Marcolin has received the ISO 13485:2016 certification, regulating quality management systems regarding medical devices at international level.
The certification is valid for three years and was granted by independent assurance, risk management and trust provider DNV – in respect to the “planning, production and marketing of non-active ophthalmic medical devices, i.e. optical frames and frames with blue-light blocking lenses”.
Marcolin is said to be the first player in the industry – among manufacturers – to have received this certification. The ISO 13485:2016 standard aims to favour the global harmonisation of the requirements imposed by the various international regulations on medical devices and provides presumption of conformity with the essential requirements of these key regulations.
Marcolin’s Traceability Project, which supports the continuous monitoring of the supply chain with respect to all frames placed on the market, played a key role in obtaining the certification, said the company.
All sunglasses and ophthalmic frames made by Marcolin have a lasered serial number on the side (also featured on the label of all the products, together with the manufacturing date), to allow the traceability of the frames, from manufacturing to distribution.
The ISO Certification and the Traceability Project are part of a wider ESG plan developed by the company that considers – economic, social and environmental – sustainability as one of the pillars of its development strategy.