Origin Achieves ISO 13485 Certificate for Best Practice in Medical Devices

ISO 5 cleanroom contract manufacturing

Origin have invested £12 million in a state-of-the-art ISO 5 filling facility. As part of the facility we have developed a kitting service.

The internationally agreed ISO standard is the main standard for medical devices and demonstrates to regulators our ongoing commitment to quality and best practice.

ISO 13485 is a stringent standard Origin can apply to control systems and processes to ensure the safety and efficacy of its medical devices.

The certification will support ongoing customer partnerships and open new opportunities where ISO 13485 is a pre-requisite for doing business, assuring customers that the Medical Device / IVD products they intend to purchase will meet their requirements for quality.

It will also allow Origin to sell medical devices in major markets such as the EU and Canada.

The achievement follows years of investment by Origin into 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.

Gaining ISO 13485 status will help Origin achieve its business goals of growing its reputation within the competitive healthcare sector – particularly among big pharma, upholding customer satisfaction, promoting better decision making, creating a culture of continual improvement and increasing employee engagement.

Staff across the business have access to standards documentation, helping to identify any issues, improve products and streamline the manufacturing process.

All ISO standards are reviewed every five years to consider whether revision is required to keep it current and relevant for the marketplace. ISO 13485 (2016) is designed to respond to the latest quality management system practices, including changes in technology and regulatory requirements and expectations.

Rich Quelch, Global Head of Marketing commented: 

“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.”