-
--> Gary Larson (The Far side) has returned. <--
ISO 17025 - Requirement to Monitor Environment
- Thread starter greif
- Start date
Elsmar Forum Sponsor
We do measurements in various parts of the building. Typical office conditions.
We have one instrument in a temp/rh controlled clean room for which we specify the max measuring conditions to be 65-70 F, 35-50% RH.
In the office areas we specify the max conditions as;
66-76 F, 5-70% RH.
Temperature range potential changes are included in our uncertainties.
The overall building is 3 floors around 15000 SF total. Individual rooms are typ. 15 x 25 ft.
We report the temp and rh at time of measurement.
We have one instrument in a temp/rh controlled clean room for which we specify the max measuring conditions to be 65-70 F, 35-50% RH.
In the office areas we specify the max conditions as;
66-76 F, 5-70% RH.
Temperature range potential changes are included in our uncertainties.
The overall building is 3 floors around 15000 SF total. Individual rooms are typ. 15 x 25 ft.
We report the temp and rh at time of measurement.
First, the only areas that will be audited are the ones where 17025 accredited calibration or testing takes place.
In those areas you will need to document (they will ask for the document) the environmental conditions required to be suitable for laboratory activities. That will include temperature and humidity, but can include anything that can influence your results, such as vibration, dust, or electrical supply quality.
The lab shall "monitor, control, and record environmental conditions". You need to be able to produce records that show that the conditions are within the controls you have established (and what happens if they drift out of control), this will be true for all areas where 17025 activities are conducted.
You can probably get away with thermohygrometers and showing that you are recording the data on your records, but be prepared to prove that those areas have been kept in control. That's why most labs have recorders in each area, so they can produce the history.
In those areas you will need to document (they will ask for the document) the environmental conditions required to be suitable for laboratory activities. That will include temperature and humidity, but can include anything that can influence your results, such as vibration, dust, or electrical supply quality.
The lab shall "monitor, control, and record environmental conditions". You need to be able to produce records that show that the conditions are within the controls you have established (and what happens if they drift out of control), this will be true for all areas where 17025 activities are conducted.
You can probably get away with thermohygrometers and showing that you are recording the data on your records, but be prepared to prove that those areas have been kept in control. That's why most labs have recorders in each area, so they can produce the history.
We have temperature/RH dataloggers in most of our lab rooms, and we do accredited calibrations in most of those rooms. My question is:
1. Do the dataloggers (or their probes) necessarily need to be accredited themselves?
2. Is a single point calibration at ambient conditions sufficient, or do we need to calibrate them for linearity at three points?
3. Do we necessarily need to report the datalogger/probe on calibration certificates?
From time to time we have assessors cite us for all three. Our argument against number 1 is that we are only monitoring the lab conditions for compliance to our quality system. Our argument against number 2 is that we have so many probes (49 at last count) spread across several locations that it's logistically difficult taking a unit out of service and shipping it off for calibration, so instead they're calibrated in place against a calibrated master probe. Our argument against number 3 is that the item being calibrated does not have any parameter traceable to the probe in that room that would matter (e.g. a 2% panel volt meter).
So what say ye?
1. Do the dataloggers (or their probes) necessarily need to be accredited themselves?
2. Is a single point calibration at ambient conditions sufficient, or do we need to calibrate them for linearity at three points?
3. Do we necessarily need to report the datalogger/probe on calibration certificates?
From time to time we have assessors cite us for all three. Our argument against number 1 is that we are only monitoring the lab conditions for compliance to our quality system. Our argument against number 2 is that we have so many probes (49 at last count) spread across several locations that it's logistically difficult taking a unit out of service and shipping it off for calibration, so instead they're calibrated in place against a calibrated master probe. Our argument against number 3 is that the item being calibrated does not have any parameter traceable to the probe in that room that would matter (e.g. a 2% panel volt meter).
So what say ye?
