A quality management system (QMS) is vital to the success of any manufacturer. In the medical field, a strong QMS is essential to the realization of any device. An unsupported, improperly designed QMS can result in higher production costs, regulatory problems, and—most important—low quality products. The lack of a high functioning QMS could spell doom for medical device companies and their contract manufacturers/suppliers. So, this week we consulted our quality and regulatory teams to talk about the importance of a well maintained QMS, the key factors that separate a good QMS from a bad QMS, and Biomerics’ commitment to quality.
What is a QMS, and why is it necessary in the medical device industry?
According to Anita Dalrymple, a Regulatory Affairs Project Manager and Quality Engineer for Biomerics, “In any business, a QMS is a system for creating products and services that conform to customer requirements. In essence it is a tool used to improve the profitability of the business. However, in the medical field, the QMS is a tool for making devices safer.”
Matt Bainsmith, a Quality Engineer for Biomerics, added, “A robust QMS is driven by the necessity to continuously improve products and processes. Sometimes people see the QMS as a burdensome check put in place by an external institution and refuse to buy-in. In reality, a QMS is a tool that evolves over time to help companies continuously deliver the highest quality product.
“With medical companies, a good QMS is necessary because the components and devices that are manufactured are intended for critical applications. The government, the physician placing the device, and the person receiving the device all expect the highest possible quality.”
What are the key factors of a good QMS?
“The most critical factor of a good QMS is management support and total company buy-in,” explained Matt. “To have a good QMS, companies need to realize that there is always room for improvement—whether that means improving a process, product, or entire system, they should always be looking for ways to make things more efficient and effective. Of course, the only way for continuous improvement to thrive is to have a culture and management team that understands the importance of producing high quality products. If a company has a culture that doesn’t support someone raising their hand to say that something is wrong, or something needs to be fixed, then that company can find itself in a lot of trouble.
“Another important QMS factor that is often overlooked is the idea of internal auditing. This involves setting a schedule to examine the system and processes for deficiencies and gaps. These audits help companies find areas of improvement, which further supports the idea of a continuous improvement culture.”
“One key factor of a good QMS is a high commitment to customer satisfaction at every level of the company—especially management,” added Anita. “Companies should have a culture dedicated to understanding customer requirements and creating products and services that satisfy those requirements.
“Well defined, robust processes that interact well are another important factor of a successful QMS. A QMS should consistently produce the same result; quality must be built, not inspected, into products. An efficient QMSs has processes and support systems that are simple and clearly laid out. A good QMS will also have well trained employees who understand the system and purpose of the system. The more solid the foundation and groundwork of the QMS, the easier it is to maintain and improve.”
What separates a good QMS from a bad QMS?
“A good QMS is set up in such a way that it continually improves in small increments,” remarked Anita. “A bad QMS is constantly being changed—it doesn’t have a solid foundation, robust processes, or a good support system.
“A good QMS is aimed at satisfying customer requirements. A bad QMS is generally just in place to meet regulations and paperwork requirements. A good QMS will have set processes, goals, and support systems—a bad QMS will not.”
“Often times, it’s the culture of the company that separates a good QMS from a bad one,” added Matt. “Companies with management teams that are involved in the development and maintenance of the QMS will create a better QMS than companies that do not.
“Also, with a good QMS, companies make the benefits of high functioning quality processes and systems clear to employees. People at all levels know that improving the QMS will help them meet customer requirements and increase profitability. Organizations that have a bad QMS don’t understand this. They believe the QMS is solely the responsibility of the quality and regulatory departments. This type of thinking usually leads to poor quality and unhappy customers.”
Biomerics’ Quality Commitment:
Biomerics considers it our responsibility to protect the safety of the public by providing effective medical products. In order to meet these requirements, we expect ethical behavior of our employees, and encourage ethical behavior of our business partners.
Biomerics strives to provide superior service while manufacturing products that meet or exceed our customers’ expectations. In order to meet these ongoing objectives, we commit to provide:
- Defect-Free Products and Services
- On-Time and In-Full Delivery
- Compliance with all Relevant International Standards and Statutory/Regulatory Requirements
- Continual Improvement through Employee Development and Ongoing Refinement of our Quality Management Systems
What quality support can Biomerics provide?
Our QMS is dynamic and capable of handling devices with complex requirements and manufacturing specifications. Our design, manufacturing, and quality engineering teams work in close collaboration to ensure that customer expectations are exceeded at every level of the device manufacturing process.
To learn more, send us an email (csr@biomerics.com), give us a call (801-895-2578), or visit the Quality section of our website.
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