If you’re in the medical device industry, the term 21 CFR Part 820 is more than just regulatory jargon; it’s the foundation of your entire operation. Getting this right isn’t just about avoiding an FDA warning letter. It’s about building a framework for safety, effectiveness, and trust into every product you create. The requirements can feel overwhelming, especially when you’re focused on innovation and growth. This guide is designed to demystify the regulations and break them down into actionable steps. We’ll walk through the essential components, from design controls to CAPA, helping you build a compliant 21 CFR 820 quality system that serves as a business asset, not just a regulatory burden.
Key Takeaways
- Treat Quality as Your Foundation: 21 CFR Part 820 is the FDA’s mandatory rulebook for entering the U.S. market. A compliant quality system isn’t just about passing an inspection; it’s a core business strategy that requires clear leadership commitment and documented processes for your product’s entire lifecycle.
- Master Your Core Control Systems: Most compliance failures happen in a few key areas. To stay on track, build robust and well-documented processes for Design Controls, Document Controls, and especially Corrective and Preventive Actions (CAPA) to find and fix issues at their source.
- Prepare for Harmonization and Build a Lasting Culture: The upcoming Quality Management System Regulation (QMSR) will align U.S. rules with the global ISO 13485 standard by February 2, 2026. Use this transition to create a single, efficient quality system and foster a company-wide culture where compliance becomes a shared, daily responsibility.
What is 21 CFR Part 820?
If you’re in the medical device space, you’ve likely come across the term 21 CFR Part 820. It might sound like a complex code, but it’s essentially the FDA’s foundational rulebook for quality. Getting a handle on this regulation isn’t just about checking a box; it’s about building a framework for safety and effectiveness into everything you do. Let’s break down what it is and why it’s so fundamental to your business.
Understanding the Quality System Regulation (QSR)
At its core, 21 CFR Part 820 is the FDA’s Quality System Regulation (QSR). It lays out the current good manufacturing practice (CGMP) requirements that all medical device manufacturers must follow for products sold in the United States. Think of it as the minimum standard for your quality management system. The regulation isn’t just about the final product. It’s designed to ensure your devices are safe and effective throughout their entire lifecycle, from the initial design concept all the way to manufacturing, packaging, labeling, and servicing. It establishes the necessary controls and processes to make sure every device you produce meets the required specifications and performs as intended for the end user.
Why the QSR is Crucial for Medical Device Makers
Compliance with the QSR is not optional—it’s a prerequisite for doing business. The main purpose of this regulation is to ensure that medical devices are consistently produced and controlled according to strict quality standards. Following these rules is essential for any manufacturer looking to obtain FDA approval and legally market their devices in the U.S. Beyond market access, the QSR is your roadmap for operational excellence and risk management. It forces you to have clear processes for everything, including how to handle non-conforming products. The ability to properly track files and document compliance is a central theme of the regulation, as this documentation is critical for proving product quality, ensuring patient safety, and protecting your business during an FDA inspection.
Breaking Down the 21 CFR Part 820 Quality System
Getting a handle on 21 CFR Part 820 means understanding its core components. Think of the Quality System Regulation (QSR) not as one giant, intimidating rule, but as a set of interconnected systems that work together to ensure your medical device is safe and effective from concept to customer. When you break it down into its key subparts, the requirements become much more approachable and actionable. Each piece has a distinct purpose, but they all link back to the central goal of building quality into your product and processes. Let’s walk through the key pillars you absolutely need to master to build a compliant and effective quality system.
Design Controls
This is where quality begins. The FDA wants to see that you’re building safety and effectiveness into your device from the very first sketch, not trying to test it in at the end. The rules for Design Controls (Subpart C) provide a framework for this. It’s a systematic approach that prevents you from fixing costly mistakes down the line. You must plan your design process, clearly define what the device needs to do based on user needs (design inputs), and then create a design that meets those requirements (design outputs). You’ll also need to regularly review, verify, and validate the design to prove it works as intended. Think of it as creating a detailed, evidence-based roadmap for your product before you start building.
Document Controls
If it isn’t written down, it didn’t happen. That’s the mantra behind Document Controls (Subpart D). This part of the regulation requires you to manage all quality-related documents, from standard operating procedures (SOPs) to product specifications. Every critical document must be reviewed, approved, signed, and dated by designated individuals before it’s put into use. These approved documents need to be readily available at the points of use to ensure everyone is working from the correct version. Just as importantly, you must have a formal process for making changes. Any updates require a clear record of what was changed, who approved it, and when, maintaining a transparent and traceable document history.
