Validation and verification guesswork

Dr Bignardi has done a lot of work with validation and verification required by ISO 15189 for just one laboratory device.

Validation and verification of automated urine particle analysers.

He reports it more simply in the Royal College of Pathologists Bulletin,


Note: the standards are lacking in detail to give free reign the imagination of UKAS inspectors.

As we have explained previously, the ISO managements standards are designed with a hypocritical vagueness because of the symbiotic relationship they have with the inspection side of the quality cartel.

Dr Bignardi has tried to make it more simple and sensible.  Professionals rise to the challenge of complying.  Will this approach work with all the non-standardised inspectors?

It remains to be seen whether the years of work in this one aspect of meeting the ISO standard will make much difference to patient outcomes.


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