Hi!

I would like to have your imput regarding the following issue..we have internal labs. These labs have been certified in ISO17025... the company overall is ISO/TS16949.

We would like to know if we could skip ISO/TS internal audits in the labs due to they are in compliance with ISO17025. I could record this into the internal audit notes/calendar and show this to the external TS auditors.

What do you think about it? Could I skip the internal audits in the labs?

:)

I don't know if you could "skip" addressing the ISO/TS standard, but I would deploy a strategy so you wouldn't have to do two audits, i.e, combining checklists. I would make one audit count for both standards, I do that now with some of my OHSAS18001, ISO9001 and ISO14001 audits. 3rd party auditors have not had a problem with it. :cfingers:

We would like to know if we could skip ISO/TS internal audits in the labs due to they are in compliance with ISO17025. I could record this into the internal audit notes/calendar and show this to the external TS auditors.

What do you think about it? Could I skip the internal audits in the labs?

:) From memory you can skip the internal audits. I presume under your 17025 accreditation you carry out your lab audits. There is no sense in duplicating effort.

It's been awhile since I looked at both standards in depth - I'm not confident that you can just do the ISO 17025 audit and clim it mets the needs of ISO/TS as well. I do agree with chaosweary that you can combine the 2 audits into 1. We did that at a former employer with QS-9000 and ISO Guide 25.

With my current employer, when possible we combine ISO 14001 & ISO/TS 16949 audits into 1 audit. We also typically combine process and system type audits for ISO/TS into 1 audit rather than having separate ones. At neither employer, did our registrar have problems with the combined audits, which were spelled out within our quality management system.

Thankyou, thankyou, thankyou to all of you.... I will update my internal audit agenda adding a note that the labs are covered by ISO/IEC17025 audits... Also, I will request the labs to send me the external audit report & Cert...this is the information I will add this into internal audits notes..

Great!! thankyou so much for your comments..I will let you know if I have an issue in my next the surveillance audit

Thankyou, thankyou, thankyou to all of you.... I will update my internal audit agenda adding a note that the labs are covered by ISO/IEC17025 audits... Also, I will request the labs to send me the external audit report & Cert...this is the information I will add this into internal audits notes..

Great!! thankyou so much for your comments..I will let you know if I have an issue in my next the surveillance audit

:caution: What you plan wouldnt be sufficient. There are two ways in which you can handle this.

One - as suggested by many, have a common audit schedule and a common audit record for both the certificates.

Two - Have a periodic audit of your lab. Remember, you are free to set the frequency at once a year. Checklist - Check whether the ISO 17025 certification / accreditation is valid. You have to periodically review the validity of your claim that your labs need not be audited any deeper. This is similar to re-evaluation of your suppliers (7.4) You are simply treating your labs as externaly certified internal suppliers.

From the A2LA web site: http://www.a2la.org/faq/faqfinder170252005.cfm

Do laboratories accredited to ISO/IEC 17025 also meet ISO 9000? 04/30/2005
1.6
2005


According to the 2005 version of the Standard (within the Introduction), “Care has been taken…to incorporate all those requirements of ISO 9001 that are relevant to the scope of testing and calibration services that are covered by the laboratory’s management system.” In addition, “Testing and calibration laboratories that comply with this International Standard will therefore also operate in accordance with ISO 9001.”

However, laboratories may not claim ISO 9000 registration based solely on their ISO/IEC 17025 accreditation, though additional evaluation against ISO 9001/9002 should not be necessary for laboratories accredited to ISO/IEC 17025.
It is also noted in the Introduction to ISO/IEC 17025 that conformity of a laboratory’s quality management system to the requirements of ISO 9001 does not of itself demonstrate the competence of the lab to produce technically valid data and results.


Al...

To clarify my earlier post - combining is not the same as saying that the ISO 17025 audit meets the requirements of ISO/TS 16949. It requires that both ISO 17025 and ISO/TS 16949 requirements be reviewed and that the applicable requirements from both be applied to the area of interest (your internal lab) and factored into your internal audit schedule.

