We Ensure Conformity
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Conformity Assessment is the process carried out by the manufacturer of demonstrating whether specified requirements relating to a product have been fulfilled. A product is subjected to conformity assessment both during design and production phase.
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Modules
There are eight modules (named with the letters from A to H). They lay down the responsibilities of the manufacturer (and his authorised representative) and the degree of involvement of the in-house accredited or notified conformity assessment body. They are the components of the conformity assessment procedures laid down under Decision No 768/2008/EC, the ‘horizontal menu
Several modules have their variants. The reason for providing variants within modules (this applies for all variants of all modules laid down under Decision No 768/2008/EC) is to enable the necessary level of protection to be ensured for products presenting higher level of risk while avoiding the imposition of a heavier module. The idea is to minimise the burden on manufacturers to the extent possible.
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Modules |
Description |
| A Internal production control |
Covers both design and production. The manufacturer himself ensures the conformity of the products to the legislative requirements (no EU-type examination). |
| A1 Internal production control plus supervised product testing |
Covers both design and production. A + tests on specific aspects of the product carried out by an in-house accredited body or under the responsibility of a notified body chosen by the manufacturer. |
| A2 Internal production control plus supervised product checks at random intervals |
Covers both design and production. A + product checks at random intervals carried out by a notified body or inhouse accredited body. |
| B EU-type examination |
Covers design. It is always followed by other modules by which the conformity of the products to the approved EU-type is demonstrated. A notified body examines the technical design and or the specimen of a type and verifies and attests that it meets the requirements of the legislative instrument that apply to it by issuing an EU-type examination certificate. There are 3 ways to carry out EU-type examination: 1) production type, 2) combination of production type and design type and 3) design type. |
| C Conformity to EU-type based on internal production control |
Covers production and follows module B. Manufacturer must internally control its production in order to ensure product conformity against the EU-type approved under module B. |
| C1 Conformity to EU-type based on internal production control plus supervised product testing |
Covers production and follows module B. Manufacturer must internally control its production in order to ensure product conformity against the EU-type approved under module B. C + tests on specific aspects of the product carried out by an in-house accredited body or under the responsibility of a notified body chosen by the manufacturer (*). |
| C2 Conformity to EU-type based on internal production control plus supervised product checks at random intervals |
Covers production and follows module B. Manufacturer must internally control its production in order to ensure product conformity against the EU-type approved under module B. C + product checks at random intervals tests on specific aspects of the product carried out by a notified body or in-house accredited body. |
| D Conformity to EU-type based on quality assurance of the production process |
Covers production and follows module B. The manufacturer operates a production (manufacturing part and inspection of final product) quality assurance system in order to ensure conformity to EUtype. The notified body assesses the quality system. |
| D1 Quality assurance of the production process |
Covers both design and production. The manufacturer operates a production (manufacturing part and inspection of final product) quality assurance system in order to ensure conformity to legislative requirements (no EU-type, used like D without module B). The notified body assesses the production (manufacturing part and inspection of final product) quality system. |
| E Conformity to EU-type based on product quality assuranc |
Covers production and follows module B. The manufacturer operates a product quality (= production quality without the manufacturing part) assurance system for final product inspection and testing in order to ensure conformity to EU-type. A notified body assesses the quality system. The idea behind module E is similar to the one under module D: both are based on a quality system and follow module B. Their difference is that the quality system under module E aims to ensure the quality of the final product, while the quality system under module D (and D1 too) aims to ensure the quality of the whole production process (that includes the manufacturing part and the test of final product). E is thus similar to module D without the provisions relating to the manufacturing process |
| E1 Quality assurance of final product inspection and testing |
