Summit CNC is ISO 13485:2016 Certified

Click here to view Summit CNC’s ISO 13485:2016 certificate

We are excited to announce that our Denver, CO machine shop is officially ISO 13485:2016 certified to perform precision machining and assembly of components for the medical device industry. 

Where it all began

Since our inception, we have provided CNC machining and assembly services to our customers in the medical device industry. Over time, we had multiple customers request that we pursue ISO 13485 certification because they wanted us to have the necessary accreditations to fulfill their production machining and assembly needs, in addition to the prototype and fixturing work we were already doing. 

Onwards and upwards

During the summer of 2023, we began integrating ProShop ERP software into our business. We went with ProShop over other ERP & QMS software systems because of its intuitive, machine shop-focused design and its fully integrated QMS module that provided the interface, documentation, and resources necessary for us to obtain ISO 13485:2016 and AS9100D certifications.

After completing our integration of ProShop in October of last year, we started setting up our QMS for ISO 13485:2016 certification. After six months of thorough preparation with our QMS coordinator, we are pleased to announce that we recently passed all stages of the audit with zero findings!

How does our ISO 13485:2016 certification benefit you, the customer?

As you may be aware, ISO 13485:2016 is one of the most stringent quality standards that regulates the manufacturing industry. It is not easy to implement and receive certification for this standard, which is why only a small percentage of machine shops are currently accredited.

Our certification requires us to verify and document each phase of an in-scope job. From start to finish, each step of the process is inspected and certified based on your specifications; including the quote, to when we receive a purchase order, create work orders, machine, inspect, and ship the final parts to you. Records are securely held in our ERP’s digital ecosystem so we can refer back to them at any time in the future.

As an ISO 13485:2016 certified machine shop that is continuously striving to be the best at what we do, you can trust us for your CNC machining and assembly needs with the confidence that you are working with a contract manufacturing partner you can count on!

We’d love to work with you on your next project! Contact us or request a quote today to get started!