Production and Process Controls
Once your design is locked in, you have to make sure you can build it consistently and correctly every single time. Production and Process Controls (Subpart G) cover everything that happens on the manufacturing floor. This means you must establish and follow procedures to ensure the final product meets its specifications without deviation. You’re responsible for controlling the manufacturing environment to prevent contamination, properly maintaining your buildings and equipment, and managing the raw materials you use. This subpart also requires you to validate any processes where the output can’t be fully verified by later testing, like sterilization or aseptic filling, to ensure they reliably produce the intended result.
Quality Audits
How do you know your quality system is actually working as intended? Through audits. Quality audits are systematic, independent reviews of your quality system procedures and activities. The goal is to verify that you’re following your own rules and that those rules meet the FDA’s requirements. Audits aren’t about placing blame; they are essential for identifying any gaps or areas of non-compliance before an FDA inspector does. They provide the objective evidence you need to make corrections and continuously improve your processes. Regular internal audits are a cornerstone of a healthy quality system, demonstrating your commitment to maintaining compliance and driving improvement from within your organization.
Corrective and Preventive Actions (CAPA)
Problems will inevitably arise, but what matters most is how you handle them. The Corrective and Preventive Actions (CAPA) subpart requires you to establish a formal system for dealing with nonconformities and other quality issues. This isn’t just about fixing a single bad product. It’s about investigating the root cause of the problem, taking corrective action to fix it, and implementing preventive action to ensure it never happens again. A strong CAPA process involves analyzing data from all parts of your quality system—from customer complaints to audit findings—to identify and address potential issues proactively. It’s the engine of your quality system, driving continuous improvement and preventing future failures.
How to Build a Compliant Quality System
Building a compliant quality system from the ground up can feel like a huge undertaking, but it’s entirely achievable when you break it down into clear, manageable steps. Think of your Quality System Regulation (QSR) not as a regulatory checklist you have to get through, but as the strategic blueprint for your entire operation. A well-designed QMS is a powerful business asset that drives consistency, reduces risk, and ultimately leads to safer, more effective products. It’s the operational backbone that supports everything you do, from the earliest design sketches to how you handle customer feedback years after a product launch.
Getting these foundational elements right from the start is one of the smartest investments you can make. It will save you from the stress of FDA warning letters, the high costs of product recalls, and the reputational damage that comes with non-compliance. A proactive approach to quality management builds confidence—not just with regulators, but with your partners, investors, and customers. It signals that your company is serious about its commitments and has the internal controls needed to deliver on its promises. The following steps outline the core pillars of a compliant and effective quality system. By focusing on these key areas, you can build a framework that not only satisfies 21 CFR Part 820 but also fosters a true culture of quality within your organization.
Define Management’s Role and Responsibility
A quality system without leadership buy-in is just a binder on a shelf. Your first and most critical step is to clearly define management’s role and commitment. This starts with a formal quality policy—a document that acts as your company’s constitution for quality. From there, your leadership team must establish an organized structure and dedicate the necessary resources, both in people and funding, to bring that policy to life. The FDA requires you to appoint a specific management representative who has the authority to oversee the quality system and report directly to top leadership on its performance. This ensures quality is a core business strategy with clear management responsibility and accountability.
Organize Your Resources and Training
Your people are your most valuable resource, and the QSR places a strong emphasis on ensuring they are qualified for their roles. Every team member involved in design, manufacturing, or quality processes must have the appropriate background, training, and experience. It’s not enough for them to simply be qualified; you must maintain detailed documentation to prove it. Keep meticulous records of each employee’s education, skills, and ongoing training activities. This creates a transparent record of your team’s capabilities and demonstrates a tangible commitment to competence. A well-trained team of personnel is far less likely to make costly errors and is better equipped to consistently uphold the high standards your quality system demands.
Map Out Product Realization and Traceability
From the moment raw materials arrive at your facility to the time a finished product reaches the end-user, you need a clear and unbroken chain of information. This is the essence of product realization and traceability. You must establish and follow procedures to identify a product at every single stage of its lifecycle. This is typically accomplished by assigning a unique device identifier or lot number that allows you to track a specific device or batch through all manufacturing, distribution, and installation processes. This comprehensive product traceability is non-negotiable, as it is absolutely essential for efficiently investigating any issues that arise or conducting a swift and targeted recall if one ever becomes necessary.
