We recently had an ISO 13485 audit and the auditor had the questions below. Are there different ways to make sure the candidate is competent in the particular standard?
- How did you update to new standard? How do you know the candidate is good for internal audit for ISO: 2016 standard? Does he/she have 13485 competence?
- The basic ISO trainings were updated and he/she is trained for that. SOP along with test taken was provided for documentation.