Lifts Directive

and
Market Surveillance
ADCO Lifts
2015-04-24
1

Economic Operators
An economic operator is a natural or a legal person who
acts as at least in one of the following roles
Installer of a lift
Manufacturer of a safety component for lifts
Authorised representative for a manufacturer or an installer
Importer of a safety component
Distributor of a safety component

Lift Industry
Newly installed lifts per year: ~ 125,000
Existing lifts: ~ 5.8 million
Existing lifts, CE marked: estimated ~ 2 million
Many companies, whether large or SMEs
have operations in more than one member state
Manufacturers or importers with products distributed across EU
To be incorporated into lifts, or
Spare parts for existing lifts
Installers operations in several countries
Install own products, and/or
Source material from different suppliers

have multiple roles (as economic operators) within the

delivery chain
have operation outside the EU territories

Market Surveillance
Generally positive experience with the Lifts Directive
Free circulation of safe lifts and safety components

New and explicit market surveillance requirements of

2014/33/EU are the most welcome improvement for the
application of the Lifts Directive
Industry make all efforts for smooth implementation of
2014/33/EU
Industry wishes
Clarification of the new requirements
This is specially important due to absence of the transition period
Harmonised procedures across the EU
Avoid unnecessary burden to the economic operators as well as the
national authorities

Main question is about the reporting obligations related to

risks
2014/33/EU, article 7(8), article 8(8) and article 10(7)

Market Surveillance
For the installer
1) Installers who consider or have reason to believe that a lift which they have placed
on the market is not in conformity with this Directive shall immediately take the
corrective measures necessary to bring that lift into conformity.
2) Furthermore, where the lift presents a risk, installers shall immediately inform the
competent national authorities of the Member States in which they placed the lift on the
market to that effect, giving details, in particular, of the non-conformity and of any
corrective measures taken.

Same requirements are applicable to the manufacturer and

similar requirements for other economic operators
Main questions are about the second paragraph above
Considering the structure of the lift industry and harmonised
approach with a minimum burden to all
Which risk to be reported?
When should it be reported?
How to report?
To whom to submit the report?
5

Process of managing nonconformities

1
Potential nonconformity

Closing the
Notification

Risk
Assessment

3
Define
corrective
Action

5
Execution of
corrective
action

4
Notification
6

Which risk to be reported and when

Risk assessment and notification (steps 1-4 of
the process)*

Likelihood

sk
Ri

o
gr

up

sk
Ri
Severit
y

gr

Risk assessment
according to EN ISO 14798

Maintenance

sk
Ri

up
o
r

(Carried out by the economic operator)

Manufacturing /
installation

Non-conformity

Supply chain

(Identified by the economic operator)

Design

p
ou

Serious
Risk

Notificatio
n

(Risk group 1)

Subject
to
review
(Risk group
2)

Managemen
t decision
for
notification

No risk or
No
comparabl action
e
required
(Risk group 3)

Notification to the authorities to be done after completion of the risk

assessment and defining the corrective actions.
* Actual procedures implementing this process are subject to the internal rules and processes of each individual
installer/manufacturer/importer organization.

EN ISO 14798
Specific Risk assessment and reduction methodology for lifts
and escalators
First publication in 2004
Adopted as EN ISO standard in 2013
Widely used around the world
For developing lift safety standards
By lift and safety component designers for developing new products
Evaluations of designs not described within standards
By Notified Bodies and other assessment bodies
Increasingly used for risk assessment of the existing installations
ISO 9001, ISO 18000 and ISO 31000, which are widely used by the
companies, are bec oming more risk assessment based

Provides a common basis for evaluation and understanding

of the risk profiles and relevant actions
EN ISO 14798 methodology is very similar to RAPEX and they 8
could be matched closely

Relation between
RAPEX risk assessment
and EN ISO 14798

Risk assessment in RAPEX guide

2010/15/EU

RAPEX Severity Index

EN ISO 14798
Severity Levels

1: Injury or consequence that after basic

treatment (first aid, normally not by a doctor)
does not substantially hamper functioning or
cause excessive pain; usually the
consequences are completely reversible.

