Informative Notice
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Establishing conformity of measuring instruments
To pursue this activity, an entry permit is required.
The establishment of conformity of measuring instruments is carried out by a legal entity or a sole trader notified to the Metrology Institute (hereinafter referred to as ‘competent authority’). The procedure of conformity establishment commences on the basis of a request to approve the type of a measuring instrument filed with the authority by the manufacturer or their representative.
In the procedure of conformity establishment, the competent authority inspects and tests a measuring instrument in line with legislation.
The establishment of conformity of a measuring instrument or a module is carried out by the competent authority in the following manners:
- module A: declaration of conformity on the basis of internal control,
- module A1: declaration of conformity on the basis of internal control and testing of products by the notified body,
- module B: examination of the type,
- module C: declaration of conformity with the type on the basis of internal control,
- module C1: declaration of conformity with the type on the basis of the internal control of production and testing of products by the notified body,
- module D: declaration of conformity with the type on the basis of quality assurance of the production procedure,
- module D1: declaration of conformity on the basis of quality assurance of the production procedure,
- module E1: declaration of conformity on the basis of examination and testing quality assurance,
- module F: declaration of conformity with the type on the basis of product certification,
- module F1: declaration of conformity on the basis of product certification,
- module G: declaration of conformity on the basis of direct certification of an individual measuring instrument,
- module H: declaration of conformity on the basis of comprehensive quality assurance,
- module H1: declaration of conformity on the basis of comprehensive quality assurance and examination
The competent authority carried out the following manners of establishing conformity of non-automatic scales:
- type examination of the European Community,
- direct certification of an individual measuring instrument by the European Community,
- certification by the European Community,
- declaration of the European Community on type conformity (guarantee of quality of production).
The establishment of conformity of measuring instruments is carried out at the national and European levels.
Applies for SKD:
- Technical testing and analysis M71.200
Conditions
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Notified bodies for the establishment of conformity of measuring instruments are legal entities and sole traders who were appointed by the director of the Metrology Institute. Their task is to establish conformity of measuring instruments with crucial requirements, and carry out procedures to establish conformity.
The procedure to appoint a legal entity or a sole trader commences by filing a request for notification at the Metrology Institute. The director of the Institute appoints a three or more-member committee which prepares an opinion on the suitability of the request. Based on the study of the request, submitted documentation and assessment visit with the applicant, the director provides an opinion. The committee issues its own opinion no later than one month of the date when the request is compete. Then the committee submits the request to the director of the Institute who issues a decision on the appointment or rejects the request for appointment.
The notification is carried out by the minister responsible for the economy on the basis of the minister responsible for metrology. The body for the establishment of conformity is notified to the European Commission, and to Member States of the European Community and of the European Economic Area.
The establishment of conformity is carried out at the national and European levels. At the national level, persons appointed by the Metrology Institute carry out the task, while at the European level, persons notified by the European Commission who were previously appointed by the Institute establish conformity of measuring instruments.
The notification includes:
- a statement of the notified body,
- module for conformity establishment,
- identification number determined by the Commission,
- types of measuring instruments to which the notification refers,
- and if necessary, accuracy classes of measuring instruments, measuring technology and all qualities of the measuring instruments that limit the scope of the notification.
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Applicants who wish to pursue this activity must register the business activity, and have the appropriate legal status.
Cross-border/temporary provisions of activity
The activity of establishing conformity does not fall within the Services Directive. In this case, cross-border pursuit of the activity is not possible. Entities in the Republic of Slovenia may pursue this activity by appointment by the Metrology Institute.