2 of Regulation (EC) No 765/2008;

"notified body" means a body which has been appointed by a

Member State and notified to the European Commission and the

other Member States, pursuant to Article 21 of the Lifts Directive,

to carry out one or more of the conformity assessment procedures

mentioned and referred to in regulations 16 and 17;

"placing on the market" means

-

the first making available on the market of a safety

component for lifts, or

-

the supply of a lift for use on the European Union

market in the course of a commercial activity, whether

in return for payment or free of charge;

"recall " in relatio n to a lif t means any measure aimed at

achieving the dismantling and safe disposal of a lift, and in relation

to a safety component for lifts means any measure aimed at

achieving the return of a safety component for lifts that has already

been made available to the installer or to the end-user;

"safe" in relation to a lift or safety component, means that the lift or,

in the case of a safety component, the lift in which it is to be installed,

when properly installed and maintained and used for its intended

purpose conforms to all the relevant essential health and safety

requirements and is not liable to endanger the health or safety of persons

or, where appropriate, the safety of property, and cognate expressions

shall be construed accordingly;

"technical specification" means a document that prescribes

technical requirements to be fulfilled by a lift or a safety

component for lifts;

"Union harmonisation legislation" means any Union legislation

harmonising the conditions for the marketing of products;

"withdrawal" means any measure aimed at preventing a safety

component for lifts in the supply chain from being made available

on the market.

(2) The putting into service of lifts or the making available on

the market of safety components for lifts regulated by the Lifts

Regulations, 2002, and which were placed on the market before

20th April, 2016, shall not in any way be impeded.

(3) Certificates and decisions by notified bodies under the Lifts

Regulations, 2002, shall also be valid under these regulations.

(1) These regulations shall apply to lifts permanently

serving buildings and constructions and intended for the transport

of

(a) persons;

(b) persons and goods;

(c) goods alone if the carrier is accessible, that is to say a

person may enter it without difficulty, and fitted with

controls situated inside the carrier or within reach of a

person inside the carrier.

(2) These regulations shall also apply to the safety components

for lifts listed in Schedule III for use in the lifts referred to in the

sub-regulation (1).

(3)

These regulations shall not apply to

(a) lifting appliances whose speed is not greater than 0,15

m/s;

(b) construction site hoists;

(c) cableways, including funicular railways;

(d) lifts specially designed and constructed for military or

police purposes;

(e) lifting appliances from which work can be carried out;

(f)

mine winding gear;

(g) lifting appliances intended for lifting performers

during artistic performances;

(h) lifting appliances fitted in means of transport;

(i)

lifting appliances connected to machinery and

intended exclusively for access to workstations

including maintenance and inspection points on the

machinery;

(j)

rack and pinion trains; and

(k) escalators and mechanical walkways.

(4) Where, for lifts or safety components for lifts, the risks

referred to in these regulations are wholly or partly covered by

specific European Union law, these regulations shall not apply or

shall cease to apply in the case of such lifts or safety components

for lifts and such risks as from the application of that specific

European Union law.

(1) The making available on the market of lifts shall not be

prohibited, restricted or impeded or putting into service of lifts or

the making available on the market of safety components for lifts

on their territory which comply with these regulations.

(2) At trade fairs, exhibitions or demonstrations, the showing

of lifts or safety components for lifts which are not in conformity

with these regulations, provided that a visible sign clearly indicates

that they are not in conformity and will not be placed or made

available on the market until they have been brought into

conformity. During demonstrations, adequate safety measures shall

be taken to ensure the protection of persons.

(3) The provisions of these regulations shall not prevent from

adopting provisions in conformity with the European Union law

that are deemed necessary to ensure that persons are protected

when the lifts in question are put into service or used, provided that

this does not mean that the lifts are modified in a way not specified

in these regulations.

(1) All appropriate measures must be taken to ensure that

the lifts covered by these regulations may be placed on the market

and put into service only if they comply with these regulations,

when properly installed and maintained and used for their intended

purpose.

(2) All appropriate measures must be taken to ensure that

safety components for lifts covered by these regulations may be

made available on the market and put into service only if they

comply with these regulations when properly incorporated and

maintained and used for their intended purpose.

(1) Lifts covered by these regulations shall satisfy the

essential health and safety requirements set out in Schedule I.

(2) Safety components for lifts covered by these regulations shall

satisfy the essential health and safety requirements set out in

Schedule I and enable the lifts in which they are incorporated to

satisfy those requirements.

(1) All appropriate measures to ensure that the person

responsible for work on the building or construction and the

installer both provide each other with the necessary information

and take the appropriate steps in order to ensure the proper

operation and safe use of the lift.

(2) All necessary measures to ensure that shafts intended for

lifts do not contain any piping or wiring or fittings other than that

necessary for the operation and safety of the lift.

(1) When placing a lift on the market, installers shall

ensure that it has been designed, manufactured, installed and tested

in accordance with the essential health and safety requirements set

out in Schedule I.

(2) Installers shall draw up the technical documentation and

carry out the relevant conformity assessment procedure referred to

in regulation 17 or have it carried out.

(3) Where compliance of the lift with the applicable essential

health and safety requirements has been demonstrated by that

procedure, the installer shall draw up an EU declaration of

conformity, ensure that it accompanies the lift, and affix the CE

marking.

(4) The installer shall keep the technical documentation, the EU

declaration of conformity and, where applicable, the approval

decision(s) for 10 years after the lift has been placed on the market.

(5) When deemed appropriate with regard to the risks presented

by a lift, installers shall, to protect the health and safety of

consumers, investigate, and, if necessary, keep a register of

complaints, and of non-conforming lifts.