Level 4: Does not

result in injury,
occupational illness, or
system or
environmental damage

2: Injury or consequence for which a visit to

A&E may be necessary, but in general,
hospitalisation is not required. Functioning may
be affected for a limited period, not more than
about 6 months, and recovery is more or less
complete.

Level 3: Minor injury,

minor occupational
illness, or minor system
or damage

3: Injury or consequence that normally requires

hospitalisation and will affect functioning for
more than 6 months or lead to a permanent
loss of function.

Level 2: Severe injury,

severe occupational
illness, or major system
or environmental
damage

4: Injury or consequence that is or could be

Level 1: Death,

Risk assessment in RAPEX guide

2010/15/EU

8 levels of probability in RAPEX

Probability of damage during the foreseeable lifetime of the product

Risk assessment in RAPEX guide

2010/15/EU

Comparison of probability levels for 50 years lifetime of lifts

RAPEX
probability
during
foreseeable
lifetime of
product

Probability per
year of a lift
(50
years lifetime)

Probability
level according
to
EN
ISO 14786

> 50 %

> 1/100

A-B

> 1/10

> 2/1 000

> 1/100

> 2/10 000

C-D

> 1/1 000

> 2/100 000

> 1/10 000

> 2/1 000 000

D-E

> 1/100 000

> 2/10 000 000

> 1/1 000 000

> 2/100 000 000

E-F

< 1/1 000 000

< 2/100 000 000

Risk assessment in RAPEX guide

2010/15/EU

Application of RAPEX risk levels on EN ISO 14798 risk assessment

Severity
Probability

2
3
Risk level

Serious

Serious

Serious

High

Serious

Serious

Serious

High

Serious

Serious

Serious

Medium

C-D

Serious

Serious

Serious

Medium

Serious

Serious

High

Low

D-E

Serious

High

Medium

Low

High

Medium

Low

Low

E-F

Medium

Low

Low

Low

Low

Low

Low

Low

Risk assessment in RAPEX guide

2010/15/EU

Comparison with EN ISO 14798 risk levels for new lifts

Probabilit
y

Severity
2
3
Risk level

Probabilit
y

Serious Serious Serious

High

Serious Serious Serious

High

Serious Serious Serious Medium

C-D

Serious Serious Serious Medium

Serious Serious

High

Low

D-E

Serious

High

Medium

Low

High

Medium

Low

Low

E-F

Medium

Low

Low

Low

Low

Low

Low

Low

RAPEX risk levels

C
C-D
D
D-E
E
E-F
F

Severity
2
3
Risk level

re
u
s
a
e
M

d
re
i
qu
e
sr

ew
i
v
Re

d
e
r
ui
q
re

n
o
i
t
ac

d
re
i
u
eq

No
EN ISO 14798 risk levels

Risk assessment in RAPEX guide

2010/15/EU

Procedures and risk levels similar between RAPEX and EN ISO 14798

According to RAPEX guide notification is required for serious risks

Probabilit
Application in line with EN ISO 14798
y

Notification and corrective

measures required
Case by case decision on
corrective measures and
voluntary notification
No corrective measures and
notification required

A
B
C
D
E
F

Severity
2
3
Risk level

Which risk to be reported and when

Risk assessment and notification (steps 1-4 of
the process)*

Likelihood

sk
Ri

o
gr

up

sk
Ri
Severit
y

gr

Risk assessment
according to EN ISO 14798

Maintenance

sk
Ri

up
o
r

(Carried out by the economic operator)

Manufacturing /
installation

Non-conformity

Supply chain

(Identified by the economic operator)

Design

p
ou

Serious
Risk

Notificatio
n

(Risk group 1)

Subject
to
review
(Risk group
2)

Managemen
t decision
for
notification

No risk or
No
comparabl action
e
required
(Risk group 3)

Notification to the authorities to be done after completion of the risk

assessment and defining the corrective actions.
* Actual procedures implementing this process are subject to the internal rules and processes of each individual
installer/manufacturer/importer organization.

16