Further thoughts by the author…

January 2002

The most difficult concept for developers to grasp about product quality is that no one agency or authority sets the standards for their product. The market place and users' expectations are actually the progenitors of quality requirements.

Regulatory agencies and authorities (e.g. UL, FCC, CE, CFR, ISO and FDA) do specify some rules regarding functionality such as interference with the environment, safety, user interface and health interactions, but quality aspects are really not specified. These agencies do, however, recommend process by which a product's quality can be sufficiently controlled and kept consistent.

So… as a product developer, you are the one who will define and assure the quality aspects for your product - not someone else. As far as those agency rules pertinent to your product, you are responsible for implementing and validating them.

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