I recently started a job building up the quality system of a very small company (15 workers).
There is no manufacturing and most people are doing R&D.
Management want to introduce a quality system (kudos to them!) and that's where I come in.
However my background is quality management in a larger company that manufactured and marketed their products. I am unsure how much the ISO 13485 applies to all the R&D work being done.
Obviously things like calibration, traceability, etc. are important but are there specific rules regarding ISO and R&D?
Thanks
Mandy
There is no manufacturing and most people are doing R&D.
Management want to introduce a quality system (kudos to them!) and that's where I come in.
However my background is quality management in a larger company that manufactured and marketed their products. I am unsure how much the ISO 13485 applies to all the R&D work being done.
Obviously things like calibration, traceability, etc. are important but are there specific rules regarding ISO and R&D?
Thanks
Mandy