Frey is pleased to announce the company has once again successfully passed ISO certification and is in conformance with PN-EN ISO 13485:2016-04, in the following scope of activities:
ISO 13485: 2016-04 certificate is a globally recognized and mostly widely used quality management system for medical devices. Frey Quality Management System (QMS) around design and development, manufacturing and sales for ophthalmic and optometric devices demonstrates the company commitment to continued product optimisation and process excellence. This outcome is due all Frey personnel unswerving dedication across the entire company.
The audit was managed by the Polish Centre for Testing and Certification. The new ISO 13485:2016 standard audit process is now undertaken on yearly basis and is significant undertaking by Frey. Yearly audits greatly assists Frey to lift levels of organizational performance and meet the high demands of the ophthalmic and optometric market. Perhaps the most important change would be the adoption of a risk management based approach throughout all areas of the Frey QMS. This includes design development, purchasing and outsourced processes, training and competence. This important change crosses all touch points of the company. Achieving this latest certification will enhance Frey brand and ophthalmology and optometry devices credibility and marketability worldwide.