How to become a Certified ISO 13485 Auditor

[58431Check]

Try CALISO9000. They have a 22 hour lead auditor course that I took.

 

[Sidney Vianna]

So do you mean that it doesn't matter if take a not certified course? Can we register with IRCA as a certified auditor then?

It does matter. If you want to attain proper certification from IRCA or another recognized Personnel Certification Body, the course you take must be PROPERLY accredited, but remember that taking the course and passing the test is just ONE COMPONENT of the auditor certification process.

 

[Castaway99]

What are the prerequisites? How many years of experience is expected in the medical industry? And what about auditing against 93/42/EEC?

 

[Castaway99]

My question: How many years of experience in the medical device industry is required as a prerequisite to becoming a ISO 13485 auditor. Off course one has to attend and pass the LA course and all that, and then probably audit as a trainee,then as an auditor and then lead an audit team . Thats fine.

 

[Castaway99]

Will experience working as a consultant for a medical device manufacturing company (QMS implementation, Regulatory compliance) count?

 

[AndyN]

Castaway - in what context are you asking? Do you want to become a CB auditor? If so, the CB is going to define what qualification criteria they use, so we can't tell you much. Have you reviewed the IRCA or Exemplar requirements? They will tell you everything you need to know. Your LA course materials should also provide some guidance - have you checked there?

 

[Castaway99]

Hi Ajit,
How many years of work experience is required as a prerequisite for becoming an ISO 13485 auditor?

 

[Castaway99]

Thanks Andy , I will take a dekko at IRCA/Examplar requirements...........

 

[Ajit Basrur]

Hi Ajit,
How many years of work experience is required as a prerequisite for becoming an ISO 13485 auditor?

This is a very subjective question and depends on the person on where (s)he is placed in the learning curve.

 

[Castaway99]

Hi Andy, checked Examplar & IRCA, nothng mentioned about experience in medical device manufacturing industry. Like in TS16949, AIAG requires that you should have 3 years of experience in the auto industry in the past 5 years or something like that. Its very specific.