- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Pwynt Penodol mewn Amser (23/04/2009)
- Gwreiddiol (Fel y’i mabwysiadwyd gan yr UE)
Directive 2009/23/EC of the European Parliament and of the Council of 23 April 2009 on non-automatic weighing instruments (Codified version) (Text with EEA relevance) (repealed)
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Version Superseded: 20/04/2016
EU Directives are published on this site to aid cross referencing from UK legislation. Since IP completion day (31 December 2020 11.00 p.m.) no amendments have been applied to this version.
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 in addition,
a written declaration that the application has not been lodged with any other notified body,
the design documentation, as described in Annex III.
The applicant shall place at the disposal of the notified body an instrument, representative of the production envisaged, hereinafter the ‘type’.
The certificate shall have a validity period of 10 years from the date of its issue, and may be renewed for subsequent periods of 10 years each.
In the event of fundamental changes to the design of the instrument, e.g. as a result of the application of new techniques, the validity of the certificate may be limited to two years and extended by three years.
applications received for EC type-examination,
EC type-approval certificates issued,
applications for type-certificates refused,
additions and amendments relating to documents already issued.
Each notified body shall moreover inform all the Member States forthwith of withdrawals of EC type-approval certificates.
Each Member State shall make this information available to the bodies which it has notified.
Modifications to the approved type must receive additional approval from the notified body that issued the EC type-approval certificate where such changes influence conformity with the essential requirements of this Directive or the prescribed conditions for use of the instrument. This additional approval is given in the form of an addition to the original EC type-approval certificate.
The manufacturer or his authorised representative established within the Community shall affix the ‘CE’ conformity marking to each instrument and the inscriptions provided for in Annex IV and shall draw up a written declaration of conformity.
The ‘CE’ conformity marking shall be accompanied by the identification number of the notified body responsible for the EC surveillance referred to in point 2.4.
The application shall include:
an undertaking to carry out the obligations arising from the approved quality system,
an undertaking to maintain the approved quality system to ensure its continuing suitability and effectiveness.
The manufacturer shall make available to the notified body all relevant information, in particular the quality system’s documentation and the design documentation of the instrument.
All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written rules, procedures and instructions. This quality system documentation shall ensure a proper understanding of the quality programmes, plans, manuals and records.
It shall contain in particular an adequate description of:
the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality,
the manufacturing process, the quality control and assurance techniques and the systematic measures 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 means to monitor the achievement of the required product quality and the effective operation of the quality system.
It shall notify its decision to the manufacturer and inform the other notified bodies thereof. The notification to the manufacturer shall contain the conclusions of the examination and, in the event of refusal, the justification for the decision.
the quality system documentation,
the design documentation,
the quality records, e.g. the inspection reports and tests and calibration data, reports on the qualifications of the personnel concerned, etc.
The notified body shall periodically carry out audits in order to ensure that the manufacturer is maintaining and applying the quality system; it shall provide the manufacturer with an audit report.
In addition, the notified body may carry out unscheduled visits to the manufacturer. During such visits, the notified body may carry out full or partial audits. It shall provide the manufacturer with a report on the visit, and, where appropriate, an audit report.
The notified body shall affix, or cause to be affixed, its identification number to the instrument the conformity of which to requirements has been established, and shall draw up a written certificate of conformity concerning the tests carried out.
The party which carries out the second stage of the procedure shall carry out those examinations and tests that have not yet been carried out.
The manufacturer or his authorised representative shall ensure that he is able to supply the notified body’s certificates of conformity on request.
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