Chapter 8 - Capabilities and MEDICS for an effective QMS

Abstract

In previous chapters, we discussed what an effective and efficient quality management system (QMS) is. Now, we begin to discuss some of the capabilities needed to establish a QMS. Medical device manufacturers need to have six key capabilities to create an effective and efficient QMS. Without these capabilities they cannot thrive, or even survive, in a competitive and ever-changing industry. These six key capabilities, or Quality System MEDICS, essential for a healthy QMS are: (i) Monitor—Ability to measure, monitor, and analyze the health of the QMS; (ii) Embrace—Ability of companies to embrace a culture of quality, compliance, and prevention; (iii) Define—Ability to define risks, prioritize issues, and drive key improvement activities; (iv) Identify—Ability to self-identify problems and nonconformities with a short feedback loop; (v) Corrective and preventive action and Improvement—Ability to fix problems robustly and establish controls to sustain the gains; (vi) Share and Communicate—Ability to share and communicate key information in a transparent manner, especially management review. If you have any serious quality or compliance issues, be sure to ask “5 Why’s” to understand contributing causes. Usually, contributing cause(s) include immaturity in one or more of the MEDICS.