Establish How You’ll Measure, Analyze, and Improve
A static quality system will quickly become an obsolete one. The final pillar of a robust QMS is creating a dynamic feedback loop for measurement, analysis, and improvement. This is most often handled through a Corrective and Preventive Action (CAPA) system. You must have documented procedures for addressing nonconformities and other quality problems. This means thoroughly investigating the root cause of an issue, taking effective action to correct it, and implementing systemic changes to prevent it from happening again. It’s a continuous cycle: you verify that your actions worked, update your processes, and communicate these changes to all relevant personnel. This commitment to continuous improvement is what transforms your QMS from a static set of rules into a powerful, living tool for growth and risk reduction.
Common Hurdles in 21 CFR Part 820 Compliance
Getting a quality system up and running is one thing; keeping it compliant is another. Even the most well-intentioned companies can stumble when it comes to the day-to-day execution of 21 CFR Part 820. The regulations are detailed, and it’s easy to let things slide if you don’t have solid processes in place. Think of it like maintaining a house—the foundation might be strong, but you still need to fix leaky faucets and patch the roof to keep everything in good working order.
Most non-compliance issues aren’t born from a deliberate choice to ignore the rules. Instead, they often grow from small oversights that snowball over time. A missing signature here, a delayed supplier review there—it all adds up. The most common tripwires for medical device companies tend to be in a few key areas: documentation, supplier management, design controls, and internal audits. These are the pillars of your quality system, and if one of them is shaky, it can put the entire structure at risk. Let’s walk through each of these common hurdles and talk about practical ways to clear them, so you can stay on the right side of FDA regulations.
Mastering Documentation and Record-Keeping
Think of your documentation as the official story of your product’s quality. If an FDA investigator asks, your records should provide clear, undeniable proof that you’re following your own procedures and the law. A major challenge is simply keeping everything organized and accessible. Your records must be easy to read and stored securely where they won’t get lost or damaged. You also need a system to handle non-conforming products, which includes the ability to track files and document compliance every step of the way. Remember, you’re required to keep these records for the expected life of the device or for two years from the date it’s sold, whichever is longer. This isn’t just about storage; it’s about creating a reliable paper trail that validates your entire quality process.
How to Manage Supplier Quality Effectively
Your quality standards don’t stop at your own facility. Every supplier, contractor, and consultant you work with is an extension of your quality system, and the FDA sees it that way, too. You are responsible for ensuring that every component and service you purchase meets your established requirements. This means you need a robust process to evaluate and select suppliers based on their ability to meet your quality needs. Don’t just pick the cheapest option. You need to define your quality expectations upfront, document them in an agreement, and continuously monitor your suppliers’ performance. Failing to manage your supply chain effectively is a direct risk to your product quality and your compliance status.
Keeping Your Design History File (DHF) in Order
The Design History File (DHF) is the complete history of your device’s design, from the initial concept to the final, market-ready product. It’s not a static folder; it’s a living collection of documents that proves you followed a controlled and methodical process. The DHF is the output of your design controls, showing how you planned the design, defined user needs (inputs), created specifications (outputs), and conducted reviews. A common mistake is treating the DHF as an afterthought. Instead, you should build it as you go. Each step—from verification testing that confirms your design meets specifications to validation that ensures it meets user needs—must be meticulously documented to create a complete and compliant DHF.
Run Internal Audits That Actually Work
Internal audits are your secret weapon for staying compliant. They are essentially a friendly “FDA inspection” that you perform on yourself. While 21 CFR Part 820 requires you to conduct them, it gives you flexibility on the frequency. The key is to perform them regularly enough to catch problems before they grow. A critical rule is that the person conducting the audit must be independent of the area being audited—you can’t grade your own homework. These audits are your chance to honestly assess your quality system, identify gaps, and implement corrective actions. Viewing them as a tool for continuous improvement, rather than a chore, will help you maintain a constant state of inspection readiness.
21 CFR Part 820 vs. ISO 13485: What’s the Difference?
If you’re in the medical device industry, you’ve definitely heard of 21 CFR Part 820 and ISO 13485. They both serve as frameworks for a Quality Management System (QMS), but they aren’t interchangeable. Think of them as two different roadmaps to the same destination: producing safe and effective medical devices. Understanding their distinct roles is essential, especially if you plan to sell your products both in the United States and on the global market.
The main distinction comes down to legal authority and geographical scope. One is a federal law you must follow to access the U.S. market, while the other is a globally recognized standard that acts as a passport to many other countries. While there’s significant overlap in their requirements—both demand robust processes for design, production, and documentation—their differences have historically required companies to maintain two slightly different systems. The good news is that the regulatory landscape is shifting toward harmonization, but for now, knowing the specific demands of each is key to staying compliant and competitive. Let’s break down what sets them apart.
