Is there ISO 13485 Guidance for Calibration Tolerance?

H

htquality

#1
Hi, one of our suppliers performs calibrations on all of their measuring devices, however, they do not specify any tolerance requirements. In one case, they calibrated a temperature controller and the "as-found" temperature was 20% off from the setpoint. It was adjusted back to the set point but there was no impact assessment or out-of-tolerance evaluation done since it was not even considered out-of-tolerance!
Is it a requirement of the standard (ISO13485) that tolerances be defined? If so, under what clause would it fall?
Thanks for your help!
 
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Jim Wynne

Staff member
Admin
#2
Re: Calibration Tolerance (ISO 13485)

Hi, one of our suppliers performs calibrations on all of their measuring devices, however, they do not specify any tolerance requirements. In one case, they calibrated a temperature controller and the "as-found" temperature was 20% off from the setpoint. It was adjusted back to the set point but there was no impact assessment or out-of-tolerance evaluation done since it was not even considered out-of-tolerance!
Is it a requirement of the standard (ISO13485) that tolerances be defined? If so, under what clause would it fall?
Thanks for your help!
I'm not familiar with 13485, but I can tell you that tolerances for measurement devices should be based on the tolerances of the things being measured. Your supplier should do a risk assessment in deciding (a) what the device tolerances should be and (b) how to react when a device is found out of tolerance. If a device is found to need adjustment when it's calibrated, the supplier should be able to provide the rationale for subesquent decisions.
 
H

htquality

#3
Re: Calibration Tolerance (ISO 13485)

I totally agree with you. They had nothing to support that an assessment was not required. I am trying to determine which standard clause to list the nonconformance against as it is not clearly mentionned in 7.6.
 

Jim Wynne

Staff member
Admin
#4
Re: Calibration Tolerance (ISO 13485)

I totally agree with you. They had nothing to support that an assessment was not required. I am trying to determine which standard clause to list the nonconformance against as it is not clearly mentionned in 7.6.
If 7.6 in 13485 is the same as 7.6 in ISO 9011:2008, it says this (in part):

...the organization shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements. The organization shall take appropriate action on the equipment and any product affected.

Records of the results of calibration and verification shall be maintained (see 4.2.4).


I don't know how they can take "appropriate action" without determining what the appropriate action should be, and recording what was done.
 

BradM

Staff member
Admin
#5
Re: Calibration Tolerance (ISO 13485)

[FONT=Arial,Bold][FONT=Arial,Bold]You could possibly cite 7.1[/FONT]


[FONT=Arial,Bold]
[FONT=Arial,Bold]
[FONT=Arial,Bold]7.1 Planning of product realization[/FONT]​
[/FONT]

The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the quality management

a) quality objectives and requirements for the product;
b) the need to establish processes, documents, and provide resources specific to the product;
c) required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance;

d) records needed to provide evidence that the realization processes and resulting product meet
requirements (see 4.2.4).
So it seems to be fairly clear that they have not done any planning to identify requirements. Even the example of 20% difference (although that sounds like a lot) may be acceptable for the process. But it's not identified anywhere.

Doing instrument verifications are good. :agree1: Some don't even do that. But they can do better, by establishing the requirements for the instrumentation.

Also, given this is medical device, I would think they should have identified (as part of the validation program) which equipment needs qualification or not. Then the requirements could figure in to that qualification program. NOTE: It can be simple, but it should be documented. :)[/FONT]​
[/FONT]​

 
P

Phil Fields

#6
Re: Calibration Tolerance (ISO 13485)

Calibration clause from 21CFR Part 820:

820.72(B) Calibration procedures shall include specific directions and limits for accuracy and precision. When accuracy and precision limits are not met, there shall be provisions for remedial action to reestablish the limits and to evaluate whether there was any adverse effect on the device quality. These activities shall be documented.

Phil
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#7
Two questions:

What is the published tolerance of the equipment in question?

What is the stated uncertainty for the calibration?
 
H

htquality

#8
Unfortunately, I do not have that information available. Does it matter though? Shouldn't the user have their own requirements based on their applications?
 

Jim Wynne

Staff member
Admin
#9
Two questions:

What is the published tolerance of the equipment in question?

What is the stated uncertainty for the calibration?
Unfortunately, I do not have that information available. Does it matter though? Shouldn't the user have their own requirements based on their applications?
I don't think it matters from htquality's perspective, because the issue is that the supplier/user found something that was 20% away from the nominal value, adjusted back to nominal, but left no trail as to the significance or lack thereof of the discrepancy. Maybe the as-found value means nothing, but there should be a record of the assessment.
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#10
For the tolerance, the organization can specify tolerance, but must document that.

The calibration provider however must be able to provide uncertainty calculations upon request or as a matter of course, for the calibration perfomed. Uncertainty is one of the requirements for calibration to be considered traceable.
 
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