How to become a Certified ISO 13485 Auditor

[Ethan Loh]

Hi everyone,

I would like to enquire how can I become a certified ISO 13485 auditor?

Do I have to take ISO 9001 certification first then take the ISO 13485 auditor course?

My objective is to become like auditors from Notified Body (SGS or TUV).

Thank you

Ethan Loh

 

[Ajit Basrur]

Its not needed to take ISO 9001 first and then proceed with ISO 13485; you could directly take on ISO 13485.

 

[Ethan Loh]

Dear Ajit, where can I find courses that will certified me in ISO 13485. I try the IRCA and it only have ISO 9001 certification.

 

[Ajit Basrur]

You can contact SGS at -

SGS Testing & Control Services Singapore Pte., Ltd.
26 Ayer Rajah Crescent #03-07
139944 Singapore
Singapore Phone: +65 63790111

They run courses that are approved by IRCA

 

[Ethan Loh]

Dear Ajit,

I had checked with them and their ISO 13485 lead auditor course is a non-certified course.

Another suggest is most welcome.

 

[Ajit Basrur]

Probably check with Neville Clarke - +65 6733 3872

 

[esh14]

So, can I know is there anyone that attended the ISO 13485 course? Is the course certified by IRCA? Thank you.

 

[Ajit Basrur]

So, can I know is there anyone that attended the ISO 13485 course? Is the course certified by IRCA? Thank you.

Could you be more specific like which country / area are you looking for ? This would help in giving more specific answers

 

[yana prus]

I've taken ISO 13485:2003 Lead Auditor course from BSI. Further details about this course can be found here
http://www.bsigroup.com/en-GB/iso-1...-medical-devices-auditor-lead-auditor-course/
I would strongly suggest you checking with NB if they expect the candidate to take IRCA certified course or maybe they would be more interested in previous significant experience in the medical device industry. Of course, Lead auditor course of ISO 13485 is very beneficial as it gives you very solid knowledge of the standard, and auditing process.

 

[esh14]

I've taken ISO 13485:2003 Lead Auditor course from BSI. Further details about this course can be found here
http://www.bsigroup.com/en-GB/iso-1...-medical-devices-auditor-lead-auditor-course/
I would strongly suggest you checking with NB if they expect the candidate to take IRCA certified course or maybe they would be more interested in previous significant experience in the medical device industry. Of course, Lead auditor course of ISO 13485 is very beneficial as it gives you very solid knowledge of the standard, and auditing process.

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?