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5. Statistical verification of conformity

Directive 2014/32/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of measuring instruments (recast) Text with EEA relevance · European Union

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure the homogeneity of each lot produced, and shall present his measuring instruments for verification in the form of homogeneous lots. A random sample shall be taken from each lot according to the requirements of point 5.3. All measuring instruments in a sample shall be individually examined and appropriate tests set out in the relevant harmonised standard(s) and/or normative document(s), and/or equivalent tests set out in other relevant technical specifications, shall be carried out in order to verify their conformity with the type described in the EU-type examination certificate and with the applicable requirements of this Directive, and to determine whether the lot is accepted or rejected. In the absence of such harmonised standard or normative document, the notified body concerned shall decide on the appropriate tests to be carried out. The statistical procedure shall meet the following requirements: The statistical control will be based on attributes. The sampling system shall ensure: a level of quality corresponding to a probability of acceptance of 95 %, with a non-conformity of less than 1 %; a limit quality corresponding to a probability of acceptance of 5 %, with a non-conformity of less than 7 %. If a lot is accepted, all measuring instruments of the lot shall be considered approved, except for those measuring instruments from the sample that have been found not to satisfy the tests. The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out, and shall affix its identification number to each approved instrument or have it affixed under its responsibility. The manufacturer shall keep the certificates of conformity at the disposal of the national authorities for 10 years after the instrument has been placed on the market. If a lot is rejected, the notified body shall take appropriate measures to prevent the placing on the market of that lot. In the event of frequent rejection of lots the notified body may suspend the statistical verification and take appropriate measures.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.