I am not a big fan of ISO standards I have seen and have said so. For example I have critiqued ISO 15197 (standard for glucose meter performance) because it doesn’t specify useful performance criteria (1). I have also said that ISO 9001 doesn’t guarantee anything about quality (2).
ISO 15189 is based on ISO 9001 but geared towards clinical laboratories. It now appears that CAP is using ISO 15189 to accredit clinical laboratories (3). My views are:
Accreditation is a good thing. I would not want my results to come from an unaccreditated clinical laboratory. But it should be understood that clinical laboratories that fail the accreditation process are rare and that when problems do occur, they are usually from accreditated clinical laboratories.
So what is my beef with ISO 15189? OK, I have not read the 2007 version, but if it is anything like the 2003 version then it is similar to ISO 9001 whereby accreditation success is judged by the documentation that the organization has, to show that it is following the processes that it has developed in all areas specified by ISO 15189 (which covers all important areas in the clinical laboratory).
The problem with this is the processes themselves may not be optimal with respect to the one quality measure that is important – the error rate in the clinical laboratory – and that (the error rate) is usually not tracked in a meaningful way such as would occur in a FRACAS (Failure Reporting And Corrective Action System). Instead, the lab is judged on its documentation of how well processes are followed. Reference 2 gives examples of how this can go wrong.
Now there is a lot of hype in reference 3 about how wonderful things are when using ISO 15189. But the only thing that matters is the error rate.
1. Krouwer JS. Six Sigma can be dangerous to your health. Accred Qual Assur 2008; in press, see: http://www.springerlink.com/content/5t379823t3766109/fulltext.html
2. Krouwer JS. ISO 9001 has had no effect on quality in the in-vitro medical diagnostics industry. Accred. Qual. Assur. 2004;9:39-43
3. See: http://www.cap.org/apps/cap.portal?_nfpb=true&cntvwrPtlt_actionOverride=%2Fportlets%2FcontentViewer%2Fshow&_windowLabel=cntvwrPtlt&cntvwrPtlt%7BactionForm.contentReference%7D=cap_today%2F1108%2F1108_ISO_15189_approval_02.html&_state=maximized&_pageLabel=cntvwr