8 benefits of a quality management system (QMS) in 2024

Implementing a quality management system (QMS) can offer noticeable benefits to your entire organization. Recognizing and communicating these benefits is critical to inspiring team members—from quality specialists to executive leaders—to prioritize quality management initiatives.

Measuring benefits of a quality management system

It's important to understand how you can measure the benefits of a QMS. Some benefits are seen through financial metrics. One study found the average QMS implementation yields 300% ROI. Empirical studies confirm that organizations reap more rewards that are not as easily measured; most notably, a heightened awareness of quality, improved brand valuation, and consistent operations. Other benefits are measured through product quality, audit performance and customer feedback.

And there is, of course, the mitigation of regulatory risk. Implementing of a QMS helps your organization comply with requirements and standards for quality-driven operations. Simply put, a QMS helps your company obey the law. Successful audits, a lack of warning letters from the FDA and, ultimately, fewer recalls of your products means fewer setbacks and monetary losses for your organization.

An effective QMS can have a transformative impact on company culture by creating a formal system of process, procedure, responsibilities, and software. However, the benefits of a functional QMS go beyond mitigating regulatory risk, ensuring compliance, and achieving certification.

Why is quality management important?

A QMS enables businesses in highly regulated industries to consistently apply quality processes to produce products that meet regulatory requirements. QMS frameworks such as ISO 9001:2015 provide a comprehensive blueprint for customer-focused quality management based on principles for leadership, the workforce, processes, improvement, evidence-based decisions, and relationships.

Research confirms that implementing a QMS aligned with standards like ISO 9001 or ISO 13485 can offer near-term benefits to adopting organizations. One Harvard Business Review study focused on organizations who achieved ISO certification, and found these companies have higher rates of "corporate survival, sales, employment growth, and wage increases than a matched group of non-adopters."

67% percent of organizations achieve at least $25,000 in savings within one year of adopting a formal QMS, with 27% saving at least $100,000.

Despite the abundant positive evidence, there is a certain number of myths about quality management systems. Some companies believe that quality systems and certification are limited to large, well-established firms. Others feel certification has little practical value.

In actuality, firms of all sizes can achieve dramatic operational benefits from implementing a QMS.

Let's see how.

Benefits of a quality management system

Why have a quality management system?

Regulatory risk, compliance and certification are critically important objectives for implementing a QMS. However, they're not the only outcomes you can expect when adopting the right quality system. Here’s a look at some of the main benefits of a good quality management system that you may not have considered:

1. Operational consistency

Inconsistent operations are the enemy of total quality management. Without standardized operations, your organization cannot consistently ensure the quality of products or improve efficiency. Business researchers have found that inconsistent business processes can have five times more negative impact on the customer than the delivery of an inferior product. In highly regulated industries, inconsistent processes which result in unreliable product quality can have particularly severe consequences.

Operational consistency is a foundational component of a QMS. Implementing a QMS requires companies to define and describe the best practices for all business responsibilities, from quality control to management review. Creating standard operating procedures (SOPs) and a prescribed series of checks and balances minimizes the risks of nonconformances and maximizes organizational efficiency.

This is a key reason why quality management is important in project management operations: QMS implementation helps companies achieve stability in project activity, and aligns efforts towards the production of quality products which meet customer expectations. A consistent approach to operations can save money. Business process standardization can reduce process costs by 15 percent and reduce errors by 30 percent. Operational consistency can offer other measurable benefits such as reduced process throughput times, fewer customer complaints, and superior forecasting ability.

2. Continuous improvement

Continuous improvement is among the core principles of ISO 9001 and other quality management systems. ISO writes that “continual improvement should be a permanent objective of the organization.” When adopting a QMS leads to cultural change, embracing the principle of improvement can have lasting benefits to the organization such as stronger performance, strategic leadership, and staff engagement.

Continuous improvement should be a primary objective for every member of the workforce to adopt the principles of gradual improvement and breakthrough improvement. SOPs should support the use of regular audits and assessments against the QMS framework to ensure progress towards standards. By training every member of the organization on the use of Plan-Do-Check-Act or Deming cycles, the organization can create a culture of constant problem solving and innovation that moves you towards a total quality management model. 

FURTHER READING: Total quality management (TQM): definition and principles

3. Employee communications and onboarding

ISO 9001 addresses the importance of internal communication, specifying that “top management shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the Quality Management System.” This verbiage places the responsibility directly on senior leadership to drive a positive employee experience, but it also emphasizes the importance of two-way communication in the organization. Organizations are encouraged to create a collaborative culture where employees provide frequent feedback.

Without cultural change, a QMS is nothing more than a series of documents and policies. Employee communications are at the core of creating a quality-driven culture where people openly share information and understand the company's values. Communication and education are vital to obtaining employee buy-in to quality objectives. Educating employees on the customer and quality systems is an ongoing objective, but training and education efforts should begin with a standardized onboarding process for new hires.

4. Evidence-based decision making

An effective QMS should create standardization and promote flexibility when needed to achieve quality objectives and embed continuous improvement. One of the benefits of a QMS in an organization is the adoption of evidence-based decision making based on real-time oversight into systems and data.

Why is data quality management important?

In practice, the concept of evidence-based decision making involves the use of data gathered through monitoring and measurement methods. This data is compared to the desired outcomes and organizational quality objectives. The real-time use of data and metrics can provide an objective understanding of whether a process is successful or requires correction. Data-informed decisions are made possible by QMS software which provides real-time oversight into systems for training, document management, compliance, and CAPA.

Evidence-based decision making can benefit the organization by removing subjectivity from leadership. The real-time use of data can facilitate continuous improvement toward strategic goals. An eQMS system which provides transparency can enable organizations to mitigate the risks of non-compliance or product quality issues in real-time.

