Lifts Regulations, 2016

Suppliment tal-Gazzetta tal-Gvern ta’ Malta, Nru. 19,546, 15 ta’ Marzu, 2016

L.N. 79 of 2016

PRODUCT SAFETY ACT

(CAP. 427)

Lifts Regulations, 2016

IN exercise of the powers conferred by articles 38 and 39 of the

Product Safety Act, the Minister for Social Dialogue, Consumer

Affairs and Civil Liberties, on the advice of the Malta Competition

and Consumer Affairs Authority, has made the following regulations:-

(1)

The title of these regulations is Lifts Regulations, Title,

commencement

2016. and scope.

(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).

(3) These regulations shall come into force on the 20th April,

2016.

In these regulations, unless the context otherwise requires

Interpretation.

"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;

"the Directive" means European Parliament and Council

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

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 relation to a lift 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 Transitional

the market of safety components for lifts regulated by the Lifts provisions.

Regulations and which were placed on the market before 20th April, S.L. 427.37.

2016, shall not in any way be impeded.

(3) Certificates and decisions by notified bodies under the

Lifts Regulations shall also be valid under these regulations.

(1)

These regulations shall apply to lifts permanently Applicability.

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 Free movement.

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 Placing on the

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

available on the

market and put into service only if they comply with these market

putting into

regulations, when properly installed and maintained and used for their service.

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

essential health and safety requirements set out in Schedule I.

requirements.

(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 Buildings or

responsible for work on the building or construction and the installer constructions

which lifts are

both provide each other with the necessary information and take the installed.

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 Obligations of

the market, manufacturers shall ensure that they have been designed the

manufacturer.

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 Obligations of

importers.

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 Cases in which

manufacturer for the purposes of these regulations and he shall be obligations

manufacturers

subject to the obligations of the manufacturer under regulation 9, apply

importers and

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

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;

(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.

Lifts and safety components for lifts which are in

conformity with harmonised standards or parts thereof the 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 EU declaration

fulfilment of the essential health and safety requirements set out in of conformity.

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

affixed by 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 Notification of

European Commission and the other Member States of bodies conformity

assessment

authorised to carry out third-party conformity assessment under these bodies.

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

(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.

21. (1) For the purposes of notification under these Requirements

regulations, a conformity assessment body shall meet the for

bodies.

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

Method for Designating Conformity Assessment Bodies Regulations. S.L. 427.45.

(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. This shall not preclude the 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 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

remuneration of the top level management and assessment 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

conformity assessment tasks are informed of, the relevant

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 with the requirements 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) Activities may be subcontracted 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 Notification

shall submit an application for notification under these regulations to procedures.

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 S.L. 427.45.

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 body only where no objections are raised by the European

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 Commission and the other Member 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

requirements laid down in regulation 21 or the Method 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 Market

appropriate measures to ensure that lifts and safety components of surveillance.

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 does

not comply with the requirements laid down in these 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

taken by Technical Regulations Division; the European 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.

(16) 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.

(17) The Technical Regulations Division, upon consultation

with the Commissioner of Police, shall immediately inform the

European Commission and the other Member States. That

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.

(18) 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.

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

(18) 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.

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

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

direct.

The penalties applicable for the infringement of any of the Penalties.

provisions of these regulations shall be those provided for in Part IV

of the Product Safety Act.

(1) The Lift Regulations are being hereby being Revocation and

saving.

revoked, hereinafter being referred to as "the revoked regulations".

(2) Any references to the revoked regulations 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.

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

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.

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.

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.

Control of loading (including overspeed)

Lifts must be so designed, constructed and installed as to prevent normal

starting if the rated load is exceeded.

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.

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

device.

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-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.

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.

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.

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

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.

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).

Counterweights must be so installed as to avoid any risk of colliding

with or falling on to the car.

Lifts must be equipped with means enabling people trapped in the car to

be released and evacuated.

Cars must be fitted with two-way means of communication allowing

permanent contact with a rescue service.

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.

Cars must be designed and constructed to ensure sufficient ventilation

for passengers, even in the event of a prolonged stoppage.

The car should be adequately lit whenever in use or whenever a door is

opened; there must also be emergency lighting.

The means of communication referred to in point 4.5 and the emergency

lighting referred to in point 4.8 must be designed and constructed so as

to function even without the normal power supply. Their period of

operation should be long enough to allow normal operation of the rescue

procedure.

