Regulatory
Bodies
In order for Coopervision to sell our products into the respective countries,
we need to adhere to the regulations set by the regulatory/notified bodies of
that country.
These notified bodies protect the consumer and they regularly audit our
sites, against the regulation known as ISO 13485.
This is to ensure that we are maintaining our Quality Management System
and are continuing to follow this required regulation.
In order for CooperVision to be able to sell our products in the UK and EU,
and retain our CE certificate, a surveillance audit is completed by TUV SUD
(EU and UK notified body) every 6 months, and a full recertification audit is
conducted every 3 years.
The USA market have a notified body called the FDA. They use a similar
standard to ISO 13485 but is a bit more stringent.
These audits are performed worldwide reviewing our Quality Management
System and processes to ensure compliance to their standard.
Each other country has its own regulations which Coopervision need to
follow, in order to sell into that country.
If we do not meet the regulations for the notified body, they could withdraw
our certificate, which means we could not sell any of our products in that
country.
If there is an issue with a plant in the USA (i.e. product recalled for serious
issue or did not pass inspection), the FDA has the power to shut the site
down on the spot.
World Map,
Regulatory Bodies