If you don't do the background work with both of the standards, then your auditors both internal and external should identify a nonconformance within your quality manangement system. If you do the background work supporting your combination of the requirements there should be no nonconformance.

I've tried unsuccessfully to find the reference but will have to give up. I remember auditing to QS there was a rule that you drew a boundary around the accredited lab (as they are already audited by an accreditation body (AB)) and the same applied for the rest of the organisation's management system - you didn't look for audits in this area as they were covered by the AB. But I can't find it - perhaps someone who currently audits for a TS CB can shed some light?

I've tried unsuccessfully to find the reference but will have to give up. I remember auditing to QS there was a rule that you drew a boundary around the accredited lab (as they are already audited by an accreditation body (AB)) and the same applied for the rest of the organisation's management system - you didn't look for audits in this area as they were covered by the AB. But I can't find it - perhaps someone who currently audits for a TS CB can shed some light?

The auditors I work with will audit a company's internal lab for TS. If the internal lab happens to have accreditation to ISO 17025, and note that in the report. We may also review the last audit report to that accreditation, and note that. I typically follow the usual process linkages to make sure everything is in order as it links to the other processes. Our audit does not go into the technical depth that an A2LA or LAB audit would, however.

The auditors I work with will audit a company's internal lab for TS. If the internal lab happens to have accreditation to ISO 17025, and note that in the report. We may also review the last audit report to that accreditation, and note that. I typically follow the usual process linkages to make sure everything is in order as it links to the other processes. Our audit does not go into the technical depth that an A2LA or LAB audit would, however.
Thanks, H.
The OP was about whether the company should include the labs in their TS audit programme (even though they have to have 17025 audits to maintain their lab accreditation).

My post was that they don't have to audit the lab under TS but others disagree. As a current TS auditor
do they have to duplicate
can they integrate the audits
can they "ring fence" the lab and just do lab audits

Look forward to your views.

do they have to duplicate

No.

can they integrate the audits

Yes. This will basically be a 17025 audit for the defined scope. This will also be marked as 16949 audit completed. 16949 has no additional requirements.

can they "ring fence" the lab and just do lab audits


No. 16949 audit is necessary. In this audit it is sufficient to note that the lab has a valid 17025 accreditation for the desired scope. No further checks are necessary.

Note: We are assuming that the scope required by 16949 and that defined under 17025 are same.

Thanks, H.
The OP was about whether the company should include the labs in their TS audit programme (even though they have to have 17025 audits to maintain their lab accreditation).

My post was that they don't have to audit the lab under TS but others disagree. As a current TS auditor

do they have to duplicate
can they integrate the audits
can they "ring fence" the lab and just do lab auditsLook forward to your views.

I'm not aware of anything in TS that would allow them to "ring around their internal labs" and leave them out of their internal audits, or from their QMS. I see it as a process like any other, and they should define it in their system and handle it just like their other processes. I think ISO 17025 supports that view as well.

They certainly can and should integrate it with their other audits. I don't expect they should audit it any differently, unless ISO 17025 has particular audit requirements.

They certainly can and should integrate it with their other audits. I don't expect they should audit it any differently, unless ISO 17025 has particular audit requirements.

17025 covers all requirements of 16949. Not the other way round.

A friend in the SMMT (oversight body here in the UK) gave me the following explanation of their expectation of how the CB should assess the interface for an accredited lab:

Regarding the lab, if the lab is accredited, it would still needed to be in the audit plan, but the audit would be short and focus on any requirements in TS that are not covered in 17025 (e.g. Focus on performance, employee empowerment/motivation etc)
Hope this helps ....

Thanks again Paul.... This is a point of view that I didn't see before.. I will take in consideration this last comment for my internal audits regarding the labs... excelent!!! Now I feel more confident in what I will do..

best regards,
Soulmas