Regulatory Mandate vs. Voluntary Standard
The most fundamental difference between these two is their authority. The FDA’s 21 CFR Part 820, also known as the Quality System Regulation (QSR), is a mandatory law in the United States. If you want to legally market and sell a medical device to American consumers, you have no choice but to comply with every part of it. It’s not a suggestion or a set of best practices; it’s a legal requirement enforced by the FDA.
On the other hand, ISO 13485 is an international standard, not a law. It’s technically voluntary. However, it has become the gold standard for medical device quality management systems around the world. To sell your device in major markets like the European Union, Canada, or Australia, you’ll almost certainly need to be ISO 13485 certified. So, while it’s “voluntary,” it’s a practical necessity for global market access.
Key Similarities and Overlaps
Despite their differences in legal standing, 21 CFR Part 820 and ISO 13485 share a common goal and a lot of common ground. Both are designed to ensure that medical device manufacturers consistently produce devices that are safe and perform as intended. At their core, both standards require you to establish and maintain a formal Quality Management System (QMS).
This means both frameworks call for similar elements. You’ll find requirements for management responsibility, ensuring leadership is actively involved and provides adequate resources. Both demand strict controls over design, documentation, and production processes to ensure consistency and quality. They also require systems for corrective and preventive actions (CAPA), supplier management, and record-keeping. If your QMS is built to satisfy one, you’re already well on your way to meeting the requirements of the other.
What It Means for Selling Globally
So, what does this all mean for your business strategy? It depends entirely on where you plan to sell your products. If your market is exclusively within the United States, your compliance efforts should be laser-focused on meeting the FDA’s 21 CFR Part 820 requirements. This is your non-negotiable ticket to entry.
However, if you have ambitions to sell internationally, you’ll need to incorporate ISO 13485 into your QMS. For years, this has meant that global companies had to juggle two sets of similar-but-not-identical requirements, which created extra work and complexity. To streamline this, the FDA is replacing the QSR with the new Quality Management System Regulation (QMSR), which will align U.S. regulations with ISO 13485. This change will make it much easier for companies to maintain a single, harmonized quality management system for multiple markets.
The Real Costs of Non-Compliance
Thinking about cutting corners on your quality system? It’s tempting, but the consequences of falling short of 21 CFR Part 820 requirements are serious. Non-compliance isn’t just about getting a formal letter from the FDA; it can trigger a cascade of problems that affect your finances, your brand’s reputation, and even your freedom to operate. The risks go far beyond a simple fine, creating long-term damage that can be difficult, if not impossible, to repair. Understanding these stakes is the first step in appreciating why a robust quality system isn’t just a regulatory hurdle—it’s a fundamental business asset.
FDA Enforcement Actions
When the FDA finds that a company isn’t meeting its standards, it has several tools at its disposal. These enforcement actions can start with a warning letter but can quickly escalate to seizures of your product, injunctions that halt production, and consent decrees that put your operations under strict, costly oversight. A common trigger for these actions is a failure to manage non-conforming products or maintain proper documentation. You must have solid processes for tracking files and proving compliance. These aren’t just suggestions; they are requirements the FDA will check during an inspection, and failing to meet them can put your entire business on pause.
Financial and Reputational Impacts
The financial fallout from non-compliance can be staggering. Beyond the direct costs of fines and legal fees, a product recall can cost millions in logistics, replacement products, and lost sales. The damage to your company’s reputation can be even more severe and long-lasting. In an industry built on trust, a public compliance failure erodes confidence among customers, health care providers, and investors. This is especially challenging for manufacturers who operate in both U.S. and international markets, as a compliance issue in one region can create doubt and scrutiny everywhere you do business. Rebuilding that trust takes years of flawless execution.
Potential Legal Ramifications
In the most serious cases, non-compliance can lead to significant legal trouble. Failure to follow FDA regulations can result in civil penalties, but it doesn’t stop there. The agency can pursue legal actions that include steep fines, injunctions to stop you from manufacturing and selling your devices, and even criminal charges against the company and its executives. These aren’t empty threats. The FDA holds company leadership responsible for ensuring public safety, and when a company knowingly markets a non-compliant or unsafe device, the individuals in charge can be held personally liable. The risk of legal action makes it absolutely critical to treat your quality management system with the seriousness it deserves.