(6) Installers shall ensure that lifts bear a type, batch or serial

number or other element allowing their identification.

(7) Installers shall indicate, on the lift, their name, registered

trade name or registered trade mark and the postal address at which

they can be contacted. The address shall indicate a single point at

which the installer can be contacted. The contact details shall be in

at least the Maltese or English language.

(8) Installers shall ensure that the lift is accompanied by the

instructions referred to in point 6.2 of Schedule I, in at least the

Maltese or English language. Such instructions, as well as any

labelling, shall be clear, understandable and intelligible.

(9) Installers who consider or have reason to believe that a lift

which they have placed on the market is not in conformity with

these regulations shall immediately take the corrective measures

necessary to bring that lift into conformity. Furthermore, where the

lift presents a risk, installers shall immediately inform the

Technical Regulations Division to that effect, giving details, in

particular, of the non-conformity and of any corrective measures

taken.

(10) Installers shall, further to a reasoned request from the

Technical Regulations Division, provide it with all the information

and documentation in paper or electronic form necessary to

demonstrate the conformity of the lift with these regulations, in

either Maltese or English language. They shall cooperate with the

Technical Regulations Division, at its request, on any action taken

to eliminate the risks posed by lifts which they have placed on the

market.

(1) When placing their safety components for lifts on the

market, manufacturers shall ensure that they have been designed

and manufactured in accordance with regulation 6(2).

(2) Manufacturers shall draw up the technical documentation

and carry out the relevant conformity assessment procedure

referred to in regulation 16 or have it carried out.

(3) Where compliance of a safety component for lifts with the

applicable essential health and safety requirements have been

demonstrated by that procedure, manufacturers shall draw up an

EU declaration of conformity, ensure that it accompanies the safety

component for lifts and affix the CE marking.

(4) Manufacturers shall keep the technical documentation, the

EU declaration of conformity and, where applicable, the approval

decision(s) for 10 years after the safety component for lifts has

been placed on the market.

(5) Manufacturers shall ensure that procedures are in place for

series production to remain in conformity with these regulations.

Changes in product design or characteristics and changes in the

harmonised standards or in other technical specifications by

reference to which conformity of a safety component for lifts is

declared shall be adequately taken into account.

(6)

When deemed appropriate with regard to the risks

presented by a safety component for lifts, manufacturers shall, to

protect the health and safety of consumers, carry out sample testing

of safety component for lifts made available on the market,

investigate, and, if necessary, keep a register of complaints, of non-

conforming safety components for lifts and recalls of the safety

components for lifts, and shall keep distributors and installers

informed of any such monitoring.

(7) Manufacturers shall ensure that safety components for lifts

which they have placed on the market bear a type, batch or serial

number or other element allowing their identification, or, where the

size or nature of the safety component for lifts does not allow it,

that the required information is provided on the label referred to in

regulation 19(2).

(8) Manufacturers shall indicate on the safety component for

lifts their name, registered trade name or registered trade mark and

the postal address at which they can be contacted or, where that is

not possible, on the label referred to in regulation 19(2). The

address shall indicate a single point at which the manufacturer can

be contacted. The contact details shall be either in Maltese or

English language.

(9) Manufacturers shall ensure that the safety component for

lifts is accompanied by the instructions referred to in point 6.1 of

Schedule I, in at least the Maltese or English language. Such

instructions, as well as any labelling, shall be clear, understandable

and intelligible.

(10) Manufacturers who consider or have reason to believe that

a safety component for lifts which they have placed on the market

is not in conformity with these regulations shall immediately take

the corrective measures necessary to bring that safety component

for lifts into conformity, to withdraw it or recall it, if appropriate.

Furthermore, where the safety component for lifts presents a risk,

manufacturers shall immediately inform the Technical Regulations

Division to that effect, giving details, in particular, of the non-

conformity and of any corrective measures taken.

(11) Manufacturers shall, further to a reasoned request from the

Technical Regulations Division, provide it with all the information

and documentation in paper or electronic form necessary to

demonstrate the conformity of the safety components for lifts with

these regulations, in at least the Maltese or English language.

(12) They shall cooperate with the Technical Regulations

Divisions, at its request, on any action taken to eliminate the risks

posed by safety components for lifts which they have placed on the

market.

(1) A manufacturer or an installer may, by a written

mandate, appoint an authorised representative. The obligations laid

down in regulation 8(1) or in regulation 9(1) and the obligation to

draw up technical documentation referred to in regulation 8(2) or in

regulation 9(2) shall not form part of the authorised

representative’s mandate.

(2) An authorised representative shall perform the tasks

specified in the mandate received from the manufacturer or the

installer. The mandate shall allow the authorised representative to

do at least the following

(a) keep the EU declaration of conformity and, where

applicable, the approval decision(s) relating to the

manufacturer’s or the installer’s quality system, and

the technical documentation at the disposal of the

Technical Regulations Division for 10 years after the

safety component for lifts or the lift has been placed

on the market;

(b) further to a reasoned request from a Technical

Regulations Division, provide that authority with all

the information and documentation necessary to

demonstrate the conformity of the safety components

for lifts or the lift;

(c) cooperate with the Technical Regulations Division, at

their request, on any action taken to eliminate the risks

posed by the safety component for lifts or the lift

covered by the authorised representative’s mandate.

(1) Importers shall place

only

compliant

safety

components for lifts on the market.

