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ISO/TS16949 Internal Calibration Lab need to include Production Equipments

D

dvd101

#1
Hi all,

I am drafting the Internal Calibration Lab Scope per ISO/TS16949 7.6.3.1, my question is:
Do the internal calibration Lab's need to cover production equipment when the production equipment need to calibrate by the internal calibration lab or just list out the equipments that Calibration Lab own is good for the requipment? Please advice!
 
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BradM

Staff member
Admin
#2
Hello there!

Just so I understand- You have a facility with an internal calibration lab. You perform calibration on equipment at your facility. You are writing a scope for the lab. Are you asking if that scope should cover all the instruments that lab services, or cover just the standard instruments?

I am not knowledgable in 16949, so I can't give you a good answer. Outside of specifics under that specification, I would think you would list your competency. So, you would list your capabilities (with uncertainty).
 
P

PaddlerCelia

#3
I think your scope document could refer to measurement 'Standards' documents to define the lab equipment required to calibrate the production equipment. If you then note which 'standards' document was used when you calibrate the production equipment on its calibration record as stated in TS16949 7.6.2 you should comply.
Records should list ALL equipment (instruments, gages, jigs) used for measuring, testing and gaging. This includes lab and production. The owner of the gage is not relevant and you should also include gages owned
by employees and customers. Database software is essential for recording all
these details. Good software will record which reference equipment (lab gages) is used to calibrate another gage. It will also verify that the gage used to calibrate another has an 'In calibration' status thus providing traceability.
Regards
Celia
 

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K

Ken K

#4
What I did was list all equipment in our company which is calibrated. If certain equipment is calibrated by an outside source, I included who they are and who they are accredited by.

For internally calibrated equipment, I listed the calibration procedure used and the equipment used to calibrate.

This way I have one list to cover everything.
 
V

vanputten

#5
The point of a Lab Scope document is to define the scope of internal calibration ability. What items does your organiztion calibrate internally? The answer to thsi question is what goes into the Lab Scope document.

No matter where the equipment is used, if it is calibrated internally, then it should fall within the documented scope of the lab.
 

Helmut Jilling

Auditor / Consultant
#6
I think your scope document could refer to measurement 'Standards' documents to define the lab equipment required to calibrate the production equipment. If you then note which 'standards' document was used when you calibrate the production equipment on its calibration record as stated in TS16949 7.6.2 you should comply.
Records should list ALL equipment (instruments, gages, jigs) used for measuring, testing and gaging. This includes lab and production. The owner of the gage is not relevant and you should also include gages owned
by employees and customers. Database software is essential for recording all
these details. Good software will record which reference equipment (lab gages) is used to calibrate another gage. It will also verify that the gage used to calibrate another has an 'In calibration' status thus providing traceability.
Regards
Celia

You seem to be including a whole gage list in your Lab calibration Scope, which can be compliant, but makes the docuemnt unwieldy. The intent of the scope is simply to describe what calibration tests you are qualified to perform. Definition 3.1.5 in the TS standard gives a good, simple description (pg 3).
 
#7
Where would we be without Helmut???

He's got it in one!

My advice, building on this point is to take a look at some calibration houses which are accredited to ISO/IEC 17025 2005 and access their scope of accreditation. I used this approach to write a TS lab scope.
 
P

PaddlerCelia

#8
You seem to be including a whole gage list in your Lab calibration Scope, which can be compliant, but makes the docuemnt unwieldy. The intent of the scope is simply to describe what calibration tests you are qualified to perform. Definition 3.1.5 in the TS standard gives a good, simple description (pg 3).
Sorry I did not explain myself well. I agree the scope document should be short and simple but should make reference to a database or list of all equipment.
 

Helmut Jilling

Auditor / Consultant
#9
Sorry I did not explain myself well. I agree the scope document should be short and simple but should make reference to a database or list of all equipment.

OK. But, in your QMS, there should already be a list of all the gages in the calibration program. The scope discusses which of those you are competent to calibrate internally. The rest must be calibrated by professionals externally. Whatever you use to achieve that will be your choice, of course.
 
A

Al Dyer

#10
dvd,

Do you have contacts at other companies that are already registered that would share their method with you? As there are multiple ways to comply you could find a method that fits your particular needs. It's worth a try.

Al...
 
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