IATF 16949 7.1.5.3.2 External Laboratory - On Site Calibration

Casana

Blueberry Nut
#1
I have a question regarding 7.1.5.3.2, External Laboratory.
If equipment calibration activities are done on site, using our purchased traceable standards, by a person contracted by us just for this activity, is that considered EXTERNAL or INTERNAL laboratory calibration? I was thinking that if ask our lab team to confirm this person is following our calibration procedures, then maybe they could just be considered a 'temporary lab employee' rather than an 'external service provider.'
I’m trying to decide if I need to ask them to become ISO 17025 accredited.
Thoughts?
 
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Ninja

Looking for Reality
Trusted Information Resource
#3
I’m trying to decide if I need to ask them to become ISO 17025 accredited.
If they aren't already, then don't ask them to. Get the job done...the rest is paperwork.
Understand that if they are not already accredited, and you call this "Internal", then you are responsible for everything that follows...
 

Casana

Blueberry Nut
#5
If they aren't already, then don't ask them to. Get the job done...the rest is paperwork.
Understand that if they are not already accredited, and you call this "Internal", then you are responsible for everything that follows...
We have no issues with taking accountability for what to do with the data/ what happens next. I just worry that we'll get a finding just because he's an outside contractor doing work on site...
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#6
They issue the report, listing what they reviewed, standard/reference used and final result/ evaluation.
So, it seems that you have a situation where you are engaging with an external lab. A convoluted situation where, despite being an external lab, they use your standards to perform calibration.
 

sswaim

Registered
#7
16949 provides options to use a calibration provider that is not 17025 accredited. Section 7.1.5.3.2 lays out the requirements for evaluating external an external laboratory w/o 17025.

Please refer to “OR” at the end of the second paragraph of 7.1.5.3.2. Or, “There shall be evidence that the external laboratory is acceptable to the customer.” “NOTE Such evidence (customer acceptance) may be demonstrated by a customer assessment (I could suggest that create an SOP that references your requirements and then your company conducts an audit of the laboratory in question to prove how they meet your requirements).
 

Sebastian

Trusted Information Resource
#8
In my opinion everything depends on calibration report "header".
If header looks like one of your internal system records, then even external person is involved in performing calibration activities, requirements related to external laboratory do not apply.
If header looks like external document, then they apply.
 

dwperron

Trusted Information Resource
#9
I have seen this handled both ways in the industry, and both are acceptable.
There are labs who will bring in "rent-a-tech" help. Those folks are considered part of your internal organization, so they would be considered your internal calibrations.
There are also labs that hand over their own equipment to be used by an outside calibration organization. Those calibrations are then done by the outside organization.
Whoever is responsible for issuing the calibrations is responsible for the accreditation, QMS, procedures, training, etc., all the back end calibration lab operations.
 
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