(2) Before placing a safety component for lifts on the market,

importers shall ensure that the appropriate conformity assessment

procedure referred to in regulation 16 has been carried out by the

manufacturer. They shall ensure that the manufacturer has drawn

up the technical documentation, that the safety component for lifts

bears the CE marking and is accompanied by the EU declaration of

conformity and the required documents, and that the manufacturer

has complied with the requirements set out in regulation 9(7) and

(8).

(3)

Where an importer considers or has reason to believe that a

safety component for lifts is not in conformity with regulation 6(2),

he shall not place the safety component for lifts on the market until

it has been brought into conformity. Furthermore, where the safety

component for lifts presents a risk, the importer shall inform the

manufacturer and the market surveillance authorities to that effect.

(4) Importers shall indicate on the safety component for lifts

their name, registered trade name or registered trade mark and the

postal address at which they can be contacted or, where that is not

possible, on its packaging or in a document accompanying the

safety component for lifts. The contact details shall be in either

Maltese or English language.

(5) Importers shall ensure that the safety component for lifts is

accompanied by the instructions referred to in point 6.1 of

Schedule I in at least the Maltese and English language.

(6) Importers shall ensure that, while a safety component for

lifts is under their responsibility, its storage or transport conditions

do not jeopardise its compliance with the essential health and

safety requirements referred to in regulation 6(2).

(7) When deemed appropriate with regard to the risks presented

by a safety component for lifts, importers shall, to protect the

health and safety of consumers, carry out sample testing of safety

components for lifts made available on the market, investigate, and,

if necessary, keep a register of complaints, of non-conforming

safety components for lifts and recalls of safety components for

lifts, and shall keep distributors and installers informed of any such

monitoring.

(8) Importers who consider or have reason to believe that a

safety component for lifts which they have placed on the market is

not in conformity with these regulations shall immediately take the

corrective measures necessary to bring that safety component for

lifts into conformity, to withdraw it or recall it, if appropriate.

Furthermore, where the safety component for lifts presents a risk,

importers shall immediately inform the competent national

authorities of the Member States in which they made the safety

component for lifts available on the market to that effect, giving

details, in particular, of the non-compliance and of any corrective

measures taken.

(9) Importers shall, for 10 years after the safety component for

lifts has been placed on the market, keep a copy of the EU

declaration of conformity and, where applicable, of the approval

decision(s) at the disposal of the market surveillance authorities

and ensure that the technical documentation can be made available

to those authorities, upon request.

(10) Importers shall, further to a reasoned request from a

Technical Regulations Division, provide it with all the information

and documentation in paper or electronic form necessary to

demonstrate the conformity of a safety component for lifts in a

language which can be easily understood by that authority. They

shall cooperate with that authority, at its request, on any action

taken to eliminate the risks posed by safety components for lifts

which they have placed on the market.

(1) When making a safety component for lifts available on

the market distributors shall act with due care in relation to the

requirements of these regulations.

(2) Before making a safety component for lifts available on the

market, distributors shall verify that the safety component for lifts

bears the CE marking, that it is accompanied by the EU declaration

of conformity, by the required documents and by the instructions

referred to in point 6.1 of Schedule I, in either the Maltese or

English language and that the manufacturer and the importer have

complied with the requirements set out in regulation 9(7) and (8)

and regulation 11(4), respectively.

(3) Where a distributor considers or has reason to believe that a

safety component for lifts is not in conformity with regulation 6(2),

he shall not make the safety component for lifts available on the

market until it has been brought into conformity. Furthermore,

where the safety component for lifts presents a risk, the distributor

shall inform the manufacturer or the importer to that effect as well

as the market surveillance authorities.

(4) Distributors shall ensure that, while a safety component for

lifts is under their responsibility, its storage or transport conditions

do not jeopardise its compliance with regulation 6(2).

(5) Distributors who consider or have reason to believe that a

safety component for lifts which they have made available on the

market is not in conformity with these regulations shall make sure

that the corrective measures necessary to bring that safety

component for lifts into conformity, to withdraw it or recall it, if

appropriate, are taken. Furthermore, where the safety component

for lifts presents a risk, distributors shall immediately inform the

competent national authorities of the Member States in which they

made the safety component for lifts available on the market to that

effect, giving details, in particular, of the non-compliance and of

any corrective measures taken.

(6) Distributors shall, further to a reasoned request from the

Technical Regulations Division, provide it with all the information

and documentation in paper or electronic form necessary to

demonstrate the conformity of a safety component for lifts. They

shall cooperate with the Technical Regulations Division, at its

request, on any action taken to eliminate the risks posed by safety

components for lifts which they have made available on the market.

An importer or distributor shall be considered a

manufacturer for the purposes of these regulations and he shall be

subject to the obligations of the manufacturer under regulation 9,

where he places a safety component for lifts under his name or

trademark or modifies a safety component for lifts already placed

on the market in such a way that compliance with the requirements

of these regulations may be affected.

(1) Economic operators shall, on request, identify the

following to the Technical Regulations Division

(a) any economic operator who has supplied them with a

safety component for lifts;

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(b) any economic operator to whom they have supplied a

safety component for lifts;

(2) Economic operators shall be able to present the information

referred to in sub-regulation (1) for a period of 10 years after they

have been supplied with a safety component for lifts and for a

period of 10 years after they have supplied a safety component for

Lifts and safety components for lifts which are in

c o n fo rm i ty w i th h a r mo ni s e d s t a n dar d s o r pa rt s t he re of t he

references of which have been published in the Official Journal of

the European Union shall be presumed to be in conformity with the

essential safety requirements set out in Schedule I covered by those

standards or parts thereof.

