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High voltage testing - ISO 17025 - 7.2.2 Validation of methods and 7.3 Sampling

S

socky

Registered
#1
#1
Hello,
I am working at a laboratory for high voltage testing. We are performing most of our tests according to international standards which can be seen as already validated. But we have one SOP which was introduce in 2003, I think. After such a long time it should be clear it is validated enough, and there was never a problem according to ISO 17025:2005. Also, right now there is no plan to introduce new methodes in our laboratory.

Now my question is: Do we need to introduce a process for validating methods in our laboratory? It's the same with sampling, we do not take samples we only receive test or calibration items. Which is handled in 7.4.

Can I just say that we are not doing it, or do I need a pro forma process?
 
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chris1price

chris1price

Trusted Information Resource
#2
#2
I would suggest having a process and documenting all the methods that are used, if only to identify that they are based on ISO or pharmacopeia and do not require further validation. Doing so may well identify things you have missed.
 
D

dwperron

Trusted Information Resource
#3
#3
Now my question is: Do we need to introduce a process for validating methods in our laboratory? It's the same with sampling, we do not take samples we only receive test or calibration items. Which is handled in 7.4.

If you are using a non-standard method (the SOP you generated yourselves) the 15025:2017 requires in 7.2.2 that you " shall validate non-standard methods, laboratory-developed methods and standard methods used outside their intended scope or otherwise modified. The validation shall be as extensive as is necessary to meet the needs of the given application or field of application."

As part of the validation, 7.2.2.4 defines the records of the validation process that you must retain.
 
S

socky

Registered
#4
#4
Thank you for all your help.

I will define a Validation prozess. It should not be that hard since we have enough data to support our SOP.
 
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