Internal Auditors for ISO 9001:2015 and ISO 13485:2016

Hi!

As of now we are certified of ISO 9001:2015 and ISO 13485:2016. Our Internal Auditors attended and passed the Internal Audit training under ISO 9001:2015 automatically they are entitled to conduct Internal Audit for ISO 9001:2015.

Are they also entitled to conduct Internal Audit for ISO 13485:2016? or they need to under go first the Internal audit training for ISO 13485:2016 before they conduct internal audit for ISO 13485:2016 standards?


Second Concerned:

We are planning to send our personnel to Lead Auditor Training of ISO 9001:2015. He is also knowledgeable in ISO 13485:2016 he is also a certified Internal Auditor for ISO 9001:2015 and ISO 13485:2016.

If we send him to Lead Auditor Training and if he pass the exam. Is he entitle to conduct an Internal Audit training to our personnel and certified them as are Internal Auditors for ISO 9001:2015 and ISO 13485:2016?


Thank you for the answer.

 

Not really. Taking a course doesn't automatically mean competency. It's like taking a driver's training class - does it make you competent to drive on the roads under ALL conditions? No! Have you determined what would make an auditor competent? Experience, for example? Being coached?

If they are not qualified or entitled to conduct internal audit to are ISO 13485:2016, even they attended the ISO 9001:2015 training, meaning we have to send them to separate training for ISO 13485? to be come internal auditors to that standards?



What's the purpose in sending someone to this course? 3 or 4 of the training days are the same thing!

If we not send some of are personnel to lead auditor course, who is the right person to trained to are personnel for them to be entitled to conduct internal audit.



No! Passing an auditor course doesn't bestow any ability to train others. It's not a "train the trainer" course, it's an auditor course. Think about who trains car drivers? Father? Brother? Husband? Were they good trainers or did they get angry or frustrated "Why don't you do what I do?"[/QUOTE]

Meaning even he/she trained and passed the ISO lead auditor training he is still not entitled to trained are personnel to become internal auditors? and if we send her/him for the train the trainer is he/she will be entitled to train are personnel to become internal auditor? instead of sending him to ISO Lead Auditor training course?

 

Being in training, of any kind, doesn't make anyone competent. It takes more than going to a course. Going to a train-the-trainer course doesn't instantly make you a great trainer.

Can I ask what the objective is here? What does the organization hope to get for all this training? The outcome? If you can't express that, then you might want to sit down and figure THAT out. It seems to me that you are willing to spend money and I can't see what the return is. Help me understand.[/QUOTE]


My objectives are to increase the numbers of our Internal Auditors, to avoid yearly sending of our employees in the Internal Audit Training, and to have an in-house trainer for creating internal auditor. If we have our personnel who can train are employee in internal audit we will lessen the annual cost for the outside internal audit training.