Conformity assessment is a process carried out by the manufacturer to determine whether certain requirements for a product have been met. A product is subject to conformity assessment at both the design and production stages, and the manufacturer must carry out the conformity assessment itself, even if the design or production is subcontracted.
Depending on the legal regulations in force, there are many different conformity assessment options available to manufacturers. The guideline on the implementation of product rules prepared by the European Union provides an overview of conformity assessment options. Some of these options are:
The manufacturer shall issue a declaration of conformity after having carried out all necessary checks, compiled the technical dossier and ensured compliance with the manufacturing process.
In general, conformity assessment should be carried out by a separate department within the organization of the company and a declaration of conformity must be drawn up. This section should not participate in any activity other than conformity assessment within the organization and act independently and impartially from any commercial, design and manufacturing organization. This section must demonstrate the same technical competence and impartiality as an accredited body.
The manufacturer must obtain conformity assessment services from a third party external conformity assessment body (notified body) in accordance with the relevant directives. The notified bodies shall be authorized by the national authorities and formally notified to the European Commission. If the European Commission considers it appropriate, it is published in a database called NANDO (new approach notified and designated organizations).
If the manufacturer is outside the European Union, a technical file should be kept by the representative of the European Union of the company and, where necessary, submitted to the national authorities for inspection and control. The technical dossier should contain essentially all the information and documentation required to prove that the product complies with the applicable requirements.
In the meantime, harmonized standards are voluntary standards used to demonstrate compliance with the essential requirements of the directives. The use of these standards is not mandatory. However, these standards need to be taken into account in order for manufacturers to prove that the product complies with the essential requirements of the relevant directive.
For example, the European Parliament and Council directive 2009 / 48 / EC on toy safety has been published. The standards harmonized by the CEN within the framework of this directive are:
EN 71-1: 2014 + A1: 2018 Section 1: Mechanical and physical properties
EN 71-2: 2011 + A1: 2014 Section 2: Flammability
EN 71-3: 2013 + A3: 2018 Section 3: Migration of some elements
EN 71-4: 2013 Section 4: Experiment sets for chemistry and related activities
EN 71-5: 2015 Section 5: Chemical toys other than experimental sets
EN 71-7: 2014 + A2: 2018 Section 7: Finger paints - Requirements and test methods
EN 71-8: 2018 Section 8: Home activity toys
EN 71-12: 2013 Section 12: N-Nitrosamines and N-nitrosatate substances
EN 71-13: 2014 Section 13: Olfactory board games, cosmetic kits and gift games
EN 71-14: 2014 + A1: 2017 Section 14: Domestic trampolines
In addition, the following standard has been harmonized by CENELEC (European Electrotechnical Standardization Committee):
EN 62115: 2005 Electric toys - Safety
To summarize, the competent authorities do not issue a CE Certificate or CE Certificate. The sole responsibility lies with the manufacturer. If only the notified body is involved in the process under the relevant directives, it performs product tests and approves. However, in this case, the obligation to affix the CE Mark to the products is on the manufacturer.
Our company also provides CE Certificate services within the scope of certification services. Thanks to these services, enterprises are able to produce more efficient, high performance and quality products in a safe, fast and uninterrupted manner.
CE Certificate services provided within the scope of certification services are only one of the services provided by our organization in this respect. Many other certification services are also available.