Do we have to conduct tests during internal audit of ISO 17025:2005?

[amanbhai]

I am confused about the internal audit clause of ISO/IEC 17025:2005 that says "The internal audit programme shall address all elements of the management system, including the testing &/ or calibration activities".
Does that implies that we have chemist to perform test during the intenal audit? OR
We can address this without performing the tests?
I am confused about that, can I get help from some guru?

 

[Mr Niceguy]

We have interpreted it to mean that tests must be observed in internal audits wherever possible. More importantly our external assessor AB interprets it that way. Prior to assessment thay ask us to make sure the tests are available for observation. Too many non-conformities being flagged up after observation by your AB mean possibly your AB will note your internal audits are ineffective and issue an improvement action. It's happened to us in the past and we had to improve our internal audits by better team briefing and training measures.

 

[W. de Jong]

Hi,

No, there is no need to perform an -on the spot- analysis or something. But it says that besides the management system personell, infrastructure, mgt review etc. also the technical aspects of the standard, in other words 'the whole standard'.
We do perform an vertical 'sample survey(?)' where i follow a calibration from start to finish. On paper cause that is one that's already been done. If its possible to review a test during the audit i see no reason why you shouldn't.

BR, Wouter

 

[crendfrey]

We have interpreted it to mean that tests must be observed in internal audits wherever possible. More importantly our external assessor AB interprets it that way. Prior to assessment thay ask us to make sure the tests are available for observation. Too many non-conformities being flagged up after observation by your AB mean possibly your AB will note your internal audits are ineffective and issue an improvement action. It's happened to us in the past and we had to improve our internal audits by better team briefing and training measures.

One phase of our internal audit concerns calibration at customer sites.
We send in an observer with the technician who checks the previous tech’s work (scale tags, seals, paperwork up to date etc…) observes the current calibration and documentation. We choose these customers mostly at random or one that has had a complaint somewhere aling the line. Customers like it. AB likes it. It is not much more work for us as we are there for regular calibrations anyway. We are able to quell any concerns a customer may have and/or avoid any problems that could become serious.
Our techs have gotten used to us doing this once they realized it was not to find anything wrong with their work, only to document what a great job they do for us and our customers.

…..as an aside, we of course will set up complete calibration demonstrations for our reassessment : .

 

[BradM]

Internal audits can be one of the most valuable assets within a quality system. Basically, this allows you a self-check within your system.

Are you following your procedures? Are you doing all the steps that you state you are? Does it make good business practice.

As an internal auditor, could you not view the calibration activities while they are occurring? I would think you would want to observe evidence of competency and following the procedures. Too, as is in most businesses, you will probably have someone more experienced than the others. Do they add a step that the others don't do?

I would think the internal audit program should be able to provide evidence that the management system is conducting routine evaluations/ assessments of the testing/ calibration program. This will assist in making sure adequate resources are dedicated to properly get the job done.

 

[Ken K]

My question would be is your internal auditor qualified to observe testing/calibrations and make a judgement as to the validity of the way they are performed.


We are always asked to have test samples ready to go before our assessments. The auditor randomly picks tests for us to perform from our Lab Scope and observes them.

 

[Hershal]

Let's get real.....

Many labs have a limited number of personnel.....

A strict interpretation of that requirement mens that the technical aspect of the internal audit must be conducted by a technically qualified individual.....however that is not always possible.....

Some organizations that are accredited may be able to - in cooperation with their accrediting body - use the AB assessment AS the technical part of the audit.....

Understand, this is NOT recommended nor preferred.....but may be the only realistic option.....

Hope this helps.

Hershal

 

[amanbhai]

My question would be is your internal auditor qualified to observe testing/calibrations and make a judgement as to the validity of the way they are performed.


We are always asked to have test samples ready to go before our assessments. The auditor randomly picks tests for us to perform from our Lab Scope and observes them.

My lab does not have the trained internal auditor except myself. When i audit I ask lab manager to monitor tests as my Technical expert. The reason is a) The chemist perform the tests the same way, the result may not be different
b) we don't have the other option.
But is it the requirement of the standard to monitor tests during the internal audit? or we may just go without it or we may review the results of tests previously performed & reported to the customer?

 

[BradM]

My lab does not have the trained internal auditor except myself. When i audit I ask lab manager to monitor tests as my Technical expert. The reason is a) The chemist perform the tests the same way, the result may not be different
b) we don't have the other option.
But is it the requirement of the standard to monitor tests during the internal audit? or we may just go without it or we may review the results of tests previously performed & reported to the customer?

IMHO, Hershal is an expert that I respect greatly in this area. I would feel highly confident in going with his suggestions/recommendations.

While I still feel that all internal audits can be highly beneficial, as Hershal suggested, there is an element of reality here that cannot be ignored.

Would it be overly burdensome for you to train others to audit internally? What about asking your customer to observe the process?