Get Ready for the New Quality Management System Regulation (QMSR)
A significant shift is on the horizon for medical device manufacturers. The FDA is updating its long-standing quality system rules to better align with global standards. This change, known as the Quality Management System Regulation (QMSR), will replace the current Quality System Regulation (QSR). While the deadline might seem far off, now is the perfect time to understand what’s changing and how to prepare your business for a smooth transition. Getting ahead of this will not only ensure you remain compliant but can also streamline your quality processes, especially if you have your sights set on international markets. Let’s walk through what the QMSR is, what it means for your operations, and what you can do to get ready.
What is the QMSR?
The FDA is officially updating the name of its quality rules for medical devices. What was known as the Quality System Regulation (QS Regulation) is now the Quality Management System Regulation (QMSR). Both versions fall under the same section of the federal code, 21 CFR Part 820. This isn’t just a simple name change; it signals a fundamental shift in the FDA’s approach to quality management. The new QMSR is designed to harmonize U.S. regulations with the international standards used by many other countries. This move aims to create a more unified and efficient regulatory framework for the global medical device industry.
How the QMSR Changes Things
The biggest change with the QMSR is its alignment with an international standard, ISO 13485:2016. By incorporating this standard, the FDA is making it easier for manufacturers to meet quality requirements across different countries. The agency believes the core principles of ISO 13485 are very similar to the old rules, ensuring that devices will continue to be safe and effective. The final rule was issued in early 2024, but you have time to prepare. The official effective date for the new QMSR is February 2, 2026. Until that day, you must continue to follow the existing QS Regulation to remain compliant.
Your Action Plan for the Transition
With the 2026 deadline in mind, your first step is to get familiar with the requirements of ISO 13485:2016. Start by conducting a gap analysis to see how your current quality system measures up against the international standard. This will show you exactly where you need to make updates. Remember to keep following the current QS Regulation until the transition date. The FDA is also preparing by updating its own systems and training its inspection staff. If you need help understanding the new requirements or developing a transition plan, working with a regulatory compliance expert can provide clarity and ensure you’re on the right track for a seamless switch.
How to Maintain Long-Term Compliance
Achieving initial compliance with 21 CFR Part 820 is a huge milestone, but the work doesn’t stop once you get the green light. The real challenge—and where many companies stumble—is maintaining that compliance over the long haul. Your Quality System Regulation (QSR) isn’t a static document you can file away. Think of it as a living part of your organization that needs consistent attention and care to stay healthy and effective. Long-term compliance is about building resilient systems that can adapt to new regulations, product changes, and team growth. It’s a proactive approach that protects your business from costly FDA enforcement actions and solidifies your reputation as a trusted manufacturer.
Letting compliance efforts slide can lead to more than just a warning letter. It can result in product recalls, legal trouble, and a loss of customer trust that’s incredibly difficult to win back. The key is to move from a reactive, “fire-fighting” mindset to a proactive one where quality is woven into the fabric of your daily operations. This isn’t just about ticking boxes for an auditor; it’s about creating a sustainable framework that supports consistent product quality and patient safety. Below, we’ll cover three core pillars for maintaining your compliance long-term: committing to continuous improvement, leveraging technology, and building a true culture of quality across your entire company.
Commit to Continuous Improvement
A compliant quality system is never truly “finished.” It should be a dynamic framework that evolves with your business. Continuous improvement means you are always looking for ways to make your processes more effective and efficient. This involves scheduling regular reviews of your QMS to identify potential weaknesses before they become major problems. It’s also critical to have robust processes in place to deal with non-conforming products, ensuring you can track, document, and resolve issues thoroughly. By consistently analyzing your performance data and implementing corrective and preventive actions (CAPAs), you create a powerful feedback loop that drives your quality system forward and demonstrates a serious commitment to compliance.
Use Technology to Streamline Quality Management
Relying on paper-based systems or scattered spreadsheets to manage your quality system is a recipe for headaches and human error. Modern technology offers a much better way. Implementing an electronic Quality Management System (eQMS) can transform your compliance efforts from a cumbersome chore into a streamlined, integrated process. This type of eQMS software centralizes all your documentation, automates workflows for reviews and approvals, and provides a clear audit trail for every action taken. This not only makes it easier to demonstrate compliance during an inspection but also frees up your team to focus on strategic quality initiatives instead of administrative busywork. It’s an investment that pays for itself in efficiency and peace of mind.
