United Kingdom Statutory Instruments

(a) a safety analysis is undertaken; and

(b) a safety report is prepared.

    (3) The main contractor shall ensure, in relation to the construction or modification of a cableway installation that - 

(a) that installation complies with - 


(i) any relevant measures specified in the safety report,

(ii) special conditions (if any) imposed by the Executive under regulation 17(8), and

(iii) conditions imposed (if any) by the Secretary of State under regulation 19(3) with the stage 1 authorisation;



(b) that installation complies with such of the essential requirements as relate to that type of installation;

(c) a technical file has been compiled which contains - 



(i) the safety analysis;

(ii) the safety report; and

(iii) the declarations of conformity and the accompanying technical documentation relating to any safety component or subsystem which forms a part of the cableway installation.

(a) appointed by the Secretary of State as a notified body for the purpose of these Regulations and notified to the Commission and other Member States pursuant to regulation 15; or

(b) appointed by a Member State other than the United Kingdom and notified by the Member State concerned to the Commission and the other Member States pursuant to Article 16(1) of the Cableway Installations Directive;

(a) sections 19 to 22 (enforcement);

(b) sections 23 (provisions supplementary to 21 and 22) and 24 (appeal against improvement or prohibition notice);

(c) sections 25A (power of customs officers to detain articles and substances) and 26 (power to indemnify inspectors);

(d) section 27 (obtaining of information) and section 27A (information communicated by the Commissioners of Customs and Excise);

(e) sections 33 to 42 (provisions as to offences); and

(f) Section 48(1) to (3) (application to the Crown).

 -  eliminate or, if that is not possible, reduce risks by means of design and construction features,

 -  define and implement all necessary measures to protect against risks which cannot be eliminated by the design and construction features,

 -  define and state the precautions which should be taken to avoid the risks which it has not been possible to eliminate completely by means of the provisions and measures referred to in the first and second indents.

     2.3. Consideration of external factors

Installations must be so designed and constructed as to make it possible to operate them safely, taking into account the type of installation, the nature and physical features of the terrain on which it is installed, its surroundings and atmospheric and meteorological factors, as well as possible structures and obstacles located in the vicinity either on the ground or in the air.

     2.4. Dimensions

The installation, the subsystems and all its safety components must be dimensioned, designed and constructed to withstand, with a sufficient degree of safety, all stresses encountered under all foreseeable conditions, including those which occur when not in operation, and taking account in particular of outside influences, dynamic effects and fatigue phenomena, while complying with the acknowledged rules of the art, in particular with regard to the choice of materials.

     2.5. Assembly

     2.5.1. The installation, the subsystems and all the safety components must be designed and constructed in such a way as to ensure that they can be safely assembled and put into place.

     2.5.2. The safety components must be so designed as to make assembly mistakes impossible, either as a result of construction or by means of appropriate markings on the components themselves.

     2.6. Integrity of the installation

     2.6.1. The safety components must be designed and constructed and be usable in such a way as to ensure that, in every case, their own operational integrity and/or the safety of the installation is ensured, as defined in the safety analysis in Annex III, so that their failure is highly improbable and with an adequate safety margin.

     2.6.2. The installation must be designed and constructed in such a way as to ensure that, during its operation, any failure of a component which might affect safety, even indirectly, is met by an appropriate measure being taken in good time.

     2.6.3. The safeguards referred to in points 2.6.1 and 2.6.2 must apply throughout the period between two scheduled inspections of the component concerned. The time period for the scheduled inspection of the safety components must be clearly indicated in the instruction manual.

     2.6.4. Safety components which are incorporated into installations as spare parts must satisfy the essential requirements of this Directive and the conditions relating to the smooth interaction with the other parts of the installations.

     2.6.5. Measures must be taken to ensure that the effects of a fire in the installation do not endanger the safety of persons being transported and workers.

     2.6.6. Special measures must be taken to protect installations and persons from the effects of lightning.

     2.7. Safety devices

     2.7.1. Any defect in the installation which could result in a failure endangering safety must, where practicable, be detected, reported and processed by a safety device. The same applies to any normally foreseeable external event which may endanger safety.

