ISO 9001 Calibration Requirements

T

Tyler C

#1
Hello,

I am new to the cove, so please forgive me if this has already been asked.

I am working on getting everything ready for our Stage 1 audit, and I have a question on calibration.

We have several pieces of equipment that are under service contracts. We don't do any calibration to them, other than the daily maintenance which is captured on the maintenance logs.

Should these pieces of equipment be listed on the calibration log?

Thanks in advance for any answers.
 
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T

Tyler C

#3
Re: ISO 9001:2008 Calibration Requirements

Excellent response, thank you. When you put it that way, I'm not sure how I hadn't thought of that.
 

howste

Thaumaturge
Trusted Information Resource
#4
Re: ISO 9001:2008 Calibration Requirements

ISO 9001:2008 clause 7.6 said:
Where necessary to ensure valid results, measuring equipment shall
a) be calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards...
Are they necessary to ensure valid results? If so, you are responsible to ensure that they are calibrated/verified. You don't have to do it yourself, but it needs to be done.

ISO 9001 does not require a calibration log. If you choose to use a log for your convenience (to ensure calibration/verification gets done), then I'd probably put them on the log so you don't lose track of them.
 
J

JoShmo

#5
Re: ISO 9001:2008 Calibration Requirements

... We have several pieces of equipment that are under service contracts. We don't do any calibration to them, other than the daily maintenance which is captured on the maintenance logs.

Should these pieces of equipment be listed on the calibration log? ...
Can't say either way without knowing what you're aksing about! You say "service" contracts but that doesn't tell us what equipment they are. Picks and shovels are equipment and you may have them on a service contract, but you can't calibrate them. Gotta know more stuff for a real answer.
 
T

Tyler C

#6
Re: ISO 9001:2008 Calibration Requirements

Thank you Howste. What other methods have you seen in place of a log?

JoShmo, I appreciate your feedback. I tried not giving too much info as some of the equipment is proprietary to our industry, but I understand that it makes it hard to answer.

One example of the equipment is a marking laser. It is a laser that marks the part number and some technical info along with a few other things. We don't have the capability internally to do anything to this equipment other than use it and do some minor maintenance. In this case, we don't have a service contract for calibration/verification, nor is there anything we can do in this regard. Will the auditors question this?

We do however have a service contract for a different piece of equipment where the tech comes on site and performs any maintenance beyond our ability and any calibration if necessary.

I appreciate all of your replies.
 

Marc

Fully vaccinated are you?
Leader
#7
Re: ISO 9001:2008 Calibration Requirements

The bottom line is what howste said - Nothing requires calibration unless it is used to measure something. A marking laser isn't a measurement device.

That said - You have to ensure it marks adequately and accurately. Old story: Label printer toner cartridge ran very low and could not print a human readable label. Have seen same written up as an observation in an audit, but it isn't related to calibration.

You might want to read through this old thread here: What needs to be calibrated? Nothing has changed over the years.

Also see Brad's thread: Calibration Fundamentals: The How-To Thread

The key words are: "Is it a measurement device or check fixture which is used to ensure valid results?"
 

Marc

Fully vaccinated are you?
Leader
#8
J

JoShmo

#9
Re: ISO 9001:2008 Calibration Requirements

Thank you Howste. What other methods have you seen in place of a log?

JoShmo, I appreciate your feedback. I tried not giving too much info as some of the equipment is proprietary to our industry, but I understand that it makes it hard to answer.

One example of the equipment is a marking laser. It is a laser that marks the part number and some technical info along with a few other things. We don't have the capability internally to do anything to this equipment other than use it and do some minor maintenance. In this case, we don't have a service contract for calibration/verification, nor is there anything we can do in this regard. Will the auditors question this?

We do however have a service contract for a different piece of equipment where the tech comes on site and performs any maintenance beyond our ability and any calibration if necessary.

I appreciate all of your replies.
Some would have you spending all kinds of cash chasing the holy calibration grail. Now, in the spirit of people helping people (not to spend cash) are you SURE the contractor who does service actually calibrate the stuff they serviced? You may need to get up to speed on what they ACTUALLY do, because they may CALL it calibration but it ain't. Even equipment makers get there story wrong. If you call it "calibration" you can charge more, but I can tell you it's often something less than calibration and isn't even an accurate verification. Trust me...
 
T

Tyler C

#10
Re: ISO 9001:2008 Calibration Requirements

Thank you for your input Marc. This is a very interesting concept, one which I have never heard before. It may have just shined the light I needed on this.

Just to make sure I understand, anything used at final inspection for pass/fail authority would need to be calibrated, but equipment that is not used to measure would only need verification or validation? Of course, manufacturer requirements would play in here.

Also, thank you for all of the additional resources you have shared. I will look through these as well.
 
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