What is a Robust Quality Management System and Why Does it Matter?

Just so we can be sure there’s no confusion over what we’re discussing, let’s go with the definition of a QMS most easily found on the internet which is:

“A quality management system is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction.”

Of course, that is a very general and generic explanation of what a quality management system is, and it is used for a variety of products in a variety of industries. If we narrow the definition down to just the medical device industry, the reason behind a QMS becomes:

 “Quality System requirements for medical devices have been internationally recognized as a way to assure product safety and efficacy.”

As we are well aware, when developing a medical device, the goals are to successfully get to market first, but also to ensure quality devices and components ultimately reach patients. This is why the QMS standard for medical devices is so stringent. These devices could very well end up inside a human body, helping them live a better life while dealing with a medical condition.

Given the important nature of medical devices, there are at least two sets of industry standards that require a QMS to be in place. They are:

• ISO 13485 standards
• US FDA 21 CFR 820 regulations

The FDA provides a lot of guidance for manufacturers to determine their own QMS and how extensive it can be, but let’s look a little closer at what they require.

The FDA’s 7 subsystems of a QMS for medical devices

The Food and Drug Administration requires that a medical device manufacturer have a quality management system. Many of the requirements are based on the complexity of the device, the complexity of the manufacturing process and even the size of the manufacturer itself. Regardless, a manufacturer needs to have a QMS which incorporates the following sub-systems:

1. Management controls
2. Design controls
3. Production and process controls
4. Corrective and preventative actions
5. Material controls
6. Records, documents, and change controls
7. Facilities and equipment controls

The FDA’s requirements for each of the subsystems are explained on their website, but each subsystem comes into play as the device is designed, developed, and then constructed. Management, undertaking regular audits, should oversee each subsystem to ensure they are operating properly and effectively.

As you are probably aware, being ISO 13485 certified is considered a prerequisite for approval in international markets. The ISO 13485 certification process is very complicated, so let’s take a high-level look at what it is and how it applies to the QMS for device manufacturers.

For other industries, a rigorous certification method also exists, known as ISO 9001. ISO 13485 is a part of that but applies specifically to medical device manufacturers. There are some slight differences between 13485 and ISO 9001.

• ISO 9001 requires the organization to demonstrate continual improvement
• ISO 13485 requires only that the certified organization demonstrates the quality system is effectively implemented and maintained.

Some other ISO 13485 QMS requirements include the following:

• Promotion and awareness of regulatory requirements as a management responsibility. Here are a couple of examples of market-specific regulatory requirements include:
  • The Quality System Regulation for medical devices sold in the United States, enforced by the FDA, which is known as 21 CFR 820.
  • The Medical Devices Directive 93/42/EEC, required for doing business in the European Union.
• Implementation and maintaining controls in the work environment to ensure product safety.
• Increased focus on risk management activities and design control activities during product development.
• Creation and maintenance of specific requirements for inspection and traceability for implantable devices.
• Implementation of specific requirements for documentation and validation of processes for sterile medical devices.
• Creation and implementation of specific requirements for verification of the effectiveness of corrective and preventive actions
• Adherence to specific requirements for cleanliness of products.

We have been manufacturing and bringing custom medical device components to market for decades. Over those years, we have also brought these devices to international markets, and supported so many OEMs navigate the complicated world of global regulations. In fact, Flexan’s business model includes an integrated global Quality Management System that spans all Business Units. What does it mean for OEMs who partner with us? This means:

• Our medical manufacturing facilities are ISO 13485-2016 and U.S. FDA 21 CFR compliance.
• Flexan’s leadership team has a combined 150 years of medical product manufacturing experience and every year our organization completes extensive training using custom, in-house developed materials.
• We hand-built our new product development process to support design transfer from a single mold up to a 50+ component medical device.
• Our process offers an extensive joint Customer-Supplier Risk Assessment, including PFMEA & Control Plan Development.
• A gated New Product Introduction process offering a robust internal and external audit process.
• We ensure all incoming, In-Process, and we tailor Outgoing Quality Controls for both CMO & customer compliance.

These elements allow us to consistently manufacture to the expected quality standard and mitigate the potential risks.

As you can see, having a detailed, robust QMS is necessary for medical devices in both US and global markets. Since speed to market is so important for both the device manufacturer, but also for the patients who will ultimately receive the benefits of a medical device, having the right partner to ensure quality and mitigate the risks is important.

The first step in the process is to contact us and set up an appointment to speak to one of our experts about your medical device or medical component needs.