     2.7.2. It must be possible at all times to shut down the installation manually.

     2.7.3. After the installation has been shut down by a safety device, it must not be possible to restart it unless appropriate action has been taken.

     2.8. Maintainability

The installation must be designed and constructed so as to enable routine or special maintenance and repair operations and procedures to be carried out safely.

     2.9. Nuisance

The installation must be designed and constructed in such a way as to ensure that any internal or external nuisance resulting from noxious gases, noise emissions or vibrations falls within the prescribed limits.

     3. Infrastructure requirements


     3.1. Layout, speed, distance between vehicles

     3.1.1. The installation must be designed to operate safely taking into account the characteristics of the terrain and its surroundings, atmospheric and meteorological conditions, any possible structures and obstacles located in the vicinity either on the ground or in the air in such a way as to cause no nuisance or pose no danger under any operational or servicing conditions or in the event of an operation to rescue persons.

     3.1.2. Sufficient distance must be maintained laterally and vertically between vehicles, towing devices, tracks, cables, etc., and possible structures and obstacles located in the vicinity either on the ground or in the air, taking account of the vertical, longitudinal and lateral movement of the cables and vehicles or of the towing devices under the most adverse foreseeable operating conditions.

     3.1.3. The maximum distance between vehicles and ground must take account of the nature of the installation, the type of vehicles and the rescue procedures. In the case of open cars it must also take account of the risk of fall as well as the psychological aspects associated with the distance between vehicles and ground.

     3.1.4. The maximum speed of the vehicles or towing devices, the minimum distance between them and their acceleration and braking performance must be chosen to ensure the safety of persons and the safe operation of the installation.

     3.2. Stations and structures along the line

     3.2.1. Stations and structures along the line must be designed, installed and equipped so as to ensure stability. They shall permit safe guidance of the cables, vehicles and the towing devices, and enable maintenance to be safely carried out, under all operating conditions.

     3.2.2. The entry and exit areas of the installation must be designed so as to guarantee the safety of the traffic of vehicles, towing devices and persons. The movement of vehicles and towing devices in the stations must be capable of taking place without risk to persons, taking into account their possible active collaboration to their movement.

     4. Requirements relating to cables, drives and brakes and to mechanical and electrical installations

     4.1. Cables and their supports

     4.1.1. All measures must be taken in line with the latest technological developments:

 -  to avoid cables or their attachments breaking,

 -  to cover their minimum and maximum stress values,

 -  to ensure that they are safely mounted on their supports and prevent derailment,

 -  to enable them to be monitored.

     4.1.2. It is not possible to prevent all risk of cable derailment, measures must be taken to ensure that cables can be retrieved and the installations shut down without risk to persons in the event of derailment.

     4.2. Mechanical installations

     4.2.1. Drives

The drive system of an installation must be of a suitable performance and capability, adapted to the various operating systems and modes.

     4.2.2. Standby drive

The installation must have a standby drive with an energy supply which is independent of that of the main drive system. A standby drive is not, however, necessary if the safety analysis shows that people can leave the vehicles and, in particular, towing devices easily, quickly and safely even if a standby drive is not available.

     4.2.3. Braking

     4.2.3.1. In an emergency, it must be possible to shut down the installation and/or the vehicles at any moment, under the most unfavourable conditions in terms of authorised load and pulley adhesion during operation. The stopping distance must be as short as the security of the installation dictates.

     4.2.3.2. Deceleration values must be within adequate limits fixed in such a way to ensure both the safety of the persons and the satisfactory behaviour of the vehicles, cables and other parts of the installation.

     4.2.3.3. In all installations there must be two or more braking systems, each capable of bringing the installation to a halt, and co-ordinated in such a way that they automatically replace the active system when its efficiency becomes inadequate. The traction cable's last braking system must act directly on the driving pulley. These provisions do not apply to drag lifts.

