S.I. No. 232/2017 - European Union (Lifts and Safety Components for Lifts) Regulations 2017
This is the act as published. Later amendments are not folded into the text below: each one is a separate act in this repository and an entry in this law's history.
1 amending act · 2022-07-05, S.I. No. 323/2022 - European Union (Lifts and Safety Components for Lifts) (Amendment) Re…
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 1 and will enable a lift to which they are correctly incorporated to satisfy those requirements.
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.
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 applicable 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 organisational 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 1.
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 the Directive and to carry out the necessary examinations with a view to ensuring compliance of the safety components for lifts with those requirements.
The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned assessment decision.
- 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.
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.
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.
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.
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.
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.
Regulations 16, 18, 20, 33 and 36
SCHEDULE 7 TEXT OF ANNEX VII TO THE DIRECTIVE
CONFORMITY BASED ON FULL QUALITY ASSURANCE FOR SAFETY COMPONENTS FOR LIFTS
(module H)
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 1 and to enable a lift to which they are correctly incorporated to satisfy those requirements.
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.
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 4, 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 organisational 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 1. 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 1 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 fullfil 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.
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 full 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.
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.
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.
Each notified body shall inform its notifying authority of quality system approval decision(s) issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of approval decisions refused, suspended or otherwise restricted.
Each notified body shall inform the other notified bodies of quality system approval decisions which it has refused, suspended or withdrawn and, upon request, of approval decisions which it has issued.
On request, the notified body shall provide the Commission and the Member States with a copy of quality system approval decision(s) issued.
The notified body shall keep a copy of the approval decision issued, its annexes and additions, as well as the technical documentation for 15 years from the date of their issue.
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.
Regulations 17, 18, 20, 33 and 36
SCHEDULE 8 TEXT OF ANNEX VIII TO THE DIRECTIVE
CONFORMITY BASED ON UNIT VERIFICATION FOR LIFTS
(module G)
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 1.
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 1.
- 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.
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 1.
The technical documentation shall contain at least the following elements:
- (a) a description of the lift;
- (b) design and manufacturing drawings and diagrams;
- (c) explanations necessary for the understanding of those drawings and diagrams and of the operation of the lift;
- (d) a list of the essential health and safety requirements taken into consideration;
- (e) a list of the harmonised standards applied in full or in part the references of which have been published in the Official Journal of the European Union and, where those harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential health and safety requirements of the Directive, including a list of other relevant technical specifications applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied;
- (f) a copy of the EU-type examination certificates of the safety components for lifts incorporated in the lift;
- (g) results of design calculations performed by or for the installer;
- (h) test reports;
- (i) a copy of the instructions referred to in point 6.2 of Schedule 1.
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 1. The tests shall include at least the tests referred to in point 3.3 of Schedule 5.
If the lift meets the essential health and safety requirements set out in Schedule 1 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 1.
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.
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 the Directive, and, under the responsibility of the notified body referred to in point 2.2, the latter’s identification number adjacent to the CE marking in the car of each lift.
- 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.
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.
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.
Regulations 16, 18 and 20
SCHEDULE 9
TEXT OF ANNEX IX TO THE DIRECTIVE
CONFORMITY TO TYPE WITH RANDOM CHECKING FORSAFETY COMPONENTS FOR LIFTS
(module C 2)
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 1 and will enable a lift in which they are correctly incorporated to satisfy those requirements.
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.
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.
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.
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.
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.
Regulations 17, 18 and 20
SCHEDULE 10 TEXT OF ANNEX X TO THE DIRECTIVE
CONFORMITY TO TYPE BASED ON PRODUCT QUALITY ASSURANCE FOR LIFTS
(module E)
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 9, and satisfy the applicable essential health and safety requirements set out in Schedule 1.
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.
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 1.
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 5;
- (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 1. 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 fulfill the obligations arising from the quality system as approved and to maintain it so that it remains adequate and efficient.
4.1. The installer shall keep the notified body which has approved the quality system informed of any intended change to the system.
4.2. The notified body shall assess the modifications proposed and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary.
It shall notify its decision to the installer or, where appropriate, to his authorised representative. The notification shall contain the conclusions of the assessment and the reasoned assessment decision.
The notified body shall affix, or cause to be affixed, its identification number adjacent to the CE marking in accordance with Articles 18 and 19.
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.
The installer shall, for 10 years after the last lift has been installed, 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.
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 7stem approval decision(s) issued.
