Who made ISO king

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 The document is not peer reviewed, although it undergoes its own consensus process.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.


2 Responses to Who made ISO king

  1. Jon Speer says:

    I think ISO is king when it comes to risk management for medical devices. Regulatory bodies across the world have recognized ISO 14971 as the standard for medical device risk management.

  2. Marcelo says:

    Althouth deeply involved with ISO and , even more than ISO, IEC standards, i don´t think they should be taken as “the truth”, nor the want to be, what really happens is that people which are not involved with standard development do not understand the peculiaritues of the process and do not understand the real objective of a standard (from my point of view, it reflects a state and a common view at the time it´s written and as such should be viewed as an ongoing process of knowledge aggregation).

    But this “state of the art” approach means that there´s no time nor spece in a standard to justify their requirements, simply because when you do a standard you usually has to take for granted that the one who´s reading it know a lot from the field and so can make the link you mentioned themselves. This is a real problem (here in Brazil where i live it´s even worse, i think) but that´s the way it is. But it sure can get better.

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