Tag Archives: ISO 15189

The muddled mind of a UKAS assessor

UKAS’s latest technical bulletin gives further insight into the muddled thinking that lies behind the ISO scheme. Medical Royal College examinations, Continuing Professional Development, GMC registration, revalidation etc. etc. are all unable to render doctors competent any more. And UKAS … Continue reading

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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.   http://jcp.bmj.com.sci-hub.io/lookup/doi/10.1136/jclinpath-2016-203958. He reports it more simply in the Royal College of … Continue reading

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Evaluations, validations and verifications of diagnostic tests – except ISO accreditation

  “Where two kits have equivalent performance characteristics, the one which is easier to use, cheaper, faster or requires a more easily obtainable sample might be preferred.”   UK Standards for Microbiology Investigations Q 1: Evaluations, validations and verifications of diagnostic tests, … Continue reading

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Failing to repay

As university educations become impossibly expensive for ordinary people, Gary North advises, “Here is a general rule. Any barrier to entry into any field that cannot be legally penetrated by means of a competitive examination is there for only one reason: … Continue reading

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Audit and The Emperor’s New Clothes – on view for over 20 years

We previously drew attention to, D. J. PRATT.   British Standard (BS) 5750 – quality assurance? Prosthetics and Orthotics International, 1995, 19, 31-36.  Abstract BS5750 is the British Standard on “Quality Systems”. Its equivalent in European standards is EN29000 and in the International … Continue reading

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A Decade of Reversal: An Analysis of 146 Contradicted Medical Practices

Prasad et al. have published an analysis of 146 medical practices that had to change when they were shown to have no benefits.  A large proportion of treatments remain of unknown effectiveness or may be harmful.   For this reason … Continue reading

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>90% say accreditation delivers benefits…but…

Authors employed by bodies including the US Public Health Accreditation Board (PHAB) have written that >90% of public health departments the PHAB accredits report benefits that might have been expected. This sounds a lot like ISO accreditation although the details of the … Continue reading

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“no treatment regimen was identified as having an improved clinical outcome”

Accreditation relies on auditing for total compliance with SOPs.  Inspection of this assures quality.  Even when it doesn’t. Drs Williams and Brindle reported another type of audit and showed wide variation for the treatment of an infective condition. Journal of … Continue reading

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Mr Pratt questioned BS 5750 – quality assurance?

Mr Pratt recognised the inadequacy of BS 5750 over twenty years ago.  He explained in the medical literature how Deming produced real quality in Japanese industry. D. J. PRATT.   British Standard (BS) 5750 – quality assurance? Prosthetics and Orthotics … Continue reading

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The End of Average: How to Succeed in a World That Values Sameness

Another argument against the standardised assessment of humans.  The authors deal with Taylorism but not ISOism, which has not yet entered the decline it deserves.  Maybe there’ll be a sequel. The End of Average: How to Succeed in a World … Continue reading

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