IATF 16949 7.1.5.3.2 External Calibration Laboratory Requirelents

sswaim

Registered
#1
Hello 16949 experts,

I am the quality manager for an analytical sales and service company. Our parent company is located in Europe. We as a subsidiary sell and service only instruments manufactured by us and we never use sub-contractors. All of our work is done in the field by company trained degreed chemist who uses test standards (DMMs, Decade boxes, RTD probes, proprietary reference standards...) These test standards are certified by a contracted 17025 registered calibration laboratory so we can show NIST traceability for our field calibrations of customers instruments. We are registered to ISO 9001:2015.

We have had the question arise referencing section 7.1.5.3.1 & 7.1.5.3.2 by 3rd party 16949 auditors stating that the customer has to have their instruments that are purchased from us to be certified by a 17025 registered laboratory.

I say that our instruments are proprietary and only trained personnel are allowed access to certain documentation, parts and only certified employees (field service personnel) are issued dongles to access service software for working on our instruments.

I read in 7.5.5.3.2 "there shall be evidence that the external laboratory is acceptable to the customer" as meaning it is up to the customer to set the criteria as to what is acceptable. If we meet all the other criteria, training, competency, documentation, NIST traceability... Then it should be the customer to say if we are acceptable or not as a service provider.

I welcome other opinions on this, am I interpreting this correctly?

Thanks in advance,
Scott
 
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Mikey324

Quite Involved in Discussions
#2
Let me make sure i understand correctly. Are you the manufacturer of the equipment in question? If so, the company should be fine with the fact that you don't have 17025 certification. Who better to monitor, calibrate, and service than the manufacturer?
the "note". I see no requirement that the customer purchase instruments from a certified lab. Sounds like auditor interpretation to me.

This is from the requirement "note"
Calibration services may be performed by the equipment manufacturer when a qualified laboratory is not available for a given piece of equipment. In such cases, the organization shall ensure that the requirements listed in Section 7.1.5.3.1 have been met.
 

sswaim

Registered
#3
Let me make sure i understand correctly. Are you the manufacturer of the equipment in question? If so, the company should be fine with the fact that you don't have 17025 certification. Who better to monitor, calibrate, and service than the manufacturer?
the "note". I see no requirement that the customer purchase instruments from a certified lab. Sounds like auditor interpretation to me.

This is from the requirement "note"
Calibration services may be performed by the equipment manufacturer when a qualified laboratory is not available for a given piece of equipment. In such cases, the organization shall ensure that the requirements listed in Section 7.1.5.3.1 have been met.
That is exactly how I read it too. It says 17025 "can" be used to demonstrate conformity, it is not a requirement. and under 7.1.5.3.2 second paragraph ends with "or" and proceeds to talk about a lab that is acceptable to the customer. I told him that the auditor is not auditing to the standard and making interpretations that are beyond his authority. I just like to hear second opinions and I never get to contribute to the Forum and thought this could be my chance. Thanks Mikey325
 
#4
3rd party 16949 auditors stating that the customer has to have their instruments that are purchased from us to be certified by a 17025 registered laboratory.
If this is an accurate quotation, the auditor(s) don't know what they're saying.

If so, the company should be fine with the fact that you don't have 17025 certification.
There's no such thing. It's accreditation, not certification, and hence my comment above. When folks don't use the terminology correctly, it leaves me in doubt about their actual knowledge of the requirement.
I read in 7.5.5.3.2 "there shall be evidence that the external laboratory is acceptable to the customer" as meaning it is up to the customer to set the criteria as to what is acceptable. If we meet all the other criteria, training, competency, documentation, NIST traceability... Then it should be the customer to say if we are acceptable or not as a service provider.
Exactly.
 

Pjservan

Involved In Discussions
#5
This requirement is can be very confusing indeed.

The term "customer" as used in the standard means your customer's customer. The expectation is that the calibration is to be done by an accredited lab or a customer approved sourced. The manufacturer a device can calibrate and is exempt of the ISO 17025 requirements if the calibration is unique to them where a qualified laboratory is not available.
 

Sebastian

Trusted Information Resource
#6
Please do not forget that organization shall ensure that the requirements listed in Section 7.1.5.3.1 have been met by equipment manufacturer.
 

Rameshwar25

Quite Involved in Discussions
#7
Read FAQ#7 of IATF 16949.
QUESTION 1:
When can the equipment manufacturer be used to calibrate inspection and test equipment?
If an accredited laboratory exists but is very remote and/or expensive and the inspection or test equipment manufacturer is nearby and available can they be used (even if they are not accredited to ISO/IEC 17025)?
ANSWER 1:
The inspection or test equipment manufacturer developed the methodology to maintain and adjust the equipment to meet calibration requirements as part of the design and manufacture of the inspection or test equipment. Therefore, the original equipment manufacturer of the inspection and test equipment is qualified to calibrate the equipment they designed and manufactured.
My interpretation:
an equipment manufacturer need not to be ISO 17025 accredited, but should meet (implement) all requirements of ISO 17025 standard such as WI, competency etc.
 

Howard Atkins

Forum Administrator
Leader
Admin
#9
Calibration services may be performed by the equipment manufacturer when a qualified laboratory is not available for a given piece of equipment. In such cases, the organization shall ensure that the requirements listed in Section 7.1.5.3.1 have been met.
Use of calibration services, other than by qualified (or customer accepted) laboratories, may be subject to government regulatory confirmation if required.

Please see emphasis.

There is no blanket permission for the manufacturer to calibrate but only if you cab show that there is no lab available
ISO 9001 is irrelevant as it cannot be valid for calibration
I can show traceability to NIST standards as can anyone who has had an instrument calibrated by an ISO 17025 lab
As stated before the customer is the customer of your customer.
You must also supply your Lab scope as defined in 7.1.5.3.1
 
#10
Read FAQ#7 of IATF 16949.
QUESTION 1:
When can the equipment manufacturer be used to calibrate inspection and test equipment?
If an accredited laboratory exists but is very remote and/or expensive and the inspection or test equipment manufacturer is nearby and available can they be used (even if they are not accredited to ISO/IEC 17025)?
ANSWER 1:
The inspection or test equipment manufacturer developed the methodology to maintain and adjust the equipment to meet calibration requirements as part of the design and manufacture of the inspection or test equipment. Therefore, the original equipment manufacturer of the inspection and test equipment is qualified to calibrate the equipment they designed and manufactured.
My interpretation:
an equipment manufacturer need not be ISO 17025 accredited but should meet (implement) all requirements of ISO 17025 standard such as WI, competency etc.
To Everyone,
Thanks for all of the valuable input from everyone. I think we are pretty much in agreement here. We as the manufacturer have the needed test tools, knowledge, repair parts, and documentation to service and calibrate our instruments. I am certain we can meet customer requirements laid out in IATF 16949 section 7.1.5.3.1. I also believe that since ISO is trying to harmonize their standards, 9001 and 17025 is as close as they have been since publishing these two standards. Most of our service work (>95%) which includes calibrations are performed in the field by our field service employees. The FSE use the manufacturer's proprietary procedures and only use NIST traceable standards during calibration. Even though we do not meet all of 17025 requirements we do meet many of the requirements laid out in the 17025 standard. I do not know if we would ever apply for or obtain a 17025 registration due to the overall nature of our business. I feel we are not alone in this and that is why IATF 16949 wrote the standard the way they did. They recognized this as a potential problem if they required only 17025 registered companies to perform calibrations, the customer's selection of instrumentation could be severely limited. Again, thanks for all the feedback on this question, it was very helpful.
 
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