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Skipping internal audits in internal laboratory

Paul Simpson

Trusted Information Resource
#11
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.
 
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P

potdar

#12
  • 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.
 

Helmut Jilling

Auditor / Consultant
#13
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.
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.
 
P

potdar

#14
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.
 

Paul Simpson

Trusted Information Resource
#15
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 ....
 

soulmas

Involved In Discussions
#16
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
 
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