     4.2.3.4. The installation must be fitted with an effective clamp and locking mechanism to guard against premature restarts.

     4.3. Control devices

The control devices must be designed and constructed so as to be safe and reliable, to withstand normal operating stresses and external factors such as humidity, extreme temperatures or electromagnetic interference and so as not to cause dangerous situations, even in the event of operational error.

     4.4. Communication devices

Suitable facilities must be provided to enable operational staff to communicate with one another at all times and to inform users in case of emergency.

     5. Vehicles and towing devices


     5.1. Vehicles and/or towing devices must be designed and fitted out in such a way that under foreseeable operating conditions no person can fall out or encounter any other risks.

     5.2. The fittings of vehicles and towing devices must be dimensioned and constructed so as not to:

 -  damage the cable, or

 -  slip, except where slippage does not significantly affect the safety of the vehicle, the towing device or the installation

under the most unfavourable conditions.

     5.3. Vehicle doors (on cars, cabins) must be designed and constructed in such a way as to make it possible to close and lock them. The vehicle floor and walls must be designed and constructed so as to withstand pressure and loads exerted by users under any circumstances.

     5.4. If for reasons of operational safety an operator is required on board the vehicle, the vehicle must be fitted with the equipment required for him to carry out his tasks.

     5.5. Vehicles and/or towing devices and, in particular, their suspension mechanisms must be designed and fitted so as to ensure the safety of workers servicing them in accordance with appropriate rules and instructions.

     5.6. In the case of vehicles equipped with disconnectable fittings, all measures must be taken to bring to a halt, without risk to users, at the moment of departure, any vehicle whose fitting has been incorrectly connected to the cable and, at the moment of arrival, any vehicle whose fitting has not been disconnected, and to prevent the vehicle from falling.

     5.7. Funicular vehicles and, in so far as the configuration of the installation so permits, bi-cable cable cars must be equipped with an automatic braking device on the track, when the possibility of carrier cable breaking cannot reasonably be excluded.

     5.8. Where all risk of derailment of the vehicle cannot be eliminated by other measures, the vehicle must be fitted with an anti-derailment device which enables the vehicle to be brought to a halt without risk to persons.

     6. Equipment for users
The access to embarkation areas and exit from disembarkation areas and the embarkation and disembarkation of users must be organised with regard to the movement and stopping of vehicles in such a way as to ensure the safety of persons, in particular in areas where there is a risk of falling.

It must be possible for children and persons with reduced mobility to use the installation safely if the installation is designed for the transport of such persons.

     7. Operability


     7.1. Safety

     7.1.1. All technical provisions and measures must be taken to ensure that the installation is used for its intended purpose according to its technical specification and to the specified operating conditions and that the instructions on safe operation and maintenance can be complied with. The instruction manual and the corresponding notes shall be drawn up in an official language or languages of the Community which may be determined in accordance with the Treaty by the Member State in the territory of which the installation is constructed.

     7.1.2. The persons responsible for operating the installation must be provided with the appropriate material resources and must be qualified to carry out the task in hand.

     7.2. Safety in the event of immobilisation of the installation

All technical provisions and measures must be adopted to ensure that users can be brought to safety within a set time appropriate to the type of installation and its surroundings when the installation is immobilised and cannot be restarted quickly.

     7.3. Other special provisions concerning safety

     7.3.1. Operators' stands and workplaces

Movable parts which are normally accessible in the stations must be designed, constructed and installed in such a way as to preclude any risks or, where such risks exist, be fitted with protective devices so as to prevent any contact with parts of the installation which may cause accidents. These devices must be of a type that cannot easily be removed or rendered inoperative.

     7.3.2. Risk of falling

Workplaces and working areas, including those used only occasionally, and the access to them, must be designed and constructed in such a way as to prevent persons required to work or move in them from falling. Should the construction not be adequate, they must also be provided with anchorage points for personal protective equipment to prevent falls.

