Quality Management Systems
Having a Quality Management System (QMS) is a good business practice. A QMS organizes and documents your company's approach to doing business. As your company grows, the QMS provides the foundation that allows you to train new employees and ensure that everyone is on the same page and performing tasks the same way. Quality Systems came from industry and were adopted by regulators, not the other way around.
This can still be a bit daunting for a young company, but it doesn't have to be. In reality, the issue is often that your company is focused on developing a technology into a product and doesn't have the expertise, time or passion for developing a Quality Management System. We can help you remain focused.
For many companies, we have worked with teams to establish a Quality Management System with minimal disruption of the critical research and development activities that are going on. We work within the applicable regulatory requirements for your business; however, our approach has always been to keep things as simple as possible and build on this when necessary.
We have extensive experience with ISO:9001:2008, ISO: 13485:2106 and 21CFR820. Solutions can be either paper based systems or low cost electronic systems that are 21CFR Subpart 11 compliant.