Hear from guest columnist Onega Ulanova on AI and quality management systems in manufacturing. Photo via Getty Images

The concept of quality management is so intrinsic to modern manufacturing — and yet so little understood by the general public — and has literally revolutionized our world over the past hundred years.

Yet, in the present day, quality management and the related systems that guide its implementation are far from static. They are continuously-evolving, shifting to ever-changing global conditions and new means of application unleashed by technological innovation.

Now, more than ever, they are essential for addressing and eliminating not only traditional sources of waste in business, such as lost time and money, but also the physical and pollutant waste that threatens the world we all inhabit.

But what are quality management systems, or QMS, exactly? Who created them, and how have they evolved over time? Perhaps most pressingly, where can they be of greatest help in the present world, and when can they be implemented by businesses in need of change and improvement?

In this article, we will explore the history of QMS, explain their essential role in today’s manufacturing practices, and examine how these systems will take us into the future of productivity.

Quality Management Systems: A Definition

In the United States and globally, the gold standard of quality management standards and practices is the American Society for Quality. This preeminent organization, with over 4,000 members in 130 countries, was established in 1946 and has guided practices and implementation of quality management systems worldwide.

The Society defines a quality management system as “a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives,” and further states that “a QMS helps coordinate and direct an organization’s activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis.”

From this definition, it can be understood that a good quality management system’s purpose is to establish the conditions for consistent and ever-increasing improvement through the use of standardized business culture practices.

Which QMS Standards are Most Widely Used?

The results of quality management’s remarkable growth since the 1940s has led to the rise of a number of widely-used standards, which can serve as the basis for companies and organizations to design and implement their own practices. Most of these modern quality management standards are globally recognized, and are specifically tailored to ensure that a company’s newly-developed practices include essential elements that can increase the likelihood of success.

The most widely-known entity which has designed such guidance is the International Organization for Standardization (ISO), a global organization which develops and publishes technical standards. Since the 1980s, the ISO has provided the 9000 series of standards (the most famous of which is 9001:2015) which outline how organizations can satisfy the checklists of quality management requirements and create their own best practices.

In 2020, over 1.2 million organizations worldwide were officially certified by the ISO for their quality management implementation practices.

However, it should be understood that the ISO 9000 standards are merely guidelines for the design and implementation of a quality management system; they are not systems in and of themselves.

Furthermore, the ISO is far from the only relevant player in this field. Many industry-specific standards, such as the American Petroleum Institute’s API Q1 standard, have been developed to target the highly specialized needs of particular business practices of oil and gas industry. These industry-specific standards are generally aligned with the ISO 9000 standards, and serve as complimentary additional guidance, rather than a replacement. It is entirely possible, and in many cases desirable, for a company to receive both ISO certification and certification from an industry-specific standards body, as doing so can help ensure the company’s newly-developed QMS procedures are consistent with both broad and specialized best practices.

A History of Quality Management

The concept of quality management is intrinsically tied to the development of industrial production. Previous to the industrial revolution, the concept of ‘quality’ was inherently linked to the skill and effort of craftspeople, or in other words, individual laborers trained in specialized fields who, either individually or in small groups, produced goods for use in society.

Whether they were weaving baskets or building castles, these craftspeople were primarily defined by a skill that centered them in a specific production methodology, and it was the mastery of this skill which determined the quality. Guilds of craftspeople would sign their works, placing a personal or group seal on the resulting product and thereby accepting accountability for its quality.

Such signatures and marks are found dating back at least 4,500 years to the construction of Egypt’s Great Pyramid of Giza, and came into widespread practice in medieval Europe with the rise of craft guilds.

In these early confederations of workers, a person’s mastery of a skill or craft could become a defining part of their identity and life, to the extent that many craftspeople of 13th Century Europe lived together in communal settings, while the Egyptian pyramid workers may have belonged to life-long ‘fraternities’ who returned, year after year, to fulfill their roles in ‘work gangs’.

However, in the Industrial Revolution, craft and guild organizations were supplanted by factories. Though ancient and medieval projects at times reached monumental scale, the rise of thousands of factories, each requiring human and machine contributions to generate masses of identical products, required a completely different scale of quality management.

The emphasis on mass production necessitated the use of workers who were no longer crafts masters, and thus resulted in a decrease in the quality of products. This in turn necessitated the rise of the product inspection system, which was steadily refined from the start of the Industrial Revolution in 1760 into the early 20th century.

However, inspection was merely a system of quality control, rather than quality management; in other words, simply discarding defective products did not in and of itself increase total product quality or reduce waste.

As influential American engineer Joseph M. Juran explained, in 1920s-era America, it was common to throw away substantial portions of produced inventory due to defects, and when Juran prompted inspectors at his employer’s company to do something, they refused, saying it was the responsibility of the production line to improve. Quality control, in and of itself, would not yield quality management.

As is often the case in human history, war was the driver of change. In World War II, the mobilization of millions of American workers into wartime roles coincided with the need to produce greater quantities of high-quality products than ever before.

