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Regulation (EU) 2016/424 of the European Parliament and of the Council of 9 March 2016 on cableway installations and repealing Directive 2000/9/EC (Text with EEA relevance)
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Textual Amendments
F1Words in Annex 7 Point 3.1 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(a); 2020 c. 1, Sch. 5 para. 1(1)
The application shall include:
the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well;
all necessary information on the subsystems or safety components to be manufactured;
the technical documentation in accordance with Annex VIII for one representative type of each category of subsystem or safety component to be manufactured;
the documentation concerning the quality system;
the address of the premises where the subsystems or safety components are designed, manufactured, inspected and tested;
a written declaration that the same application has not been lodged with any other [F1approved body].
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. The quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records.
It shall, in particular, contain an adequate description of:
the quality objectives and the organisational structure, responsibilities and powers of the management with regard to the design and product quality;
the technical design specifications, including standards, that will be applied and, where the relevant [F2designated standards] will not be applied in full, the means, including other relevant technical specifications, that will be used to ensure that the essential requirements of this Regulation will be met;
the design control and design verification techniques, processes and systematic actions that will be used when designing the subsystems or the safety components;
the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used;
the examinations and tests to 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 on the personnel concerned, etc.;
the means of monitoring the achievement of the required design and product quality and the effective operation of the quality system.
Textual Amendments
F2Words in Annex 7 Point 3.2 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(b); 2020 c. 1, Sch. 5 para. 1(1)
Textual Amendments
F3Words in Annex 7 Point 3.3 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(c)(i)(aa); 2020 c. 1, Sch. 5 para. 1(1)
F4Words in Annex 7 Point 3.3 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(c)(i)(bb); 2020 c. 1, Sch. 5 para. 1(1)
The audit shall include an assessment visit to the premises where the subsystems or the safety components are designed, manufactured, inspected and tested.
In addition to experience in quality management systems, the auditing team shall have at least one member experienced as assessor in the field of cableway installations and in the technology of the subsystems or safety components concerned, and knowledge of the applicable requirements of this Regulation.
The auditing team shall review the technical documentation referred to in point 3.1 to verify the manufacturer's ability to identify the applicable requirements of this Regulation and to carry out the necessary examinations with a view to ensuring compliance of the subsystems or the safety components with those requirements.
[F5The approved body] shall notify its decision to the manufacturer or his authorised representative. The notification shall contain the conclusions of the audit and the reasoned assessment decision.
Textual Amendments
F5Words in Annex 7 Point 3.3 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(c)(ii); 2020 c. 1, Sch. 5 para. 1(1)
Textual Amendments
F6Words in Annex 7 Point 3.5 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(d)(i); 2020 c. 1, Sch. 5 para. 1(1)
[F7The approved body] shall evaluate any proposed changes 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.
Textual Amendments
F7Words in Annex 7 Point 3.5 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(d)(ii); 2020 c. 1, Sch. 5 para. 1(1)
It shall notify the manufacturer or the authorised representative of its decision. The notification shall contain the conclusions of the assessment and the reasoned assessment decision.
Textual Amendments
F8Words in Annex 7 Point 3.6.1 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(e); 2020 c. 1, Sch. 5 para. 1(1)
It shall include:
the name and address of the manufacturer;
a written declaration that the same application has not been lodged with any [F9other approved body];
the technical documentation as described in Annex VIII.
Textual Amendments
F9Words in Annex 7 Point 3.6.3 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(f); 2020 c. 1, Sch. 5 para. 1(1)
That certificate and its annexes shall contain all relevant information to allow the conformity of manufactured subsystems or safety components with the examined design to be evaluated and to allow for in-service control, where applicable.
Where the design does not satisfy the applicable requirements of this Regulation, [F12the approved body] shall refuse to issue [F13a design examination] certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.
Textual Amendments
F12Words in Annex 7 Point 3.6.3 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(g)(ii)(aa); 2020 c. 1, Sch. 5 para. 1(1)
F13Words in Annex 7 Point 3.6.3 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(g)(ii)(bb); 2020 c. 1, Sch. 5 para. 1(1)
Textual Amendments
F10Words in Annex 7 Point 3.6.3 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(g)(i)(aa); 2020 c. 1, Sch. 5 para. 1(1)
F11Words in Annex 7 Point 3.6.3 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(g)(i)(bb); 2020 c. 1, Sch. 5 para. 1(1)
The manufacturer shall keep [F16the approved body] that has issued the [F17design examination] certificate informed of any modification to the approved design that may affect the conformity with the essential requirements of this Regulation or the conditions for validity of the certificate. Such modifications shall require additional approval from [F16the approved body] that issued the [F17design examination] certificate in the form of an addition to the original [F17design examination] certificate.
Textual Amendments
F16Words in Annex 7 Point 3.6.4 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(h)(ii)(aa); 2020 c. 1, Sch. 5 para. 1(1)
F17Words in Annex 7 Point 3.6.4 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(h)(ii)(bb); 2020 c. 1, Sch. 5 para. 1(1)
Textual Amendments
F14Words in Annex 7 Point 3.6.4 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(h)(i)(aa); 2020 c. 1, Sch. 5 para. 1(1)
F15Words in Annex 7 Point 3.6.4 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(h)(i)(bb); 2020 c. 1, Sch. 5 para. 1(1)
[F21Each approved body] shall inform the [F22other approved bodies] of [F23the 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.
Textual Amendments
F21Words in Annex 7 Point 3.6.5 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(i)(ii)(aa); 2020 c. 1, Sch. 5 para. 1(1)
F22Words in Annex 7 Point 3.6.5 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(i)(ii)(bb); 2020 c. 1, Sch. 5 para. 1(1)
F23Words in Annex 7 Point 3.6.5 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(i)(ii)(cc); 2020 c. 1, Sch. 5 para. 1(1)
[F24The other approved bodies may, on request, obtain a copy of the design examination certificates and any additions thereto.]
Textual Amendments
F24Words in Annex 7 Point 3.6.5 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(i)(iii); 2020 c. 1, Sch. 5 para. 1(1)
[F25The approved body] shall keep a copy of [F26the design examination] certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer until the expiry of the validity of the certificate.
Textual Amendments
F25Words in Annex 7 Point 3.6.5 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(i)(iv)(aa); 2020 c. 1, Sch. 5 para. 1(1)
F26Words in Annex 7 Point 3.6.5 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(i)(iv)(bb); 2020 c. 1, Sch. 5 para. 1(1)
Textual Amendments
F18Words in Annex 7 Point 3.6.5 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(i)(i)(aa); 2020 c. 1, Sch. 5 para. 1(1)
F19Words in Annex 7 Point 3.6.5 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(i)(i)(bb); 2020 c. 1, Sch. 5 para. 1(1)
F20Words in Annex 7 Point 3.6.5 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(i)(i)(cc); 2020 c. 1, Sch. 5 para. 1(1)
Textual Amendments
F27Words in Annex 7 Point 3.6.6 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(j)(i); 2020 c. 1, Sch. 5 para. 1(1)
F28Words in Annex 7 Point 3.6.6 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(j)(ii); 2020 c. 1, Sch. 5 para. 1(1)
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