Tag Archives: validation

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

Posted in Laboratory medicine, Medicine | Tagged , , | Leave a comment

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

Posted in Forensic science, Laboratory medicine, Science | Tagged , , , , | Leave a comment

The cartel’s stangulation technique

The quality cartel’s assessors ramp up their requirements each year.  It’s all supposed to be about the sacredness of compliance with the ISO standards and EC regulations.  But after a few years you see how the assessors are forcing you to obey the … Continue reading

Posted in Bureaucracy, Cartel, Laboratory medicine, Practical problems, Psychology, Science | Tagged , , , , , , | Leave a comment