Amcor has confirmed that its Winterbourne manufacturing site in the UK has achieved ISO 13485:2016 certification, marking a development in its healthcare packaging operations. The facility, focused on medical and healthcare packaging, now complies with internationally recognized standards required for regulated environments.
ISO 13485:2016 outlines specific requirements for quality management systems in the medical device sector, including structured risk assessment processes, regulatory alignment, and operational efficiency. The transition from ISO 9001:2015 reflects a higher level of compliance and closer alignment with expectations from medical device manufacturers. This certification supports the site’s role in delivering healthcare packaging that meets defined safety, compliance, and quality benchmarks.
During the certification process, the Winterbourne team implemented several operational improvements. These included strengthening risk management practices, enhancing supplier standards, clarifying internal procedures, and reinforcing focus on customer requirements and patient safety. These adjustments were introduced to support consistent performance in healthcare packaging production and quality management.
“Our customers recognize ISO 13485:2016 as a key quality standard for the medical device industry”, said Jon Cowgill, General Manager at Amcor Flexibles Winterbourne. „With this, we are reinforcing our commitment to a quality management system that prioritizes and protects the end patient. Gaining this certification is a huge achievement for the Winterbourne team.”
With ISO 13485:2016 certification in place, the site is positioned to support a broader range of healthcare programs, including Class I and, in time, Class IIa medical devices. This includes EU Medical Device Regulation (MDR)-compliant products and CE-marked applications. The development aligns with Amcor’s broader healthcare roadmap, which aims to have all healthcare packaging production sites across Europe, Middle East, and Africa certified to either ISO 13485:2016 (Medical) or ISO 15378:2017 (Pharma) by the end of 2027.
The site’s Quality Management System is aligned with FDA’s Quality Management System Regulation requirements, enabling it to support regulated markets in both Europe and the USA while contributing to Amcor’s healthcare packaging portfolio.