Do Reference materials for IATF need to be 17025?

#1
Do calibration oils and buffers (like viscosity oils and pH buffers) need to come from a 17025 lab to comply with IATF 16949 requirements?

We're slowly transitioning from ISO 9001 to IATF and am trying to figure out the nuances to present to the owner.
 
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Ninja

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#3
Really, @Guest?

No, they don't...but if you are using them as a tool to measure or determine acceptance criteria they must be NIST traceable (calibrated, though I'm not so sure that term can really apply to a buffer solution, I suppose it could), or at least validated as accurate in a manner your customer accepts (documented).
All of my auto customers have required A2LA, none have required 17025...but even then it was only for PPAP submission.

Are you selling the oils and buffers to auto? Or are they just tools you use to measure something else?
 
#4
Really, @Guest?

No, they don't...but if you are using them as a tool to measure or determine acceptance criteria they must be NIST traceable (calibrated, though I'm not so sure that term can really apply to a buffer solution, I suppose it could), or at least validated as accurate in a manner your customer accepts (documented).
All of my auto customers have required A2LA, none have required 17025...but even then it was only for PPAP submission.

Are you selling the oils and buffers to auto? Or are they just tools you use to measure something else?
We're in the paint and coatings industry, specifically for wheels. So we don't make buffers and oils, but rather use them for internal verifications/calibrations of our pH probes and viscosity cups.

7.1.5.3.2 External laboratory in the IATF standard says that "facilities used for inspection, test, or calibration services" needs to be done by a 17025 lab (or equivalent/ approved by supplier). So I was wondering if this requirement extended to oils and buffers.
 

Ninja

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#6
I think he was snarkily trying to say that's not where they come from...Labs don't typically sell that stuff.

#1, you aint selling it (the buffers or oils) so PPAP with what you've got...if the customer signs it, you have customer approval.
#2... don't read the standard like "what extra do I need to do?"...read it like "I'm sure we already do this, where is my evidence?"

Only if you don't find any evidence should you start looking at adding things.
We're in the paint and coatings industry, specifically for wheels.
Seems like you're already doing it... so you should already have ample evidence of customer approval...a repeat PO if nothing else (though that's a bit thin). The customer signed PPAP would be way better...and if you're already selling into auto you may have that already.
 

John C. Abnet

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#7
customers have required A2LA, none have required 17025
Good day @Ninja ;
So, hate to be "that guy" but thought it was worth while to point out that a2la is an organization and not a set of requirements. a2La accredits to given standards, such as...
ISO/IEC 17025 for Testing/Calibration Laboratories s
ISO/IEC 17020 for Inspection Bodies
ISO/IEC 17065 for Product Certification Bodies
ISO 20387 for Biobanking Facilities
ISO 15189 and CLIA for Clinical Testing Laboratories
ISO/IEC 17043 for Proficiency Testing Providers

ISO 17034 for Reference Material Producers

So if your customers "required a2la", I can only assume they were accrediting your organization to ISO 17025 (or other if applicable). Let me know if I'm missing something.

Be well
 

dwperron

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#8
Do calibration oils and buffers (like viscosity oils and pH buffers) need to come from a 17025 lab to comply with IATF 16949 requirements?

We're slowly transitioning from ISO 9001 to IATF and am trying to figure out the nuances to present to the owner.

16949 does not require 17025 accreditation, it requires "conformity" to 17025. What it states is that if you and the outside sources you use are 17025 accredited then they consider to conform. If you choose not to get accredited to 17025, when an 16949 audit comes around they can ask for evidence as to how you conform to 17025.....
That's why a lot of 16949 organizations use 17025 accredited calibration houses and supplies. It just makes the audit process easier.
 

Ninja

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#9
Thanks John,
You didn't miss anything...I simply wasn't precise (much at all, apparently as I reread) in what I wrote.

All of my auto customers have required calibration with NIST trace for measurements we did in house (reported or not) on their parts at any point in the process,
and that if we outsourced any measurements we couldn't do in house that we use an A2LA accredited lab if such a thing existed for the property measured.
We took that to additionally mean "if we send a piece out to an outside lab for verification that our measurement is adequate, it should be A2LA", and never had a customer push back on it.
 

Howard Atkins

Forum Administrator
Staff member
Admin
#10
16949 does not require 17025 accreditation, it requires "conformity" to 17025. What it states is that if you and the outside sources you use are 17025 accredited then they consider to conform. If you choose not to get accredited to 17025, when an 16949 audit comes around they can ask for evidence as to how you conform to 17025.....
That's why a lot of 16949 organizations use 17025 accredited calibration houses and supplies. It just makes the audit process easier.
Are you talking about internal or external labs
There are different requirements for both
7.1.5.3.1 Internal Laboratory
An organization's internal laboratory facility shall have a defined scope that includes its capability to perform the required inspection, test, or calibration services. This laboratory scope shall be included in the quality management system documentation. The laboratory shall specify
and implement, as a minimum, requirements for:
a) adequacy of the laboratory technical procedures;
b) competency of the laboratory personnel;
c) testing of the product;
d) capability to perform these services correctly, traceable to the relevant process standard (such as ASTM, EN, etc); when no national or international standard(s) is available, the organization shall define and implement a methodology to verify measurement system capability;
e) customer requirements, if any;
f) review of the related records.
NOTE Third-party accreditation to ISO/IEC 17025 or national equivalent may be used to demonstrate the organization's in-house laboratory conformity to this requirement.

The standard states
7.1.5.3.2 External Laboratory
External/commercial/independent laboratory facilities used for inspection, test, or calibration services by the organization shall have a defined laboratory scope that includes the capability to perform the required inspection, test, or calibration, and either:
- the laboratory shall be accredited to ISO/IEC 17025 or its national equivalent (e.g., CNAS-CL01 in China) by an accreditation body (Signatory) of the ILAC MRA (International Laboratory Accreditation Forum Mutual Recognition Arrangement – www.ilac.org) and include the relevant inspection, test, or calibration service in the scope of the accreditation (certificate); the certificate of calibration or test report shall include the mark of a national accreditation body; or - there shall be evidence that the external laboratory is acceptable to the customer.

If you use an external lab then it MUST be accredited or approved by your customer.
 
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