It means just what I choose it to mean


I previously commented that the title of EP23 makes no sense.

The EP23 subcommittee’s response to my comment is that my use of “quality control” is not what is meant in EP23.

EP22 and EP23 were originally proposed to deal with CMS’s proposal for equivalent quality control. This use of quality control clearly meant running 2 liquid control samples per day for each assay. This is how I used the term quality control, how it is used in principle in virtually any text about quality control  (which is of course uses quality control for processes other than the clinical laboratory), and how most people will understand it.

EP23 now defines quality control as “part of quality management focused on fulfilling quality requirements (ISO 9000).  Curiously, their cited reference  contains the following:

“ISO. An action to eliminate the cause of a detected non-conformity or other undesirable situation. ISO 9000. Geneva, Switzerland: International Organization for Standardization; 2005  3.6.5.”

This is the definition of a corrective action.

The problem is that EP23 is calling all corrective actions and preventive actions “quality control.” Perhaps this is to conform to some ISO terminology – I don’t have ISO 9000:2005. This is unnecessarily confusing and almost everyone will misinterpret what EP23 calls quality control.


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