Safety components for lifts shall be subject to one of the

following conformity assessment procedures

(a) the model of the safety component for lifts shall be

submitted for EU type examination set out in Schedule

IV, Part A and the conformity to type shall be ensured

with random checking of the safety component for lifts

set out in Schedule IX;

(b) the model of the safety component for lifts shall be

submitted for EU type examination set out in Schedule

IV, Part A and be subject to conformity to type based

on product quality assurance in accordance with

Schedule VI;

(c) conformity based on full quality assurance set out in

Schedule VII.

(1) Lifts shall be subject to one of the following

conformity assessment procedures

(a) if they are designed and manufactured in accordance

with a model lift that has undergone an EU-type

examination set out in Schedule IV, Part B

(i) final inspection for lifts set out in Schedule V;

(ii) conformity to type based on product quality

assurance for lifts set out in Schedule X;

(iii) conformity to type based on production quality

assurance for lifts set out in Schedule XII;

(b) if they are designed and manufactured under a quality

system approved in accordance with Schedule XI

(i) final inspection for lifts set out in Schedule V;

(ii) conformity to type based on product quality

assurance for lifts set out in Schedule X;

(iii) conformity to type based on production quality

assurance for lifts set out in Schedule XII;

(c) conformity based on unit verification for lifts set out in

Schedule VIII;

(d) conformity based on full quality assurance plus design

examination for lifts set out in Schedule XI.

(2) In the cases referred to in paragraphs (a) and (b) of sub-

regulation (1), where the person responsible for the design and

manufacture of the lift and the person responsible for the

installation and testing of the lift are not the same, the former shall

supply to the latter all the necessary documents and information to

enable the latter to ensure correct and safe installation and testing

of the lift.

(3) All permitted variations between the model lift and the lifts

forming part of the lifts derived from the model lift shall be clearly

specified (with maximum and minimum values) in the technical

documentation.

(4) By calculation and, or on the basis of design plans it is

permitted to demonstrate the similarity of a range of equipment to

satisfy the essential health and safety requirements set out in

Schedule I.

(1) The EU declaration of conformity shall state that the

fulfilment of the essential health and safety requirements set out in

Schedule I has been demonstrated.

(2) The EU declaration of conformity shall have the model

structure set out in Schedule II, shall contain the elements specified

in the relevant Schedule V to XII and, shall be continuously

updated. It shall be translated into the language or languages

required by the Member State in which the lift or safety component

for lifts is placed or made available on the market. For a lift or

safety component for lifts made available on the Maltese market,

the EU declaration of conformity shall be in at least the Maltese or

English language.

(3) Where a lift or a safety component for lifts is subjected to

more than one Union act requiring an EU declaration of

conformity, a single EU declaration of conformity shall be drawn

up in respect of all such Union acts. That declaration shall contain

the identification of the Union acts concerned including their

publication references.

(4) By drawing up the EU declaration of conformity, the

manufacturer shall assume responsibility for the compliance of the

safety component for lifts and the installer shall assume

responsibility for the compliance of the lift with the requirements

laid down in these regulations.

(1) The CE marking shall be subject to the general

principles set out in Article 30 of Regulation (EC) No 765/2008.

(2) The CE marking shall be affixed visibly, legibly and

indelibly to each lift car and to each safety component for lifts or,

where that is not possible, on a label inseparably attached to the

safety component for lifts.

(3) The CE marking shall be affixed before the lift or the safety

component for lifts is placed on the market.

(4)

The CE marking on lifts shall be followed by the

identification number of the notified body involved in any of the

following conformity assessment procedures

(a) the final inspection referred to in Schedule V;

(b) unit verification, referred to in Schedule VIII;

(c) quality assurance referred to in Schedules X, XI or

XII.

(5) The CE marking on safety components for lifts shall be

followed by the identification number of the notified body involved

in any of the following conformity assessment procedures

(a) product quality assurance referred to in Schedule VI;

(b) full quality assurance referred to in Schedule VII;

(c) conformity to type with random checking for safety

components for lifts referred to in Schedule IX.

(6) The identification number of the notified body shall be

affi xed b y the body itself or, under its instructions, by the

manufacturer or his authorised representative or by the installer or

his authorised representative. The CE marking and the

identification number of the notified body may be followed by any

other mark indicating a special risk or use.

(7) The Technical Regulations Division shall build upon

existing mechanisms to ensure correct application of the regime

governing the CE marking and shall take appropriate action in the

event of improper use of that marking.

(1) The Technical Regulations Division shall notify the

European Commission and the other Member States of bodies

authorised to carry out third-party conformity assessment under

these regulations.

(2) The Technical Regulations Division shall be responsible for

setting up and carrying out the necessary procedures for the

assessment and notification of conformity assessment bodies and

the monitoring of notified bodies, including compliance with

regulation 21.

(3) The assessment and monitoring referred to in sub-

regulation (2) shall be carried out by the National Accreditation

Board (Malta).

(4) The Technical Regulations Division shall take full

responsibility for the tasks performed by National Accreditation

Board (Malta) referred to in sub-regulation (3).

(5) The Technical Regulations Division shall inform the

European Commission of its procedures for the assessment and

notification of conformity assessment bodies and the monitoring of

notified bodies, and of any changes thereto.

(1) For the purposes of notification under these

regulations, a conformity assessment body shall meet the

requirements laid down in sub-regulations (2) to (16) and in the

Method for Designating Conformity Assessment Bodies

Regulations.

(2) A conformity assessment body shall be established under

Maltese law and have legal personality.

