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Sunday, August 19, 2012

ISO and its Neutrality Principle: just words?



The International Organization for Standardization knows and understands its role: through the development of standards through a steadfast commitment to consensus, the organization creates a voice of equality for all its member countries, and establishes a basis to promote non-barrier trade.  The organization is so committed to the concept that it framed its logo identification not as a mnemonic by as the Greek root ISO for “equal”.  Old stuff but worth repeating, in part because sometimes this commitment to equality is not always so apparent, unless excluding developing countries and regions is fully compatible with ISO equality.

But back to being more positive, recently an important committee known as  ISO CASCO circulated a new document entitled “Conformity Assessment for standards writers: Do’s and Don’t’s”.  Before I continue, a moment of explanation is in order.  When ISO committees write documents they fall into two main categories; the ones that provide information on best practices, methods, procedures, and the other ones that provide statements that can be understood as rules or expectations.  The first group are called informative documents, and the second are called normative documents

Meeting requirements in normative documents is known as being in conformance, and formally demonstrating that conformance is being met both to the word and spirit is called conformity assessment.  So ISO CASCO is the committee that oversees the rules of creating normative documents and oversees the rules for organizations that do conformity assessment.

In general there are two types of business organizations that do conformity assessment; one group calls itself Certification Bodies, and the other group calls itself Accreditation Bodies.  There are definitions that distinguish between these two groups (one group says that it measures not only compliance, but also competency and states that the group only measures compliance), but in my experience, when boots are on the ground, it is pretty difficult to see real differences between how the two actually do their assessments differently.  One group says that it perceives what it does is assures a higher level of quality, but from my perspective and experience that is pretty iffy.  

Most importantly for the present discussion, both AB’s and CB’s are represented on ISO CASCO which means they are both third party participants in standards application.  In order to be seen as not representing one group over the other, ISO CASCO has created its Neutrality Principle. It is very important to know and understand what the neutrality principle states and means.

The Do’s and Don’t’s document states: “The “neutrality principle” means that the content of the standard shall not state a preference for a form of one type of assessment over another.  In other words, the standard must be written so it can be applied by any of the following: - (a) a manufacturer or supplier (b) a user of purchaser or user and (c) an independent [third] party. “  This is very clear.  It says that a standard has to be written in a way that its application is seen to be neutral for all and exclusionary to none, on the assumption that the assessment is done competently.      

What this says to the laboratory community is that a document like ISO 15189 can be adopted by any laboratory, and that laboratory user can assess whether or not it is adopting the rules in the documents.  This is separate from the process of accreditation.  If you believe in Quality you can apply the document.  If you believe that external assessment improves the degree of compliance, then you can invite an independent third party to made an assessment over and above adoption.  

This is very important to understand, especially for small laboratories in countries that do not legislate accreditation because it reinforces the point that a laboratory can (and I think should) adopt 15189 at its own pace, and when it is ready make the second decision based on finances and commitment and business advantage as to whether it sees advantage in having a competent third party do an independent assessment about the degree of compliance.  

But here is my concern; the third iteration of ISO 15189 is about to have its final vote before formal adoption, but it contains the sentence “This international standard is not intended to be used as the basis for certification of laboratories”.  

So exactly how does that mesh with the words and the spirit of  ISO CASCO neutrality principle?  

Words or rhetoric?


2 comments:

  1. I think it is more than just words and it's important to consider these things.

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  2. I absolutely agree with you. This is incredibly important because having 15189 as a map towards clinical laboratory quality has proven to be absolutely invaluable. To have a Quality Partner group, other than ISO believe and act as if it has some ownership control over the document is a falsehood and a detriment.
    Time will tell.
    m

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