You get what you ask for

I have written before about the difference between horizontal and vertical standards. ISO/TC212 produces standards for the clinical laboratory. The following came from a talk by Dr. Stinshoff, who has headed the ISO/TC212 effort. The red highlights are from Dr. Stinshoff.

“ISO/TC 212 Strategies:

– Select new projects using the breadth and depth of the expertise gathered in ISO/TC 212; focus on horizontal standards; address topics that are generally applicable to all IVD devices; and, limit the activities of ISO/TC 212 to a level that corresponds to the resources that are available (time and funds of the delegates).

– Assign high preference to standards for developed technologies; assign high preference to performance-oriented standards; take the potential cost of implementation of a standard into consideration; and, solicit New Work Item ideas only according to perceived needs, which should be fully explained and supported by evidence.

– Globalize regional standards that have a global impact”

 

What is meant by performance-oriented standards? “ISO Standardisation Performance vs. Prescriptive Standards:

Whenever possible, requirements shall be expressed in terms of performance rather than design or descriptive characteristics. This approach leaves maximum freedom to technical development….

(Excerpt of Clause 4.2, ISO/IEC Directives, Part 2, 2004)”

So one reason ISO/TC212 produces horizontal standards is because that is their strategy.

 

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