Cytiva’s manufacturing center of excellence in Cardiff has received ISO 13485:2016 certification, an internationally recognized standard for Quality Management Systems (QMS) in the medical device industry.
ISO 13485 was written to support medical device manufacturers in designing a QMS and builds on the ISO 9001, ISO 9000:2008 model to ensure a risk-based approach to compliance within a regulated medical device manufacturing environment.
"The Cardiff facility has been ISO 9001 certified for many years and it has been our goal to achieve ISO 13485 certification to demonstrate our continued commitment to providing a high standard quality management system aligned with high-quality products, effective documentation and optimized safety standards to the benefit of our customers" said Graeme Olsen, Total Quality Leader, Genomics and Cellular Research, Cytiva.
“While we already had rigorous standards in place, our diagnostic customers told us that having the official ISO 13485 accreditation would provide an extra level of reassurance and reduce the need for extra quality control documentation on their side. We are delighted to be able to help simplify and accelerate customers’ kit and assay development” said Gabriel Fernandez de Pierola, General Manager for Genomics and Diagnostic Solutions business.
ISO 13485 certification demonstrates that our Quality Management System is appropriate and effective while emphasizing the safety and efficacy requirements around training, documentation, and safety. It ensures design, development, production, delivery, and disposal of devices are safe for their intended purpose and that we make an exhaustive effort to meet customer requirements and rigorous regulatory standards.
The Cardiff site was audited and certified by Intertek Medical Notified Body AB, a Total Quality Assurance provider to industries worldwide, with more than 43 800 employees in 1000 locations in over 100 countries. The Cardiff site joins Cytiva’s manufacturing site in Dassel, Germany that previously achieved ISO 13485 accreditation.
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