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Every year, companies in the MedTech sector with ISO 13485 certification for the development of medical products undergo audits to ensure the reliability of their quality management system. This is a pivotal moment, meticulously prepared by our Quality teams, where no detail is overlooked.
At CLEIO, we see external audits as a valuable opportunity to challenge ourselves and enhance our practices. “It’s a time of great productivity, awareness, and accomplishment. As the deadline approaches, everyone’s efforts and energy are focused on a single goal: perfecting our quality management system and demonstrating our mastery of it,” explains Jean-Yves Pairet, Quality Director.
Result of the 2025 Surveillance Audit: Zero Non-Conformities!
During the 2025 surveillance audit, CLEIO achieved a flawless result: zero non-conformities. This rare outcome left a strong impression on the auditors.
This success is a testament to the dedication and rigor of our Quality Assurance team, who work meticulously year-round and are committed to the continuous improvement of our processes. The involvement of all our teams, along with their consistent adherence to procedures and training programs, also played a major role in this achievement.
A Recognition of Our Strengths
In addition to the absence of non-conformities, several positive aspects of our way of working were highlighted during the audit:
- Our proactive management of customer feedback, demonstrating our commitment to continuous improvement and to the satisfaction of those who place their trust in us.
- The competence and technical expertise of our teams, reflecting the high quality of our work.
- Our sustained efforts to maintain and improve our processes, providing clear evidence that our quality system is both evolving and well integrated into our operations.
We can be proud of this great result, which allows us to approach next year’s recertification audit with confidence. Well done to all our teams: you’ve proven that together, we can achieve great things!