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

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.

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

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.

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

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;

(i)

where appropriate, the name, address and identification number

of the notified body which carried out the EU-type examination

of safety components for lifts set out in Schedule IV, Part A and

Schedule VI, and the reference of the EU- type examination

certificate issued by that notified body;

(j)

where appropriate, the name, address and identification number

of the notified body which carried out the conformity to type

with random checking for safety components for lifts set out in

Schedule IX;

(k)

where appropriate, the name, address and identification number

of the notified body which approved the quality system operated

by the manufacturer in accordance with the conformity

assessment procedure set out in Schedule VI or VII;

(l)

the name and function of the person empowered to sign the

declaration on behalf of the manufacturer or his authorised

representative;

(m)

place and date of signature;

(n)

signature.

CONTENT OF THE EU DECLARATION OF CONFORMITY FOR

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 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 include an adequate analysis and assessment of the risk(s). The

technical documentation shall specify the applicable requirements and

cover, as far as relevant for the assessment, the design, manufacture and

operation of the safety component for lifts.

The technical documentation shall contain, where applicable, the

following

(a)

a description of the safety component for lifts, including its area

of use (in particular possible limits on speed, load and power)

and conditions (in particular explosive environments and

exposure to the elements);

(b)

design and manufacturing drawings and diagrams;

(c)

explanations necessary for the understanding of those drawings

and diagrams and the operation of the safety component for

lifts;

(d)

a list of the harmonised standards applied in full or in part the

references of which have been published in the Official Journal

of the European Union and, where those harmonised standards

have not been applied, descriptions of the solutions adopted to

enable the safety component for lifts to meet the conditions

referred to in point 1, including a list of other relevant technical

specifications applied. In the event of partly applied harmonised

standards, the technical documentation shall specify the parts

which have been applied;

(e)

results of design calculations performed by or for the

manufacturer;

(f)

test reports;

(g)

a copy of the instructions for the safety components for lifts;

(h)

steps taken at the manufacturing stage to ensure that series-

produced safety components for lifts conform to the safety

component for lifts examined.

4. The notified body shall

(a)

examine the technical documentation and the supporting

evidence to assess the adequacy of the technical design of the

safety component for lifts;

(b)

agree with the applicant on a location where the examinations

and tests will be carried out;

(c)

verify that the representative specimen(s) has (have) been

manufactured in conformity with the technical documentation,

and identify the elements which have been designed in

accordance with the applicable provisions of the relevant

harmonised standards, as well as the elements which have been

designed in accordance with other relevant technical

specifications;

(d)

carry out appropriate examinations and tests, or have them

carried out, to check whether, where the manufacturer has

chosen to apply the specifications of the relevant harmonised

standards, these have been applied correctly;

(e)

carry out appropriate examinations and tests, or have them

carried out, to check whether, where the specifications of the

relevant harmonised standards have not been applied, the

solutions adopted by the manufacturer applying other relevant

technical specifications enable the safety component for lifts to

meet the conditions referred to in point 1.

The notified body shall draw up an evaluation report that records the

examinations, verifications and tests carried out and their outcome.

Without prejudice to its obligations vis-à-vis the notifying authorities,

the notified body shall release the content of that report, in full or in part,

only with the agreement of the manufacturer.

5. Where the type of the safety component for lifts meets the conditions

referred to in point 1, the notified body shall issue an EU-type

examination certificate to the manufacturer. That certificate shall contain

the name and address of the manufacturer the conclusions of the EU-type

examination, any conditions of validity of the certificate and the

particulars necessary to identify the approved type.

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

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.

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 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 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.

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.

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 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.

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.

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

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.

The installer shall draw up a written EU declaration of conformity for

each lift and keep a copy of the EU declaration of conformity and the

final inspection certificate at the disposal of the national authorities for

10 years after the placing on the market of the lift. A copy of the EU

declaration of conformity shall be made available to the relevant

authorities upon request.

6. The Commission and the Member States may obtain a copy of the final

inspection certificate on request.

7. Authorised representative

The installer’s obligations set out in points 3.1 and 5 may be fulfilled by

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

provided that they are specified in the mandate.

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

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.