(3) A conformity assessment body shall be a third-party body

independent of the organisation or the lift or the safety component

for lifts it assesses. A body belonging to a business association or

professional federation representing undertakings involved in the

design, manufacturing, provision, assembly, use or maintenance of

lifts or safety components for lifts which it assesses, may, on

condition that its independence and the absence of any conflict of

interest are demonstrated, be considered such a body.

(4)) (a) A conformity assessment body, its top level

management and the personnel responsible for carrying

out the conformity assessment tasks shall not be the

designer, manufacturer, supplier, installer, purchaser,

owner, user or maintainer of lifts or safety components

for lifts which they assess nor representative of any of

those parties. Thi s sh al l no t preclude t he use of

assessed lifts or safety components for lifts that are

necessary for the operations of the conformity

assessment body or the use of lifts or safety

components for lifts for personal purposes. This does

not preclude the possibility of exchange of technical

information between the manufacturer or the installer

and the body.

(b) A conformity assessment body, its top level

management and the personnel responsible for

carrying out the conformity assessment tasks shall not

be directly involved in the design, manufacture or

construction, the marketing, installation, use or

maintenance of those lifts or safety components for

lifts, or represent the parties engaged in those

activities. They shall not engage in any activity that

may conflict with their independence of judgement or

integrity in relation to conformity assessment

activities for which they are notified. This shall in

particular apply to consultancy services.

(c) Conformity assessment bodies shall ensure that the

activities of their subsidiaries or subcontractors do not

affect the confidentiality, objectivity or impartiality of

their conformity assessment activities.

(5) Conformity assessment bodies and their personnel shall

carry out the conformity assessment activities with the highest

degree of professional integrity and the requisite technical

competence in the specific field and shall be free from all pressures

and inducements, particularly financial, which might influence

their judgement or the results of their conformity assessment

activities, especially as regards persons or groups of persons with

an interest in the results of those activities.

(6)

(a) A conformity assessment body shall be capable of

carrying out all the conformity assessment tasks

assigned to it by Schedule IV to XII and in relation to

which it has been notified, whether those tasks are

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carried out by the conformity assessment body itself or

on its behalf and under its responsibility.

(b) At all times and for each conformity assessment

procedure and each kind or category of lifts or safety

components for lifts in relation to which it has been

notified, a conformity assessment body shall have at

its disposal the necessary

(i)

personnel with technical knowledge and

sufficient and appropriate experience to perform

the conformity assessment tasks;

(ii) descriptions of procedures in accordance with

which conformity assessment is carried out,

ensuring the transparency and the ability of

reproduction of those procedures. It shall have

appropriate policies and procedures in place that

distinguish between tasks it carries out as a

notified body and other activities;

(iii) procedures for the performance of activities

which take due account of the size of an

undertaking, the sector in which it operates, its

structure, the degree of complexity of the

product technology in question and the mass or

serial nature of the production process.

(c) A conformity assessment body shall have the means

necessary to perform the technical and administrative

tasks connected with the conformity assessment

activities in an appropriate manner and shall have

access to all necessary equipment or facilities.

(7) The personnel responsible for carrying out conformity

assessment tasks shall have the following

(a) sound technical and vocational training covering all

the conformity assessment activities in relation to

which the conformity assessment body has been

notified;

(b) satisfactory knowledge of the requirements of the

assessments they carry out and adequate authority to

carry out those assessments;

(c) appropriate knowledge and understanding of the

essential safety requirements set out in Schedule I, of

the applicable harmonised standards and of the

relevant provisions of Union harmonisation legislation

and of national legislation;

(d) the ability to draw up certificates, records and reports

demonstrating that assessments have been carried out.

(8) The impartiality of conformity assessment bodies, their top

level management and assessment personnel shall be ensured. The

r e m u ne r a t i o n o f t he to p l e v el m a n a ge m e n t an d a s s e s s m e n t

personnel of a conformity assessment body shall not depend on the

number of assessments carried out or on the results of those

assessments.

(9) Conformity assessment bodies shall take out liability

insurance unless liability is assumed by the State in accordance

with national law, or the Member State itself is directly responsible

for the conformity assessment.

(10) The personnel of a conformity assessment body shall

observe professional secrecy with regard to all information

obtained in carrying out their tasks under Schedule IV to XII or any

provision of national law giving effect to it, except in relation to

the competent authorities of the Member State in which its

activities are carried out. Proprietary rights shall be protected.

(11) Conformity assessment bodies shall participate in, or

ensure that their personnel responsible for carrying out the

c o n f o r m i t y a s s e s s m e n t t a s k s a re i n f o r m e d o f , t h e r el ev a n t

standardisation activities and the activities of the notified body

coordination group established under the relevant Union

harmonisation legislation and shall apply as general guidance the

administrative decisions and documents produced as a result of the

work of that group.

(12) Where a conformity assessment body demonstrates its

conformity with the criteria laid down in the relevant harmonised

standards or parts thereof, the references of which have been

published in the Official Journal of the European Union, it shall be

presumed to comply wit h the requirem ents set out in these

regulations insofar as the applicable harmonised standards cover

those requirements.

(13) Where a notified body subcontracts specific tasks

connected with conformity assessment or has recourse to a

subsidiary, it shall ensure that the subcontractor or the subsidiary

meets the requirements set out in these regulations, and shall

inform the Technical Regulations Division accordingly.

(14) Notified bodies shall take full responsibility for the tasks

performed by subcontractors or subsidiaries, wherever these are

established.

(15 ) A ctiv iti es may be sub cont racted or carried out by a

subsidiary only with the agreement of the client.

