Amcor announced that its Winterbourne location, a centre for medical and healthcare packaging, has been certified under ISO 13485 for medical device packaging.
The ISO 13485:2016 standard sets international guidelines for quality management for medical devices. With the certification, healthcare clients are reassured that the Winterbourne site follows a risk assessment process designed to support regulatory compliance, which is aligned with regulatory compliance and patient safety.
This certification demonstrates its ability to manage risks effectively while meeting healthcare industry expectations.The standard requires strict control over processes, suppliers, and customer needs to maintain consistent quality.
Many companies in the medical sector expect their suppliers to have ISO 13485 certification, and holding this certification helps them meet their manufacturing needs.
This achievement enhances Amcor’s credibility and competitiveness as a medical packaging supplier. It strengthens the company’s position as a trusted supplier among medical device manufacturers.
The certification process took around 18 months, beginning with an assessment and a structured plan to align procedures with defined improvements. It further included the standard review along with the implementation of required system changes.
Jon Cowgill, general manager at Amcor Winterbourne, said: “Gaining this certification is a huge milestone for the Winterbourne facility team. ISO 13485:2016 is recognized by our customers as a key quality standard. Our focus has always been on safety and delivering brilliantly for our customers.”
The general manager described the certification as a major achievement and an important milestone for the team.
ISO 13485 also supports Amcor’s wider healthcare strategy across the EMEA region. It aligns with the company’s broader goal of strengthening healthcare packaging operations while contributing to its regional strategy of enhancing healthcare production standards.
By 2027, Amcor targets certification across its healthcare sites under ISO 13485 or ISO 15378. The certification was granted after a February 2026 audit and applies to the entire Winterbourne site. Covering the full site, the certification represents an upgrade from the site’s previous ISO 9001:2015 standard.
Link – https://www.packagingnews.co.uk/news/amcors-winterbourne-site-achieves-iso-13485-certification-16-03-2026