Under the quality system, each safety component for lifts shall be

inspected and appropriate tests as set out in the relevant harmonised

standards or equivalent tests shall be carried out in order to ensure that it

meets the conditions referred to in point 1. All the elements,

requirements and provisions adopted by the manufacturer shall be

documented in a systematic and orderly manner in the form of written

policies, procedures and instructions. This quality system documentation

shall permit a consistent interpretation of the quality programmes, plans,

manuals and records.

It shall contain in particular an adequate description of

(a)

the quality objectives;

(b)

the organizational structure, responsibilities and powers of the

management with regard to product quality;

(c)

the examinations and tests that will be carried out after

manufacture;

(d)

the means of monitoring the effective operation of the quality

system; and

(e)

the quality records, such as inspection reports and test data,

calibration data, reports on the qualifications of the personnel

concerned, etc.

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.

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.

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

The purpose of surveillance is to make sure that the manufacturer duly

fulfils the obligations arising out of the approved quality system.

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.

The notified body shall periodically carry out audits to ensure that the

manufacturer maintains and applies the quality system and shall provide

the manufacturer with an audit report.

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

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.

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.

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

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.

The quality system shall ensure compliance of the safety components for

lifts with the conditions referred to in point 1. All the elements,

requirements and provisions adopted by the manufacturer shall be

documented in a systematic and orderly manner in the form of written

policies, procedures and instructions. This quality system documentation

shall permit a consistent interpretation of the quality programmes, plans,

manuals and records.

It shall contain in particular an adequate description of

(a)

the quality objectives and the organizational structure,

responsibilities and powers of the management with regard to

the design and product quality;

(b)

the technical design specifications, including standards that will

be applied and, where the relevant harmonised standards will

not be applied or not applied in full, the means, including other

relevant technical specifications, that will be used to ensure that

the conditions referred to in point 1 will be met;

(c)

the design control and design verification techniques, processes

and systematic actions that will be used when designing the

safety components for lifts;

(d)

the corresponding manufacturing, quality control and quality

assurance techniques, processes and systematic actions that will

be used;

(e)

the examinations and tests that will be carried out before, during

and after manufacture, and the frequency with which they will

be carried out;

(f)

the quality records, such as inspection reports and test data,

calibration data, reports on the qualifications of the personnel

concerned;

(g)

the means of monitoring the achievement of the required design

and product quality and the effective operation of the quality

system.

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.

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.

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

The purpose of surveillance is to make sure that the manufacturer duly

fulfils the obligations arising out of the approved quality system.

The manufacturer shall for assessment purposes allow the notified body

access to the design, manufacture, inspection and testing, and storage

locations, and shall provide it with all necessary information, in

particular

(a)

the quality system documentation;

(b)

the quality records provided for in the design part of the quality

system such as results of analyses, calculations, tests;

(c)

the technical documentation for the safety components for lifts

manufactured;

(d)

the quality records provided for in the manufacturing part of the

full quality system, such as inspection reports and test data,

calibration data, reports on the qualifications of the personnel

concerned.

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.

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

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.

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.

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

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.

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

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

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.

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

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

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.

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.

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

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.

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.

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 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.

The installer shall undertake to fulfil the obligations arising from the

quality system as approved and to maintain it so that it remains adequate

and efficient.

The installer shall keep the notified body which 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

The purpose of surveillance is to make sure that the installer duly fulfils

the obligations arising out of the approved quality system.

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.

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.

Additionally, the notified body may pay unexpected visits to the lift

installation sites.

At the time of such visits, the notified body may, where necessary, carry

out tests or have them carried out in order to check the proper

functioning of the quality system and of the lift. It shall provide the

installer with a visit report and, if tests have been carried out, with a test

report.

5. The installer shall, for 10 years after the last lift has been placed on the

market, keep at the disposal of the national authorities

(a)

the documentation referred to in point 3.1(c);

(b)

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

(c)

the information relating to the changes referred to in point 3.4.1;

(d)

the decisions and reports from the notified body which are

referred to in the second paragraph of point 3.4.2 and in points

4.3 and 4.4.

6. Each notified body shall inform its notifying authority of quality system

approval decision(s) issued or withdrawn, and shall, periodically or upon

request, make available to its notifying authority the list of approval

decisions, refused, suspended or otherwise restricted.

Each notified body shall inform the other notified bodies of quality

system approval decision(s) which it has refused, suspended or

withdrawn and, upon request, of approval decision(s) which it has

issued.

On request, the notified body shall provide the Commission and the

Member States with a copy of quality system approval decision(s)

issued.

