ANNEX IVCONFORMITY ASSESSMENT PROCEDURES FOR SUBSYSTEMS AND SAFETY COMPONENTS: MODULE D: CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE PRODUCTION PROCESS
1.
Conformity to type based on quality assurance of the production process is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 5, and ensures and declares on his sole responsibility that the subsystems or safety components concerned are in conformity with the type described in F1the type examination certificate and satisfy the requirements of this Regulation that apply to them.
2.Manufacturing
The manufacturer shall operate an approved quality system for production, final product inspection and testing of the subsystems or safety components concerned as specified in point 3, and shall be subject to surveillance as specified in point 4.
3.Quality system
3.1.The manufacturer shall lodge an application for assessment of his quality system with the 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 F2other approved body;
- (c)
all relevant information for the subsystems or safety components approved under module B;
- (d)
the documentation concerning the quality system;
- (e)
the technical documentation of the approved type and a copy of F3the type examination certificate(s);
- (f)
details of the premises where the subsystem or the safety component is manufactured.
3.2.The quality system shall ensure that the subsystems or safety components are in conformity with the type(s) described in F4the type examination certificate(s) and comply with the requirements of this Regulation that apply to them.
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:
- (a)
the quality objectives and the organisational structure, responsibilities and powers of the management with regard to the product quality;
- (b)
the corresponding 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 manufacture, and the frequency with which they will be carried out;
- (d)
the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.;
- (e)
the means of monitoring the achievement of the required product quality and the effective operation of the quality system.
3.3.F5The approved 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 F6relevant designated standard.
The audit shall include an assessment visit to the premises where the subsystems or the safety components are manufactured, inspected and tested.
In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation 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 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(e), to verify the manufacturer's ability to identify the relevant requirements of this Regulation and to carry out the necessary examinations with a view to ensuring compliance of the subsystems or safety components 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.
3.4.
The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient.
3.5.The manufacturer shall keep F7the approved body that has approved the quality system informed of any intended change to the quality system.
F8The 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.
It shall notify the manufacturer of the outcome of the evaluation. In case of a reassessment, it shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision.
4.Surveillance under the responsibility of F25the approved 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 shall, for assessment purposes, allow F9the approved body access to the manufacture, inspection, testing and storage sites, and shall provide it with all necessary information, in particular:
- (a)
the quality system documentation;
- (b)
the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.
4.3.
F10The approved body shall carry out periodic audits of at least once every two years to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report.
4.4.
In addition, F11the approved body may pay unexpected visits to the manufacturer. During such visits F11the approved body may, if necessary, carry out product tests, or have them carried out, in order to verify that the quality system is functioning correctly. F12The approved body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.
5.F26CE marking and EU declaration of conformity
5.1.
The manufacturer shall affix the F13UK marking and, under the responsibility of F14the approved body referred to in point 3.1, the latter's identification number to each individual subsystem or safety component that is in conformity with the type described in F15the type examination certificate and satisfies the applicable requirements of this Regulation.
5.2.The manufacturer shall draw up a written F16declaration of conformity for each subsystem or safety component model and keep it at the disposal of the F17Secretary of State for 30 years after the subsystem or the safety component has been placed on the market. The F16declaration of conformity shall identify the subsystem or safety component model for which it has been drawn up.
A copy of the F16declaration of conformity shall be made available to the relevant authorities upon request.
6.
The manufacturer shall, for a period of 30 years after the subsystem or safety component has been placed on the market, keep at the disposal of the F18Secretary of State:
- (a)
the documentation referred to in point 3.1;
- (b)
the information relating to the change referred to in point 3.5, as approved;
- (c)
the decisions and reports of the F19approved body referred to in points 3.5, 4.3 and 4.4.
7.
F20Each approved body shall inform F21the Secretary of State of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to F21the Secretary of State the list of quality system approvals refused, suspended or otherwise restricted.
F22Each approved body shall inform F23the other approved bodies of quality system approvals which it has refused, suspended, withdrawn or otherwise restricted, giving the reasons for its decision, and, upon request, of quality system approvals which it has issued.
F24...
F27The approved body shall keep a copy of each approval decision issued and its annexes and additions.
8.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.