MARCOLIN S.p.A. RECEIVES THE ISO 13485:2016 CERTIFICATION
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MARCOLIN S.p.A. RECEIVES THE ISO 13485:2016 CERTIFICATION
Longarone (Belluno), June 23, 2022 – Marcolin S.p.A., a worldwide leading company in the eyewear industry, announces that it has received 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 – world’s leading independent assurance, risk management and trust provider, pioneering provider of digital assurance solutions – 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 the first player in the industry – among manufacturers – to have received this certification. The ISO 13485:2016 standard aims to favor the global harmonization 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.
Compliance with the ISO 13485:2016 standard is a practical foundation for manufacturers in implementing directives and regulations on medical devices, as well as in taking on their responsibilities, demonstrating, at the same time, their great commitment to the safety and quality of the medical devices sold, in order to further protect customers and product users.
A key requirement for compliance with this international standard is the company’s ability to stop the distribution of noncompliant products and to recall them from the market. Marcolin’s “Traceability Project”, which was launched by the company some time ago and which supports the continuous monitoring of the supply chain with respect to all the frames placed on the market, has played a key role in obtaining the certification.
According to this 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 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.
About Marcolin:
Marcolin is a worldwide leading company in the eyewear industry founded in 1961 in the heart of the Veneto district. It stands out for the unique ability to combine craftsmanship with advanced technologies through the constant pursuit of excellence and continuous innovation.
The brand portfolio includes: Tom Ford, Guess, adidas Sport, adidas Originals, Bally, Moncler, Max Mara, Sportmax, Zegna, Longines, OMEGA, GCDS, Barton Perreira, Tod's, Emilio Pucci, BMW, Swarovski, MAX&Co., Kenneth Cole, Timberland, GANT, Harley-Davidson, Marciano, Skechers and Candie’s. Among the house brands: WEB Eyewear, Marcolin and Viva.
Through its own direct network and global partners, Marcolin distributes its products in more than 125 countries. www.marcolin.com