Marcado CE y regulaciones relacionadas

La marca CE

Consultas para conseguir la marca CE

Podemos ayudarte a conseguir el marcado CE para introducir productos fabricados dentro de los estados miembros de la Unión Europea así como para aquellos productos que son importados. Proporcionamos servicios de asesoramiento sobre qué requisitos debe cumplir un determinado producto, además le prepararemos un programa de ensayo, o evaluaremos la conformidad nosotros mismos. Hemos adquirido experiencia en numerosos campos, tenemos a nuestra disposición una cadena de laboratorios suficientes para llevar a cabo las pruebas, y empleamos a expertos en caso de que existan parámetros específicos de un producto que deban ser verificados a través de calculaciones teóricas o a través de documentación técnica de evaluación.


Principles for granting the CE mark

Marca CE

Significa que un producto está conforme a cada uno de los requisitos impuestos bajo las bases de producción aprobadas por los directivos de la Unión Europea con el objetivo de regular el mercado europeo en su conjunto.

Marca legítima de conformidad

La Directiva que permite la aplicación del marcado CE sigue particularmente los principios y regulaciones evaluados por la comunidad. Como una marca legítima de conformidad (conocida con la marca CE) se da solo si el método de armonización total ha sido usado, mientras que al mismo tiempo prohíbe plenamente las diferentes regularizaciones nacionales, protege los intereses de la identidad pública como la directiva hace, y de forma conjunta hace seguro un procedimiento adecuado de conformidad de acuerdo a la decisión 93/465/EEC.

Marca CE vs Marca nacional de conformidad

La marca CE es un símbolo único de conformidad que incluye todos los requisitos localizados en productos fabricados de acuerdo con las regularizaciones armonizadas emitidas por la comunidad. Particularmente no se les permite a los estados miembros de la UE a incorporar dentro de sus normas nacionales cualquier referencia con varias marcas de conformidad, indicación de conformidad con los requisitos de acuerdo a productos que producen la marca CE.

En caso de una diferente marca nacional de un producto es necesario tener en cuenta lo siguiente:

- La marca nacional debe hacer referencia a una función diferente a la marca CE
- Debe quedar claro que no puede ser confundida con la marca CE
- Debe no reducir legitimidad y visibilidad a la marca CE
Todas las marcas de la conformidad de los productos (CZ) tienen el mismo significado que la marca CE y existían previamente a la implementación de la armonización, ahora son plenamente reemplazados por la marca CE cuando cualquier producto es puesto en venta en el mercado europeo.

Modules of assessing conformity (93/465/EEC)

Council Decision 93/465/EEC -

puts forward modules for the purposes of assessing conformity, these are directly specified in particular directives. This is a list of tasks which are to be carried out on the responsibility of the manufacturer and a notified body, and the tasks which the manufacturer may delegate to its authorised representative. Procedures of assessing conformity arising from particular directives are slightly different, however, their application is not difficult at all for the reason of this difference. The modules apply to the phase of designing a product or to the phase of manufacturing or to both the phases. There are eight basic modules and these eight variants may be mutually combined in various ways for the purpose of creating a complete procedure of conformity assessment.

Modules proving conformity:


Modul A: Internal production inspection – involves internal inspection of design and manufacturing, within this module no intervention is required on the part of the notified body.
Modul B: EC type verification – involves the phase of the proposal and must be followed by the module determined for the assessment of the production phase, EC certificate verifying the type issued by the notified body.
Modul C: Conformity with type – comprises the phase of production and follows module B, determines conformity with the type in accordance with EC certificate verifying the type issued in module B.
Modul D: Securing production quality – involves the phase of production and follows module B, arises from the quality control system and requires intervention of the notified body responsible for approval and supervision over the quality system for production, inspection and testing of the finished production, introduced by the manufacturer.
Modul E: Securing products quality – involves the phase of production and follows module B, arises from the quality control system and requires intervention of the notified body responsible for approval and supervision over the quality system for inspection and testing of the finished product, introduced by the manufacturer.
Modul E: Securing products quality - involves the phase of production and follows module B, arises from the quality control system and requires intervention of the notified body responsible for the approval and supervision over the quality control system and testing the finished product, introduced by the manufacturer.
Modul F: Verifying products - involves the phase of production and follows module B, the notified body checks conformity with the type in accordance with the EC certificate verifying the type issued in accordance with module B and issues the conformity certificate.
Modul G: Verifying the whole – involves the phase of designing and production, every particular product is checked by the notified body that issues the conformity certificate.
Modul H: Complex provision of quality – involves the phase of designing and the phase of production. It arises from standard ISO 9001 concerning the provision of quality and requires intervention of the notified body responsible for approval and supervision over the quality system for designing, production, inspection and testing of the finished product, introduced by the manufacturer.

Harmonized European Directives (EEC)

89/106/EEC – Building products

Conformity of building products is assessed in accordance with the regional requirements as amended within the European harmonised standards, regulations and particular decisions of the European Council. This area involves all manufacturers, importers and suppliers of particular building products.

2006/42/EEC - Machines

Conformity of machines is assessed in accordance with the regional requirements as amended within the European harmonised standards, regulations and particular decisions of the European Council. This area involves all manufacturers, importers and suppliers of particular machines.

2009/48/EEC – Safety of toys

Conformity of toys is assessed in accordance with the regional requirements as amended within the European harmonised standards, regulations and particular decisions of the European Council. This area involves all manufacturers, importers and suppliers of particular products classified as games or toys.

2009/105/EEC – Simple pressure vessels

Conformity of simple pressure vessels is assessed in accordance with the regional requirements as amended within the European harmonised standards and regulations, particular decisions of the European Council. This area involves all manufacturers, importers and suppliers of particular products classified as simple pressure vessels.

International validity

As a basic condition for establishing the requirements for a product we always choose the most internationally recognized standards and regulations, which gradually extend its accreditation to cover the widest requirements of its customers. We can provide special certificates as required by countries that have established special requirements for a particular product.

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Noticias
Sep 1 2018 12:00AM ISO 9001, ISO 14001

Le informaron que los estándares de certificación para los sistemas de gestión de calidad y sistema de gestión ambiental ISO 9001: 2008 e ISO 14001: 2004 vence el 15 de septiembre de 2018. Nuestra información muestra que durante el período de transición aún no han realizado su transferencia para nuevas revisiones de estos estándares ISO 9001: 2015 o 14001: 2015.

Sep 19 2014 12:00AM NUEVA ACREDITACIÓN ISO 27001

LL-C (Certification) ha conseguido una vez más la Acreditación para la provisión de auditorías de certificación de acuerdo a la norma ISO/IEC 27001:2013