EN ISO13485:2016 certification marks milestone for EssilorLuxottica’s lens ophthalmic plant in Italy
EssilorLuxottica’s ophthalmic plant in Sedico, Italy, has been awarded EN ISO13485:2016 certification, recognizing the excellence of the Group’s processes for the design, production and distribution of ophthalmic lenses.
Specialized in manufacturing advanced technology eyecare, EssilorLuxottica’s prescription lens ophthalmic plant in Sedico is now certified EN ISO13485:2016 “Medical devices - Quality management systems - Requirements for regulatory purposes” in addition to the previous EN ISO9001:2015 quality certification. Considering the challenge represented by Medical Device Regulation, in order to guarantee customers the best quality and service level, the Company started an accelerated path a few months ago to meet this standard requirement.
The project launched in the Sedico ophthalmic plant led to the release of the First Official Certificate on May 9, 2022 for “Contract manufacturing of non-active, non-implantable ophthalmic medical devices (ophthalmic lenses). Contract assembly and adaption of non-active medical devices (spectacles)”.
Moreover, to fully guarantee the quality and high level of maturity of the overall process, on July 4, 2022, an additional Official Certification was awarded for “Design and development, management of manufacturing and placing on the market of non-active, non-implantable ophthalmic medical devices (ophthalmic lenses). Contract manufacturing of non-active, non-implantable ophthalmic medical devices (ophthalmic lenses). Contract assembly and adaption of non-active medical devices (spectacles)”.
The certification confirms the high quality of the medical devices produced by the plant as well supports its long-term growth and competitivity. In particular, it ensures that the comprehensive management system in place helps manage risk effectively, improve processes and ensure good practices are used to consistently allow the supply of safe medical devices.
Having met all rigorous EN ISO13485:2016 certification requirements, the Sedico ophthalmic plant guarantees the presumption of conformity in a comprehensive quality management system for the design and manufacture of medical devices in Europe, Canada, USA, Japan, Australia, Singapore, and Malaysia.
Producing more than 25,000 pair of ophthalmic lenses per week, the Sedico EN ISO13485:2016 certified ophthalmic plant is located within the Group’s Sedico hub, which is considered an integrated logistic service center within EssilorLuxottica’s vast network of 23 eyewear distribution centers. Open since 2016, the Sedico hub manufactures lenses to serve the market at global level, and it is known to be one of the most technically advanced in the industry.
Previous above-mentioned certificates have been released by TÜV Italia S.r.l. (TÜV SÜD group), one of the most recognized Accredited Certification Bodies with vast experience and proficiency in the Medical Device field.
This represents another piece of the strategy the Company pursues to strive for excellence and deliver the best services for customers.