(16) Notified bodies shall keep at the disposal of the Technical

Regulations Division the relevant documents concerning the

assessment of the qualifications of the subcontractor or the

subsidiary and the work carried out by them under Schedules IV to

XII.

(1) A conformity assessment body established in Malta

shall submit an application for notification under these regulations

to the Technical Regulations Division.

(2) The application referred to in the preceding sub-regulation

shall be accompanied by a description of the conformity assessment

activities, the conformity assessment procedure or procedures and

the lifts or safety components for lifts for which that body claims to

be competent, as well as by an accreditation certificate, issued by

the National Accreditation Board (Malta) attesting that the

conformity assessment body fulfils the requirements laid down in

regulation 21 and the Method for Designating Conformity

Assessment Bodies Regulations.

(3) The Technical Regulations Division may only notify

conformity assessment bodies which have satisfied the

requirements laid down in regulation 21 and the Method for

Designating Conformity Assessment Bodies Regulations.

(4) The Technical Regulations Division shall notify conformity

assessment bodies to the European Commission and the other

Member States using the electronic notification tool developed and

managed by the European Commission.

(5) The notification shall include full details of the conformity

assessment activities, the conformity assessment procedure or

procedures and the lifts or the safety component for lifts concerned

and the relevant attestation of competence.

(6) The body concerned may perform the activities of a notified

b o dy on l y w her e n o o b je c t io n s a r e ra is e d b y t he E ur o pe a n

Commission or the other Member States within two weeks of a

notification. Only such a body shall be considered a notified body

for the purposes of these regulations.

(7) The Technical Regulations Division shall notify the

European Com missio n and the other Mem ber States of any

subsequent relevant changes to the notification.

(8) Where the Technical Regulations Division has ascertained

or has been informed that a notified body no longer meets the

requirem ents laid down in regulation 21 or the Met hod for

Designating Conformity Assessment Bodies Regulations, or that it

is failing to fulfil its obligations, the Technical Regulations

Division shall restrict, suspend or withdraw notification as

appropriate, depending on the seriousness of the failure to meet

those requirements or fulfil those obligations. It shall immediately

inform the European Commission and the other Member States

accordingly.

(9) In the event of restriction, suspension or withdrawal of

notification, or where the notified body has ceased its activity, the

Technical Regulations Division shall take appropriate steps to

ensure that the files of that body are either processed by another

notified body or kept available to the responsible notifying and

market surveillance authorities, at their request.

(10) The Technical Regulations Division shall provide the

Commission, on request, with all information relating to the basis

for the notification or the maintenance of the competence of the

body concerned.

(1) Notified bodies shall carry out conformity assessments

in accordance with the conformity assessment procedures provided

for in regulations 16 and 17.

(2) Conformity assessments shall be carried out in a

proportionate manner, avoiding unnecessary burdens for economic

operators. Conformity assessment bodies shall perform their

activities taking due account of the size of an undertaking, the

sector in which it operates, its structure, the degree of complexity

of the technology of the lift or safety component for the lift in

question and the mass or serial nature of the production process. In

so doing, they shall nevertheless respect the degree of rigour and

the level of protection required for the compliance of the lift or

safety component for the lift with these regulations.

(3) Where a notified body finds that the essential safety

requirements of these regulations or corresponding harmonised

standards or other technical specifications have not been met by a

manufacturer, it shall require that manufacturer to take appropriate

corrective measures and shall not issue a certificate of conformity.

(4) Where, in the course of the monitoring of conformity

following the issue of a certificate, a notified body finds that a lift

or a safety component for lifts no longer complies; it shall require

the manufacturer to take appropriate corrective measures and shall

suspend or withdraw the certificate or the approval decision if

necessary.

(5) Where corrective measures are not taken or do not have the

required effect, the notified body shall restrict, suspend or

withdraw any certificates or approval decision(s), as appropriate.

(6) Notified bodies shall inform the Technical Regulations

Division of the following

(a) any refusal, restriction, suspension or withdrawal of a

certificate or approval decision;

(b) any circumstances affecting the scope of or conditions

for notification;

(c) any request for information which they have received

from market surveillance authorities regarding

conformity assessment activities;

(d) on request, conformity assessment activities

performed within the scope of their notification and

any other activity performed, including cross-border

activities and subcontracting.

(7) Notified bodies shall provide the other bodies notified these

regulations carrying out similar conformity assessment activities

covering the same lifts or safety components for lifts with relevant

information on issues relating to negative and, on request, positive

conformity assessment results.

(8) Notified bodies shall participate, directly or by means of

designated representatives, in the appropriate coordination and

cooperation groups for notified bodies organised by the European

Commission.

(1) The Technical Regulations Division shall take

appropriate measures to ensure that lifts and safety components of

lifts may only be placed on the market if they satisfy the essential

health and safety requirements set out in Schedule I.

(2) Article 15(3) and Article 17 to 22 of Regulation (EC) No

765/2008 shall apply to lifts and safety components for lifts.

(3) Where the Technical Regulations Division have sufficient

reasons to believe that a lifts or a safety component for lifts

covered by these regulations presents a risk to the health or safety

of persons or, where appropriate to the safety of property, they shall

carry out an evaluation in relation to the lift or safety component

for lifts concerned covering all relevant requirements laid down in

these regulations. The relevant economic operators shall cooperate

as necessary with the market surveillance authorities for that

purpose.

