EssilorLuxottica strengthens global quality with ISO 13485 certification supported by DNV
Embedding medical device excellence across a global organization
When EssilorLuxottica set out to unify and strengthen its quality processes for medical devices across multiple countries, the goal was clear: to create a consistent, robust framework capable of meeting both regulatory scrutiny and the expectations of a global customer base.
With help from DNV, that ambition became a reality. EssilorLuxottica has achieved ISO 13485 certification for its end-to-end quality management system, covering ophthalmic lenses and related activities from shaping and assembly to distribution and commercialization.
The certification goes beyond a single site. It includes the company’s central lens laboratory, local subsidiaries, and the Customer Interaction Center, reflecting a deeply integrated approach to quality management across business functions and geographies.
Aligning quality across complex operations
As a global leader in the vision care and eyewear industry, EssilorLuxottica operates within a highly regulated and technically demanding environment. Achieving ISO 13485 certification at scale meant aligning diverse internal processes, from production to customer support, under one consistent quality system.
The company also needed to demonstrate that every link in its value chain followed the same rigorous standards, ensuring product safety, process reliability, and traceability throughout.
Building a trusted, long-term partnership
EssilorLuxottica turned to DNV not only for certification but also as a strategic partner with decades of experience in assurance and medical device standards. The collaboration builds on a relationship that began in 1997 with the company’s first ISO 9001 certification.
Together, EssilorLuxottica and DNV extended this approach across the organization, certifying new locations, aligning internal teams and processes, and embedding a culture of continuous improvement. The result is a robust, audit-ready system that reflects the company's leadership in both innovation and quality.
Driving trust in medical devices and the people behind them
Achieving ISO 13485 certification has positioned EssilorLuxottica as a benchmark for quality in medical devices. More than just a compliance milestone, the certification demonstrates the company’s ability to deliver consistent, safe, and high-quality products, and its commitment to customers and patients alike.
It also reinforces the value of long-term collaboration, showing how sustained partnerships between companies and assurance providers can help raise industry standards while building internal capability and confidence. This achievement further highlights DNV’s role in advancing global medical device quality and supporting organizations in creating future-ready assurance systems.
