Laboratory Requirements

M

Mkrickel

We are a plastic injection molder with a quality department that does routine inspections with calipers, micrometers, etc..

We do not do any testing or in-house calibration, so do we need to comply with section 4.10.6.

Please help
Thanks MK
 
D

Dan Larsen

My first impression is no. Take a look at the glossary and the definition of "laboratory". This assumes that all your inspections are performed outside of a lab and that you have a calibration schedule for equipment that involves outside suppliers (who are ISO Guide 25/17025 accredited).

I'd write around it (and be prepared to defend it) in the policy: "Company ABC does not maintain an in-house laboratory or calibration facilities, therefore the requirements of paragraph 4.10.6 do not apply. When these services are subcontracted to outside suppliers, the suppliers shall be accredited to ISO Guide 25/17025."
 
D

D. Scott

Dan's point is well made however you have to be very careful here. It should not be a question of "taking the inspection/measurement samples to a lab". It depends on if the measurement/inspection is done within the parameters of the process. Taking the samples to a building, a room, or a designated area (as well as many other obscure situations)would require you to meet the requirements of 4.10.6.

Only if the testing/measurement were in-process and not moved from the process would the in-house lab requirement not apply.
See: https://www.aiag.org /quality/4.10.6.html
 
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