K
Internal Auditor Qualifications – ISO13485 vs. ISO9001
Hi
We are an ISO9001:2008 registered contract electronics manufacturer who is in the process of adding ISO13485:2003 certification.
My question is with respect to the internal audit training requirements. We have an audit team who are all formally trained ISO9001 internal auditors. What additional training is needed for these auditors to be considered competent to internally audit a QMS that now includes ISO 13845? Is full ISO 13485 Internal Audit training required or is awareness/overview training of the differences between 13485 and 9001 sufficient given that my team are already trained in internal audit techniques?
Thanks in advance for your responses.
Hi
We are an ISO9001:2008 registered contract electronics manufacturer who is in the process of adding ISO13485:2003 certification.
My question is with respect to the internal audit training requirements. We have an audit team who are all formally trained ISO9001 internal auditors. What additional training is needed for these auditors to be considered competent to internally audit a QMS that now includes ISO 13845? Is full ISO 13485 Internal Audit training required or is awareness/overview training of the differences between 13485 and 9001 sufficient given that my team are already trained in internal audit techniques?
Thanks in advance for your responses.

