Techniques to improve results, not documentation improves quality

I get to vote on GP26, CLSI’s document on a quality management system. Rejecting GP26 is like voting to reject apple pie, so here are my reasons.

GP26 is similar to ISO 9001 and ISO 15189. The latter ISO standard is being used to accredit laboratories. GP26 had a bad start – the driving force behind GP26 was a person from the Abbott Quality Institute and this person’s pitch was made at CLSI a year before FDA delivered to Abbott the biggest IVD fine at the time for lack of quality.

Any CLSI document should describe the history of the procedure and any criticisms. GP26 does not do this. Since GP26 follows ISO 9001, the ample criticism of ISO 9001 should be discussed, such as comments by John Seddon  or me (Krouwer JS. ISO 9001 has had no effect on quality in the in-vitro medical diagnostics industry. Accred. Qual. Assur. 2004;9:39-43).

ISO 9001 and ISO 15189 focus on documentation rather than results. To its credit, GP26 does have a section about results.  But although “quality goals” are mentioned several times, there is no example of what these goals might be. If there were a specific goal, such as an overall error rate where errors were classified as to severity and frequency of occurrence then one could use the observed errors to select quality indicators rather than have laboratory management select them from a long list as suggested by GP26.

And there is no mention of FMEA in GP26.


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