Conformity assessment procedure for elevators

Placing Lifts on the Market

Until April 20, 2016, the placing of elevators (and safety components for elevators) on the market was governed primarily by Act No. 22/1997 Coll. on technical requirements for products, and its implementing Government Regulation No. 27/2003 Coll., which establishes technical requirements for elevators. The legal framework of Act No. 22/1997 Coll. did not provide sufficient scope for the proper transposition of directives developed in accordance with the NLF principles; therefore, it was necessary to transfer these directives under the new Act No. 90/2016 Coll. on the conformity assessment of specified products when placed on the market; for details, see here.

Act No. 22/1997 Coll., on technical requirements for products, which was amended by Act No. 91/2016 Coll., remains in force alongside the new Act No. 90/2016 Coll. on conformity assessment. Government Regulation No. 122/2016 Coll. (implementing regulation to Act No. 90/2016 Coll.) repeals, as of April 20, 2016, Government Regulation No. 27/2003 Coll. (implementing regulation to Act No. 22/1997 Coll.).

Elevators that meet the requirements of Government Regulation No. 27/2003 Coll. may continue to be put into service if they were placed on the market before April 20, 2016.

Safety components for elevators that meet the requirements of Government Regulation No. 27/2003 Coll. may continue to be supplied to the market provided they were placed on the market before April 20, 2016. Certificates issued by notified bodies pursuant to Government Regulation No. 27/2003 Coll. remain valid under this Regulation.

Government Regulation No. 27/2003 Coll. transposed Directive 95/16/EC of the European Parliament and of the Council (on the approximation of the laws, regulations, and administrative provisions of the Member States relating to lifts) into Czech legislation. Directive No. 95/16/EC was repealed with effect from April 20, 2016, and replaced by the new Directive No. 2014/33/EU (on the harmonization of the laws of the Member States relating to lifts and safety components for lifts). This new directive is implemented into Czech legislation by Act No. 90/2016 Coll. and its implementing Government Regulation No. 122/2016 Coll.(on the conformity assessment of elevators and their safety components).

Elevators covered by Government Regulation No. 122/2016 Coll.(or the Directive) become finished products only when they are permanently installed in buildings or structures. Therefore, elevators cannot be imported into the Union; elevators are only placed on the market and not subsequently supplied to the market; consequently, there are no importers or distributors of elevators.

Government Regulation No. 122/2016 Coll.applies to safety components for elevators that are new to the Union market at the time of their placing on the market; these are therefore either new safety components manufactured by a manufacturer in the Union or new or used safety components imported from a third country.
The building owner (pursuant to Act No. 183/2006 Coll.) and the contractor shall provide each other with the necessary information and take appropriate steps to ensure the proper operation and safe use of the elevator.

Act No. 90/2016 Coll.distinguishes between placing on the market (concerning safety components) and placing on the market (concerning both safety components and elevators).

supplier - a person responsible for the design, manufacture, installation, and placing of a lift on the market;
Placing on the market – the supply of safety components for elevators for distribution or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;
placing on the market: 1) the first supply of a safety component for lifts on the market, or
2) the supply of a lift for use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;
manufacturer - a natural or legal person who manufactures a safety component for lifts or has a safety component for lifts designed or manufactured and places that component on the market under their own name or trademark;
authorized representative – a natural or legal person established in the Union who has been authorized in writing by the supplier or manufacturer to act on their behalf in performing specific tasks;
importer – a natural or legal person established in the Union who places a safety component for lifts from a third country on the Union market;
distributor – a natural or legal person in the supply chain, other than the manufacturer or importer, who supplies a safety component for lifts to the market;

If a lift or a safety component for lifts complies with harmonized standards or parts thereof, the references to which have been published in the Official Journal of the European Union, it is presumed to comply with the essential technical requirements covered by those standards or parts thereof.

Lifts may be placed on the market and put into service only if, when properly installed, maintained, and used for their intended purpose, they comply with the requirements of Government Regulation No. 122/2016 Coll.

The essential technical requirements for elevators and safety components for elevators are the essential health and safety requirements set forth in Annex 1 to Government Regulation No. 122/2016 Coll., compliance with which is demonstrated through conformity assessment. Safety components for elevators must enable the elevators in which they are installed to meet these requirements.

Conformity assessment procedures for elevators
Elevators must undergo one of the following conformity assessment procedures:

a) if they have been designed and manufactured in accordance with a model elevator that has undergone EU type examination in accordance with Part B of Annex No. 4 to this Government Regulation:

1. final inspection for lifts in accordance with Annex 5 to this Government Regulation,
2. conformity to type based on product quality assurance for elevators in accordance with Annex 10 (Module E) to this Government Regulation, or
3. conformity to type based on production quality assurance for lifts in accordance with Annex 12 (Module D) to this Government Regulation,

b) if they have been designed and manufactured in accordance with a quality system approved in accordance with Annex 11 (Module H1) to this Government Regulation:

final inspection for elevators in accordance with Annex 5 to this Government Regulation,
conformity to type based on product quality assurance, in the case of elevators, in accordance with Annex 10 (Module E) to this Government Regulation, or
conformity to type based on production quality assurance for elevators, in accordance with Annex No. 12 (Module D) to this Government Regulation,

c) conformity based on unit verification for lifts, in accordance with Annex 8 (Module G) to this Government Regulation,
d) conformity based on full quality assurance and design review, in the case of elevators, in accordance with Annex 11 (Module H1) to this Government Regulation.

