Module A2
Internal production control plus supervised product checks at random intervals
1. Internal production control plus supervised product checks at random intervals is the conformity assessment
procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3, 4, and 5, and ensures and
declares on his sole responsibility that the products concerned satisfy the requirements of the legislative instrument
that apply to them.
2. Technical documentation
The manufacturer shall establish the technical documentation. The documentation shall make it possible to assess the
product's conformity with the relevant requirements, and shall include an adequate analysis and assessment of the
risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the
assessment, the design, manufacture and operation of the product. The technical documentation shall contain,
wherever applicable, at least the following elements:
— a general description of the product,
— conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.
— descriptions and explanations necessary for the understanding of those drawings and schemes and the operation
of the product,
— a list of the harmonised standards and/or other relevant technical specifications the references of which have
been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the
solutions adopted to meet the essential requirements of the legislative instrument where those harmonised
standards have not been applied. In the event of partly applied harmonised standards, the technical
documentation shall specify the parts which have been applied,
— results of design calculations made, examinations carried out, etc., and
— test reports.
3. Manufacturing
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure
compliance of the manufactured products with the technical documentation referred to in point 2 and with the
requirements of the legislative instruments that apply to them.
4. Product checks
At the choice of the manufacturer, either an accredited in-house body or a notified body, chosen by the manufacturer,
shall carry out product checks or have them carried out at random intervals determined by the body, in order to verify
the quality of the internal checks of the product, taking into account, inter alia, the technological complexity of the
products and the quantity of production. An adequate sample of the final products, taken on site by the body before
the placing on the market, shall be examined and appropriate tests as identified by the relevant parts of the
harmonised standard and/or technical specifications, or equivalent tests, shall be carried out to check the conformity
of the product with the relevant requirements of the legislative instrument.
The acceptance sampling procedure to be applied is intended to determine whether the manufacturing process of the
product performs within acceptable limits, with a view to ensuring conformity of the product.
Where the tests are carried out by a notified body, the manufacturer shall, under the responsibility of the notified
body, affix the notified body's identification number during the manufacturing process.
5. Conformity marking and declaration of conformity
5.1. The manufacturer shall affix the required conformity marking set out in the legislative instrument to each individual
product that satisfies the applicable requirements of the legislative instrument.
5.2. The manufacturer shall draw up a written declaration of conformity for a product model and keep it together with the
technical documentation at the disposal of the national authorities for 10 years after the product has been placed on
the market. The declaration of conformity shall identify the product for which it has been drawn up.
A copy of the declaration of conformity shall be made available to the relevant authorities upon request.
6. Authorised representative
The manufacturer's obligations set out in point 5 may be fulfilled by his authorised representative, on his behalf and
under his responsibility, provided that they are specified in the mandate.