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 the Directive, and, under the responsibility of the notified body referred to in point 3.1, the latter’s identification number adjacent to the CE marking in the car of each lift.
- 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.
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.
Regulations 17, 18, 20, 33 and 36
SCHEDULE 11 TEXT OF ANNEX XI TO THE DIRECTIVE
CONFORMITY BASED ON FULL QUALITY ASSURANCE PLUS DESIGN EXAMINATION FOR LIFTS
(module H1)
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 1.
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.
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 4, 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 1. 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 1 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 5);
- (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
3.1. When the design is not entirely in accordance with harmonised standards, the notified body shall ascertain whether the design conforms to the essential health and safety requirements set out in Schedule 1 and, if it does, issue an EU design examination certificate to the installer, stating the limits of the certificate’s validity and giving the details required for identification of the approved design.
3.2. Where the design does not satisfy the applicable essential health and safety requirements set out in Schedule 1, 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 1, and shall determine whether such changes require further investigation. If so, the notified body shall inform the installer accordingly.
3.3. The installer shall keep the notified body that has issued the EU design examination certificate informed of any modification to the approved design that may affect the conformity with the essential health and safety requirements set out in Schedule 1 or the conditions for validity of the certificate. Such modifications shall require additional approval — from the notified body that issued the EU design examination certificate — in the form of an addition to the original EU design examination certificate.
3.4. Each notified body shall inform its notifying authority of the EU design examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of EU design examination certificates and/or any additions thereto refused, suspended or otherwise restricted.
Each notified body shall inform the other notified bodies of the EU design examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, of the certificates and/or additions thereto which it has issued.
The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU design examination certificates and/or additions thereto. On request, the Commission and the Member States may obtain a copy of the technical documentation and of the results of the examinations carried out by the notified body.
3.5. The installer shall keep a copy of the EU design examination certificate, its annexes and additions together with the technical documentation at the disposal of the national authorities for 10 years after the lift has been placed on the market.
- 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 1. 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 1 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 Articles 18 and 19.
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.
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.
Each notified body shall inform its notifying authority of full quality system approval decision(s) issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of approval decisions refused, suspended or otherwise restricted.
Each notified body shall inform the other notified bodies of quality system approval decision(s) which it has refused, suspended or withdrawn, and, upon request, of approval decisions which it has issued.
The notified body shall keep a copy of the approval decision issued, its annexes and additions, as well as the technical documentation for 15 years from the date of their issue.
On request, the notified body shall provide the Commission and the Member States with a copy of quality system approval decision(s) issued.
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 the Directive, and, under the responsibility of the notified body referred to in point 3.1, the latter’s identification number adjacent to the CE marking in the car of each lift.
- 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.
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.
Regulations 17, 18 and 20
SCHEDULE 12 TEXT OF ANNEX XII TO THE DIRECTIVE
CONFORMITY TO TYPE BASED ON PRODUCTION QUALITY ASSURANCE FOR LIFTS
(module D)
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 a 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 11, and satisfy the applicable essential health and safety requirements set out in Schedule 1.
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.
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 1.
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 1.
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.
4.1. The installer shall keep the notified body that has approved the quality system informed of any intended change to the system.
4.2. The notified body shall assess the modifications proposed and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary.
It shall notify its decision to the installer or, where appropriate, to his authorised representative. The notification shall contain the conclusions of the assessment and the reasoned assessment decision.
The notified body shall affix, or cause to be affixed, its identification number adjacent to the CE marking in accordance with Articles 18 and 19.
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.
The installer shall, keep at the disposal of the national authorities for a period ending of 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 points 3.4.2., and in points 4.3 and 4.4.
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.
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 the Directive, and, under the responsibility of the notified body referred to in point 3.1, the latter’s identification number adjacent to the CE marking in the car of each lift.
- 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.
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.
