Internal Audits - What if performed by consultant

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#2
Re: Internal audit- What if performed by consultant

Is it a non conformance if our audit is performed by our consultant?
Although I am not an expert in 17025, I will comment:

A nonconformity (non conformance) exists when the objective evidence does not match the audit criteria. So, the question is: Where is the criteria? Does it say anywhere that internal audits cannot be performed by outside? Where is the "shall"?

I perform internal audits for several different companies (not for 17025, however). The only issue that has come up has been one of qualification. Some 3rd party auditors seem to think that if the internal audit is performed by a consultant, the consultant needs to be a certified auditor (not a problem with me, but then again.... where is the shall?).
 

Big Jim

Super Moderator
#3
Re: Internal audit- What if performed by consultant

That's a very good question, especially in light of the "auditors shall not audit their own work".

Within the consulting group I work for, internal audits are nearly always performed by a different consultant than the one that wrote the manuals and aided in starting the quality management system.

However, it has been my experience when performing registration audits where the company used different consultants, that the internal audit was nearly always performed by the same consultant that wrote the manuals.

I'll be interested in what others have to say.
 
#4
Re: Internal audit- What if performed by consultant

There will be no problem having a consultant do the internal audits, as long as they are competent! In any lab there's going to be a degree of technical issues which are part of the system, measurement uncertainty being one of them. Clearly, the auditor must be familiar with them. Now, Big Jim is somewhat correct in his comment, but for the wrong reason!

If a consultant wrote the manual, procedures etc, that's not 'auditing their own work'....it's the implementation they are auditing! But, if the consultant has done much of the technical work - the calculation of the measurement uncertainties, previously mentioned, then that would be 'their own work'.

It's common for labs to have outsider help with internal audits, since labs are often staffed by just a few people and can't simply arrange this type of thing around their (many) other duties
 
Q

Quality Priest

#5
Re: Internal audit- What if performed by consultant

In a previous company, due to the lack of resources we often employed consultants to conduct internal audits.

Not always successfully it must be added, but that was more down to one individual.

The main use of the consultants we made was to Audit the Internal Audits, thus showing a better degree of impartiality than if I had conducted the audit.

We kept this very transparent with our regulatory authority, who were more than happy to accept these consultant audits.
 

Randy

Super Moderator
#6
The only question is the competence of the auditor...demonstrated personal attributes and demonstrated ability to apply knowledge and skill
 
A

amanbhai

#7
thanks for all the replies.
with these replies, I can expand this for other standards e.g. ISO 9001.
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#8
Consultants can complete the internal audit, but you have to watch one thing, that is if the consultant does not have the TECHNICAL competence, then you will need someone to complete the technical part of the internal audit. Under the requirements of ISO/IEC 17025, the technical operations must also be audited as a part of the internal audit.

Auditor certification is a plus, but unlike the 9K world, it is not a primary driver.

Hope this helps.
 

krishkaar

Involved In Discussions
#9
Indian Accreditation Board - NABL has issued guideline document (No. 161 on Management Review Meeting and Internal Audits)

Sec 2.4 runs like this.
The audits shall be carried out by qualified personnel who understand the
technical requirements they are auditing and who are trained specifically in
auditing techniques and processes..........

Based on the above, NABL seems to be suggesting that the Internal Auditor should have undergone formal training. In fact the Assessors insist verifying such an evidence.
------------------------
So it is possible that even though the Standard (ISO 17025) per say does not mean formal training, the Accreditation Boards perhaps are.

Any comments.
 
S

samsung

#10
Indian Accreditation Board - NABL has issued guideline document (No. 161 on Management Review Meeting and Internal Audits)

Sec 2.4 runs like this.
The audits shall be carried out by qualified personnel who understand the
technical requirements they are auditing and who are trained specifically in
auditing techniques and processes..........

Based on the above, NABL seems to be suggesting that the Internal Auditor should have undergone formal training. In fact the Assessors insist verifying such an evidence.
------------------------
So it is possible that even though the Standard (ISO 17025) per say does not mean formal training, the Accreditation Boards perhaps are.

Any comments.
Will you please elaborate if the 'guideline document' (NABL 161) applies to 'NABL accreditation' or to ISO 17025. Further, I didn't get the point when the document states "The audits shall be carried out.....". A guideline document, normally, doesn't make something mandatory but advises what it considers as the best option among the several possibilities yet without quoting the other available options.
 
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