Chapter 9 - Compliance must result in improved quality

Abstract

Quality and compliance are often see as a burden on the organization. They are sometimes seen as a cost, taking resources away from revenue generating functions. The quality organization is seen as slow, bureaucratic, and risk averse. In particular, compliance is frequently seen as the police force out to give tickets and slow the organization down. There are several things that can be done to change these negative perceptions. By making positive contributions to the organization and helping to reduce risk, quality can be seen as adding value to the organization. In part 4, we will explore ways to add value to the organization. The quality organization should be seen as a valued partner and earn a “seat at the table.” A seat at the table represents the opportunity to be heard and to make a positive difference to the organization. Regulators have ever increasing expectations for quality and compliance from medical device companies. Customers demand quality, safety, and efficacy from the medical devices they use. Providers are feeling the burdens of out of control health care costs and need to pass that on to the companies they purchase devices from. And employees and shareholders need efficient, stable, consistent results from the quality management system. Understanding, communicating, and mitigating the risks of these realities to the organization will help to earn a seat at the table for the quality organization.