Module A2

Module A2

Internal production control together with product inspections at random intervals

Internal production control combined with supervised product checks at random intervals is a conformity assessment procedure whereby the manufacturer fulfills the obligations set out in points 2, 3, 4, and 5 and, under its sole responsibility, ensures and declares that the products in question meet the requirements of the applicable legal instrument.

Technical documentation

The manufacturer shall draw up technical documentation. The documentation shall enable the conformity of the product with the applicable requirements to be assessed and shall include an adequate analysis and assessment of risks. The technical documentation shall specify the applicable requirements and, to the extent necessary for the assessment, cover the design, manufacture, and operation of the product. The technical documentation must contain, where relevant, at least the following elements:

— a general description of the product,

— conceptual design and manufacturing drawings and diagrams of components, subassemblies, circuits, etc.,

— descriptions and explanations necessary for understanding these drawings and diagrams and the operation of the product,

— a list of harmonized standards or other relevant technical specifications published in the Official Journal of the European Union and applied in full or in part, and a description of the solutions adopted to meet the essential requirements of the legislative instrument where such harmonized standards have not been applied; in the case of partially applied harmonized standards, the technical documentation shall specify the parts that have been applied,

— results of design calculations, tests performed, etc.,

— test reports.

3.	Manufacturing The manufacturer shall take all necessary measures to ensure that the manufacturing process and its control ensure the conformity of the manufactured products with the technical documentation referred to in point 2 and with the requirements of the legal instruments applicable to them.

Product inspections

At the manufacturer’s discretion, either an accredited in-house body or a notified body selected by the manufacturer shall carry out or have carried out product inspections at random intervals determined by the manufacturer to verify the quality of internal product inspections, taking into account, among other things, the technological complexity of the products and the quantity produced. Prior to placing the product on the market, the body shall take an appropriate sample of the finished products directly on site, which must be examined and subjected to the appropriate tests set out in the relevant parts of the harmonized standards or technical specifications, or to equivalent tests, in order to verify the product’s conformity with the relevant requirements of the legal instrument.

The procedure for determining the acceptability of the samples to be used shall establish whether the manufacturing process for the product in question is operating within acceptable limits to ensure product conformity.

If the tests are carried out by a notified body, the manufacturer shall, during the manufacturing process, affix the notified body’s identification number to the products under the responsibility of the notified body.

Conformity Marking and Declaration of Conformity

5.1	The manufacturer shall affix the required conformity marking specified in the legal instrument to each individual product that meets the relevant requirements of the legal instrument.

5.2

The manufacturer shall draw up a written declaration of conformity for the product model in question and keep it, together with the technical documentation, at the disposal of the national authorities for a period of ten years after the product has been placed on the market. The declaration of conformity shall identify the product for which it was drawn up.

A copy of the declaration of conformity shall be made available to the competent authorities upon request.

6.	Authorized Representative The manufacturer’s obligations set out in Section 5 may be fulfilled on his behalf and under his responsibility by his authorized representative, provided they are specified in the mandate.