This is the first in a series of articles on the new Quality Management System Regulation (QMSR). The QMSR was published as a final rule on January 31, 2024 with an effective date of February 2, 2026. This series is intended to help companies fully prepare for the complicated journey ahead.
Table of Contents
Quality Management System Regulation (QMSR) Series Topics
- Transitioning to the Quality Management System Regulation (QMSR) – History of the Quality System Regulation (QSR)
- From the top: Key differences among the QSR, QMSR, and ISO 13485:2016
- The QMSR – Focus on definitional differences from past practice
- The QMSR – Focus on Risk
- The QMSR – Focus on CAPA
We plan to publish many more articles on this topic and want it to be useful to the entire industry so please comment and reshare. Let us know what is on your mind so we can address it and get stronger with you.
History of the Quality System Regulation (QSR)
The Quality System Regulation (QSR) was officially published by the FDA on January 4, 1996, under 21 CFR Part 820. This regulation, to a large extent, mirrored the ISO 9000 series of international quality system standards. The QSR set forth the essential quality system requirements that manufacturers of medical devices must follow to comply with the Federal Food, Drug, and Cosmetic Act (FDCA).
The QSR was a response to the growing need for a systematic approach to ensure the quality and reliability of medical devices. It provided a comprehensive framework for companies, encompassing aspects such as design controls, production and process controls, finished device acceptance, and quality audits.
Recognizing the need to continue to evolve its regulatory framework to address the complexities of modern medical device development and manufacturing, the FDA has now created the Quality Management System Regulation (QMSR). The QMSR is part of the FDA’s broader initiatives to harmonize its regulations with international standards, particularly ISO 13485, which sets the global benchmark for quality management systems in the medical device sector.
It is crucial to realize that the QMSR is not a simple replacement of the QSR but is an alignment and modernization of the regulatory environment that emphasizes risk management, post-market surveillance, and a greater alignment with international best practices.
This modernization aims to streamline compliance for manufacturers operating in global markets while also enhancing the safety and effectiveness of medical devices. Thus, it is critical that manufacturers recognize that while the QMSR retains features from both the legacy regulation and the standard, it also introduces unique requirements of its own.
What this means in plain language is that your current compliance status will not guarantee a future state of compliance. Whether you are currently compliant to the QSR, ISO 13485:2016, or both, you have work to do, and we can help you do it.
Why Compliance Architects?
Because we have done the hardest part of the work already.
Using the tools of modern databases and project planning, we have mapped out the differences among the three regulations and figured out where the gaps are. In fact, just with the QSR and ISO 13485, our tool had identified a minimum of 132 pairs of requirements that need alignment and created roadmaps for each of them.
We can then use these roadmaps to streamline your internal assessment of compliance and help create a risk-based plan to close the gaps that will not only shorten your time to compliance but also strengthen your overall compliance posture along the way.
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