- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Pwynt Penodol mewn Amser (01/01/2007)
- Gwreiddiol (Fel y’i mabwysiadwyd gan yr UE)
Directive 2004/22/EC of the European Parliament and of the Council of 31 March 2004 on measuring instruments (Text with EEA relevance) (repealed)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Version Superseded: 20/04/2016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:
all relevant information for the instrument category envisaged;
the documentation concerning the quality system;
the technical documentation of the approved type and a copy of the EC-type examination certificate.
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 must permit a consistent interpretation 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 examinations and tests that will be carried out after manufacture;
the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.;
the means to monitor the effective operation of the quality system.
In addition to experience in quality management systems, the auditing team shall possess appropriate experience in the relevant field of metrology and instrument technology, and knowledge of the applicable requirements of this Directive. The evaluation procedure shall include an inspection visit to the manufacturer's premises.
The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the examination and the reasoned assessment decision.
The notified body shall evaluate the changes proposed and decide whether the changed quality system will still satisfy the requirements referred to in paragraph 3.2 or whether a re-assessment is required.
It shall notify its decision to the manufacturer. The notification shall contain the conclusions of the examination and the reasoned assessment decision.
the quality system documentation;
the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.
the documentation referred to in the second indent of paragraph 3.1;
the change referred to in the second subparagraph of paragraph 3.5, as approved;
the decisions and reports from the notified body which are referred to in paragraph 3.5, final subparagraph, paragraph 4.3 and paragraph 4.4.
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