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  • Writer's pictureRichard Kadri-Langford

Occuity Upholds Excellence by Successfully Passing Annual ISO 13485:2016 Audit

Occuity is delighted to have recently undergone its annual surveillance audit for the ISO 13485:2016 certification. This rigorous process is not just a routine check-up; it's a cornerstone of our commitment to maintaining the highest standards in our Quality Management System (QMS) and ensuring the safety and reliability of our products. Here's a closer look at the audit and its significance for Occuity.


The Audit Explained

The ISO 13485:2016 certification is pivotal for manufacturers in the medical device industry. It sets out the requirements for a comprehensive QMS that governs the design, development, production, and distribution of medical devices. The audit was a two-day event, conducted by two expert auditors who meticulously reviewed our documentation, focusing primarily on our PM1 Pachymeter processes but also examining AX1 Axiometer™ documents. Their visit to our offices allowed the auditors to gain an in-depth understanding of our operations and adherence to the QMS standards we've set.


A Successful Outcome

We are proud to announce that the audit was a success. Occuity has maintained its ISO 13485 certification, with the auditors identifying no majors, and only three minor non-conformities, which have already been rectified. This result is a testament to the robustness of our manufacturing area, the rigour of our design processes, and our overall compliance with the stringent standards set by ISO. The auditors were particularly impressed with how well-established our QMS is, reflecting our dedication to quality and excellence.

"We’re delighted with the team, and the great feedback we received." said CEO Dan Daly, continuing, “To only receive three minors and no majors is a testament to the exceptional work of our QMS team in ensuring we are in the best possible shape to move forward.”


The Importance of ISO 13485

Achieving and maintaining ISO 13485 certification is crucial for several reasons. First and foremost, it ensures that our products are designed and manufactured to meet the highest quality standards. This certification also signifies to our customers, partners, and regulators that Occuity is committed to continuous improvement and customer satisfaction. Perhaps most importantly, it will enable us to sell the PM1 when it receives CE Marking. Failure to maintain this certification would have precluded us from doing so.


Looking Forward

As we await the issuance of our updated certificate, we reflect on the importance of this audit and what it means for the future. Maintaining our ISO 13485:2016 certification ensures that the scope of our QMS—encompassing design, manufacturing, and distribution—remains in effect. This achievement paves the way for us to continue bringing our groundbreaking diagnostic technologies to the market, contributing to the betterment of healthcare outcomes globally

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