European Agency of Inspecting and Certification

Assessment Modules

Assessment Module – A1

Internal production control plus supervised product testing

Internal production control plus supervised product testing is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down below, and ensures and declares on his sole responsibility that the products concerned satisfy the requirements of the legislative instrument that apply to them.

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 harmonized 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.

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 and with the requirements of the legislative instruments that apply to them.

For each individual product manufactured, one or more tests on one or more specific aspects of the product shall be carried out by the manufacturer or on his behalf, in order to verify conformity with the corresponding requirements of the legislative instrument. At the choice of the manufacturer, the tests are carried out either by an accredited in-house body or under the responsibility of a notified body chosen by the manufacturer. 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.

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 and 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.

Assessment Module B

EC-type examination

EC-type examination is the part of a conformity assessment procedure in which a notified body examines the technical design of a product and verifies and attests that the technical design of the product meets the requirements of the legislative instrument that apply to it.

The manufacturer shall lodge an application for EC-type examination with a single notified body of his choice.

The application shall include:

• the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address a written declaration that the same application has not been lodged with any other notified body,

• the technical documentation.

The technical documentation shall make it possible to assess the product’s conformity with the applicable requirements of the legislative instrument 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.

Be aware that assessment module B never stands alone and requires second assessment module C, F or D!

Assessment Module C

Conformity to type based on internal production control

Conformity to type based on internal production control is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down below, and ensures and declares that the product(s) concerned are in conformity with the type described in the EC-type examination certificate and satisfy the requirements of the directive that apply to them.

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured products with the approved type described in the EC-type examination certificate and with the requirements of the applicable directive that apply to them. The manufacturer shall affix the required conformity marking to each individual product that is in conformity with the type described in the EC-type examination certificate and draw up a written declaration of conformity for a product model and keep it 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 model for which it has been drawn up. A copy of the declaration of conformity shall be made available to the relevant authorities upon request.

If manufacturer has an authorised representative the manufacturer’s obligations may be fulfilled by him, , provided that they are specified in the mandate.

Assessment Module F

Conformity to type based on product verification

Conformity to type based on product verification is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down below, and ensures and declares on his sole responsibility that the products concerned, are in conformity with the type described in the EC-type examination certificate and satisfy the requirements of the legislative instrument that apply to them.

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured products with the approved type described in the EC-type examination certificate.

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 products for verification in the form of homogeneous lots.

The manufacturer shall affix the required conformity marking set out in the legislative instrument, and, under the responsibility of the notified body, the latter’s identification number to each individual product that is in conformity with the approved type described in the EC-type examination certificate and satisfies the applicable requirements of the legislative instrument. The manufacturer shall draw up a written declaration of conformity for each product model and keep it 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 model for which it has been drawn up. A copy of the declaration of conformity shall be made available to the relevant authorities upon request.

Assessment Module G

Conformity based on unit verification

Conformity based on unit verification is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down below, and ensures and declares on his sole responsibility that the product concerned, is in conformity with the requirements of the legislative instrument that apply to it.

The manufacturer shall establish the technical documentation and make it available to the notified body. 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, wherever applicable, contain 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 harmonized 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.

The manufacturer shall keep the technical documentation at the disposal of the relevant national authorities for 10 years after the product has been placed on the market.

The manufacturer shall affix the required conformity marking set out in the legislative instrument and, under the responsibility of the notified body referred to in point 4, the latter’s identification number to each product that satisfies the applicable requirements of the legislative instrument.

The manufacturer shall draw up a written declaration of conformity and keep it 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.

Assessment Module D

– Conformity to type based on quality assurance of the production process

Conformity to type based on quality assurance of the production process is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down below, and ensures and declares on his sole responsibility that the products concerned are in conformity with the type described in the EC-type examination certificate and satisfy the requirements of the legislative instrument that apply to them.

The manufacturer shall operate an approved quality system for production, final product inspection and testing of the products concerned, and shall be subject to surveillance.

The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the products concerned.

The application shall include:

• the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well,

• a written declaration that the same application has not been lodged with any other notified body,

• all relevant information for the product category envisaged,

• the documentation concerning the quality system,

• the technical documentation of the approved type and a copy of the EC-type examination certificate.

The quality system shall ensure that the products are in conformity with the type described in the EC-type examination certificate and comply with the requirements of the legislative instrument that apply to them.

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. The quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records. It shall, in particular, contain an adequate description of:

• the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality,

• the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used,

• the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out,

• the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc., and

• the means of monitoring the achievement of the required product quality and the effective operation of the quality system.

The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient and keep the notified body that has approved the quality system informed of any intended change to the quality system.

The manufacturer shall, for assessment purposes, allow the notified body access to the manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular:

• the quality system documentation,

• the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.

The manufacturer shall affix the required conformity marking set out in the legislative instrument, and, under the responsibility of the notified body, the latter’s identification number to each individual product that is in conformity with the type described in the EC-type examination certificate and satisfies the applicable requirements of the legislative instrument.

The manufacturer shall draw up a written declaration of conformity for each product model and keep it 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 model for which it has been drawn up. A copy of the declaration of conformity shall be made available to the relevant authorities upon request.