Fundamentals – Quality Management in Medical Technology

What is the Purpose of a Quality Management System?

The fundamental idea is to establish a system that enables a continuous, iterative increase in quality. This system is designed to prevent a previously achieved quality level from being lost. It should provide a framework that systematically addresses errors and extracts information to be used for system improvement.

A Quality Management System (QMS) defines a company’s operational framework, within which products and services should be designed to achieve high customer satisfaction. Customer satisfaction is tied to meeting customer requirements, including regulatory demands.

Which Companies Need a QMS?

That depends on the industry a company operates in. In medical technology, for instance, a QMS is legally mandated. In other sectors, QM systems are voluntary.

There are also different standards that address the specific requirements for QM systems. ISO 13485 is applicable to manufacturers of medical devices and IVDs, as it describes requirements specific to medical technology. ISO 9001, on the other hand, is applicable to all types of companies, as it describes general requirements for QM systems.

What Makes QM in Medical Technology so Special?

In medical technology, it’s not just about manufacturing products and services that ensure customer satisfaction. It’s about human health. For this reason, medical technology is more heavily regulated than other sectors, and this is reflected in manufacturers’ QM systems.

Many manufacturers of medical devices and IVDs operate internationally. Consequently, their QM systems must also reflect the requirements of various target markets. This demands a lot from the responsible employees, as they must identify and implement all applicable requirements within the QMS. However, in certain countries, it’s not easy to identify all applicable requirements if one doesn’t speak the local language.

Furthermore, quality management in medical technology is subject to regular audits by notified bodies and authorities. These audits serve as an additional safety factor to enforce the industry’s high quality standards.

What Challenges Does this Sector Face?

There is a challenge that exists in almost all companies in connection with quality management: the lack of awareness of the QMS’s importance and a poor understanding of its requirements are issues we regularly observe in the industry.

Additionally, within QM, the fear of errors is widespread. After all, you’re QM, so you don’t make mistakes. You’re the party that provides a framework for others to make no or fewer errors. From a QM perspective, errors are often equated with a loss of face. But that is precisely the first major mistake! This attitude sometimes leads to regulatory and normative requirements being interpreted with an unnecessary strictness. It results in QM systems becoming unnecessarily bloated and the workload disproportionately increasing relative to the benefits.

If Quality Management is Done Right, It’s a Blessing. If Done Wrong, It’s a Curse. Fundamentally, QM should be Implemented for the Company Itself, not for the Notified Body or Authority.

– Thinqbetter

What Does Thinqbetter Advise?

If you are currently establishing a QMS, be sure to involve subject matter experts. It is crucial that these individuals are capable of building a QMS specifically for your company. A QMS should be tailor-made and customized. It must serve your purposes while ensuring you meet all applicable requirements.

A QMS should not primarily be about implementing requirements, forcing you to integrate your existing workflows into it. That creates resentment, friction, and frustration – and rightly so!

Errors made in the very early stages of QMS creation are later almost impossible to rectify. Therefore, involve experts and all relevant personnel from the outset. Build the QMS step by step, and simultaneously foster understanding within your company. Good mutual understanding is a crucial pillar of efficient collaboration.

Prevent employees in your company from developing an aversion to QM by addressing the topic correctly from the start. Your QMS will be a permanent companion – you wouldn’t marry someone you can’t stand, would you?