If you are a supplier (vs Device manufacturer) it depends on who you want to sell to..
We are a looking to sell into both the medical market (both device and pharma) as well as into non-medical areas... A lot of people outside of the device arena have have no idea about 13485 but are familiar with 9001...
We initially certified for 9001 last year, and this spring got certified for 13485 ... our QMS only had minor tweaks in preparation for 13485...(but have 2 quality manuals). Most of our QMS was based on old pharma SOPs form 15 years ago (the organization was looking to cover GMP and 9001) from the start, and the 9001 registrar knew were were going to go for a dual certification. We used the same registrar for 13485.
- Karen
Last edited:
