Guardpack is proud to announce that we have achieved ISO 13485:2016 certification, a globally recognised standard for quality management systems specific to the medical device industry. This is a pivotal step in our journey as we expand into medical device manufacturing, specifically in the production of medical wet wipes, tissues, and liquid or cream-filled sachets.
This milestone follows months of meticulous preparation and company-wide commitment, with our ISO 13485 accreditation demonstrating that Guardpack has implemented robust, regulatory-compliant quality systems that meet the expectations of some of the world’s most stringent healthcare markets. It is also a formal acknowledgment of our long-standing commitment to safety, consistency, and continuous improvement.
“Achieving ISO 13485 is a significant step forward for Guardpack,” says Jeremy Freedman, Managing Director. “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.”
Why ISO 13485 Matters
ISO 13485 certification unlocks new doors for us in the highly regulated medical manufacturing space. It requires rigorous adherence to quality control, risk management, and documentation standards that ensure the design, manufacture, and distribution of medical products are safe and effective.
For Guardpack, this means we can now officially serve customers in the healthcare and medical sectors, providing them with single-use sachet and wipe solutions for applications such as:
- Disinfection of medical devices
- Skin preparation before medical procedures
- Eye cleansing
- Wound and stoma cleaning
- Vial and port disinfection
- Saline wipes and hub cleaning
These products are critical to infection prevention and patient safety, which lie at the heart of modern medical care.
Supporting Our Growth Strategy
Being awarded ISO 13485 certification represents a major milestone in our strategic journey. This was in part made possible by the funding we received through Anglia Ruskin University’s Arise ABOVE Programme. This vital support was the catalyst for our entry into medical device manufacturing, enabling us to establish a thorough gap analysis leading us to build our robust quality management system (QMS). With this foundation, we are able to ensure compliance with stringent regulatory standards and bolster our reputation as a trusted supplier to the healthcare sector.
Thanks to this funding, it set us on the path to not only achieve certification but also positioned ourselves for significant growth in the medical and life sciences sectors and expanded our capacity to meet rising demand from healthcare providers.
Strengthening Customer Confidence
At Guardpack, quality has always been at the forefront of our manufacturing ethos. This certification builds on our existing ISO 9001:2015 and ISO 14001:2015 accreditations and marks a deeper alignment with the requirements of our current and future medical clients.
Our partners can be assured that we deliver traceable, high-quality, and compliant solutions every time.
Innovation Meets Compliance
The medical industry is evolving, and so are the needs of our customers. Today’s healthcare providers are looking for innovative, sustainable packaging formats that reduce plastic waste and improve patient safety. Our sachet formats offer clear advantages:
- Lower environmental footprint – Compared to a 50ml plastic bottle (~13g), our equivalent sachet uses only ~5.3g of plastic.
- Reduced wastage and improved shelf life – Single-use sterile sachets help prevent contamination and eliminate the need to discard partially used bulk containers.
We believe our ISO 13485-certified production facility in the UK is now ideally positioned to support this shift. Whether the goal is to enhance hospital hygiene, improve outpatient care, or support in-home use, Guardpack’s sachets and wipes are designed for safety, convenience, and sustainability.
A Culture of Continuous Improvement
This achievement is just the beginning. ISO 13485 certification requires ongoing audits, reviews, and improvements. We see this not as a challenge, but as an opportunity.
Certification has helped formalise what has always been part of our company DNA: a drive to constantly refine our processes, embrace innovation, and anticipate customer needs. Whether we’re investing in new machinery, enhancing our capabilities, or training our staff in the latest GMP (Good Manufacturing Practice) protocols, we are committed to a culture of excellence.
Looking Ahead
Our certification was made possible by the dedication of our entire team – from quality assurance to production, procurement to packaging. We also want to thank our loyal customers who have continually placed their trust in us. Your confidence has helped shape the rigorous systems we have today.
At Guardpack, we are excited about what lies ahead. Our ISO 13485 certification means we’re ready to:
- Partner with OEMs, hospitals, pharmacies, and medical distributors
- Co-develop bespoke wipe and sachet products tailored to niche needs within the healthcare and medical sectors
- Deliver consistent, regulatory-compliant solutions at scale
Visit our Medical & Life Sciences page to learn more about our capabilities.
If you are seeking a trusted, certified partner for your next medical wipe or sachet innovation, we’d love to start the conversation. Get in touch with us today by filling out our contact form, email us at trade@guardpack.co.uk, or speak to one of the team today on 01245 505807.