Build a Company-Wide Culture of Quality
Regulatory compliance can’t be the sole responsibility of one person or department. For compliance to be sustainable, it needs to be part of your company’s DNA. Building a culture of quality means every employee—from the production line to the C-suite—understands the importance of the QSR and their specific role in upholding it. This starts with strong leadership commitment and extends through comprehensive training programs that go beyond just reading procedures. When your team understands the “why” behind the current good manufacturing practice (CGMP) requirements, they become active participants in maintaining standards. This shared ownership turns compliance from a regulatory burden into a collective goal that strengthens your entire operation.
Helpful Tools and Resources for Compliance
Staying on top of your quality system requirements doesn’t have to be a solo mission. A wealth of resources is available to help you build, manage, and maintain a compliant system. From specialized software that streamlines your workflow to official FDA guidance that clarifies the rules, leaning on the right tools can make all the difference. Think of these resources as your support system, helping you stay organized, informed, and prepared for whatever comes your way.
Software Solutions for Quality Management
Managing every document, procedure, and record manually is a recipe for headaches and potential errors. This is where an electronic Quality Management System (eQMS) comes in. These platforms are designed to centralize your quality processes and automate critical tasks. For instance, FDA 21 CFR Part 820 compliance software is built specifically for medical device companies. These tools help you manage everything from document control and employee training to CAPAs and audits, ensuring all your records are in one accessible and secure place. An eQMS can significantly simplify how you demonstrate compliance with QSR requirements, freeing up your team to focus on quality rather than paperwork.
FDA Guidance Documents and Official Resources
When you have questions about the regulations, it’s always best to go straight to the source. The FDA’s official text for the Quality System Regulation is found in the Electronic Code of Federal Regulations (eCFR). The full text of 21 CFR Part 820 — Quality System Regulation outlines every requirement in detail, stating that “each manufacturer must establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device.” Beyond the regulation itself, the FDA website offers a library of guidance documents that provide insight into the agency’s current thinking on specific compliance topics, which can be incredibly helpful for interpretation.
Industry Associations and Training Programs
You aren’t the first person to work through these challenges, and you can learn a lot from the experiences of others. Industry associations and specialized training programs offer valuable perspectives on best practices and common pitfalls. Understanding the most frequent triggers for FDA 21 CFR 820 non-compliance, such as inadequate procedures for non-conforming products, helps you focus your efforts where they matter most. These resources can also help you understand the broader regulatory landscape and prepare for changes. For tailored support, working with expert consultants can provide your team with the specific training and guidance needed to address your unique operational needs.
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Frequently Asked Questions
I’m just starting out. Does 21 CFR Part 820 apply to my small company? Yes, it absolutely does. The FDA’s Quality System Regulation applies to all medical device manufacturers who intend to sell their products in the United States, no matter the size of your company. The key is to build a quality system that is appropriate for your specific products and operations. You don’t need the same complex procedures as a massive corporation, but you do need to meet all the foundational requirements for things like design controls, documentation, and production controls.
What’s the real difference between a corrective action and a preventive action? This is a great question because the two are often lumped together. Think of it this way: a corrective action is reactive. It happens after a problem, like a customer complaint or a failed product test, has already occurred. Your goal is to investigate the root cause and fix the system so that specific problem doesn’t happen again. A preventive action is proactive. It involves analyzing your data and processes to spot potential problems before they ever happen and taking steps to prevent them entirely.
If I plan to sell globally, should I just focus on ISO 13485 instead of 21 CFR Part 820? You’ll need to address both, but the good news is they are becoming much more aligned. If you want to sell in the U.S., compliance with 21 CFR Part 820 is mandatory. For many other countries, like those in the EU, ISO 13485 certification is your ticket to market access. The best strategy is to build a single, harmonized quality system that satisfies both. With the FDA’s move to the new QMSR, which incorporates ISO 13485, creating one unified system is becoming the standard approach.
What’s the first step I should take to prepare for the new QMSR? The deadline is February 2, 2026, which gives you time, but you shouldn’t wait. Your best first step is to perform a gap analysis. This means systematically comparing your current quality system, which is based on the old QSR, against the requirements of ISO 13485:2016. This analysis will give you a clear, actionable checklist of exactly what policies, procedures, and documents you need to update to be ready for the transition.
My team is small. How can we manage all this documentation without getting overwhelmed? This is one of the most common challenges, and trying to manage it with paper binders or messy shared drives is a recipe for non-compliance. I strongly recommend looking into an electronic Quality Management System, or eQMS. This type of software is designed specifically to automate and streamline document control, training records, and CAPA processes. It creates a central, secure hub for all your quality records, making it much easier to stay organized and prove compliance during an audit.