7. CE marking and EU declaration of conformity

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.

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

The installer shall lodge an application for assessment of his quality

system with a single notified body of his choice.

The application shall include

(a)

the name and address of the installer, and, if the application is

lodged by the authorised representative, his name and address as

well;

(b)

all relevant information on the lifts to be installed, in particular

information which makes for an understanding of the

relationship between the design and operation of the lift;

(c)

the documentation on the quality system;

(d)

the technical documentation described in point 3 of Schedule IV,

Part B;

(e)

a written declaration that the same application has not been

lodged with any other notified body.

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. This quality system

documentation shall permit a consistent interpretation of the quality

programmes, plans, manuals and quality records.

It shall contain in particular an adequate description of

(a)

the quality objectives and the organisational structure,

responsibilities and powers of the management with regard to

design and product quality;

(b)

the technical design specifications, including standards that will

be applied and, where the relevant harmonised standards will

not be applied in full, the means, including other relevant

technical specifications that will be used to ensure that the

applicable essential health and safety requirements set out in

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.

Design examination

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.

Where the design does not satisfy the applicable essential health and

safety 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.

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.

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.

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.

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.

The installer shall undertake to fulfil the obligations arising from the

quality system as approved and to maintain it so that it remains adequate

and efficient.

The installer shall keep the notified body that has approved the quality

system informed of any intended change to the system.

The notified body shall assess the modifications proposed and decide

whether the modified quality system will continue to satisfy the

requirements referred to in point 3.2 or whether a reassessment is

necessary.

It shall notify its decision to the installer or, where appropriate, to his

authorised representative. The notification shall contain the conclusions

of the assessment and the reasoned assessment decision.

The notified body shall affix, or cause to be affixed, its identification

number adjacent to the CE marking in accordance with Regulation 19.

4. Surveillance under the responsibility of the notified body

The purpose of surveillance is to make sure that the installer duly fulfils

the obligations arising out of the approved quality system.

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.

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.

Additionally, the notified body may pay unexpected visits to the

premises of the installer or to the installation site of a lift. At the time of

such visits, the notified body may, where necessary, carry out tests or

have them carried out in order to check the proper functioning of the

quality system. It shall provide the installer with a visit report and, if

tests have been carried out, with a test report.

5. The installer shall, keep at the disposal of the national authorities for a

period ending 10 years after the lift has been placed on the market

(a)

the documentation referred to in point 3.1(c);

(b)

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

(c)

the information relating to the changes referred to in the second

paragraph of point 3.5;

(d)

the decisions and reports from the notified body which are

referred to in the fourth paragraph of point 3.5 and in points 4.3

and 4.4.

6. Each notified body shall inform its notifying authority of full quality

system approval decision(s) issued or withdrawn, and shall, periodically

or upon request, make available to its notifying authority the list of

approval decisions refused, suspended or otherwise restricted.

Each notified body shall inform the other notified bodies of quality

system approval decision(s) which it has refused, suspended or

withdrawn, and, upon request, of approval decisions which it has issued.

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

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

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.

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

The installer shall lodge an application for assessment of his quality

system with a single notified body of his choice.

The application shall include

(a)

the name and address of the installer, and, if the application is

lodged by the authorised representative, his name and address as

well;

(b)

all relevant information for the lifts to be installed;

(c)

the documentation on the quality system;

(d)

the technical documentation of the lifts to be installed;

(e)

a written declaration that the same application has not been

lodged with any other notified body.

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.

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.

The installer shall undertake to fulfil the obligations arising from the

quality system as approved and to maintain it so that it remains adequate

and efficient.

The installer shall keep the notified body that has approved the quality

system informed of any intended change to the system.

The notified body shall assess the modifications proposed and decide

whether the modified quality system will continue to satisfy the

requirements referred to in point 3.2 or whether a reassessment is

necessary.

It shall notify its decision to the installer or, where appropriate, to his

authorised representative. The notification shall contain the conclusions

of the assessment and the reasoned assessment decision.

The notified body shall affix, or cause to be affixed, its identification

number adjacent to the CE marking in accordance with Regulation 19.

4. Surveillance under the responsibility of the notified body

The purpose of surveillance is to make sure that the installer duly fulfils

the obligations arising out of the approved quality system.

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.

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.

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

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.

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.

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.

B

€3.24