Covers both design and production. The manufacturer operates a product quality (= production quality without the manufacturing part) assurance system for final product inspection and testing in order to ensure conformity to the legislative requirements (no module B (EU-type), used like E without module B). The notified body assesses the quality system. The idea behind module E1 is similar to the one under module D1: both are based on a quality system. Their difference is that the quality system under module E1 aims to ensure the quality of the final product, while the quality system under module D1 aims to ensure the quality of the whole production process (that includes the manufacturing part and the test of final product). E1 is thus similar to module D1 without the provisions relating to the manufacturing process. |
| F Conformity to EU-type based on product verification |
Covers production and follows module B. The manufacturer ensures compliance of the manufactured products to approved EU-type. The notified body carries out product examinations (testing of every product or statistical checks) in order to control product conformity to EU-type. Module F is like C2 but the notified body carries out more systematic product checks |
| F1 Conformity based on product verification |
Covers both design and production. The manufacturer ensures compliance of the manufactured products to the legislative requirements. The notified body carries out product examinations (testing of every product or statistical checks) in order to control product conformity to the legislative requirements (no EU-type, used like F without module B) Module F1 is like A2 but the notified body carries out more detailed product checks. |
| G Conformity based on unit verification |
Covers both design and production. The manufacturer ensures compliance of the manufactured products to the legislative requirements. The notified body verifies every individual product in order to ensure conformity to legislative requirements (no EU-type). |
| H Conformity based on full quality assurance |
Covers both design and production. The manufacturer operates a full quality assurance system in order to ensure conformity to legislative requirements (no EU-type). The notified body assesses the quality system. |
| H1 Conformity based on full quality assurance plus design examination |
Covers both design and production. The manufacturer operates a full quality assurance system in order to ensure conformity to legislative requirements (no EU-type). The notified body assesses the quality system and the product design and issues an EU design examination certificate. Module H1 in comparison to module H provides in addition that the notified body carries out a more detailed examination of the product design. The EU-design examination certificate must not be confused with the EU-type examination certificate of module B that attests the conformity of a specimen 'representative of the production envisaged', so that the conformity of the products may be checked against this specimen. Under EU design examination certificate of module H1, there is no such specimen. EU design examination certificate attests that the conformity of the design of the product has been checked and certified by a notified body. |
A — Internal production control.
A1 — Internal production control plus supervised product testing.
A2 — Internal production control plus supervised product checks at random intervals.
B + C — EU-type examination (B) followed by Conformity to EU-type based on internal production control (C).
B + C1 — EU-type examination (B) followed by Conformity to EU-type based on internal production control plus supervised product testing (C1).
B + C2 — EU-type examination (B) followed by Conformity to EU-type based on internal production control plus super- vised product checks at random intervals (C2).
B + D — EU-type examination (B) followed by Conformity to EU-type based on quality assurance of the production pro- cess (D).
D1 — Quality assurance of the production process.
B + E — EU-type examination (B) followed by Conformity to EU-type based on product quality assurance (E).
E1 — Quality assurance of final product inspection and testing.
B + F — EU-type examination (B) followed by Conformity to EU-type based on product verification (F).
F1 — Conformity based on product verification.
G — Conformity based on unit verification.
H — Conformity based on full quality assurance.
H1 — Conformity based on full quality assurance plus design examination.
Notified bodies carry out the tasks pertaining to the conformity assessment procedures referred to in the applicable technical harmonisation legislation when a third party is required.
Notified bodies are free to offer their conformity assessment services, within their scope of notification, to any economic operator established either inside or outside the Union. They may carry out these activities also on the territory of other Member States or of third countries.
- Notified bodies must provide relevant information to their notifying authority, the market surveillance authorities and other notified bodies.
- Notified bodies must operate in a competent, non-discriminatory, transparent, neutral, independent and impartial manner.
- Notified bodies must have at their disposal the necessary personnel, who have sufficient and relevant knowledge and experience to carry out conformity assessment in accordance with Union harmonisation legislation in question.
- Notified bodies must make adequate arrangements to ensure confidentiality of the information obtained in the course of conformity assessment.
- Notified bodies must be adequately insured to cover their professional activities, unless liability is assured under the national legislation of the notifying Member State.
- Notified bodies may demonstrate their competence through accreditation, which is the preferred way to assess their technical competence.