15 Aug FDA adopts ISO 13485 QMSR
In January of 2024, the FDA finally pulled the trigger on adopting ISO 13485 which is the international standard for quality management systems for medical devices.
What does this mean for your Quality Systems and Practices?
This change initiates the transition from the legacy Quality System Regulation (QSR), into the new Quality Management System Regulation (QMSR). Although the alignment is not perfect, the FDA chose to retain some elements from 21 CFR 820.30.
The QSR has been in place since 1996 so there is a considerable amount of history and legacy information to consider, and this may pose some challenges to companies that have been operating under the QSR for some time.
The FDA retained aspects of complaint management, labeling, and packaging controls, so those elements will be an easy transition for those used to the QSR but may prove challenging to those that have just been operating under a 13485-compliant system.
Here’s a breakdown on what is changing in the quality management system and how your company can address it before the FDA’s deadline.
With all due respect to Mr. Bob Dylan, the terms, they are a-changin’. Possibly, the biggest impact of the new quality management systems is what is now excluded.
The adoption of the QMSR eliminates terms that have been around for decades…
DHF – Design History File
DMR – Device Master Record
DHR – Device History Record
With this specific language out of the equation, it is likely going to be difficult to ‘exercise’ these historical terms, and more difficult to effect a clean transition into the new terminology. This will have to be diligently managed throughout the transition.
Under the new QMSR, companies may now be expected to submit:
- Internal audit reports
- Management review records
- Supplier management records
Historically, the FDA did not require companies to provide these internal (and possibly informal) documents of their processes. However, now that these reports and records may be subject to review by the FDA, companies should be encouraged to formalize those processes and their accompanying documentation, (i.e. “be careful how you word that, because the FDA might see it”). Companies will need to educate employees and implement a better internal system for their reports and records in order to remain effective and efficient in their quality management without unintentionally “planting landmines” that could prevent FDA approval.
Remember, though, introspective assessments are key here… it’s better to find and address issues internally rather than having an external auditor or inspector find them.
Now, you may be asking how to update your company’s quality management systems for the new regulations?
In our experience we typically see companies in need of guidance to create the system from scratch, conduct a secondary process audit, or implement a few tweaks to streamline and align with the updates and requirements.
Companies are probably in one of 3 conditions:
- The company has no Quality Management System (QMS) and are looking to set one up. With the new QMSR, basing it on ISO 13485 will cover most of the FDA requirements but, as noted above, there are a few additional FDA-specific requirements that would need to be included.
- The company already has an ISO 13485-compliant QMS but wants to expand to market in the United States and needs to comply with the new QMSR to do so. This could be accomplished by applying a few additional requirements and should not be too disruptive.
- The company is QMS compliant with the original QSR and needs to transition to the new QMSR. The challenges described earlier regarding terminology changes, what is now excluded, and what is potentially subject to submission and review will need to be addressed along with other ISO 13485-specific and additional FDA requirements.
Realtime has ensured the compliance of ISO 13485 and/or 21 CFR 820 or QMS’ for numerous companies and would be happy to discuss how we can help you navigate these industry adjustments. The only question remains, how quickly do these QMSR standards need to be implemented?
Deadline for the new FDA QMSR Submission Updates?
Companies have two years to implement the transition.
While there is no need to act with immediate urgency, companies should begin planning the transition to ensure smooth operations and ultimate transparency of documentation by the deadline. The key is to start planning ASAP. Auditors love documented plans; it shows you’re trying to stay on top of things.
Our team at Realtime believes that this change is healthy, as it should enable more consistent audits/inspections and provide more streamlined quality management systems.
Given the landscape of requirements and regulations is always changing, our incredible team of specialists remain vigilant in their adaptation of the latest certifications. We maintain a birdseye view to expertly guide organizations through the various complexities of the compliance process every step of the way.
Let our ISO 13485-certified organization filled with knowledgeable/certified quality and design engineers assist you in navigating this transition to the new QMSR.
Visit us at www.therealtimegroup.com or call us at 972-985-9100 to see how we can help you with your product development and testing!
