Quality management systems (QMS) ensure ongoing product quality and enhancement while also satisfying customer expectations.

A QMS offers a framework for organizing business structures, methods, resources and policies to align product safety standards with business relationships, objectives, contracts, and agreements.

Organizations utilize QMS to not only increase productivity, but reduce waste, and manage customer complaints. A QMS allows companies to efficiently direct and coordinate their operations to meet the complexities of customer and regulatory requirements.

Such systems are available for many different industries, but are especially prevalent in industries with heavy regulatory demands such as related to food and beverages, medical devices, or environmental and transportation systems. Although QMS must address unique sets of needs, they share a few common elements:

  • Quality control instruction manual
  • Defined quality objectives, indicators, strategies and policies
  • Procedures and instructions defining internal processes for data management, quality analysis, improvements and customer satisfaction


The concept of ensuring quality and standards in production first emerged during the Industrial Revolution. With the development of mass production, goods could no longer be assembled from start to finish by the same person. Instead, large teams of people worked on specific stages of the production process. This new process required businesses to develop standards to eliminate variations in output and the quality of final products.

Frederick Winslow Taylor and Henry Ford were the first to recognize this need. Firstly, Taylor pioneered one of the earliest quality departments overseeing production and addressing production errors. After that, Ford was the first to create a standardization process for the design and development of components ensuring consistent production.

Although many players contributed to the development of QMS, Joseph M. Juran was not able to help Japanese manufacturers develop a comprehensive approach for maintaining quality of products over the entire life cycle. However, quality control has continued to evolve through the 20th century and has become a profession in and of itself.


QMS can affect multiple layers of a company’s performance. The main benefit of implementing these systems is not just to ensure that companies comply with industry regulations and products meet customers’ needs. Secondary benefits of a QMS include:

  • Managing and lowering costs
  • Setting company-wide direction
  • Reducing waste
  • Improving processes
  • Fostering growth and profit opportunities
  • Building trust in companies and products
  • Engaging staff
  • Identifying and facilitating training opportunities
  • Preventing errors

Although a QMS is not intentionally designed to increase revenue, proper implementation frequently increases profit margins and the bottom line.


There are a number of different QMS standards available for a variety of different industries. The general standard system is called ISO 9001:2015. This standard describes all of the requirements a company must meet in order to implement their own QMS. Internationally, ISO 9001 is the most widely known and implemented standard. Organizations that follow these standards must meet all defined criteria and pass detailed audits.

Some industries have to follow these standards, which are listed here. For a detailed look at standards required in the medical device industry check out SaMD Quality Management.


Unfortunately, QMS can be highly complex and difficult to successfully implement. Before establishing a QMS, companies need to review their overall business strategy and create a system based on specific needs, objectives, services and products. Here you can see the necessary steps, whenever you want to implement a QMS successfully in an organization:

  1. Design, outline and build the framework of the QMS.
  2. Iteratively deploy the QMS by breaking out each process into multiple sub processes.
  3. Use systematic and routine audits to control and measure progress.
  4. Review and improve the QMS based on the results of the audits.

When developing a QMS, organization is key. Proper and thorough documentation alleviates a world of headaches and makes tracking, monitoring, updating and also accessing the QMS seamless for everyone involved. It is also important to ensure sufficient resources are available for implementing and managing the QMS. 


Product quality is reflected not just in durability and reliability, but in performance aswell. Quality plays an important role in differentiating a company from its competitors. Businesses that have properly implemented a QMS can be confidence that they will deliver superior quality products and also achieve higher profits.

As software developers and consultants working in the regulated software world, we use QMS on a daily basis.  Our work documentation protocols ensure that your SaMD products will comply with ISO 13485 standards. Contact our experts for a comprehensive look at how these standards may apply to software used in your industry.