At last – “an important paper”


Tom Lewis has drawn our attention to perhaps the first paper that presents data damning ISO lab accreditation:


The tweeters sound familiar with clinical audit used for improvement but don’t seem aware that ISO audits are not exactly mis-using clinical audit. That’s the way ISO audits are meant to be – checking compliance without much hope of meaningful improvement.  The paper notes how even the idea of “laboratory audit” – as in accountancy but sans the numbers – is rather ill-conceived because it can only work in a closed system where the numbers add up.

One strength of the paper is that it attacks accreditation at its foundation. Accreditation exists mainly to enforce inspection – it was the rear-guard action of redundant factory inspectors – not really to assure or improve as it alleges.

Another strength is that it provides lots of solid data in simple graphs to show how little value audits have.

A third strength is the mostly internet-accessible references that allow readers to explore the history and criticisms of accreditationism.

How sad is it that it took so many years for anyone to point this out in the scientific literature?

Or how many times have less insightful editors prevented similar papers seeing the light of day?

The much-copied emperor of inspections was never really up to the job. It’s a pity the paper is not in a journal that is likely to be read more widely across disciplines because it really ought to be.  Definitely worth tweeting more widely.


Wilson, I. G., Smye, M. and Wallace, I. J. C. (2015), Meta-audit of laboratory ISO accreditation inspections: measuring the old emperor’s clothes. MicrobiologyOpen. doi: 10.1002/mbo3.314

This entry was posted in History, Introduction, Laboratory medicine, Medicine, NHS, Science and tagged , , . Bookmark the permalink.

One Response to At last – “an important paper”

  1. Pingback: One of the biggest scams in the world | ISOwatch

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