 -  they are capable of reacting to an initial breakdown or failure detected so as to remain either in a state that guarantees safety, in a lower operating mode or in a fail-safe state,

 -  they are redundant and are monitored, or

 -  they are such that the probability of their failure can be evaluated and they are of a standard equivalent to that achieved by safety devices that meet the criteria in the first and second indents.

Safety analysis must be used to draw up the inventory of risks and dangerous situations in accordance with Article 4(1) of this Directive and to determine the list of safety components referred to in Article 4(2) thereof. The result of the safety analysis must be summarised in a safety report.

 -  the references of this Directive,

 -  name, business name and full address of the manufacturer or his authorised representative established in the Community. An authorised representative must also give the name, business name and full address of the manufacturer,

 -  description of the component (make, type, etc.),

 -  details of the conformity declaration procedure used (Article 7 of this Directive),

 -  all relevant provisions with which the component must comply and, in particular, the conditions of use,

 -  the name and address of any body notified, involved in the conformity procedure and the date of the EC examination certificate with details, where appropriate, of the duration and conditions of validity of the certificate,

 -  where appropriate, the reference of the harmonised standards applicable,

 -  identification of the person empowered to sign on behalf of the manufacturer or his authorised representative established in the Community.

 -  the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well,

 -  a written declaration that the same application has not been lodged with any other notified body,

 -  the technical documentation, as described in point 3.

The applicant must place at the disposal of the notified body a specimen, representative of the production envisaged and hereinafter called "type". The notified body may request further specimens if needed for carrying out the test programme.

     3. The technical documentation must enable the conformity of the component with the requirements of this Directive to be assessed. It must, as far as is relevant for such assessment, cover the design, manufacture and operation of the component.

The documentation must contain as far as is relevant to assessment:

 -  a general type-description,

 -  conceptual design and manufacturing drawings and schemes of components, subassemblies, circuits, etc.,

 -  descriptions and explanations necessary for the understanding of the said drawings and schemes and the operation of the product,

 -  the list of the European specifications referred to in Article 2(2) of this Directive, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements where the European specifications referred to in Article 2(2) of this Directive do not exist,

 -  the results of design calculations made, examinations carried out, etc.,

 -  test reports.

It must also indicate the field of use of the component.

     4. The notified body:

     4.1. must examine the technical documentation, verify that the type has been manufactured in conformity with the technical documentation and identify the components which have been designed in accordance with the relevant provisions of the European specifications referred to in Article 2(2) of this Directive as well as those which have been designed without applying the relevant provisions of those European specifications;

     4.2. must perform or have performed the appropriate examinations and necessary tests to check whether, where the European specifications referred to in Article 2(2) of this Directive have not been applied, the solutions adopted by the manufacturer meet the essential requirements of this Directive;

     4.3. must perform or have performed the appropriate examinations and necessary tests to check whether, where the manufacturer has chosen to apply the relevant European specifications, these have actually been applied;

     4.4. must agree with the applicant the location where the examinations and necessary tests are to be carried out.

     5. Where the type meets the provisions of this Directive, the notified body must issue an EC type-examination certificate to the applicant. The certificate must state the name and address of the manufacturer, the conclusions of the examination, the conditions for its validity, the duration thereof and give the necessary data for identification of the approved type.

A list of the relevant parts of the technical documentation must be annexed to the certificate and a copy kept by the notified body. If the notified body refuses to issue an EC-type certificate to the manufacturer, the former must provide detailed reasons for such refusal. Provision must be made for an appeals procedure.

     6. The applicant must inform the notified body that holds the technical documentation concerning the EC type-examination certificate of all modifications of the approved component which must receive additional approval where such changes may affect the conformity of the component with the essential requirements for the prescribed conditions for its use. This additional approval is given in the form of an addition to the original EC type-examination certificate.

     7. Each notified body must communicate to the other notified bodies the relevant information concerning the EC type-examination certificates and additions issued and withdrawn.

     8. The other notified bodies may receive copies of the EC type-examination certificates and/or their additions. The Annexes to the certificates must be kept at the disposal of the other notified bodies.

