Leading wet wipe and sachet manufacturer, Guardpack has been awarded ISO 13485:2016 certification, the internationally recognised standard for quality management systems specific to the medical device industry. This is a pivotal moment for the specialist manufacturer in their journey as they expand into medical device manufacturing, with a focus on the production of medical wet wipes, tissues, and sachets containing liquid or cream.
The new accreditation is a testament to Guardpack’s long-standing commitment to safety, consistency, and continuous improvement. With ISO 13485 in place, the company is now formally equipped to supply healthcare and medical sector clients with critical single-use solutions designed for applications including: the disinfection of medical devices, wound and stoma cleaning, as well as skin preparation before medical procedures. These products are critical to infection prevention and patient safety, which lie at the heart of modern medical care.
Guardpack’s Managing Director, Jeremy Freedman says, “Achieving ISO 13485 is a significant step forward for Guardpack. It demonstrates our commitment to continual improvement and robust quality systems, building on existing relationships within the healthcare and medical sectors, whilst opening new opportunities to deliver innovative sachet and wet wipe solutions.”
ISO 13485 certification unlocks new doors for Guardpack in the highly regulated medical manufacturing space. It allows them to partner with OEMs, hospitals, pharmacies, and medical distributors who require rigorous adherence to quality control, risk management, and documentation standards to ensure the highest standards of safety and effectiveness.
This achievement follows Guardpack’s successful application for funding through Anglia Ruskin University’s Arise ABOVE Programme in 2024, which provided critical support for the company’s transition into medical manufacturing. The funding helped conduct a thorough gap analysis, and implement a robust quality management system (QMS), laying the groundwork for regulatory compliance and future growth.
Building on existing certifications – ISO 9001:2015 (Quality Management) and ISO 14001:2015 (Environmental Management) – the addition of ISO 13485 solidifies Guardpack’s position as a trusted manufacturing partner for the healthcare industry.
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