Marcolin has become the first eyewear manufacturer to receive the ISO 13485:2016 certification regulating, at the international level, quality management systems regarding medical devices.
The certification is valid for three years and was granted by DNV – the independent assurance, risk management and trust provider – with respect to the “planning, production and marketing of nonactive ophthalmic medical devices, i.e., optical frames and frames with blue-light blocking lenses”.
The ISO 13485:2016 standard aims to harmonise requirements for medical devices imposed by various international regulations and provides a presumption of conformity with the essential requirements of these key regulations. Compliance with the standard demonstrates commitment to the safety and quality of medical devices sold, to protect customers and product users.
A key requirement for compliance is the company’s ability to stop the distribution of non-compliant products and recall them from the market. Marcolin’s “Traceability Project”, launched some time ago, which supports the continuous monitoring of the supply chain with respect to all the frames placed on the market, has played a vital role in obtaining the certification.
In accordance with the project, all the sunglasses and optical frames made by Marcolin have a lasered serial number on the temple (also featured on the label of all the products, together with the manufacturing date), to allow the frames to be traced from manufacturing to distribution. The ISO Certification and the Traceability Project are part of Marcolin’s wider ESG plan that considers economic, social, and environmental sustainability as one of the pillars of its development strategy.
