Can ISO 9001 Lead Auditor lead all the other Audits (TS16949, ISO14001 & ISO13485)?

[yiwenkoh]

Our company is certified in ISO 9001, 16949, 14001 & 13485, can QMS ISO 9001 lead auditor be a lead auditor in overall?

[Colin]

I am not quite sure I know what you mean by 'lead auditor overall'. There is no requirement for a 'lead auditor' to exist in the standards.

Lead auditor is the title given to the person who leads an audit team and is also a grade of registration with IRCA for example.

[Randy]

16949...only if the auditor has passed a course accredited by the aiag I think

13485...passed a med device audit course most likely

14001...no restrictions other than not being familiar with the standard and probably not knowing an aspect if slapped in the face by it.

Everything is relevant and everything requires "competence" so in the end you'd be looking at some NC's from your CB auditors.

[AndyN]

In Reply to Parent Post by yiwenkoh

Our company is certified in ISO 9001, 16949, 14001 & 13485, can QMS ISO 9001 lead auditor be a lead auditor in overall?

If we are discussing an internal auditor, then it may be O.K. It's not necessary that the lead auditor be an expert in all these standards, as long as there's someone who has competency in each of the specifics of, say, 13485.

If we are speaking of an external auditor (may be a CB auditor) then it's possible that they have competency in all standards. In my experience, the lead auditor doesn't have to be an expert in all, since they may have someone who is more experienced in one of the standards.

I'm interested to know what type of organization has both ISO/TS 16949 certification and ISO 13485?

[SilverHawk]

The ISO 9001 Lead Auditor (assuming that he/she has passed the 5-day IRCA/RABQSA accrediated auditor course) should be competent in the auditing techniques and approcahes but the specific requirements in ISO 13485 & ISO/TS 16949 required additional areas in term of supplemental requirements. While the ISO 14001 empahsises on the aspect & impacts issues.

So the team leader should be exposed to the respective requirements of the other management systems...

[yiwenkoh]

In Reply to Parent Post by AndyN

If we are discussing an internal auditor, then it may be O.K. It's not necessary that the lead auditor be an expert in all these standards, as long as there's someone who has competency in each of the specifics of, say, 13485.

If we are speaking of an external auditor (may be a CB auditor) then it's possible that they have competency in all standards. In my experience, the lead auditor doesn't have to be an expert in all, since they may have someone who is more experienced in one of the standards.

I'm interested to know what type of organization has both ISO/TS 16949 certification and ISO 13485?

Thanks of your reply.

We are contract manufacturing for automotive & medical parts.

[Gert Sorensen]

In Reply to Parent Post by Randy

16949...only if the auditor has passed a course accredited by the aiag I think

13485...passed a med device audit course most likely

14001...no restrictions other than not being familiar with the standard and probably not knowing an aspect if slapped in the face by it.

Everything is relevant and everything requires "competence" so in the end you'd be looking at some NC's from your CB auditors.

Nice one, Randy!