Quality management at Marcolin recognised with international certification

The company shared that achieving the international standard forms part of its wider sustainability goals

KY Marcolin

Marcolin has received the ISO 13485:2016 certification, which regulates quality management systems needed to provide medical devices. 

Granted by DNV, an independent assurance, risk management and trust provider, the certification is valid for three years. Marcolin suggested it is the first manufacturer in the industry to have received the certification.

The certification aims to harmonise the requirements of different international regulations on medical devices, setting out the requirements for a quality management system specific to the medical devices industry.

Compliance with the standard is a practical foundation for manufacturers in addressing medical device regulations, as well as for demonstrating their commitment to the safety and quality of medical devices.

An important requirement for certification is the ability to stop distribution of any non-compliant products and recall them.

Marcolin’s Traceability Project played a key role in achieving this, as it continuously monitors the supply chain, the company shared.

All sunglasses and optical frames made by Marcolin have a serial number lasered on the side – as well as included on the label of the product along with the manufacturing date. This serial number allows for traceability of the frames from manufacturing to distribution.

Marcolin shared that achieving the ISO Certification and delivering the Traceability Project are a key part of the company’s wider environmental, social and governance sustainability plan.