Regulation 2
SCHEDULE 13 TEXT OF ANNEX XIV TO THE DIRECTIVE
CORRELATION TABLE
| Directive 95/16/EC | Directive 2014/33/EU |
| Article 1(1) | Article 1(1), first subparagraph |
| — | Article 1(1), second subparagraph |
| Article 1(2), first subparagraph | Article 2(1) |
| Article 1(2), second subparagraph | Article 1(1) |
| Article 1(2), third subparagraph | |
| Article 1(3) | Article 1(2) |
| Article 1(4), first indent of first subparagraph | Article 2(6) |
| Article 1(4), second indent of first subparagraph | Article 2(5) |
| Article 1(4), fourth indent of first subparagraph | Article 2(7) |
| Article 1(4), fifth indent of first subparagraph | Article 2(3) |
| Article 1(4), second subparagraph | Article 16(3) |
| Article 1(4), third subparagraph | Article 16(4) |
| Article 1(5) | Article 1(3) |
| — | Article 2(1) |
| Article 2(1), first indent | Article 4(1) |
| Article 2(1), second indent | Article 4(2) |
| Article 2(2) | Article 6(1) |
| Article 2(3) | Article 6(2) |
| Article 2(4) | Article 3(3) |
| Article 2(5) | Article 3(2) |
| Article 3, first paragraph | Article 5(1) |
| Article 3, second paragraph | Article 5(2) |
| Article 4(1) | Article 3(1) |
| Article 4(2) | — |
| — | Articles 7 to 14 |
| Article 5(1) | Article 14 |
| Article 6(1) and (2) | — |
| Article 6(3) and (4) | Article 42 |
| Article 7(1), first subparagraph | Article 38(1) |
| Article 7(1), second subparagraph | Article 38(5) |
| Article 7(2), first subparagraph | Article 39(3) |
| Article 7(3) | |
| Article 7(4) | Article 40(4) |
| Article 8(1)(a) | Article 15 |
| Article 8(1)(b) and (c) | — |
| Article 8(2) | Article 16 |
| Article 8(3), first and third indents | Article 17(2) and Article 19(3) |
| Article 8(3), second indent | Article 7(3) |
| Article 8(4) | — |
| Article 8(5) | Article 12 |
| Article 9(1) | Article 20 |
| Article 9(2) | |
| Article 9(3) | Article 30(1) |
| — | |
| Article 10(1) | — |
| Article 10(2) | Article 19(1) |
| Article 10(3) | — |
| Article 10(4)(a) | Article 41(1)(a) |
| Article 10(4)(b) | — |
| Article 11 | — |
| — | Article 43 |
| Article 12 | — |
| Article 13 | — |
| Article 14 | — |
| Article 15(1) and (2) | — |
| Article 15(3) | Article 45(2) |
| Article 16 | Article 46 |
| Article 17 | Article 49 |
| Annex I | Annex I |
| Annex II, Part A | Annex II, Part A |
| Annex II, Part B | Annex II, Part B |
| Annex III | Article 18 |
| Annex IV | Annex III |
| Annex V, Part A | Annex IV, Part A |
| Annex V, Part B | Annex IV, Part B |
| Annex VI | Annex V |
| Annex VII | — |
| Annex VIII | Annex VI |
| Annex IX | Annex VII |
| Annex X | Annex VIII |
| Annex XI | Annex IX |
| Annex XII | Annex X |
| Annex XIII | Annex XI |
| Annex XIV | Annex XII |
| — | Annex XIII |
| — | Annex XIV |
GIVEN under my Official Seal,
26 May 2017.
MARY MITCHELL O’CONNOR,
Minister for Jobs, Enterprise and Innovation.
EXPLANATORY NOTE
(This note is not part of the Instrument and does not purport to be a legal interpretation.)
The Regulations transpose into national legislation the provisions of Directive 2014/33/EU, which set out the requirements for the making available on the market and putting into service, as well as the essential health and safety requirements relating to the design and installation of lifts and the manufacture of and making available on the market of safety components for lifts. These Regulations also set out the obligations on economic operators in relation to these products and the required conformity assessment procedures for such products. These Regulations also give further effect to Regulation (EC) No. 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No. 339/93 and include duties to have proper market surveillance procedures consistent with EU Regulation 765/2008.
The provisions of the Regulations come into immediate effect with the exception of Regulation 7(3) relating to the provisions of a refuge or free space beyond the extreme positions of a lift, which shall come into operation from 1 November 2017.
The Regulations do not impede the making available on the market of products covered by Directive 95/16/EC which are in conformity with that Directive and which were placed on the market before 20 April 2016.
The Regulations revoke and replace the European Communities (Lifts) Regulations 1998, ( S.I. No. 246 of 1998 ) and European Communities (Lifts) (Amendment) Regulations 2008 ( S.I. No. 406 of 2008 ).
Footnotes
OJ No. L 96, 29.3.2014, p.251.
OJ No. L 218, 13.8.2008, p.30.
OJ No. L 213, 7.9.1995, p.1.
OJ No. L 316, 14.11.2012, p.12.
OJ L 157, 9.6.2006, p. 24.
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