What good is it? Often the mantra of the obsessively practical or the hopelessly cynical, a “what good is it?” response typically indicates disgust, disappointment, or disdain—maybe all three.

In the medical device industry, one absolute—which shows no signs of abating—is the need to maintain documentation.

We need to think about redefining work. Until we—anyone who wishes to bring about organizational change—redefine the actual value-creating work of the business, we haven’t made any changes that are meaningful.

The new ISO 9001, scheduled for publication in late 2015, introduces the term “knowledge.” As knowledge was not addressed by the previous version of ISO 9001, the depth of this topic and the approach to it are new.