     9. The manufacturer or his authorised representative must keep with the technical documentation copies of EC type-examination certificates and their additions for at least 30 years after the last component has been manufactured.

Where neither the manufacturer nor his authorised representative is established within the Community, the obligation to keep the technical documentation available is the responsibility of the person who places the component on the Community market.

 -  all relevant information for the component category envisaged,

 -  the documentation concerning the quality system,

 -  if applicable, the technical documentation of the approved type and a copy of the EC type-examination certificate.

     3.2. The quality system must ensure compliance with the type as described in the EC type-examination certificate and with the requirements of this Directive.

All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. The quality system documentation must permit a consistent interpretation of the quality programmes, plans, manuals and records.

It must in particular contain an adequate description of:

 -  the quality objectives and the organisational structure, responsibilities and powers of the management with regard to competent quality,

 -  the manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used,

 -  the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out,

 -  the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.,

 -  the means to monitor the achievement of the required component quality and the effective operation of the quality system.

     3.3. The notified body must assess the quality system to determine whether it satisfies the requirements referred to in point 3.2. It presumes conformity with these requirements in respect of quality systems that implement the relevant harmonised standards.

The auditing team must have at least one member with experience of evaluating in the component technology concerned. The evaluation procedure must include an inspection visit to the manufacturer's premises.

The decision must be notified to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision.

     3.4. The manufacturer must undertake to discharge the obligations arising from the quality system as approved and to maintain it in an appropriate and efficient manner at a proper and efficient level.

The manufacturer or his authorised representative must keep the notified body that has approved the quality system informed of any intended updating of the quality system.

The notified body must evaluate the modifications proposed and decide whether the modified quality system will still satisfy the requirements referred to in paragraph 3.2 or whether a reassessment is required.

It must notify its decision to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision.

     4. Surveillance under the responsibility of the notified body

     4.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

     4.2. The manufacturer must allow the notified body entrance for inspection purposes to the places of manufacture, inspection and testing, and storage, and must provide it with all necessary information, in particular:

 -  the quality system documentation,

 -  the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.

     4.3. The notified body must periodically carry out audits to make sure that the manufacturer maintains and applies the quality system and must provide an audit report to the manufacturer.

     4.4. Additionally the notified body may pay unexpected visits to the manufacturer. During such visits the notified body may carry out or cause to be carried out, tests to verify that the quality system is functioning correctly, if necessary. The notified body must provide the manufacturer with a visit report and, if a test has taken place, a test report.

     5. The manufacturer must, for period ending at least 30 years after the last component has been manufactured, keep at the disposal of the national authorities:

 -  the documentation referred to in the second indent of the second subparagraph of point 3.1,

 -  the updating referred to in the second paragraph of point 3.4,

 -  the decisions and reports from the notified body which are referred to in points 3.4, 4.3 and 4.4.

     6. Each notified body must give the other notified bodies the relevant information concerning all quality system approvals issued and withdrawn.

 -  a statistical method,

 -  a sampling plan with its operational characteristics.

     5.4. In the case of accepted lots, the notified body must affix, or cause to be affixed, its identification number to each component, and shall draw up a written certificate of conformity relating to the tests carried out. All components in the lot may be put on the market, except those components from the sample which were found not to be in conformity.

If a lot is rejected, the notified body or the competent authority must take appropriate measures to prevent the putting on the market of that lot. In the event of the frequent rejection of lots the notified body may suspend statistical verification.

The manufacturer may, under the responsibility of the notified body, affix the latter's identification number during the manufacturing process.

     5.5. The manufacturer or his authorised representative must ensure that he is able to supply the notified body's certificates of conformity on request.

 -  a general description of the type,

 -  conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,

 -  descriptions and explanations necessary for the understanding of said drawings and schemes and the operation of the component,

 -  a list of the relevant European specifications applied in total or partially referred to in Article 2(2) of this Directive, as well as a description of the solutions adopted by the manufacturer to meet the essential requirements of the Directive, where the European specifications referred to in Article 2(2) have not been applied,

 -  the results of the design calculations made, examinations carried out, etc.,

 -  test reports,

 -  fields of use of components.