Products subject to conformity assessment are elevators that are permanently installed in buildings and structures and are intended for the transport of persons, persons and goods, or goods only, provided that the load-bearing part is accessible—that is, it can be entered without difficulty—and is equipped with control devices on the load-bearing part or within reach of a person located on it.

Elevators must be subject to one of the following conformity assessment:	a) if they have been designed and manufactured in accordance with a model elevator which has undergone EU type examination in accordance with Part B of Annex 4 to the Government Regulation:	final inspection	Annex 5
		Module E	Annex 10
		Module D	Annex No. 12
	b) if they were designed and manufactured in accordance with a quality system approved in accordance with Annex No. 11 to the Government Regulation:	Final inspection	Annex No. 5
		Module E	Annex 10
		Module D	Appendix No. 12
	(c) Conformity based on the verification of each individual elevator	Module G	Annex 8
	(d) Conformity based on full quality assurance and design review of the lift	Module H1	Annex 11

In the cases referred to in paragraph 1(a) and (b), where the person responsible for the design and manufacture of the elevator is not the same as the person responsible for the installation and testing of the elevator, the person responsible for the design and manufacture of the elevator shall make available to the person responsible for the installation and testing of the elevator all necessary documents and information so that the latter person can ensure the correct and safe installation and testing of the elevator.

All permitted differences between the model lift and lifts derived from the model lift are clearly specified in the technical documentation (with maximum and minimum values).

Technical documentation for lifts in accordance with Annex 4 (Module B):

The technical documentation must include, where relevant, the following elements:

a) a description of the model elevator clearly indicating all permitted modifications to the model elevator,

b) design and manufacturing drawings and diagrams,

c) explanatory notes necessary for understanding the drawings and diagrams and the operation of the elevator,

d) a list of the essential technical requirements considered,

e) a list of harmonized standards the references to which have been published in the Official Journal of the European Union and which have been applied in full or in part, and a description of the solutions adopted to meet the essential technical requirements set out in this Regulation where those harmonized standards have not been applied, including a list of other relevant technical specifications that have been applied.

In the case of partially applied harmonized standards, the technical documentation shall specify the parts that have been applied,

f) a copy of the EU Declaration of Conformity for safety components for lifts incorporated into the lift,

g) the results of design calculations performed by or for the supplier,

h) test reports,

i) a copy of the instructions in accordance with Section 6.2 of Annex No. 1 to this Government Regulation, and

j) measures taken during the installation phase to ensure that series-produced elevators comply with the essential technical requirements.

Technical documentation for elevators pursuant to Annex No. 8 (Module G) The
technical documentation must contain at least the following elements:
a) a description of the elevator,
b) conceptual design and manufacturing drawings and diagrams,
c) explanatory notes necessary for understanding the aforementioned drawings and diagrams and the operation of the elevator,

d) a list of the essential technical requirements taken into account,

f) a copy of the EU type-examination certificates for safety components for lifts incorporated into the lift,

g) the results of design calculations performed by or for the supplier,
h) test reports; and
i) a copy of the lift instructions in accordance with point 6.2 of Annex No. 1 to this Government Regulation.

Technical documentation for elevators pursuant to Annex 12 (Module D)
The documentation of the production quality system must include, in particular, an adequate description of:
a) quality objectives and the organizational structure, responsibilities, and authorities of management regarding product quality,
b) the methods, procedures, and systematic activities to be used in production, inspection, and quality assurance,
c) the inspections and tests to be carried out before, during, and after installation,
d) quality records, such as inspection reports, test records, calibration records, and reports on the qualifications of the personnel concerned; and
e) the means of monitoring the achievement of the required product quality and the effective operation of the quality system.

It is permissible to demonstrate the similarity of a series of devices by means of calculations or design drawings to show how the essential technical requirements have been met.

Where appropriate in view of the risks posed by the elevator, the manufacturer shall, for the purpose of protecting the health and safety of consumers, conduct investigations and, where necessary, maintain a register of complaints and non-conforming elevators.
ensure that the elevator bears a type or serial number or other element allowing for its identification,
shall indicate on the elevator their name or registered trademark and a delivery address at which they can be contacted; the address must specify a single location where the supplier can be contacted; contact details shall be provided in the Czech language,
ensure that the elevator is accompanied by instructions in the Czech language; these instructions and any other markings must be clear and comprehensible.
A supplier who believes or has reason to believe that a lift they have placed on the market does not comply with the technical requirements set forth in the government regulation shall immediately take the corrective measures necessary to bring that lift into compliance. Furthermore, if the elevator poses a risk, the supplier shall immediately inform the supervisory authority or the competent authority of another Member State of the European Union in which the elevator was placed on the market, providing details, in particular regarding the non-compliance and the corrective measures taken.

