Over the years of my career I have had the opportunity to be engaged in the domains of standards development and application. I have had a hands-on relationship that has involved documents from the very local to the very international.
There are differences between those documents written very local versus those written far and abroad. Those written “closer-to-home” tend to get right to the point and can be very specific. They don’t need to worry too much about being too broad in nature because they are written and designed for local use only. There are no concerns about having conflicts with regulation because local regulations requirements can be written in from the get-go. You never see the sentence that says “national regulations need apply” because that is a given. On the other hand, the international documents take a broader and more generalized perspective. The notion of variation has to be build in through lack of specificity. The documents need to address the needs for laboratories of all capabilities from the resource-wealthy and resource-limited alike.
There are two essential characteristics that bring these documents together. Regardless of where they are designed they have to be consensus documents and they have to be regularly reviewed to ensure they are fresh and relevant.
They are written by groups of people and validated by even larger groups of people at support the documents or do not. There must be an agreement everyone agrees to agree. Not everyone has to love it, or even like it, but there is universal that everyone can live with it. Everyone. Period. That is what makes standards so powerful. Everyone has a say and everyone has a buy-in and everyone agrees.
Further, the group has an obligation to study the document again, perhaps every five or seven years. The group may not necessarily be the same people, but the group will have a consistent interest in the topic at hand. That way the document can continue to be relevant or it will come to an appropriate end.
As a user, these are very important concept. If a document exists as a standard, it means that it has been seen by many people, all of whom have agreed to support it. Before you disregard the document as a waste of time, or a personal mission, you need to accept and recognize and appreciate that many people had the chance to reject it, and chose to not. Before rejecting it out of hand, perhaps you have to give it a second look.
As a comment, one of the problems that we have in laboratories is that many of our colleagues are not aware what the term “consensus document” means. Many don’t recognize or appreciate the power of consensus and renewal. That is not totally the audience’s fault. Most documents are published without mentioning these critical factors.
If I was a standards editor and publisher, I would gather information about the voting response rate and include it as an informative note on page 2. “This international document was reviewed and approved by 7500 informed persons from 700 institutions from 73 countries.” That information is all available and the reader would likely have to think about it.
One organization that I work with includes a comment sheet which presents every comment submitted as evidence that consensus was actually achieved. That could get difficult and onerous with open international documents that get many, many letters of concern.
But recently I have run into a document that seems to take a different path. This is an organization (for the purposes of this entry the organization shall go unnamed) that writes what it purports to be a standard (they call it a standard), but as best as I can sort out, it is written only by internal writers. I understand that there may be some external reviewers, but nowhere does one find evidence of consensus agreement. To my sense and sensibilities this is a severe credibility gap.
I will approach them with all due caution.
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