ISO 9001 Surveillance Audit Nonconformance - Thermometers not Calibrated

C

Chance

#1
Hi Covers,

We had a ISO 9001 surveillance very recently. Everything went very well except that the auditor said that our temperature readings taken from our system is not validated against a certified thermometer.

My question is, is it possible to calibrate a thermometer? If yes, how?

Also, there is no regulatory requirement nor ISO requirement that dictates that we have to do it.

ISO 9001 says that where necessary, to ensure valid results, we have to calibrate equipment.

Should I dispute his finding?
 
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Stijloor

Leader
Super Moderator
#2
Re: ISO 9001 Surveillance - Thermometers not calibrated

What is purpose of the thermometers? Are they used to control a process or verify product specifications?

Stijloor.
 
C

Chance

#3
Re: ISO 9001 Surveillance - Thermometers not calibrated

What is purpose of the thermometers? Are they used to control a process or verify product specifications?

Stijloor.
The thermometers are just used to verify that our temperature system is displaying the right temperature readings intended for a specific area. For example if the temperature system is suppose to maintain a certain area at 70 degrees, we validate that room temperature if it is maintaned at 70 degrees. Please comment. Thanks.:agree:
 
Last edited by a moderator:
C

Chance

#4
Re: ISO 9001 Surveillance - Thermometers not calibrated

Our thermometer is use to verify that the temperature system is providing the temperature that we want. It is like you buy a thermometer at home to check if your thermostat is working as intended.
We use 2 separate device to make sure that both are displaying accurate readings. The auditor want us to buy another one that is certified as accurate. I believe its an overkill.
 

Stijloor

Leader
Super Moderator
#5
Re: ISO 9001 Surveillance - Thermometers not calibrated

Our thermometer is use to verify that the temperature system is providing the temperature that we want. It is like you buy a thermometer at home to check if your thermostat is working as intended.
We use 2 separate device to make sure that both are displaying accurate readings. The auditor want us to buy another one that is certified as accurate. I believe its an overkill.
Are the thermometers essential for controlling a process and/or verifying product specifications?
These are important criteria for inclusion in a formal calibration system.

We can not answer your question based on your 2 previous posts. :confused:

Stijloor.
 

Ninja

Looking for Reality
Trusted Information Resource
#6
My question is, is it possible to calibrate a thermometer? If yes, how?
Hi Chance,

This question is separate from your other and is easier.

Yes it is possible, but may require you to get a different temperature gage than what you are using now.
We use a digital temperature gage (cheapie from Cole Parmer) and have it calibrated by the same company that does our mics, calipers, etc. They won't do a glass/mercury or glass/whatever liquid type, but the electronic ones they do.

As to whether you NEED to have it done, the questions above are on point...is it part of validation or process control, or just a 'nice to know' data point?
 

Jim Wynne

Leader
Admin
#7
Re: ISO 9001 Surveillance - Thermometers not calibrated

Hi Covers,

We had a ISO 9001 surveillance very recently. Everything went very well except that the auditor said that our temperature readings taken from our system is not validated against a certified thermometer.

My question is, is it possible to calibrate a thermometer? If yes, how?

Also, there is no regulatory requirement nor ISO requirement that dictates that we have to do it.

ISO 9001 says that where necessary, to ensure valid results, we have to calibrate equipment.

Should I dispute his finding?
The thermometers are just used to verify that our temperature system is displaying the right temperature readings intended for a specific area. For example if the temperature system is suppose to maintain a certain area at 70 degrees, we validate that room temperature if it is maintaned at 70 degrees. Please comment. Thanks.:agree:
If calibration isn't necessary to ensure valid results (for whatever the temperature readings are used for) you don't have to calibrate. I'm wondering, though, why this temperature business is documented as a requirement in your QMS. What happens if the temperature is 75°?
 

Sidney Vianna

Post Responsibly
Leader
Admin
#8
Re: ISO 9001 Surveillance - Thermometers not calibrated

What happens if the temperature is 75°?
:agree1: Or 65[sup]o[/sup]? Instead of simply asking if ISO 9001 requires this or that, we should put our thinking caps on and ..... think!

Currently, there are two non-calibrated gages providing a temperature reading! If I were the auditor, I would be thinking: this must be somewhat important; otherwise, why have a redundant temperature reading system? So, if it is important, the temperature reading should be reliable. In order to be reliable, I should have the thermometer (or gage) calibrated; if not, how can I trust the reading?

But the basic question is what Jim asked. What would be the impact to product conformity (if any) if the temperature was off by 2, 3, 5, 10 degrees? Until THAT question is answered, we are just speculating here.
 
C

Chance

#9
Re: ISO 9001 Surveillance - Thermometers not calibrated

Are the thermometers essential for controlling a process and/or verifying product specifications?
These are important criteria for inclusion in a formal calibration system.

We can not answer your question based on your 2 previous posts. :confused:

Stijloor.
Controlling the process? NO. It is only use to verify whether our temperature system is working as intended ex: 70 degrees +/-5. Whatever is inside the controlled temperature area, does not go to our customer, no effect to our end products.
 
C

Chance

#10
As to whether you NEED to have it done, the questions above are on point...is it part of validation or process control, or just a 'nice to know' data point?
Our thermometers are not part of a process control. It is just for a nice to know data point to have.:agree:
 
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