Cylite, the Melbourne-based manufacturer of the Hyperparallel OCT (HP-OCT), has announced it has received ISO (International Organization for Standardization) certification of its new production site in Mulgrave, in the city’s south-east.
Cylite moved to its new site several months ago and shifted its manufacturing line there soon after.
The company said the ISO 13485:2016 certification of the new site is another important milestone for the company and is a required step to prove that its complete quality management system (QMS) and associated manufacturing processes comply to global manufacturing standards, and in doing so, ensures that it continuously delivers high-quality products and services that meet regulatory and customer requirements.
To achieve this milestone, Cylite had to undergo an audit of its processes and equipment, plus the physical Mulgrave location itself.
“This involved two intense days of on-site scrutiny from the auditor, who had flown in from overseas to undertake the assessment. While on-site, the auditor oversaw the production of several HP-OCT devices as well as auditing Cylite’s documented processes,” the company said.
It performed well throughout this exhaustive process, the company said, culminating with the award of ISO 13485:2016 certification.
“We are very pleased with this result, which is a great validation of the quality of our manufacturing processes, and we thank our quality, regulatory and production team for their hard work and diligence to allow us to achieve this goal”, the company said.
“We can now proceed full steam ahead with the manufacture of our next generation Hyperparallel OCT in preparation for our launch in the coming months.”
For more information about Cylite and the HP-OCT, visit www.cyliteoptics.com.