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Anyone had the chance to have a look at these?
Could also make interesting reading for providers outside UK looking for material on operating standards etc
Thanks for the post - I was actually about to start looking into this subject in more detail for an ISO requirement - so a very timely post & much appreciated!
Regards,
On page 36 paragraph 5.5 Equipment
3. Commercial off-the-shelf software and software tools whose operation has
an impact in obtaining results will require validation, or any existing
validation to be verified, as laid out in 5.4.5 Validation of methods.
This has been discussed at FF previously and raises quality performance issues. Having alot of experience in the area of BS5750/BABT340, ISO9000/9001 from my type approval days I know the latter QA principles in that standard underpin ISO17025 and leak into ISO17020. From my own review of ISO17025 I produced an itemised internal list and it was clear forensic examination of devices would be problematical in achieving the stated goals without the equipment being validated.
A fundamnetal QA principles is non-conforming product.
1) How is it known if the product is non-conforming if the tool used to do that is flawed in operation at the outset?
2) How will the UKAS assessor know the tool is flawed if they are not highly skilled in the subject matter?
These are two of many areas I noticed.