 -  all relevant information for the category of component envisaged,

 -  the documentation relating to the quality system.

     3.2. The quality system must ensure compliance of the components with the relevant requirements of this Directive.

All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation shall ensure a common understanding of the quality policies and procedures such as quality programmes, plans, manuals and records.

It must in particular include an adequate description of:

 -  the quality objectives and the organisational structure, responsibilities and powers of the management with regard to design and component quality,

 -  the technical design specifications, including the European specifications referred to in Article 2(2) of this Directive, that will be applied and, where the European specifications will not be applied in full, the means that will be used to ensure that the essential requirements of this Directive that apply to the products will be met,

 -  the design control and design verification techniques, processes and systematic actions that will be used when designing the components pertaining to the category of components covered,

 -  the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used,

 -  the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out,

 -  the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.,

 -  the means to monitor the achievement of the required design and component quality and the effective operation of the quality assurance system.

     3.3. The notified body must assess the quality system to determine whether it satisfies the requirements referred to in point 3.2. It shall presume compliance with these requirements in respect of quality systems that implement the relevant harmonised standard.

The auditing team must have at least one member experienced as an assessor in the product technology concerned. The evaluation procedure shall include an assessment visit to the manufacturer's premises.

The decision must be notified to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision.

     3.4. The manufacturer must undertake to fulfil the obligations arising from the quality system as approved and to uphold it so that it remains adequate and efficient.

The manufacturer or his authorised representative must keep the notified body that has approved the quality system informed of any intended updating of the quality system.

The notified body must evaluate the modifications proposed and decide whether the amended quality system will still satisfy the requirements referred to in paragraph 3.2 or whether a reassessment is required.

It must notify its decision to the manufacturer. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

     4. Surveillance under the responsibility of the notified body

     4.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

     4.2. The manufacturer must allow the notified body entrance for inspection purposes to the places of design, manufacture, inspection and testing, and storage, and shall provide it with all necessary information, in particular:

 -  the quality system documentation,

 -  the quality records as provided for by the design part of the quality system, such as results of analyses, calculations, tests, etc.,

 -  the quality records as provided for by the manufacturing part of the quality system, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.

     4.3. The notified body must periodically carry out audits to make sure that the manufacturer maintains and applies the quality system and shall provide an audit report to the manufacturer.

     4.4. Additionally, the notified body may pay unexpected visits to the manufacturer. At the time of such visits, the notified body may carry out tests or have them carried out in order to check the proper functioning of the quality system where necessary; it must provide the manufacturer with a visit report and, if a test has been carried out, with a test report.

     5. The manufacturer must, for a period ending at least 30 years after the last component has been manufactured, keep at the disposal of the national authorities:

 -  the documentation referred to in the second indent of the second subparagraph of point 3.1,

 -  the updating referred to in the second subparagraph of point 3.4,

 -  the decisions and reports from the notified body which are referred to in points 3.4, 4.3 and 4.4.

     6. Each notified body must forward to the other notified bodies the relevant information concerning the quality system approvals issued and withdrawn.

     7. Supplementary requirements; design examination

     7.1. The manufacturer must lodge an application for examination of the design with a single notified body.

     7.2. The application must enable the design, manufacture and operation of the component to be understood, and shall enable conformity with the requirements of this Directive to be assessed.

It must include:

 -  the technical design specifications, including the European specifications referred to in Article 2(2) of this Directive that have been applied,

 -  the necessary supporting evidence for their adequacy, in particular where the European specifications referred to in Article 2(2) of this Directive have not been applied in full. This supporting evidence must include the results of tests carried out by the appropriate laboratory of the manufacturer or on his behalf.

     7.3. The notified body must examine the application and where the design meets the provisions of this Directive, must issue an EC design examination certificate to the applicant. The certificate shall contain the conclusions of the examination, conditions for its validity, the necessary data for identification of the approved design and, if relevant, a description of the component's functioning.

