AMCOR has announced that its Winterbourne site has successfully achieved ISO 13485:2016 certification, an internationally recognised quality management standard for medical devices.
The certification provides healthcare customers with additional assurance that the Amcor Flexibles Winterbourne site operates a risk assessment process designed to support regulatory compliance, patient safety, and the expectations of the medical device industry.
Amcor stated that the standard requires ‘rigorous’ management of processes, supplier relationships, and customer requirements, helping ensure consistent quality and alignment with customer expectations.
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, 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 was awarded following an audit in February and covers the full Amcor Flexibles Winterbourne site.
