Thermoformed packaging manufacturer reinforces commitment to medical device industry with internationally recognised quality management standard
Macpac has further strengthened its position as one of the UK’s most trusted suppliers of plastic thermoformed packaging by achieving ISO 13485:2016 accreditation at the first attempt. The internationally recognised quality management standard confirms that the Stockport-based manufacturer’s systems meet the stringent requirements needed to support customers within the medical device sector.
The significant achievement follows the successful completion of both Stage 1 and Stage 2 assessments, during which Macpac passed a rigorous audit process designed to measure the effectiveness of its quality management systems, controls and compliance procedures for the medical device industry.
The ISO 13485:2016 accreditation places particular emphasis on risk management, document control, traceability and continuous improvement — all key areas in supporting safe, reliable and compliant supply chains for medical device packaging.
Alison Griffies, QA Manager at Macpac, said: “We are delighted to have achieved ISO 13485:2016 accreditation at the first attempt. This certification gives customers additional confidence that choosing Macpac as their preferred supplier for thermoformed plastic packaging means our processes and controls are aligned with the strict regulatory requirements of the medical device industry.”
Macpac manufactures high-quality, 100% recyclable thermoformed packaging designed to help businesses bring their products to market efficiently and responsibly.
As a third-generation family business with more than 50 years’ experience, Macpac has built a reputation for innovation, reliability and customer-focused service. The new accreditation builds on the company’s wider commitment to quality across its operations.
Macpac supplies a wide range of sectors, including medical, pharmaceutical, food, manufacturing and retail, with particular focus on technically demanding packaging projects.
From initial pack design through to full-scale production, all activity takes place under one roof at Macpac’s state-of-the-art manufacturing facility.
Alongside its continued support for customers across the UK, Macpac has also achieved strong international growth, tripling its export business over the past five years. Following the addition of Australia in 2023, the company now supplies packaging to 22 countries worldwide, supporting brands with consistent packaging solutions across multiple markets.
