Hi everyone,
I would like some advice from this very helpful and informative community. I work in RA/QA at a brand new startup company. I would say none of the employees have had any exposure to ISO 13485 or any QMS related concepts. What is the best way to train a group like this? For example, I am struggling with explaining the importance of documentation as a good practice, not just a regulatory requirement. How can I explain the connection between a company's quality policy and objectives and the day-to-day documentation, whether it's DHF or DMR? As we know, ISO 13485 leaves room for interpretation, and it tends to be very grey so I don't have regulations to back me up when I require something to be done in a certain way because so much in the quality system comes from best industry practices. If somebody has suggestions on how I can develop a better training program to tie together these concepts, it would be great.
Thanks.
I would like some advice from this very helpful and informative community. I work in RA/QA at a brand new startup company. I would say none of the employees have had any exposure to ISO 13485 or any QMS related concepts. What is the best way to train a group like this? For example, I am struggling with explaining the importance of documentation as a good practice, not just a regulatory requirement. How can I explain the connection between a company's quality policy and objectives and the day-to-day documentation, whether it's DHF or DMR? As we know, ISO 13485 leaves room for interpretation, and it tends to be very grey so I don't have regulations to back me up when I require something to be done in a certain way because so much in the quality system comes from best industry practices. If somebody has suggestions on how I can develop a better training program to tie together these concepts, it would be great.
Thanks.