A quality management system (QMS) is defined as a system of processes that ensures a high-quality approach and consistent results every time. Its purpose is to ensure that, every time a process is performed, the same information, methods, skills, and controls are used and applied in a consistent manner.
The QMS will cover all elements of design, manufacture, management of your supply base, risk management, how to handle complaints, clinical data, storage, product labeling, and much more.
Your QMS will help ensure you meet your regulatory requirements and that your device or product is safe for patients and end users. A QMS is an integral part of your regulation and must be maintained consistently. Your QMS will touch upon almost every aspect of your business, which is why everyone involved needs to be confident in it’s delivery.
The benefits of implementing a QMS include:
QMS Review Service
We can work with you to review your current QMS system to ensure your QMS is not only compliant but also simple, efficient and easy to use. As part of the review we'll also check for any non-conformance.