Safety components

Safety components for elevators may be supplied to the market and put into service only if, when properly installed, maintained, and used for their intended purpose, they meet the requirements of Government Regulation No. 122/2016 Coll.
When placing safety components for elevators on the market, the manufacturer shall ensure that these safety components for elevators are designed and manufactured in accordance with Government Regulation No. 122/2016 Coll., prepare the required technical documentation, and carry out or have carried out the relevant conformity assessment procedure specified in Section 10. If the conformity of the safety component for lifts with the relevant essential requirements has been demonstrated through the conformity assessment procedure, the manufacturer shall draw up an EU declaration of conformity, ensure that it is attached to the safety component for lifts, and affix the CE marking.The manufacturer shall keep the technical documentation, the EU Declaration of Conformity, and, where applicable, the approval decision for a period of 10 years after the safety component for lifts has been placed on the market.

The products subject to conformity assessment are safety components:

Devices for securing shaft doors.
Devices referred to in Section 3.2 of Annex 1 to this Government Regulation that prevent the fall of the car or uncontrolled movement.
Devices to prevent excessive speed.
a) Energy-absorbing buffers: non-linear or with reverse-motion damping;
b) Energy-absorbing buffers.
Safety devices for the hydraulic cylinder of the hydraulic power circuit serving as fall prevention devices.
Electrical safety devices consisting of safety circuits with electronic components.

Conformity assessment procedures for safety components for lifts

Safety components for lifts must undergo one of the following conformity assessment procedures:

a) the safety component for elevators shall be submitted for EU type examination as specified in Part A of Annex No. 4

(Module B) of this Government Regulation, and conformity to type shall be ensured through random checks of safety components for elevators in accordance with Annex 9 (Module C2) of this Government Regulation,

b) a prototype of the safety component for lifts shall be submitted for EU type examination as specified in Part A of Annex 4

(Module B) of this Government Regulation and shall be subject to conformity to type based on product quality assurance in accordance with Annex 6 (Module E) of this Government Regulation,

c) conformity based on full quality assurance in accordance with Annex 7 (Module H) to this Government Regulation.

Safety components for elevators must be subject to one of the following conformity assessment procedures:	Module B + C2	Annexes 4 and 9
	Module B + E	Annexes 4 and 6
	Module H	Annex 7

Technical documentation for safety components in accordance with Annex 4 of the Government Regulation (Module B):

a) a description of the safety component for elevators, including the area of application (in particular any limitations on speed, load, and power) and conditions (especially explosive atmospheres and weather conditions),

b) design and manufacturing drawings and diagrams,

c) explanatory notes necessary for understanding the aforementioned drawings and diagrams and the operation of the safety component for elevators,

d) a list of harmonized standards, the references to which have been published in the Official Journal of the European Union and which have been applied in full or in part, and a description of the solutions adopted to ensure that the safety component for lifts meets one or both of the conditions set out in point 1, where such harmonized standards have not been applied, including a list of other relevant technical specifications that have been applied. In the case of partially applied harmonized standards, the technical documentation shall specify the parts that have been applied,

e) the results of design calculations carried out by the manufacturer or on the manufacturer’s behalf,

f) test reports,

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

h) measures taken during the production stage to ensure that the series-produced safety components for lifts are in conformity with the tested safety component for lifts.

Technical documentation for BK pursuant to Annex No. 6 of the Government Regulation (Module E)
The quality system documentation must contain, in particular, an adequate description of:
a) quality objectives,
b) the organizational structure, responsibilities, and authorities of management regarding product quality,
c) the inspections and tests to be carried out after manufacture,
d) the means to monitor the effective functioning of the quality system, and
e) quality records, such as inspection reports, test records, calibration records, reports on the qualification of relevant personnel, etc.

Technical documentation for safety components pursuant to Annex No. 7 of the Government Regulation (Module H)

The documentation of the production quality assurance system must include, in particular, an adequate description of:
a) quality objectives and the organizational structure, responsibilities, and authorities of management with regard to design and product quality,

b) the technical design specifications, including the standards to be applied, and, where the relevant harmonized standards are not applied or are not applied in full, a description of the means, including other relevant technical specifications, to be used to ensure compliance with the conditions set out in point 1,

c) the methods of design control and verification, the procedures, and the systematic activities to be used in the design of safety components for lifts,

d) the corresponding methods, procedures, and systematic activities to be used in manufacturing, inspection, and quality assurance,

e) the inspections and tests to be carried out before, during, and after manufacture, specifying their frequency,

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

g) the means to monitor the achievement of the required design and product quality and the effective operation of the quality system.