Amcor Winterbourne achieves ISO 13485:2016 certification, strengthening its commitment to healthcare packaging

Zurich, March 16th, 2026: Amcor (NYSE: AMCR, ASX:AMC), a global leader in developing and producing responsible packaging solutions, has today announced that its Winterbourne manufacturing site in the UK, a center of excellence for medical and healthcare packaging, has achieved ISO 13485:2016 certification.

ISO 13485:2016 is the internationally recognized quality standard for the medical device industry, requiring rigorous risk assessment processes , strong regulatory alignment and streamlined operational efficiency. This represents a significant upgrade from the previous ISO 9001:2015 standard and reinforces the site’s commitment to the quality expectations of medical device manufacturers.

This certification is an important differentiator in the healthcare market. It confirms the site’s commitment to meeting medical industry expectations and to meeting the rigorous requirements for safety, compliance, and quality in order to give customers confidence in their packaging partner for regulated healthcare products.

During the certification preparation process, the team improved risk management, strengthened supplier standards, clarified procedures, and reinforced focus on customer requirements and patient safety.

“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 now in place, the site's strengthened quality system is positioned to support a broader range of healthcare programs, including Class I and, in time, Class IIa medical devices, supporting EU Medical Device Regulation (MDR)-compliant products and CE-marked applications.”

This achievement positions the site for new market opportunities where medical-grade assurance is required. It also represents an important milestone in Amcor’s broader healthcare roadmap, which plans 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.

With a Quality Management System now fully aligned to FDA’s Quality Management System Regulation requirements, the site enters its next chapter with a strengthened capability to serve regulated markets both in Europe and in the USA - to positively contribute to the expansion of Amcor’s global healthcare portfolio.

More information on Amcor’s range of packaging for medical and pharmaceutical packaging can be found here: https://www.amcor.com/products/healthcare

About Amcor
Amcor is the global leader in developing and producing responsible consumer packaging and dispensing solutions across a variety of materials for nutrition, health, beauty and wellness categories. Our global product innovation and sustainability expertise enables us to solve packaging challenges around the world every day, producing a range of flexible packaging, rigid packaging, cartons and closures that are more sustainable, functional and appealing for our customers and their consumers. We are guided by our purpose of elevating customers, shaping lives and protecting the future. Supported by a commitment to safety, over 75,000 people generate $23 billion in annualized sales from operations that span over 400 locations in more than 40 countries. NYSE: AMCR; ASX: AMC www.amcor.com | LinkedIn | YouTube