The NORMAPME booklet on standardisation and CE-marking for SMEs is available HERE

Principles of standardisation

Standardisation is a voluntary process based on consensus amongst different economic actors (industry, consumers, workers, public authorities, etc). It is carried out by independent standardisation bodies, acting at national, European and international level.

The task of framing standards that provide technical solutions for manufacturers seeking to comply with EU - directives is assigned by the European Commission to the European standardisation bodies. These standardisation assignments (Mandates) state guidelines within which standards need to be framed to meet each directive’s essential requirements. All new approach directive standards must be based on sound scientific knowledge, fit for purpose, mutually consistent and rapidly modifiable to keep pace with technological innovation. Once a harmonised standard becomes available, a manufacturer can declare that his product conforms to this standard and therefore national authorities presume that his goods comply with the directive’s essential requirements. These goods can thus be placed on the market based on the manufacturer’s declaration and with a simple certification procedure. Nevertheless, the flexibility of the new approach also allows manufacturers to use mechanisms other than applying harmonised standards to demonstrate conformity with a directive, thus providing an incentive to innovation.

Actors of International & European Standardization

• European Commission : European Union Institution regulating European standardisation, among other things. It is in charge of writing directives under the New Approach and gives mandates to CEN, CENELEC and ETSI to write standards.
• EFTA: A free trade association, gathering Iceland , Lichtenstein , Norway & Switzerland, participates in European Standardisation under the EEA treaty.
• CEN: European Standardization Organisation active in multiple sectors (chemistry, construction, consumer products, energy, environment, food, healthcare, health and safety, heating - cooling - ventilation and air conditioning, information society, materials, mechanical engineering such as machinery and pressure equipment, metrology, nanotechnology, security & defence, services, transport, etc.)
• CENELEC: European Standardization Organisation responsible for standardisation in the electro technical area.
• ETSI: European Standardization Organisation active in the telecommunications field.
• National Standardisation Organisations: They write National standards and implement European and some International Standards in their National legislation.
• ISO: International multisectoral Standardization organisation active in all fields except the electro technical and the telecommunication field
• IEC: International organisation responsible for standardisation in the electro technical area.
• ITU: International organisation active in the telecommunications field

Standards: From Need to Reality

Requests for standards work (from the private or public sector)

• may be presented by a CEN/CENELEC/ETSI member;
• may also come from a CEN/CENELEC/ETSI Technical Body;
• may also come from the CEC or EFTA, by giving Mandates to European Standardisation Organizations issued from New Approach Directives mentioning only essential requirements;
• may come from international organisations or by European trade, professional, technical or scientific organisations (to the CEN/CS)

The BT decides whether or not a project will be pursued and, if so, how it should be dealt with, in the light of all relevant information.

Standards are elaborated by Technical Committees in line with the WTO Code of the Good Practice for the Preparation, Adoption and Application of Standards . Besides this code, European standardisation is based on the four following pillars:

• standstill: it is an obligation accepted by the EAA countries to stop the elaboration of a national standard, either during the preparation of a European Standard or after its approval, which could prejudice the harmonisation intended.
• weighted voting
• implementation: The countries shall implement the European standards as national standards (usually within 6 months after the approval).
• Withdrawal of conflicting standards

Cooperation with international organisations

Although international trade within the EU is mainly represented by intra community trade, relations between European and International standards appeared quickly as a necessity. Therefore two agreements have been signed laying down the principles for the cooperation between the European and international standards bodies. The Vienna Agreement regulates cooperation between CEN and ISO and the Dresden Agreement the cooperation between CENELEC and IEC. The aim is to achieve a general exchange of information, participation in standardization projects. Above all they adopt international standards into the European system without any amendment.