It’s been a busy time over at Jenx HQ, as we’ve been working hard to achieve and maintain multiple internationally recognised certifications in manufacturing against the many challenges of a global pandemic.
We understand the immense impact our postural support products can have on the lives of young people and their families, so we strive to always deliver the very best standards for our customers.
ISO 13485:2016 – Manufacture & Distribution of Medical Devices
The ISO 13485:2016 is a certification recognised across the world for the manufacture of medical devices – defined by the ISO (the International Organization for Standardization) as ‘a product, such as an instrument, machine, implant or in vitro reagent, that is intended for use in the diagnosis, prevention and treatment of diseases or other medical conditions.’
We have just passed a recertification audit for ISO 13485:2016, which reaffirms that the postural support equipment produced by Jenx consistently meets customer’s needs and regulatory requirements.
ISO 14001:2015 – Environment Standard
In December 2020, Jenx was awarded the ISO 14001:2015 for reaching an internationally agreed standard for the requirements of an environmental management system.
This accreditation demonstrates Jenx’s consideration for all environmental issues in their operations, including air pollution, water and sewage issues, waste management, soil contamination, climate change mitigation and adaptation, and resource use and efficiency.
It also shows that Jenx are using resources efficiently for better cost control, reduced waste and recycling whenever possible.
ISO 9001:2015 – Manufacturing & Distribution Standard
Jenx are proud to be certified for ISO 9001:2015. This showcases Jenx’s ability to provide postural support products and services that meet customer and applicable statutory and regulatory requirements.
ISO 9001 helps to ensure Jenx systems run efficiently and conform to the necessary quality management standards, meaning customers get consistent, high-quality products and services.
FDA Compliance Badge
Jenx has also just received our official badge from the U.S. Food & Drug Administration (FDA), an important milestone in our ability to market medical devices in the United States. To receive this verification, Jenx had to provide evidence of compliance with the strict requirements of the FDA.
The FDA are responsible for advancing public health in the US by helping to speed up innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products to improve their health.
Dan Limb, Divisional Director of Jenx, said: “I’m immensely proud of the Jenx team for all their hard work and commitment, as without it, achieving the strict requirements necessary to attain these certifications wouldn’t have been possible.
“Having this recognition from both the FDA and the ISO will help to further cement our position in the marketplace as a leader in postural support equipment internationally, and help us to go above and beyond the needs of our customers through improved efficiency and productivity.”
Howard Johnson, Quality and H&S Compliance Manager for Jenx and Jiraffe, said: “It has been an incredible journey, transitioning from the 2008 version of the ISO 9001 standard to the 2015 version.
“I’m proud to be able to say that Jenx is part of the 30% of companies who’ve successfully completed this transition on the first attempt. We also achieved both ISO 13485:2016 and ISO 14001:2015 on the first try.
“This has culminated in moving from the Medical Device Directive to the new Medical Device so our products can be sold in Europe, as well as achieving our certificate for both designation and registration with our newly appointed EU authorised representative.”
