Tag Archives: ISO 15189

Coronavirus relaxes accreditation for a while

National chief scientists issued an NHS joint statement Supporting the healthcare science workforce response to coronavirus… (publications approval reference: 001559) on 30th March 2020…   Notice, “They must bear in mind that healthcare scientists may need to depart, possibly significantly, … Continue reading

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Is ISO 15189 accreditation really the gift that keeps on giving?

Is ISO 15189 accreditation really the gift that keeps on giving?  Yes, for the assessment cartel.  No, for labs. Green et al. have investigated the effects of ISO 15189 accrediation by INAB in a clinical biochemistry lab (https://doi.org/10.1016/j.plabm.2020.e00159). These authors … Continue reading

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COVID-19 tests

Only accreditation sufferers know how long it takes to get a diagnostic tests accredited to ISO standards (count it in months).  However, doctors and the public want millions of COVID-19 tests now. This Daily Mail article describes the options available.  … Continue reading

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Cholesterol and atherosclerosis deception

Worried about your cholesterol?  Ravnskov et al. say, don’t be. They allege decades of misleading statistics and selective reviews to sustain the hypothesis that high cholesterol is the major cause of CVD. 9. Conclusion The idea that high cholesterol levels … Continue reading

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Hundreds more medical reversals. But not ISO accreditation

Herrera-Perez et al reviewed over 3000 randomized controlled clinical trials in leading medical journals.  They found 396 reversals of practice were indicated. While medical leaders increasingly put their trust in ISO 15189 and ISO 17025 there remains a lack of evidence … Continue reading

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UKAS always doubted the “confidence” it sells

BSI sells ISO standards like ISO 17025 and 15189, designed to be vague enough to sell to vast numbers of the gullible. UKAS fills in the blanks, gratis, with documents like LAB 1.  These give the specifics in considerable detail. UKAS’s … Continue reading

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UKAS now “a partner to Government”

In a BMTA interview with retired chief executive of UKAS, Paul Stennett MBE, we learn, What is most satisfying is that UKAS is now seen as being a partner to Government, helping to deliver their regulatory agenda and in many cases … Continue reading

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Statistical pitfalls of accreditation

While doctors who experience UKAS assessments are becoming increasingly cynical about them, few have yet called out accreditation and stopped it. Stephen Senn’s comment in Nature, Statistical pitfalls of personalized medicine.  Misleading terminology and arbitrary divisions stymie drug trials and can … Continue reading

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CQC inspections have “little measurable impact” on services, analysis finds

The BMJ has reported a lack of evidence that the inspection regime of the Care Quality Commission improves services. Can we now expect similar scrutiny of UKAS’s inspections of pathology services? We might predict that those employed in the lab … Continue reading

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The most common nonconformities encountered during the assessments of medical laboratories in Hong Kong using ISO 15189 as accreditation criteria

This paper by Ho and Ho preceded that of Wilson et al. which examined ISO 17025 and was missed by these authors.  It used a similar approach to investigating the nature and number of ISO 15189 non-conformances over time. There were … Continue reading

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