     7.4. The applicant must keep the notified body that issued the EC design examination certificate informed of any modification to the approved design. Modifications to the approved design must receive additional approval from the notified body that issued the EC design examination certificate where such changes may affect conformity to the essential requirements referred to in Article 3(1) of this Directive or the prescribed conditions for use of the component. This additional approval is given in the form of an addition to the original EC design examination certificate.

     7.5 The notified bodies must forward to the other notified bodies the relevant information concerning:

 -  the EC design examination certificates and additions issued,

 -  the EC design approvals and additional approvals withdrawn,

 -  the EC design examination certificates and additions refused.

 -  the reference of this Directive,

 -  the name and address of the person who ordered EC examination,

 -  a description of the subsystem,

 -  the name and address of the notified body which carried out the EC examination, referred to in Article 11 of this Directive,

 -  all relevant provisions with which the subsystem must comply, in particular any operating restrictions or operating conditions,

 -  the outcome of EC examination referred to in Annex VII (EC conformity certificate),

 -  particulars of the person who is authorised to sign a legally binding declaration for the manufacturer, or his authorised representative or, where such a person is not available, the natural or legal person, who places the subsystem on the market.

 -  in conformity with the provisions of the Directive and other relevant provisions in compliance with the Treaty,

 -  in conformity with the technical documentation, and

 -  completed.

     2. The examination of the subsystem is carried out at each of the following stages:

 -  design,

 -  construction and acceptance trials once the subsystem has been completed.

     3. The technical documentation accompanying the examination certificate must comprise the following:

 -  construction plans and calculations, electrical and hydraulic diagrams, control circuit diagrams, description of computer and automatic systems, operating and servicing instructions, etc.,

 -  a list of the safety components referred to in Article 4(2) of this Directive which are used in the subsystem,

 -  copies of the EC declaration of conformity as provided for in Annex IV for these safety components together with the corresponding construction plans and a copy of the reports on any other tests and trials carried out.

     4. Documentation and correspondence in connection with EC examination procedures must be drawn up in the same language or languages as the instruction manual referred to in point 7.1.1 of Annex II.

     5. Surveillance

     5.1. It shall be ensured by means of surveillance that during construction of the subsystem the obligations arising from the technical documentation are fulfilled.

     5.2. The notified body responsible for EC examination must have permanent access to the production shops, storage areas and, where necessary, to prefabrication areas, testing plants and more generally to any locations it feels it needs to visit in order to perform its task. The manufacturer or his authorised representative or, where such a person is not available, the natural or legal person who places the subsystem on the market must provide it with, or arrange for it to be provided with, any documents required to that end, notably the plans and technical documentation relating to the subsystem.

     5.3. The notified body responsible for EC examination must periodically carry out audits to ensure compliance with the provisions of this Directive. On each visit it must provide the site supervisor responsible with an audit report. It may ask to be brought in to inspect various stages of the work.

     5.4. In addition, the notified body may pay unexpected visits to the production shops. During such visits it may carry out full or partial audits. The notified body must draw up a report on the visit and, where necessary, submit an audit report to the site supervisor responsible.

     6. Each notified body must publish periodically the relevant information concerning:

 -  all applications for EC examination received,

 -  all EC examination certificates issued,

 -  all EC examination certificates refused.

 -  sound technical and professional training,

 -  satisfactory knowledge of the requirements of the tests they carry out and adequate experience of such tests,

 -  the ability required to draw up the certificates, records and reports required to authenticate the performance of the tests.

     5. The impartiality of inspection staff must be guaranteed. Their remuneration must not depend on the number of tests carried out or on the results of such tests.

     6. The notified body must take out civil liability insurance unless its liability is assumed by the State in accordance with national law or the Member State itself is directly responsible for the inspections.

     7. The staff of the body must be bound by professional secrecy (except vis-à-vis the competent administrative authorities of the State in which its activities are carried out) with regard to all information it acquires in carrying out its tasks under this Directive or any provision of national law giving effect to it.