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?
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?