The editorial below is a useful summary of the history and future plans for ISO 15189 in European laboratories.
The authors say proof of its value comes from the fact that this originally voluntary process has already been made mandatory in two countries.
“It is important to bear in mind that accreditation according to the ISO 15189 International Standard was conceived as a voluntary process, as is clearly highlighted by the inclusion of a specific clause (8.4.3 in the latest revision of the International Standard) on “continual improvement”. The evidence that in some countries, such as France and, at least in part, Belgium, accreditation according to the ISO 15189 is mandatory is further proof of its value and may facilitate the efforts of clinical laboratories to comply with a series of consensually developed and harmonized requirements other than with some national or regional standards.”
There is no mention of proof coming from evidence that accreditation efficiently delivers what it claims.
Few laboratories are currently accredited. They’re really going to enjoy this expensive journey towards harmonisation.
Will they ever find that they have arrived?
Will it make any difference to patients?
Will anyone count the opportunity costs of better care that has been lost because accreditation fails to deliver real quality, ensuring only inspectability?