(4) Where, in the course of the evaluation referred to in sub-

regulation (3), the Technical Regulations Division find that a lift

d o e s n o t c o m p l y w i t h t h e r e q u i r e m en t s l a i d d o w n i n t h e s e

regulations, they shall without delay require the installer to take all

appropriate corrective actions to bring the lift or safety component

for lifts into compliance with those requirements, to withdraw the

safety component for lifts from the market, or to recall it within a

reasonable period, commensurate with the nature of the risk, as

they may prescribe. They shall also inform the notified body

accordingly.

(5) Article 21 of Regulation (EC) No 765/2008 shall apply to

the measures referred to in sub-regulation (4).

(6) Where the Technical Regulations Division consider that

non-compliance is not restricted to the Maltese territory, it shall

inform the European Commission and the other Member States of

the results of the evaluation and of the actions which they have

required the economic operator to take.

(7) The economic operator shall ensure that all appropriate

corrective action is taken in respect of all the lifts or safety

components for lifts concerned that it has made available on the

market throughout the European Union.

(8) Where the installer does not take adequate corrective action

within the period referred to in sub-regulation (4), the Technical

Regulations Division shall take all appropriate provisional

measures to prohibit or restrict the placing on the Maltese market

or the use of the lifts concerned, or recall it.

(9) Where the relevant economic operator does not take

adequate corrective action within the period referred to in sub-

regulation (4), the Technical Regulations Division shall take all

appropriate provisional measures to prohibit or restrict the safety

component for lifts being made available on their national market,

to withdraw the safety component for lifts from that market or to

recall it.

(10) The Technical Regulations Division shall inform the

European Commission and the other Member States, without delay,

of those measures.

(11) The information referred to in the sub-regulation (10) shall

include all available details, in particular the data necessary for the

identification of the non-compliant lift or safety component for

lifts, the origin, the nature of the non-compliance alleged and the

risk involved, the nature and duration of the national measures

taken and the arguments put forward by the relevant economic

operator. In particular, the Technical Regulations Division shall

indicate whether the non-compliance is due to either of the

following

(a) failure of the lift or the safety component for lifts to

meet the essential health or safety requirement of these

regulations; or

(b) shortcomings in the harmonised standards referred to

in regulation 15 conferring a presumption of

conformity.

(12) When the procedure under these regulations is initiated by

another Member State, the Technical Regulations Division, shall

without delay inform the European Commission and the other

Member States of any measures adopted and of any additional

information at their disposal relating to the non-compliance of the

lift or the safety component for lifts concerned, and, in the event of

disagreement with the adopted national measure, of their

objections.

(13) Where, within three months of receipt of the information

referred to in sub-regulation (10), no objection has been raised by

either a Member State or the European Commission in respect of a

provisional measure taken by a Member State, that measure shall be

deemed justified.

(14) In such cases, the Technical Regulations Division shall

ensure that appropriate restrictive measures, such as withdrawal of

the lift or the safety component for lifts from the Maltese market,

are taken in respect of the lift or the safety component for lifts

concerned without delay.

(15) Where on completion of the procedure set out in sub-

regulations (7) and (8), objections are raised against the measures

t a k e n b y Te c h n i c a l R e g u l a t i o n s D i v i s i o n ; t h e E u r o p e a n

Commission shall conduct an evaluation including appropriate

consultations with these entities and the relevant economic operator

or operators.

(16) If, on the basis of this evaluation, the national measure is

considered justified, the Technical Regulations Division shall take

the measures necessary to ensure that the placing on the market or

use of the non-compliant lift or the safety component for lifts is

withdrawn from the Maltese market and shall inform the European

Commission accordingly. If, on the basis of this evaluation, the

national measure is considered unjustified, the national measure

shall be withdrawn.

(17) Where, having carried out an evaluation under sub-

regulation (3), the Technical Regulations Division, finds that

although a lift or the safety component for lifts is in compliance

with these regulations, it presents a risk to the health or safety of

persons or to other aspects of public interest protection, it shall

require the relevant economic operator to take all appropriate

measures to ensure that the lift or the safety component for lifts

concerned, when placed on the Maltese market, no longer presents

that risk, to withdraw the lift or the safety component for lifts from

the market or to recall it within a reasonable period, commensurate

with the nature of the risk, as it may prescribe.

(18) The economic operator shall ensure that corrective action is

taken in respect of all the lifts or safety components for lifts

concerned that he has made available on the market throughout the

European Union.

(19) The Technical Regulations Division, upon consultation

with the Commissioner of Police, shall immediately inform the

E u r o p e a n C o m m i s s i o n a n d t h e o t h e r M e m b e r St a t e s . T h a t

information shall include all available details, in particular the data

necessary for the identification of the lift or the safety component

for lifts concerned, the origin and the supply chain of the lifts or

safety component of lifts, the nature of the risk involved and the

nature and duration of the national measures taken.

(20) Without prejudice to sub-regulations (3) to (14), where the

Technical Regulations Division and, or the Commissioner of Police

make one of the following findings, it shall require the relevant

economic operator to put an end to the non-compliance concerned

(a) the CE marking has been affixed in violation of Article

30 of Regulation (EC) No 765/2008 or of regulation

19;

(b) the CE marking has not been affixed;

(c) the identification number of the notified body has been

affixed in violation of regulation 19 or has not been

affixed where required by regulation 19;

(d) the EU declaration of conformity has not been drawn

up;

(e) the EU declaration of conformity has not been drawn

up correctly;

(f)

technical documentation is either not available or not

complete;

(g) the name, registered trade name or registered trade

mark or the address of the installer, manufacturer or

importer has not been indicated in compliance with

regulation 8(7), regulation 9(8) or regulation 11(4);

(h) the information allowing identification of the lift or

the safety component for lifts has not been indicated in

compliance with regulation 8(6) or regulation 8(5);

(i)

the lift or the safety component for lifts is not

accompanied by the documents referred to in

regulation 8(8) or regulation 9(9) or those documents

are not in compliance with the applicable

requirements.

