06 Article Kent Kallsen Qms H1

QMS that works for us, our clients

Quality Management Systems (QMS) are used in businesses big and small to help insure that business processes are focused on meeting customer requirements and enhancing client satisfaction.

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 Delve.

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 Delve s 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 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:

"Delve is committed to providing exceptional product design and innovation services to our clients. Our focus on quality has resulted in high client satisfaction ratings, as well as significant innovations in strategy, design, and engineering that have revolutionized businesses and enriched lives. Our commitment includes a focus on ensuring we are working in accordance with ISO 13485:2016 and FDA regulatory requirements. We will monitor and continuously improve our process to ensure the effectiveness of Delve’s quality system for decades to come."

If you want to learn more about our QMS, please don't hesitate to contact us.

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