Excellence Beyond Compliance

12

Maintenance (and Improvement)

Aristotle taught that moral virtue comes about as a result of habit.¹ So also by developing the right habits, we are best able to maintain our QMS. In fact, through the habits we cultivate, we will be able not only to maintain it, but to improve it as well.

Regulations and quality standards for medical device companies would have us believe that “maintenance” is the watchword. Officially, this is correct. One of the reasons to justify the original establishment of ISO 13485 as a stand-alone standard was the requirement in ISO 9001:2000 for continual improvement of the QMS—a requirement deemed inappropriate in a regulated industry. Although in regulations the authorities do not in so many words require improvements ...