QMSR (Quality Management System Regulation) Explained: What FDA QSR & ISO 13485 Harmonization Means for Medical Device Companies

On February 23, 2022, FDA released its proposed rule for the new Quality Management System Regulation (QMSR).

The proposed QMSR will be the result of aligning the current good manufacturing practice (cGMP) requirements of the FDA’s Quality System Regulation (QSR) with the international consensus standard for medical device quality management systems, ISO 13485:2016.

Cue the applause, because the medical device industry has been buzzing about harmonization between FDA’s QSR and ISO 13485 since 2018, and now it’s finally happening!

Well, almost. The document FDA released is a proposed rule. There are several steps before it’s finalized, including:

• The public advisory committee meeting of the Device Good Manufacturing Practice Advisory Committee on March 2, 2022.

• A 90-day public comment period and subsequent revisions by FDA

• A one-year period between finalization of the rule and its implementation

Still, this is a major step toward harmonization, and one that medical device professionals have been waiting for for a long time.

So, let’s cut to the chase: why is FDA harmonizing the standards, what do the new changes look like, and what will this change for medical device companies?

BONUS RESOURCE: Download your free copy of our FDA QSR & ISO 13485 QMS Checklist by clicking here.

Why is FDA proposing this change?

While ISO 13485 has been revised repeatedly over the past two decades, the QSR remains nearly unchanged since it was released in 1996. 

In its proposed rule, FDA admits that “regulatory expectations for a QMS have evolved since the current part 820 was implemented over 20 years ago,” and that, “By proposing to incorporate ISO 13485 by reference, we are seeking to explicitly require current internationally recognized regulatory expectations for QMS for devices subject to FDA’s jurisdiction.”

FDA also notes that it has paid attention to the revisions to ISO 13485 over the years, and the agency feels the 2016 version of the standard is closely aligned with requirements of 21 CFR Part 820. All ISO standards are reviewed every five years to decide whether they need updating, and the current version of ISO 13485 was last confirmed in 2020. 

FDA repeatedly mentions in its proposed rule that the QMS requirements in Part 820 and ISO 13485 are substantially similar: “Where ISO 13485 diverges from the current part 820, these differences are generally consistent with the overall intent and purposes behind FDA's regulation of QMSs.”

As such, it makes sense for FDA to harmonize the two and eliminate the redundancy and inefficiency that many medical device companies face while attempting to satisfy the requirements of both the QSR and ISO 13485. 

The agency believes that harmonization will further the cause of “regulatory simplicity and global harmonization and should reduce burdens on a regulated industry, thereby providing patients more efficient access to necessary devices.” 

FDA also estimates that harmonization will save medical device companies at least $439 million over the next decade by reducing the compliance burden on medical device companies that currently have to comply with both standards.

How does the QMSR differ from the QSR?

FDA is proposing to incorporate ISO 13485 “by reference,” meaning the new QMSR will address certain requirements by referencing their location in ISO 13485:2016. This will, of course, result in substantial changes to 21 CFR Part 820 as we know it. 

FDA states they are “proposing additional definitions, clarifying concepts, and additional requirements, all of which would require compliance within a manufacturer’s QMS in addition to ISO 13485.”

The good news is, many of these changes are semantic in nature and don’t change the basic QMS requirements for medical device companies. For instance, you’ll notice that the term “device master record” is nixed under the current proposal, as it isn’t used in ISO 13485 and the concept behind it is adequately covered in ISO 13485’s requirement for a medical device file. 

On the other hand, there are terms and definitions in ISO 13485 that “would create inconsistencies with the Federal Food Drug & Cosmetic Act and its implementing regulations.” In these cases, the FDA’s definitions will supersede those of ISO 13485. For example, ‘device’ and ‘labeling’ will supersede the definitions for ‘medical device’ and ‘labelling’ in ISO 13485.

The FDA’s stance on the melding of Part 820’s definitions with those of ISO 13485 can be found in Section 5, Part B of the proposed rule.

The proposed rule also includes several new sections in Part 820:

• Section 820.7 - Incorporation by reference

• Section 820.10 - Requirements for a quality management system 

• Section 820.15 - Clarification of concepts

• Section 820.35 - Control of records

• Section 820.45 - Device labeling and packaging controls

Finally, one of the biggest differences between ISO 13485:2016 and the QSR is that the international standard places a greater emphasis on risk management. 

FDA notes that they expect manufacturers to integrate risk management activities throughout their QMS and across the product lifecycle, but they also acknowledge that ISO 13485 more explicitly establishes those requirements. The incorporation of ISO 13485 by reference will ensure the new QMSR has a more overt stance on the importance of risk management in design controls.

BONUS RESOURCE: Download your free copy of our FDA QSR & ISO 13485 QMS Checklist by clicking here.

What does the FDA QSR transition to ISO 13485 mean for medical device manufacturers?

While this may seem like a lot of change for medical device manufacturers, it’s important to keep in mind that FDA already believes ISO 13485 to be substantially similar to the current QSR. 

It’s a good idea to keep an eye on this proposed rule and any revisions to it that come out after the public comment period, but this won’t result in a total overhaul of your QMS. This harmonization is more about making life easier for everyone. 

With that said, there are a few things to keep in mind regarding the proposed rule to harmonize the FDA QSR with ISO 13485:2016:

• Once the rule is finalized, there will be a one-year waiting period before it goes into effect. 

• The proposed rule would also result in the replacement of the current Quality System Inspection Technique (QSIT) with a new approach that is consistent with the new QMSR requirements.

• FDA is proposing to harmonize the QSR with ISO 13485:2016, which is the latest version of the ISO standard. Any future revision to ISO 13485 would first need to be evaluated by FDA before being incorporated into the QMSR.

• Just because QMSR will be harmonized with ISO 13485, that doesn’t mean you’ll be issued an ISO 13485 certification of conformance after an inspection. And if you already are ISO 13485 certified, that won’t exempt you from FDA inspections.

Finally, remember this is a proposed rule and it’s all still subject to change. Still, this is an excellent opportunity to read up on how FDA views the relationship between the QSR and ISO 13485 and how they currently plan on harmonizing the two.

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