In the realm of medical device development, a QMS should also ensure that processes align with ISO 13485 standards and US FDA 21 CFR 820 regulations, which is the backbone of our QMS at Design Concepts.
It is no secret that despite the obvious good intentions of a QMS that they can also get a bad rap for creating undesirable "paperwork" and processes that are viewed as slowing down progress and, in the worst cases, squelching innovation. It is that bad reputation that made the development of QMS for Design Concepts a critical initiative for us.
We needed a QMS that was thoughtfully developed, focused on value-add to the organization, and aligned with the requirements of ISO-13485 and the FDA. A key attribute for our QMS was it needed to ensure we had the flexibility to take on projects that fall outside of the medical device and healthcare realm.
Our solution was to create a tiered approach that allows our projects to be run under our QMS design controls or our clients as defined in the contract governing the work. This allows us to tailor our approach for individual client needs while ensuring that roles and responsibilities are defined and well understood.
The tiered system approach has provided us the flexibility we need.
The tiered system approach has provided us the flexibility we need and feels like a real win for our implementation, and the success stories don't stop there. With 50 years to hone our craft, we have always focused on continuous improvement and disseminating best practices through the organization. With our latest embodiment of our QMS, we have been able to take our onboarding to the next level with improved tracking and an easy-to-navigate file structure for finding important documents.
While having a well-functioning QMS is a requirement for medical device development and therefore a bit status quo, I'm proud of our latest incarnation and how well the organization has embraced it.
At the heart of a QMS is the quality policy. Here is ours:
"Design Concepts is committed to providing world-class product design and innovation services by delivering outstanding customer experiences from a team of dedicated professionals working diligently on our client’s behalf. We are driven by our mission to design cool stuff to drive business success and make life better. Our focus on quality includes both a passion for creativity and design excellence as well as adherence to our quality management system."
If you want to learn more about our QMS, please don't hesitate to give me a call.
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