ISO 13485 Lead Auditor Re-Training Requirements

L

Lily123

#1
Hi all,
I have the IRCA ISO 13485:2003 Internal / Lead auditor qualification, completed in Aug 2008,
I am soon starting a new position in Medical Devices, primarily to get this company ready for Stage II accreditation to ISO 13485. (Internal audits, gap analysis,etc...)
As my certificate is now out of date (small print states valid for 3 years) do I need to again sit the 5 day Lead Auditor or will the 2 day Internal Auditor course suffice?
I also notice that ISO 13485:2003 is still the latest revision ?
I have carried out Internal/Lead audits to ISO 13485 since 2008, although in the past 12 months I have been in the GMP Pharma field...
Hope some-one can help, as I would not like to personally be "non-conforming" for my new job ! :D

Thanks in advance, Lily
 
Elsmar Forum Sponsor
#2
Re: ISO 13485 Lead Auditor re-training

First of all, welcome to the Cove!!!!! :bigwave:

There is no requirement that I know of for being certified to do implementation. Many of us maintain certification just because it tends to add the perception of credibility. If you want to regain your certification, you probably should contact IRCA and see what they say about the required steps to regaining your cert. Depending on how long your cert has elapsed, you might just have to pay a little bit more money..
 
L

Lily123

#3
Re: ISO 13485 Lead Auditor re-training

Thanks Dave,
I have contacted both IRCA and my course provider, it seems that I only need re-certify (sit course and exam again) if I wish to remain/become a IRCA registered certified lead auditor or work for a 3rd party assessor.
If the standard is revised , I will need some type of re-assessment.
As I have been carrying out Medical Device internal audits and kept my CPD up to date, and because I will be involved (only!) in QMS maintenance/implementation I do not need to re-certify,
Lot clearer now ! Thanks Lily
 
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