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Four Tips for Building an Effective Quality Management System

A robust quality management system (QMS) is important to every company, but just as no two companies are the same, no two quality management systems can be identical either. It is important to ensure that the system you develop serves the needs of your company specifically, improving operations and mitigating risk, not just fulfilling quality requirements. Whether you are building a brand-new system or looking to improve what is already in place, these tips will help guide you to a QMS that fits your unique needs.

Focus on your gaps: When developing your quality management system, keep the focus on where you already know there are existing gaps. Concentrating on these areas will close immediately obvious problems but will also help to reveal where other connected gaps may be. If you are unsure of where your most vital gaps are, studying the greatest areas of risk and waste may help guide your system development.

When focusing on gaps, consider practices that will limit risk. Identify the areas that have proven most prone to errors or where human errors present the greatest risk. Immediately addressing these areas is vital to reducing both long and short-term risk. Many times, errors are caused by a lack of proper training or through an inconsistently applied process. Focusing on improvements in these areas of your QMS will show immediate benefits.

Most companies know where there is internal waste – either of time, resources, or expertise. Your QMS is more than a requirement of ISO or another standard. It should genuinely improve your operations. One readily apparent area where your QMS can actively help your company is through reducing this waste. If, for instance, you find that a great deal of time is wasted in re-work for a certain process, a part of your QMS should directly address improvement for that area. Whether that takes the form of additional training, a work instruction, or some other method should be discussed with those who most often perform the activity.

Keep it simple: There is a sometimes a misconception that in order to be robust and effective, a QMS must necessarily be complicated. In fact, the more complicated the system, the more difficult it will be to maintain. A QMS too complicated to be effectively maintained is, in some ways, worse than no QMS at all. It creates the assumption that there are strong controls in place, when in reality many employees may be cutting corners or ignoring requirements altogether.

Keeping it simple means that your QMS must be easy to understand. A system that is too difficult to read and understand, or too convoluted to follow will slowly become misinterpreted, incorrectly implemented, and eventually, ignored.

A QMS designed to be successful over the long term must necessarily be easy to maintain. If it is too difficult to keep up with QMS requirements, entropy will eventually take over and the QMS will slowly deteriorate as human nature seeks the path of least resistance.

Think forward: In order to ensure your QMS is not obsoleted as your company grows, think forward while you build it. The goal of a QMS is to anticipate and circumvent quality problems. But often overlooked is that your QMS must also be able to grow and develop with your company. Without this ability, you will constantly be overhauling your system every few years in response to company or industries changes, wasting valuable resources and creating some of the very problems the system should have been designed to avoid. Make sure the system is flexible enough to allow for changes and look for where potential problems may arise as your company grows. What areas will undergo stress with increased demand? Where are employees likely to try cutting corners as they get busy? These should be areas of focus as your QMS is developed.

Give ownership: As with any significant change, wide spread buy-in is a requirement for long-term success. To achieve company-wide buy-in, seek involvement from as many employees as possible. Encourage widespread input to the writing of procedures, create cross-functional brainstorming teams, and ask questions from those who will be most frequently using procedures and various forms. If employees feel they have helped to build they will be motivated to help maintain correctly. And by involving the entire team in the process, you will ensure that everyone understands the system, how it works, and why it is so important.


Wherever you may be in the development of your quality management system, and whatever your need may be, Medpoint has the experts and experience to help you succeed. Let us partner with you to ensure your QMS works for your company and produces the best results. Contact us today: hello@medpoint.com or +1 800-200-9292.