5. Increased profits

Research has established that many organizations achieve a direct financial return on QMS implementation. An ISO literature review of 42 studies identified several reasons QMS support profitability. Internal, external, and signaling benefits all collectively contribute to stronger financial performance:

• Internal benefits such as increased efficiency and productivity lower costs
• External benefits such as increased sales or new market access impact income
• Signaling benefits include new market access or increased market share

This study highlights the value of a QMS implementation for organizations that aren't positioned to profit from higher sales, such as start-ups in the R&D phases of product development. Adopting a QMS can maximize internal efficiency and create a reliable baseline as the company's product approaches market approval.

Management systems can improve efficiency by preventing problems throughout the product lifecycle by providing tools to identify issues before they result in rework, waste, or nonconformances.

6. Improved customer (and patient) satisfaction

One of the main benefits of an ISO 9001 quality management system is its strong and consistent overall focus on customer satisfaction.

ISO 9001 includes a number of requirements related to customer satisfaction, which include but aren't limited to:

• Clause 8.2.1. communicating with customers to obtain feedback, including complaints
• Clause 9.1.2 monitoring customer perceptions of the extent to which their needs have been met
• Clause 9.1.3.b obtaining, monitoring, measuring, analyzing, and evaluating customer satisfaction.

Using your QMS as a tool to measure and analyze customer satisfaction is required by multiple standards. Greater customer understanding can drive more customer-focused business practices to improve outcomes, reduce complaints and churn, and increase your overall profitability.

Why is quality management important in healthcare? For the same reason, but with a slightly different focus. Patient focus, rather than purely commercial customer focus, should be your guiding light, with the safety and efficacy of your life-saving product your number-one priority.

Embedding quality management processes that anticipate, analyze and respond to patient needs, in the same way you would with your other stakeholders and buyers, is the best way to ensure your product does what it's meant to.

The end result? Happier, healthier patients that trust and rely on your product. That can only be a good thing.

7. Minimized mistakes & rework

The cost of poor quality, including rework and recalls, can range from 15 to 35 percent of total business costs in many regulated industries. Externally discovered product failures which are found by customers or regulatory bodies are generally 5 to 10 times more expensive than mistakes discovered earlier in the process.

In the life sciences and pharmaceutical industries, rework can have a ripple effect. Delayed time to market can result in a loss of competitive advantage, brand devaluation, or other lasting disadvantages.

A QMS reduces rework with a number of approaches to discovering potential quality issues earlier. Digitized work instructions allow organizations to streamline certification and calibrate tools. The result is more opportunities to discover quality issues before they result in costly rework.

8. Market expansion

A QMS can simplify the process of quickly scaling to enter new markets, territories and sectors by letting you more easily meet new compliance requirements and accommodate new global stakeholders.

This can allow organizations to move with agility in a competitive landscape and focus on innovation and building business relationships, instead of creating compliant systems from the ground up.

Importance of quality management

The benefits of implementing a quality management system are diverse, but they're not a magic potion. Implementing a QMS cannot cure an organization which isn't led from the top by engaged, quality-focused management. Successfully shifting to a quality-driven culture requires full support from the leadership team and a commitment to change.

Leadership sets the tone for motivating teams to invest time, energy, and money into quality management. Move forward with a clear consensus on the importance of quality management and its role in the organization's success. Encourage team members to participate in implementation, championing the value of compliance as a best practice, not a baseline.

Provide incentives for participation that reinforce the importance of QMS. When employees recognize that management cares about their insights and opinions, it can build morale by giving them a sense of ownership over the organization's success. Quality management systems should also be supported with education and training, to ensure that everyone knows how to use it effectively.

FURTHER READING: How to develop and implement a quality management system

What happens if you don't get a quality management system?

Not getting a quality management system can reduce expenditure, in the short term, on things like training, document creation and implementation. However, it's likely to cost your organization more than it saves. There are risks associated with failing to get a QMS or delaying that acquisition.

One of the key disadvantages is related to compliance and standards. Without a QMS system that is built to simplify the fulfilment of regulatory requirements and certification, your organization will be at higher risk of regulatory delays or costly fines. Not using an ISO QMS is a barrier to receiving ISO certification. Other risks can include:

• Loss of competitive advantage due to agility and quality issues
• Difficulty scaling to grow or expand product lines
• More wasted resources due to manual quality processes
• Frustrated employees due to poor systems for collaboration
• Inconsistent product quality, resulting in customer complaints and other risks

A note on company size and QMS implementation

Appropriate fit is among the most important considerations when looking to build a quality management system and reap its benefits. While QMS implementation can introduce significant change, the change should be logical and provide clear value. Trying to force overly complicated processes or documenting ideal processes that simply don't match your operational reality is a recipe for disaster. The right QMS should fit seamlessly into your current organization, then provide a framework for tweaks and improvements as you identify them.

It's also important to note that the benefits of a digital QMS are even more dramatic than quality systems run on more traditional tools like paper, spreadsheets and electronic folders. QMS software digitizes, centralizes, automates and accelerates key elements of your quality system, making the benefits of your quality management system even more impactful.

It's the reason why, in our 2024 survey of thousands of life science quality professionals, we found that less than half (42%) of companies still use paper and spreadsheets to build their quality systems. Forward-looking and quality-centric companies are already turning to QMS software, also known as electronic quality management systems (eQMS), to make their quality stronger and more optimized.

FURTHER READING: The top 5 electronic quality management system (eQMS) platforms

The importance of the quality management system

Why is quality management important? Because it's the core of how modern, regulated and mature companies do business. The benefits of a quality management system, properly managed and maintained, will be dramatic and long-lasting for your organization.

The best time to get one is right now!