U
UncertainInTbilisi
Hi:
This is my first post. Please pardon me if i am on the wrong forum for this. I am a selftaught misguided voice for quality in a emereging economy where ISO is something relatively new.
I am working in facility without a active QMS and my task is to set up a calibration program. Sounds simple until you have no authority for implementation; or a mentor to argue the finer points of compliance with. I have been invited to provide some guidance to a outside entity related to their recent audit findings.
In my past experience at a 13485 lab we used something called verification to side step the requirement for statements of uncertainty on in-house "calibration" documents. I need to find out if this is a generally accepted practice or if it was a the result of an agreement with our clients. Could it be used to defend the same practice in 17025 lab that is not engaged in providing calibration services for outside parties?
I am also curious about BSC certification reports. I did not speak with the auditor but I believe there may have been a question of uncertainty statements for BSC certification reports. In my past life, I hired a reputable company to do the BSC certification work, reviewed the report and filed it; without questioning anything beyond pass fail status. Our BSC template is one provided by a certified NSF 49 trainer, also lacking a statement of uncertainty. What is the rationale I can use to explain this away?
Thanks,
Dazed and Confused
This is my first post. Please pardon me if i am on the wrong forum for this. I am a self
I am working in facility without a active QMS and my task is to set up a calibration program. Sounds simple until you have no authority for implementation; or a mentor to argue the finer points of compliance with. I have been invited to provide some guidance to a outside entity related to their recent audit findings.
In my past experience at a 13485 lab we used something called verification to side step the requirement for statements of uncertainty on in-house "calibration" documents. I need to find out if this is a generally accepted practice or if it was a the result of an agreement with our clients. Could it be used to defend the same practice in 17025 lab that is not engaged in providing calibration services for outside parties?
I am also curious about BSC certification reports. I did not speak with the auditor but I believe there may have been a question of uncertainty statements for BSC certification reports. In my past life, I hired a reputable company to do the BSC certification work, reviewed the report and filed it; without questioning anything beyond pass fail status. Our BSC template is one provided by a certified NSF 49 trainer, also lacking a statement of uncertainty. What is the rationale I can use to explain this away?
Thanks,
Dazed and Confused