Product conformity assessment
It is obligatory for every producer of products covered by UE directives
Product conformity audit
It is a service addressed to the producers, exporters, importers and distributors who look for optimization of means, costs and time, to introduce their products to the EU and the domestic markets. Furthermore, it is a service to those who look for the confirmation of the fact that their products comply with all the necessary requirements.
Scope of application
The product conformity assessment covers the following products:
- toys – EU Council directive 88/378/EHS
- personal protective equipment – EU Council directive 89/686/EHS
- construction products – EU Council directive 89/106/EHS
- medical devices – EU Council directive 93/42/EHS
- active implantable medical devices – EU Council directive 90/385/EHS
- in vitro diagnostic medical devices– EU Council directive 98/79/EHS
- low voltage – EU Council directive 2006/95/ES
- electromagnetic compatibility – EU directive 2004/108/ES
- simple pressure vessels – EU directive 87/404/EHS
Procedure of conformity audit
- definition of the requirements for the product to be released
- evaluation of the product in terms of its conformity and the means of conducting the research
- preparation of all the necessary documents to conduct the conformity assestment
- the selection of the accredited and notified body in terms of costs, time and quality of services
- representation of the client before the above mentioned body
- supervision over the correct execution of the certification process and the research
Benefits of conformity audit
The conformoty audit is a reliable, objective and full answer to the questions that every producer, importer and distributor might ask, e.g.:
- how to release the product into the market?
- has my product been audited properly?
- where can i conduct all the required research?
- how much time and how much money I have to spend to legaly release the product into the market?
- how optimize the costs and tume of the product conformity assestment?
- The quality management system ISO 9001
- Environmental management system ISO 14001
- Safety management system OHSAS 18001
- Laboratory management system ISO 17025
- Factory Production Control System FPC