Hello,

Just had a reassesment audit with my registered body for ISO 13485, CMDCAS, and CE marking, I was issued a NCR for "The requirement for internal auditor qualification is not being followed." Clause 6.2.2 and the evidence was "Internal auditors have not been trained to CMDCAS or CE marking requirements. Proc ----- requires the origanization to keep records for internal auditors to conduct the internal audits." I have never seen or heard of training courses for auditing CE or CMDCAS and the only ones I have been able to find online are for registered bodys, not quality managers. Does anyone know if this auditor training is required and if so were I can find it. I'm not sure how to write a corrective action if no such training exsist.:confused:

Thank-you in advance!!!

Hello,

Just had a reassesment audit with my registered body for ISO 13485, CMDCAS, and CE marking, I was issued a NCR for "The requirement for internal auditor qualification is not being followed." Clause 6.2.2 and the evidence was "Internal auditors have not been trained to CMDCAS or CE marking requirements. Proc ----- requires the origanization to keep records for internal auditors to conduct the internal audits." I have never seen or heard of training courses for auditing CE or CMDCAS and the only ones I have been able to find online are for registered bodys, not quality managers. Does anyone know if this auditor training is required and if so were I can find it. I'm not sure how to write a corrective action if no such training exsist.:confused:

Thank-you in advance!!!

Hi tapawlik and welcome to the Cove! :bigwave:

Do your internal audit procedures state that you audit for compliance to CMDCAS/CMDR/MDD, etc.? If so, then I'm afraid you will need to have the training in those standards (or any of them that are referenced in your procedures). We just went through the same thing. The good news is that there are now webinars in CE marking and CMDCAS/CMDR and MDD, so obtaining the necessary training should not be so difficult as it would have been a year or two ago.

We were able to attend a webinar on CMDCAS/CMDR with BSI, and I also know that DNV offers a free webinar on CE Marking. (NOTE: I am in no way affiliated with either DNV or BSI.)

I hope this helps, and good luck....:bigwave:

Thank-you for the information, I was going wrong by looking for auditor training courses and not just training on the standards.:biglaugh: