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Impact of Standards on Industry & Manufacturers

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1 Author(s)
Levin, Mort ; Manager, Quality & Regulatory Affairs, Hewlett-Packard Medical Products Group

Based on the discussion in this article, the evaluation of each measure of the effect of standards on industry is listed in Table 1. The impact of standards is considered to be insignificant, small, or significant. Admittedly, these are not precise evaluations and, for a given product or a given manufacturer, the scoring may be different. From an industry point of view, all of the marks are in the insignificant to small catergory. Why, then is there a concern about the impact of standards on industry? Here are some possible answers. Dealing with standards, for the highly active fraction of the 56,000 people involved in standards development or equipment design is a frustrating and time consuming task. The development of standards covers years, involves a constant influx of new faces and ideas, contains subtle or outspoken desires to protect the status quo and involves long sessions at which emotions frequently run high. Furthermore, some of the participants may not be that knowledgable about all of the aspects of design, manufacture and application of the product in question. This lack creates frustration and leads to a vocalization that generates an impression that all standards have a large negative impact. For some, the complaint may be correct. For the industry as a whole, this does not seem to be the case. There also is the retrospective impact of standards to consider.

Published in:

Engineering in Medicine and Biology Magazine, IEEE  (Volume:3 ,  Issue: 1 )