ISO 13485 and its new role in the US – harmonization between the Quality System Regulation and the ISO standard

Aaron Hoare Date published: Sep 20, 23

The US Food and Drug Administration (FDA) has proposed a revision of the current good manufacturing practice (CGMP) guidelines of the Quality System (QS) Regulation for medical devices. The aim is to bring it in sync with the international consensus standard, aligning with the quality management system (QMS) principles enforced by regulatory bodies in other countries. All indicators suggest that this will be going ahead.

The proposed alignment would incorporate the international standard specific to med device quality management systems, namely, the 2016 version of ISO 13485, formulated by the International Organization for Standardization (ISO).

This proposed regulatory update would also include additional guidelines to harmonize with the existing stipulations in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its executing regulations.

These changes, if approved, will help clarify the device CGMP requirements for combination products and enhance regulatory alignment with other authorities to streamline device regulation and expedite the introduction of safe, effective, high-quality devices for patients. This refers to conforming edits to 21 CFR Part 4 to clarify the device CGMP requirements for combination products.

Want to learn more about the FDA’s proposed Quality Management System Regulation and the new role of ISO 13485:2016? Hear from regulatory affairs expert, Joanne Rupprecht, in this webinar covering these proposed changes and ISO 13485 in detail.

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Why is the FDA harmonizing these regulations?

There are two main answers to this question. Ultimately, the FDA is committed to continually improving the safety, effectiveness, and overall quality of medical devices on the US market. Meeting patient needs is essential.

If (or more likely when) this action is finalized, better harmonization between the Quality System Regulation (more specifically, in relation to 21 CFR Part 820) and ISO 13485 is seen as a way to unlock these safety, effectiveness, and quality goals. In particular, this is because it will better align standards in the US with regulatory authorities around the world. After all, ISO 13485 is the definitive international standard governing medical devices, so it is recognized globally as a signifier of quality in medical device organizations.

The other driving force behind this change is that ISO 13485 already shares a lot of similarities with the QS regulation. The main requirements of ISO 13485 and the actions required for compliance are very comparable to those under Part 820.

The only glaring difference between the two is the risk managements requirements that form a core part of ISO 13485, since the only risk-specific requirement outlined in 21 CFR 820 is listed in § 820.30 (g) Design controls. But this really only covers risk analysis as part of the design validation process.

It is believed, therefore, that adopting the wider focus on risk that is core to ISO 13485 as part of the QS regulation will be overwhelmingly to the benefit of the quality, safety, and effectiveness of medical devices in the US.

What can you do to prepare for these changes?

The most obvious thing you can do is to familiarize yourself with the requirements of ISO 13485:2016. Or, better still, if you attain ISO 13485 certification, you can practically guarantee that you will be compliant with any changes the FDA make.

The FDA also state, with regards to training, that “FDA staff will complete training on the final rule, the revised inspection technique and changes to associated policies and procedures. Additionally, broader Quality Management System trainings have been, and will continue to be, deployed within the FDA to familiarize affected staff with quality management system concepts and requirements.”

It is also likely that, once the ruling is passed, the FDA will not make QMSR effective until at least one year after the final rule is passed. So, you will have plenty of time to connect with the FDA and regulators over your transition.

But for your peace of mind, remember: any organization already compliant with 21 CFR Part 820 should be able to comply with ISO 13485, and vice versa.

Manage your transition and compliance with a sound quality management system

The best way to manage this change is to already have a quality management system in place that meets the requirements of 21 CFR Part 820 or ISO 13485 with ease. There is no doubt that using tried-and-trusted quality management software to uphold unshakeable standards of quality is the key to unlocking compliance.

Ideagen Quality Management is trusted across the globe with this task. It includes modules for managing everything from CAPA and risk, all the way down to tracking the performance of individual suppliers and customer complaints. This makes meeting regulatory requirements straightforward, especially when you take advantage of the software to create clear audit trails.

Want extra information on how Ideagen Quality management can benefit your medical device organization? Learn more about the solution today and book a conversation with our team.

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