Amcor’s Winterbourne site achieves ISO 13485 certification

Packaging Solutions

Amcor has announced that its Winterbourne site has successfully achieved ISO 13485:2016 certification. 

ISO 13485:2016 is an internationally recognised quality management standard specifically for medical devices.

The new certification provides healthcare customers with additional assurance that the site operates a risk assessment process designed to support regulatory compliance, patient safety and the expectations of the medical device industry. The standard requires rigorous management of processes, supplier relationships and customer requirements, helping ensure consistent quality and alignment with customer expectations.

Many organisations in the sector require their suppliers to hold ISO 13485:2016 certification. The certification strengthens Amcor’s position as a supplier to medical device manufacturers. 

Preparation for certification took approximately 18 months, beginning with an assessment against quality standards followed by the development and implementation of a structured plan to align processes and procedures with ISO 13485:2016 requirements. 

Jon Cowgill, general manager at Amcor Winterbourne, based in Bristol, said: ‘Gaining this certification is a huge milestone for the Winterbourne facility team. ISO 13485:2016 is recognised by our customers as a key quality standard.

‘Our focus has always been on safety and delivering brilliantly for our customers. Achieving ISO 13485:2016 is a great achievement for the team and endorsement for the Winterbourne site.’

The certification also supports the company’s broader healthcare packaging strategy across the EMEA region, where healthcare production sites are working towards achieving either ISO 13485 or ISO 15378 certification by the end of 2027.

The certification was awarded following an audit in February 2026. The certification covers the full Amcor Flexibles Winterbourne site and represents an improvement on the site’s previous ISO 9001:2015 quality management standard.