PHARMACEUTICAL packaging specialist Origin has announced its intention to grow its reputation within the healthcare sector after being awarded ISO 13485 certification.
The firm explained the internationally agreed ISO standard is the main standard for medical devices and demonstrates to regulators the company’s commitment to quality and best practice.
ISO 13485 is a standard Origin can apply to control systems and processes to ensure the safety and efficacy of its medical devices. The move has been tipped to support ongoing customer partnerships and open new opportunities where the certification is a pre-requisite for doing business. It also means Origin will be able to sell medical devices in markets such as the EU and Canada.
Origin added that the achievement follows years of investment in ‘state-of-the-art’ facilities, the introduction of nearly 50 new QMS policies and procedures, the allocation of over 750 work hours to audit-related activity, and two compliance audits by the certification body with involvement from many departments.
Staff across the business will have access to standards documentation when they need it, which Origin said will help them to ‘identify any issues, improve products and streamline the manufacturing process’.
Rich Quelch, global head of marketing at Origin, said, “Being awarded ISO 13485 status is a testament to Origin’s commitment to the highest safety and quality standards in its medical devices and packaging. We’re incredibly proud of this achievement and it marks an important milestone for Origin – it will support us to engage with more pharmaceutical and healthcare companies globally.”
