ISO/IEC 17025 Sampling Plans - Sampling clauses not applicable for test labs?

E

el_quixiote

#1
Hi. We are starting a project to get our laboratories accredited under iso/iec 17025.

We already have QS-9000 certification since > 5 years.

Our labs are not responsible for sampling nor for designing sampling plans. These activities are deployed by operation people and by product engineering people respectively.

Besides, our labs are not responsible for the GO/NO GO decision. This decision is taken by QA people using a system that has the sampling results and the customer requierements for each product.

So, our labs are focused on determination of properties of each sample that is delivered to them.

My question is: If we declare in our Quality Manual that the sampling clauses are not applicable for our labs, would it be a nonconformancy ?

OMC

Thanks in advance....
 
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T

tomvehoski

#2
You did not mention what type of sampling you are doing. Is it selecting x parts out of lot size y, or sampling chemicals, solutions, etc.

I don't think you can claim an exemption. If other departments write the sampling procedures, just adopt those as your laboratory procedures. Make sure they meet all of the requirements of 5.7. It may not be enough to say sample 10% or 10 ml from container. Do you need to make sure you get samples from throughout a production run? Does a liquid have to be mixed prior to sampling? There could me many other factors to address.

Tom
 
K

Ken K

#3
Section 5.7 of our manual simply states:

Sampling requirements of ISO17025 does not apply to the lab"

It has been audited and approved with no questions asked.
 
E

el_quixiote

#4
thanks you for your responses.

We produce steel flat products and our sampling procedures refers to chemical analysis and mechanical properties.

We follow ASTM standar sampling procedures or meet customer requierement if it is more specific.

We can write down some references about the sampling standars we are following. Question: Is an ISO/IEC 17025 auditor entitled to make judgements about the sampling plans we are using?
 
T

tomvehoski

#5
If you are using ASTM standard procedures, I would simply note what those are and use them as your procedure. There is no need to rewrite them, unless you feel they need clarification.

The auditor judgement will depend on the type of tests you are doing. If you customer says follow ASTM Standard # 12345, and it references a sampling plan, you must. If there is no requirement you should be able to use what is appropriate and generally accepted for the application.

Tom
 
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