Steps to Creating a Culture of Quality in the Workplace

Different people define quality differently. Some consider meeting compliance needs to be quality. Some define quality as improving the quality of life for a patient using their device. Some define quality as improving the quality of life for a patient using their device.

Developing a quality culture within your company is different from meeting the quality regulatory norms and standards, and this post will explain all you are required to know. It is important for medical device companies to strive to refine and improve their culture. Let's first look at what the term "quality culture" really means.

Quality Culture: What Does It Mean?

Those who make decisions based on the goal of quality work are part of true quality cultures. When all company levels recognize that quality shouldn't just be achieved to meet regulatory requirements, but for its sake, you have a quality culture.

Several companies have their quality policy displayed on their office walls. Employees may be able to narrate the policy, but do they really care? Do they really memorize it, or is it a chore? The difference is significant.

Everything you do should be centered around the end user, the patients who will benefit from your products.

In order to make a safe and efficient product, a quality culture is essential. Your team probably already has one if everyone keeps that in mind at all times.

Without a quality culture, your company doesn't care about end users, leaving you with an opportunity to improve every aspect of your business and raise the level of service you offer.

How to Create a Quality Culture?

Check out our top tips for making your company's quality culture the best it can be.

Outline the Company's Values and Define Them

A clear definition of your company values is the first step toward raising the standard of your quality culture or establishing a new one. Are your company's values quality-oriented? Do you agree with these values? Are there any improvements that can be made?

Your company culture should follow the same process. Set a good example for your team by fostering your quality culture now, and it will naturally flourish.

Creating an environment where employees assume that any product, they touch will eventually be used by a member of their family is one effective way to accomplish this. Quality culture, whether it's in product development or commercialization practices, is established through this holistic approach.

As you consider your values, keep the patient in mind. Discuss with your employees and team the goals you're trying to achieve with your activities once you figure out how you're going to foster a quality culture. The quality culture initiative is often treated as a future project at the research stage, which in my opinion is unwise.

Even if you think you won't need a quality culture until later in your company's life cycle, it will be extremely hard to change certain practices and habits by then. In your opinion, would it be better to deal with a potential problem in its infancy, or to wait until it develops into a systemic problem?

Getting a project right the first time saves time and resources compared to an overhaul.

Develop a Quality Culture Among Employees

An investment in training pays dividends throughout a company's development. A variety of activities reinforce the values of quality culture during training for adept teams.

Corporate training is often ineffective, which is a sad fact. One month after learning information, 90% of it is forgotten, according to research! The cost of external training makes this statistic extremely concerning.

Part of this is, in our opinion, due to the mindset of the people being trained.

Training can be conducted all over the world, but it needs to be understood by the trainee that it will be beneficial and actually add value, both to the trainee and to the company. There are times when training is mandated by regulations or disciplinary measures following audits or inspections, but it shouldn't be looked at as a checkbox option. Teams can improve products and processes through training.

In general, there is no way to measure how effective training is - a certificate is worthless if an individual does not retain the information needed to function effectively. This can be navigated by adopting a quality mindset.

Don't Chase Compliance, Pursue Quality

Compliance can be a burdensome process for many companies, but true quality goes hand in hand with compliance.

We can think of an example of a fast-food restaurant that is compliant with regulations on paper, but does not produce a quality product on the ground.

The attention paid to internal and external stakeholder needs, including patients, will result in a high level of quality that naturally leads to compliance.

Many companies build quality systems only to satisfy regulatory requirements, but this is another missed opportunity to establish a quality culture.

It is common for companies focused solely on compliance to view quality culture as a task for the Quality department, but it must be approached as a company-wide effort. Due to their authority to inspect work, request do-overs, and thus halt progress momentum, quality teams are often viewed as separate from the rest of the organization.

If you come across this attitude within your own company, you should be vigilant in correcting it. It's clearly not a fair way to view Quality staff members. In everything you do and every interaction across departments, your organization should embrace a quality mindset.

Everyone wants to feel like they're doing something important, and if your team develops and produces activities, they all do something that matters - you just have to make sure they understand their role in the process so they feel a certain way.

Simply put, when quality is embraced in every aspect of a company, the result is a better product and fewer headwinds.

Early Implementation of Document Control is Essential

To ensure that records and other data are organized and accountable, document control policies and procedures should be in place.

Document control allows for scaling and makes quality repeatable. It's your way of proving your documentation is in compliance with regulations.

Document controls should be implemented as early as possible, like quality culture itself. It is easier to keep track of things when errors and faults are caught early in the process.

As an example, let's say you're at the research stage and you're sending out design outputs to be manufactured. In the event that you could have prevented a documentation error during this process, you could have budgeted for a more stringent document management system. It can delay the project and waste significant resources.

A quality management system (QMS) can greatly facilitate document control. In order to address and solve pain points in processes like document control. In paper-based systems or applications that aren't designed to handle the specific data sets required for medical devices, it is very easy for documents to get lost.

For simple implementation and management as you scale, each document can be monitored for approval status with full traceability.


There is no better way to create a solid product that will be valued by everyone than to establish a true quality culture. A VC firm tends to place a higher valuation on a startup that plans its quality approach long-term, in our experience.

With a true quality culture, that impression is probably accurate, as it gives them the impression that your company can succeed and grow over time.

All companies, regardless of their stage, should strive to foster a quality culture in order to build strong relationships with regulators, VCs, and end users.

You have now been provided with everything you need to get started on improving your quality culture and embarking on a new stage in your career.

Updated on: 02-Feb-2023


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