Aldevron Breakthrough Blog

Why Apply ISO 13485 Principles in a Protein Manufacturing Facility?

January 18, 2023 / by Aldevron

A stepping-stone in ongoing quality improvement

The ISO 13485 standard covers the quality management system (QMS) requirements for medical devices (like CT scanners, blood perfusion pumps, diagnostic IVD tests) including requirements for regulatory purposes. Certification is granted by a third-party registrar through an annual audit process with renewal every three years. Unlike global medical device governmental regulations, the ISO 13485 standard is the same whether you are manufacturing in Italy, Africa or the United States.

So how does this apply to a protein manufacturing facility such as our Madison location? ISO 13485 harmonizes with the FDA’s requirements for a QMS (outlined in 21CFR820) which are part of the Current Good Manufacturing Practices (cGMP) regulations governing medical devices. Several years ago, the FDA announced their intentions to use ISO 13485 as the basis for their QMS legislation changes and they continue to signal their move in that direction.

Other countries have adopted the use of ISO 13485 via the Medical Device Single Audit Program (MDSAP) so that routine FDA-like inspection is no longer required for medical device manufacturers who are certified to MDSAP.

Why become ISO 13485 certified?
Although pharmaceutical requirements are more stringent than 21CFR820 and ISO 13485, these same quality management system standards are also the basic QMS requirements for pharmaceutical manufacturers.

By implementing the ISO 13485 QMS standard, we are able to demonstrate a high level of commitment at our Madison production facilities, showing clients that we take quality very seriously, and that we have a system in place to control the manufacturing environment and processes.

It’s just one of the critical steps as we work to develop, implement and improve manufacturing processes, procedures and controls to meet evolving client needs. It helps create a continuous improvement culture and discover opportunities to gain efficiencies in our processes. Lastly, it helps improve decision-making using facts and data, and employee engagement as they are integral to finding ways to reduce errors and avoid rework.

Are there other benefits to ISO 13485 certification?
You bet! The standard requires commitment from management to support the continued effectiveness of the QMS, including deploying the resources needed and monitoring the results. Additionally, developing, validating, and following standard procedures and controlling our environment creates efficiencies in operations and reduces the need for investigation and rework. Changes to procedures are carefully considered with respect to risk and impact, both for our operations and well as for our clients.




Aldevron serves the biotechnology industry with custom production of nucleic acids and proteins. Thousands of clients use Aldevron-produced plasmids, RNA and gene editing enzymes for projects ranging from research grade to clinical trials to commercial applications. Aldevron specializes in cGMP manufacturing and is known for inventing the GMP-Source® quality system. Aldevron operates the largest cGMP plasmid DNA manufacturing facility in the world at company headquarters in Fargo, North Dakota, with additional facilities in Madison, Wisconsin, and Lincoln, Nebraska.