BS5750 is the British Standard on “Quality Systems”. Its equivalent in European standards is EN29000 and in the International Standards Organisation ISO9000. This paper points out that these standards lay down formalised procedures and require documentation but do not ipso facto lead to quality assurance. The author points to the Japanese post-war industrial success as being an example of Total Quality Management within the framework provided by the philosophy of Dr. W. Edwards Deming (1988 and 1993). This philosophy on the management of “systems” to provide high quality products and services is briefly outlined. The author argues that improvement in prosthetic and orthotic services will not be reached through implementation of BS5750 but rather through radical rethinking and the adoption and application of the Deming philosophy.
We have stressed the difference between clinical audit that has the possibility of improving practice and of ISO compliance audit of laboratories. However, this is not to offer unquestioning support for the introduction of pseudo-accountancy into medicine or any other non-financial discipline. After all, the big accountancy firms are allowed to sign off the banksters’ loan and stockmarket frauds and governments turn a blind eye.
It is also twenty years since Dr Fulton recognized medical audit as an Emperor’s New Clothes situation – RA Fulton. Audit: The Emperor’s New Clothes. Journal of Evaluation in Clinical Practice, 2, 3, 199-201.
In point 5 he saw External Quality Assurance as a possible alternative to audit, devoid of its hostility and with an emphasis on improvement. However, EQA was just one element that was engulfed by the ISO laboratory standards. Now an improvement has been reduced to an “improvement action record”, evidence for inspection. EQA samples still show wrong results. Accreditation’s attempt to control everything continues to fail.
Next year Earnshaw made related points about clinical audit, its expense and difficulty in verification:
Clinical audit is undeniably a theoretically worthwhile and useful activity. A considerable sum of money and large amounts of clinical time have been spent establishing audit activity in the UK. It was promised that audit would be a tool for improving clinical services to patients and yet this has been difficult to verify. This article reviews the costs and potential benefits of audit.
While last year’s paper of Wilson et al. was able to put some figures on the ineffectiveness of accreditation, it simply showed there has been little interest in putting the claims to the test over twenty years. But it keeps the dissent alive.
The staff who succeeded these insightful earlier authors have been much more impressionable in allowing this nonsense to grow.