Why ISO 13485?
ISO 13485 is an international standard that supports medical device manufacturers in designing a Quality Management System (QMS) that optimises all of the processes involved. This ensures that design, development, production, installation and delivery remain consistent and reliable, resulting in medical devices that meet all regulatory requirements and are guaranteed to be safe for the consumer.
Origin’s Quality Management System
We’ve invested huge volumes of time, expertise and capital into developing a QMS that emphasises the safety and efficacy of medical devices. Best practice remains firmly at the heart of everything we do, which is why we have recently introduced almost fifty new QMS policies and procedures into our day-to-day operations. This required over 750 work hours of audit-related activity and two compliance audits, resulting in the gaining of ISO 13485.
Reflecting our commitment to continuous improvement, we will ensure that Origin retains ISO 13485 certification and provides only the highest calibre of cleanroom liquid filling and contract kitting services to clients around the globe.
The benefits of ISO 13485
When you choose Origin for contract filling and kitting services, you gain the knowledge that you’re working with a pharmaceutical packaging specialist that is dedicated to upholding ISO 13485 standards. There are multiple benefits that come with this certification, such as:
Our QMS is designed to facilitate faster cycle times and optimise the supply chain process.
ISO 13485 focuses on significant reduction of waste in terms of overproduction, excess inventory, waiting, defects and scrap materials. This gives you the reassurance that the production phase is as environmentally sustainable as possible.
Thanks to the system being optimised, the amount of labour is minimised. This helps to simultaneously reduce costs and ensure the highest quality of product due to highly efficient production.
A requirement of ISO 13485 certification is regular quality auditing and process optimisation. As a result, you can rest assured that systematic improvement is at the heart of all operations.
With over 50 years of experience working with many of the world’s leading brand owners, we’re proud to offer our customers a range of custom-made solutions developed in our state-of-the-art cleanrooms in the UK, Poland and the US.
Our facilities enable us to manufacture innovative thermoformed solutions, such as sterile barrier packaging, engineered to maximise revenue, reduce cost and increase your speed to market. No matter what you need when it comes to a cleanroom facility for the production, filling, packaging and labelling of medical and healthcare products, Origin Pharma Packaging will deliver a truly exceptional solution.