(21) Where the non-compliance referred to in sub-regulation

(20) persists, the Technical Regulations Division shall take all

appropriate measures to restrict or prohibit the use of the lift or to

recall it, or to restrict or prohibit the making available on the

Maltese market of the safety component for lifts or ensure that it is

recalled or withdrawn from the Maltese market.

(22) The powers of the Commissioner of Police under this

regulation may be exercised by any officer or other entity as he

may direct.

Part IV of the Product Safety Act shall apply to proceedings

in relation to any offence under these regulations

Provided that criminal actions for offences under these

Regulations shall be prescribed by the lapse of six years.

(1) Any references in existing laws, regulations and

administrative provisions to the Lift Regulations, 2002, shall be

construed as references to these regulations.

(2) Any references in existing laws, regulations and

administrative provisions to Directive 2007/23/EC shall be

construed as references to Directive 2013/29/EU.

LIFTS

Schedule I

ESSENTIAL 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 these

regulations 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 Schedule, the

essential health and safety requirements of Schedule 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 Schedule 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.

LIFTS

Lifts driven by friction pulleys must be designed so as to ensure stability

of the traction cables on the pulley.

Machinery

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.

The installer must ensure that the lift machinery and the associated

devices of a lift are not accessible except for maintenance and in emergencies.

Controls

The controls of lifts intended for use by unaccompanied disabled persons

must be designed and located accordingly.

The function of the controls must be clearly indicated.

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

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

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.

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.

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

Lift cars must be completely enclosed by full-length walls, fitted floors

and ceilings included, with the exception of ventilation apertures, and with full-

LIFTS

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 sub-paragraph 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

LIFTS

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 Schedule 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 Schedule 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.

Schedule 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, 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 Schedule IV, Part A and Schedule VI, 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 conformity to type with random

checking for safety components for lifts set out in Schedule IX;

(j)

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 Schedule VI or VII;

(k) the name and function of the person empowered to sign the declaration

on behalf of the manufacturer or his authorised representative;

(l)

place and date of signature;

(m) signature.

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 Schedule 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 Schedule 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

Schedule 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

Schedule 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 Schedule X, XI or XII;

(l)

the name and function of the person empowered to sign the declaration

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on behalf of the installer or his authorised representative;

(m) place and date of signature;

(n) signature.

Schedule 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 Schedule 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.

Schedule IV

EU-TYPE EXAMINATION FOR LIFTS AND SAFETY COMPONENTS FOR

LIFTS

(Module B)

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 Schedule 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

incl ude an adeq uate analysis and assessment of th e r isk(s). Th e 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

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

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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 Schedules

attached.

The EU-type examination certificate and its Schedules 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 Schedules 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.

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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 Schedule 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 Schedule 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

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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

Schedule 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 these regulations, 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 Schedule 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

Schedule 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

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applying other relevant technical specifications meet the corresponding

essential health and safety requirements of these regulations.

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

Schedule 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 Schedules

attached.

The EU-type examination certificate and its Schedules 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 Schedule 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 Schedules 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 Schedule 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 Schedule 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.

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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 Schedule 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.

Schedule 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 Schedule 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 Schedule 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 Schedule 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 Schedule 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 Schedule 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

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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

Schedule 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 Schedule 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 Schedule 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 Schedule 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

Schedule 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 Schedule 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 these regulations, 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

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authorised representative, on his behalf and under his responsibility, provided that

they are specified in the mandate.

Schedule 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 Schedule 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;

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(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

Schedule 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 these regulations 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

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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.

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Schedule 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

Schedule 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 Schedule 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;

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(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

Schedule 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 Schedule 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

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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,

schedules 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.

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Schedule 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 Schedule 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 Schedule 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

Schedule 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 these regulations, 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 Schedule I.

4. Verification

The notified body chosen by the installer shall examine the technical

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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 Schedule I. The tests

shall include at least the tests referred to in point 3.3 of Schedule V.

If the lift meets the essential health and safety requirements set out in

Schedule 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 Schedule 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 these regulations, 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.

Schedule 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 Schedule I and will enable a lift in which they are correctly

incorporated to satisfy those requirements.

2. Manufacturing

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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.

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Schedule 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

Schedule XI, and satisfy the applicable essential health and safety requirements set

out in Schedule 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 Schedule 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 Schedule 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

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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 Schedule 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 Regulation 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;

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(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 these regulations, 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.

Schedule 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

Schedule 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.

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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 Schedule 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 Schedule 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

instructi ons. This q ualit y system do cum entati on sh all p erm it a consist en t

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 Schedule 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

Schedule 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 Schedule 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

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requirements set out in Schedule 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 Schedule 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

Schedule 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

Schedules 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 Schedule 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 Schedule 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

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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 regulation 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

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request, of approval decisions which it has issued.

The notified body shall keep a copy of the approval decision issued, its

Schedule 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 these regulations, 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.

Schedule 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 Schedule XI, and satisfy the applicable essential health and

safety requirements set out in Schedule 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;

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(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 Schedule 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 Schedule 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 regulation 19.

4. Surveillance under the responsibility of the notified body

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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 these regulations, 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,

LIFTS

provided that they are specified in the mandate.

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 Schedule 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.