ISO 17025 8.5 Actions to address risks and opportunities


Quality Coordinator - Hitachi High-Tech
We're going to be assessed to the new edition at the end of the year, sooner than I anticipated, so digging in and reading a lot. There are some good crosswalk help with ANAB, Eurolab and others.

I've been mulling over this section for a while. What I find interesting is the NOTE in 8.5.2. After all this Shall consider this and that, it states there is no formal requirement for formal methods.. or documented .. process.

Was this glossed over in the final working of the standard? It's so vague as to question what to do or if there is a need to document anything.

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Jen Kirley

Quality and Auditing Expert
Staff member
I am going to go off of the 9001 standard, which also uses the term "consider" without further detail. Even 9000:2015 does not define the term. So we are left to dictionaries for definition of consider.

As for 8.5.2, it is also true that methods are not prescribed. That is because there could be any number of methods that would work, some better for different subjects. The organization is free to use methods of their choosing.

In case it helps, EuroLab has published an ISO/IEC 17025:2017 Handbook. I have no affiliation with EuroLab.
From my limited training so far regarding assessment for the new 17025, the audits will have a much more "dialog" feel than a "Let's go over the checklist and see your documents".

You should expect to be asked how your lab handles risk, which is a driver in this standard. I would expect that you will need to demonstrate your risk assessment methods, give examples, show results. You will not need a documented method, what is important is that you achieve positive results and can demonstrate them.
What did you decide were the risks and opportunities when you addressed the Context? How do you intend demonstrating to an auditor you've considered your internal and external issues? The clue is there...

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