ISO 17025 section 4.9 - Control of Nonconforming Testing and Calibration Work

[remedina]

I have experience with ISO 9001 but new to ISO 17025. I am used to concept of nonconforming product in ISO 9001, but when it comes to nonconforming work I am a little confused. Does this section of the ISO 17025 calls for the control of nonconformamces in performing the test or calibration work, like if the work is done improperly? I get confused when I think of an item subject to test. If the test is done properly and the item does not pass the test, this is not a nonconformace as defined in this 4.9 section, right? Any help will be appreciated.

 

[Hershal]

You are exactly correct.

In particular this applies if the lab discovers the non-conforming work after the work is complete, and hopefully still before it reaches the customer. If you experience this then employ the corrective action protocols.

If the test or calibration is completed correctly and the item does not pass, then it is NOT non-conforming work, it is a failure of the unit under test.

One other point, this is one of the MOST difficult Clauses in the Standard.

 

[remedina]

Hershal, thank you. I owe you two now.

 

[AndyN]

I have also dealt with non-conformance of testing when the testing equipment fails too!

 

[zamclachia]

4.9 states 'when any aspect of its testing and/or calibration work, or the results of this work, do not conform to its own procedures or the agreed
requirements of the customer'
If I look at the typical work flow in the lab a non conformance can be raised at any stage of the process depending on what has been written in your procedures ( Or missing from your procedures). It may be agreed that the customer is notified once the sample is logged in. If this does not happen, a non conformance (NC) needs to be raised. If the sample integrity is compromised due to poor storage conditions - NC. If your procedures state that you shall run a reference material with the analytical run and the results shall be in specified limits. If either condition is not respected -NC. Anything that could negatively affect the management or technical system results in a NC. The purpose of a NC is to improve the quality system regardless of where the issue may be.

 

[lucasso]

How is this requirement to be interpreted:
"4.9.1
a) <...> and actions (including halting of work and withholding <...>) are defined and taken when nonconforming work is identified."

Does this mean that
a) actions should be defined AFTER nonconformity is identified and, say, written up in the Nonconforming work protocol,
b) or that actions should be defined and writen up in Quality Manual in advance in case the nonconformity happens?

If i read the English version of the standard it kind of implies the a) version, but if i read the translation of the standard to my native language it kinda suggests the b) version.

Which is it?

 

[Hershal]

It means that the policy and procedure have to define at least general steps to be taken in advance and people trained on the procedure and steps (keep records of the training).

It also means that if non-conforming work is found then the steps must be implemented right away, and if additional specific steps are necessary which is possible, those can be identified at the time and documented.

Also, the policy/procedure MUST SPECIFICALLY identify the person(s) having authority to authorize resumption of work.

Hope this helps.