Who made ISO king

November 1, 2007

I have been working on a CLSI (Clinical Laboratory and Standards Institute) standard on risk management.  A preliminary version is available. This version needs revision and is getting it. As part of this process, comments are received and addressed using a consensus process. Having seen a few of the comments, one of them bothers me, not so much about the issue raised but the justification supplied, which is that the CLSI document deviates from the ISO standard on risk management – 14971. So this blog entry questions whether ISO documents should be taken as gospel.

I have commented  before on a specific ISO document – 9001. The title of my article says it all – “ISO 9001 has had no effect on quality in the in vitro medical diagnostics industry.”

ISO 14971 states things without providing any justification. There is a bibliography at the end but no links from the text to the bibliography. The document is not peer reviewed, although it undergoes its own consensus process. One is basically supposed to take ISO 14971 as correct because it is “based on an international group of experts”. I put the preceding phrase in quotes because, anyone serving on an ISO committee is automatically conferred expert status (this is true for CLSI committees as well).

So perhaps it is not even iconoclastic to question an ISO document, and one should certainly not suppress an idea because it deviates from an ISO document.