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 quality management system 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.
Advena are the only consultancy team you need to bring your In-vitro Diagnostic (IVD) through the ever changing regulatory hurdles to approval.
As specialists in simplifying regulatory compliance for small and medium-sized enterprises,
our consultancy services are tailored to your needs at competitive cost-effective rates. We
provide expertise for the full IVD regulatory approval cycle.
The benefits of implementing a Quality Management System include:
Advena are highly experienced in the creation of Quality Management System, and will create one in a form most convenient for you; paper systems, electronic systems, or even a web-based system such as ACTIV which allows the user to access from anywhere in the world. Your QMS can be tailored to suit your organization structure and requirements.
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.
