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View Full Version : Different Requirements from different Accreditation Bodies


Elynn
17th March 2008, 04:45 AM
My company is an ISO 17025 accredited Lab by our local AB.

Due to customer requesting for a particular accreditation from a foreign AB (A little weird request, I know)... we have recently completed another round of audit. From the session, I experienced a round of confusion more than the stress sitting in the interogation room. There seems to be some differences in defining the clauses by our local and foreign ABs... :(

I do not wish to go into details as that would take pages to type... But anyone experienced that?

harry
17th March 2008, 05:58 AM
I can feel your pain, Elynn. That's why we have a thread here entitled: International Differences in Third Party Auditing and Auditors. (http://elsmar.com/Forums/showthread.php?t=23177&highlight=different+country)

Generally, I would say that compared to the Americans, the British are more conservative (and we in Singapore/Malaysia are more influenced by them). Continental Europe could be even more - perhaps due to cultural and language issues. An international forum like the Cove is a good place for us to exchange ideas and learn from each other. At least I know the limits in interpretations of specific issues from the various regions.

RLewing
17th March 2008, 07:27 AM
The International Laboratory Accreditation Cooperation (ILAC) has been going on for a while (only 7 years so far), so not all Accreditation Bodies may have yet reached the status of complying to the "ILAC Mutual Recognition Arrangement". http://www.ilac.org/ilacarrangement.html

So first check if both your AB's are signatories: http://www.ilac.org/documents/mra_signatories.pdf

After joining the cooperation, the bodies need still to be evaluated for their competence in the specific segment.

I suggest you study that website and after that you might ask the nasty question about having passed the ILAC evaluation from your two AB's. Of course, if the difference is not big, you don't have much of a case.

Your positive approach alternative would be to have the AB's to recognize each other's assessments. The foreign AB should be able to recognize the local AB's assessment visit (because of the ILAC cooperation) and they might give you their accreditation with only "office study" of your local AB's assessment report. (From my earlier history I remember one case where Finnish and Chinese accreditation bodies had this kind of case. One common assessment visit at the lab was done, thereafter changing documents did much of the job.)

Of course much depends on your local AB's technical competence in the area. They may need to use foreign technical competence anyway.

Elynn
18th March 2008, 08:53 AM
Fortunately and unfortunately, I have been audited by the Asians, Germans and Americans, quite a challenge when come to accommodating the differences...
Harry, I have read the thread you provided... Well, I guess the intend to standardization is 'open' to debate. :cool:

RLewing
19th March 2008, 03:47 AM
Fortunately and unfortunately, I have been audited by the Asians, Germans and Americans, quite a challenge when come to accommodating the differences...

Very seldom the requirements are in contradiction, though. My solution is to exceed all expectations:cool::biglaugh:

I always knowingly adjust my mindset as close as possible to the auditor's, and, believe it or not, we get along well.

I guess the intend to standardization is 'open' to debate. :cool:
Well, some standardization is better than no standardization.

AndyN
19th March 2008, 07:47 AM
Fortunately and unfortunately, I have been audited by the Asians, Germans and Americans, quite a challenge when come to accommodating the differences...
Harry, I have read the thread you provided... Well, I guess the intend to standardization is 'open' to debate. :cool:

Is it the AB's have differences of approach, or it is the auditors? I would understand that AB's should be fairly close in their 'interpretations' hence using an AB that's part of some mutual agreement pact.

However, if you are expecting auditors to be all in (lock) step over interpretations, then don't hold your breath! It's unlikely that is ever going to happen, as much as we'd expect it. There are too many variable at play. I agree they should be in the same book, but not necessarily on the same page with their approach. Is that what you're expecting/experiencing?

Randy
20th March 2008, 12:11 AM
If your auditors are interpreting....change auditors!

Auditors shouldn't interpret,they should look at the requirement and determine if there is sufficient objective evidence present to verify effective conformance to it.

How an organization chooses to conform is not the auditors business nor their decision.

An organization in achieving conformance is like a cop gaining entry into a house while serving a warrant....he can go in the front, go in the back, climb thru a window, come up thru the floor or down thru the roof and at times just hook up a big old truck with a chain to pull out the walls if necessary. The only requirement is to get in....achieving conformance is the same thing.

Elynn
20th March 2008, 03:50 AM
If your auditors are interpreting....change auditors!


That's cool.... :cool:

I was sitting in the audit as I am not in-charge of the sister-lab but hoping to gain from the audit trails and style.. also because i am the internal auditor for the Lab.

Taking the simpler one of the few examples is the interprtation of the 3 clauses:
a. 4.9 - Control of non-conforming testing / Calibration work...
b. 4.10 - Corrective Action
c. 4.11 - Preventive Action

According the latest audit... there are no connections... Yes or No?

Randy
20th March 2008, 03:56 AM
What do you mean by connections?

Hershal
20th March 2008, 04:38 AM
Elynn,

The first thing that should have happened is that if your local AB is a signatory to ILAC/APLAC then they should have asked the other AB to let the customer know that your accreditation is acceptabe - that is the way the MRAs are supposed to work.

As for the Clauses, there is a lot of connection and interaction between all the Cluases of 17025, obviously some more so than others.

4.9, 4.10, 4.11 are all linked, and unfortunately there is some interpretive room within the Clauses and the interaction of them. An example is preventive action, which is built in to the Standard, and (personal opinion only here) your preventive action procedure should include the management review, internal audit, customer feedback, PT/ILC, and similar as examples of preventive action but not limited to them.

Hope this helps.

Elynn
20th March 2008, 04:40 AM
What do you mean by connections?

Sorry for not being clear...
1. Are these 3 clauses not somehow linked?
2. With a CA, is there a need for PA is most causes (Though a PA can exist without a CA)?
3. When a non-conformance is found, shouldnt a CA / PA been put in place?

Elynn
20th March 2008, 04:51 AM
As during the Audit, auditor said that a CA, if any PA recommendation, is different from clause 4.11 - meaning that a PA documented from a CA, doesnt meaning we are meeting 4.11.... (???)

I have to admit that I was totally lost. Or was I wrong all the time (together with other external Auditors)??

That's just one of the few confusions...