QMS implementation: Making it useful

Creating and leading a medical device company that focuses on the quality of its products from start to finish not only builds its culture but ensures growth and success. Finding a way to standardize that effort is crucial. MedDev companies should know how to communicate and manage staff through these standardized processes.

The overall purpose of establishing a QMS is to set the framework and requirements of a medical device company. The QMS sets up company processes, rules, and expectations. It defines how things should be done in the company and what documents and records will be generated.

A framework of the QMS

The QMS is a framework that is driven by policies and procedures and requires detailed documentation. The primary goal of QMS is to ensure products are created in a systematic foreseeable way that best meets the real needs of customers. Medical devices are designed and built to be effective with great attention given to patient safety.

The QMS is not a machine or an application but is the fundamental quality process architecture on which the organization stands. The term “QMS” includes all the people, processes, stakeholders, and technologies that are involved in an organization’s culture of quality. A better understanding of internal and external stakeholders and their needs is fundamental to define the role of quality.

QMS implementation

Today, the quality is often viewed as the function that checks on documents and other people’s work to ensure it complies with the SOPs and regulations. Also, it isn’t unusual for employees to think of QMS as a set of restrictive, long, and unclear documents.

The QMS doesn’t need to be complicated, it should allow the medical device company to do what it does best. Complexity is added to the QMS due to a misunderstanding of the standard’s requirements.

So, implementing the QMS is what it should avoid:

- adding processes and layers of complexity

- supporting unclear quality objectives and measures

- trying to catch somebody is doing something wrong

When QMS implementation is forced into the organization, employees often feel that their processes become complex with no logical reason.

When a medical device company adopts a culture of quality, the success of its implementation can depend on whether core principles reflect the quality or can be efficiently changed to embrace quality through dedicated change management.