Category Archives: Laboratory medicine

Laboratory medicine

ISO 9001’s ongoing decline

Chris Paris has evaluated the 2016 ISO report on ISO 9001’s uptake.  Read his analysis here. The ISO hasn’t bothered to correct misleading figures designed the inflate the standard’s popularity but it continues its secular trend of decline. China and … Continue reading

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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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Essential Services Laboratories

If you’ve read John Seddon you will know that the front office – back office arrangement will be a disaster.  It may have been sold promising economies of scale and a new computer system, neither of which will work out … Continue reading

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Randox rogues show ISO doesn’t balance

We saw before that Randox Testing Services paid UKAS for ISO accreditation of forensic testing.  Accreditation couldn’t stop employees rendering the results unreliable by falsifying QC results.  Randox called in the police. The Daily Mail reports on the continuing investigation, … Continue reading

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Inside the minds of pathology reformers

Reforms to pathology services according to the Carter Report are still doing poorly.  The cover-up of the failures is working better: Pathology Networks The morning session provided attendees with different perspectives on Pathology Networks; appropriately titled ‘Networks – a blessing or a curse’. … 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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EU 2017/625 recognizes expense of ISO accreditation. But still requires it.

Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health … Continue reading

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Exciting developments in healthcare

UKAS says Brexit will require more accreditation.  HM Government seems inclined to believe this.  The Royal College of Physicians (RCP), NHS England, the Institute of Physics and Engineering in Medicine (IPEM), the Royal College of Radiologists (RCR) and the Society … 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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Disgruntled rogue scientists, but accredited

“Rogue scientists” disgruntled with management at Randox forensic services allegedly doctored samples.  Unsurprisingly this led to hundreds of false convictions and other major injustices.  Here is the Daily Mail’s account. Maybe privitising the forensic service wasn’t so smart. Naturally, services … Continue reading

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