A
amyjpowers
Hi, quality folks,
I work for a design and development/R&D facility that develops a natural medicinal salve for treatment of wound care. It's considered a class II medical device. We are an organization of less than 15. I came on board 2 months ago and was tasked with setting up a QMS where no formal systems exist.
As we continue to develop our QMS in preparation for ISO 13485 registration in the future I've run into a couple of snags....or maybe I'm over thinking.....like that's NEVER happened!
We design and develop. The output of our design system is manufacturing specifications that will be sent to our (pending) contract manufacturing organization (CMO). We'll have a Feedback System in place and our lab will be involved with testing/approvals before final manufacturing can take place. Since all of our manufacturing is outsourced, and without "shirking" any responsibility, is it necessary for us to maintain systems for:
All thoughts are greatly appreciated.
I work for a design and development/R&D facility that develops a natural medicinal salve for treatment of wound care. It's considered a class II medical device. We are an organization of less than 15. I came on board 2 months ago and was tasked with setting up a QMS where no formal systems exist.
As we continue to develop our QMS in preparation for ISO 13485 registration in the future I've run into a couple of snags....or maybe I'm over thinking.....like that's NEVER happened!
We design and develop. The output of our design system is manufacturing specifications that will be sent to our (pending) contract manufacturing organization (CMO). We'll have a Feedback System in place and our lab will be involved with testing/approvals before final manufacturing can take place. Since all of our manufacturing is outsourced, and without "shirking" any responsibility, is it necessary for us to maintain systems for:
- Control of Production and Service Provision
- Monitoring and Measuring of Product
- Control of NC Product
All thoughts are greatly appreciated.