To counteract the loss of skilled factory labor, the United States government implemented the Training Within Industry program, which utilized 10-hour courses to educate newly-recruited workers in how to conduct their work, evaluate their efficiency, and suggest improvements. Similar training programs for the trainers themselves were also developed. By the end of the war, more than 1.6 million workers had been certified under the Training Within Industry program.

Training Within Industry represented one of the first successful implementations of quality management systems, and its impact was widely felt after the end of the war. In the ashes of conflict, the United States and the other Allied Powers were tasked with helping to rebuild the economies of the other wartime combatants. Nowhere was this a more pressing matter than Japan, which had seen widespread economic devastation and had lost 40 percent of all its factories. Further complicating the situation was the reality that, then as now, Japan lacked sufficient natural resources to serve its economic scale.

And yet, within just 10 years of the war’s end, Japan’s economy war growing twice as fast per year than it had been before the fighting started. The driver of this miraculous turnaround was American-derived quality management practices, reinterpreted and implemented with Japanese ingenuity.

In modern business management, few concepts are as renowned, and oft-cited for success, as kaizen. This Japanese word, which simply means “improvement,” is the essential lesson and driver of Japan’s postwar economic success.

Numerous books written outside Japan have attempted to explain kaizen’s quality management principles, often by citing them as being ‘distinctly Japanese.’ Yet, the basis for kaizen is actually universal and applicable in any culture or context; it is, simply put, an emphasis on remaining quality-focused and open to evolution. The development of kaizen began in the post-war period when American statistician William Edwards Deming was brought to Japan as part of the US government’s rebuilding efforts.

A student of earlier quality management thought leaders, Deming instructed hundreds of Japanese engineers, executives, and scholars, urging them to place statistical analysis and human relationships at the center of their management practices. Deming used statistics to track the number and origin of product defects, as well to analyze the effectiveness of remedies. He also reinstated a key idea of the craftsperson creed: that the individual worker is not just a set of hands performing a task, but a person who can, with time, improve both the self and the whole of the company.

Deming was not alone in these efforts; the aforementioned Joseph M. Juran, who came to Japan as part of the rebuilding program several years later, also gave numerous lectures expounding similar principles.

Like Deming, Juran had previously tried to impart these approaches to American industry, but the lessons often fell on deaf ears. Japanese managers, however, took the lessons to heart and soon began crafting their own quality management systems.

Kaoru Ishikawa, who began by translating the works of Deming and Juran into Japanese, was one of the crucial players who helped to create the ideas now known as kaizen. He introduced a bottom-up approach where workers from every part of the product life cycle could initiate change, and popularized Deming’s concept of quality circles, where small groups of workers would meet regularly to analyze results and discuss improvements.

By 1975, Japanese product quality, which had once been regarded as poor, had transformed into world-class thanks to the teachings of Deming, Juran, and kaizen.

By the 1980s, American industry had lost market share and quality prestige to Japan. It was now time for US businesses to learn from Deming and Juran, both of whom at last found a receptive audience in their home country. Deming in particular achieved recognition for his role in the influential 1980 television documentary If Japan Can, Why Can’t We?, in which he emphasized the universal applicability of quality management.

So too did kaizen, which influenced a new generation of global thought leaders. Arising out of this rapid expansion of QMS were new systems in the 1970s and ‘80s, including the Six Sigma approach pioneered by Bill Smith and Motorola in 1987. Ishikawa, who saw his reputation and life transformed as his ideas spread worldwide, eventually summed up the explanation as the universality of human nature and its desire to improve. As Ishikawa said, “wherever they are, human beings are human beings”.

In no small part due to the influence of the thought leaders mentioned, quality management systems are today a cornerstone of global business practice. So influential are the innovators of these systems that they are often called ‘gurus.’ But what are the specific benefits of these systems, and how best can they be implemented?

How QMS Benefits Organizations, and the World

The oft-cited benefits of quality management systems are operational efficiency, employee retention, and reduction of waste. From all of these come improvements to the company’s bottom line and reputation. But far from being dry talking points, each benefit not only serves its obvious purpose, but also can dramatically help benefit the planet itself.

Operational efficiency is the measurement, analysis, and improvement of processes which occur within an organization, with the purpose of utilizing data and consideration to eliminate or mediate any areas where current practices are not effective.

Quality management systems can increase operational efficiency by utilizing employee analysis and feedback to quickly identify areas where improvements are possible, and then to guide their implementation.

In a joint study conducted in 2017 by Forbes and the American Society for Quality, 56 percent of companies stated that improving operational efficiency was a top concern; in the same survey, 59 percent of companies received direct benefit to operations by utilizing quality management system practices, making it the single largest area of improvement across all business types.

Because operational improvements inherently reduce both waste and cost, conducting business in a fully-optimized manner can simultaneously save unnecessary resource expenditure, decrease pollutants and discarded materials, and retain more money which the company can invest into further sustainable practices. Efficiency is itself a kind of ‘stealth sustainability’ that turns a profit-focused mindset into a generator of greater good. It is this very point that the

United States government’s Environmental Protection Agency (EPA) has emphasized in their guidance for Environmental Management Systems (EMS). These quality management system guidelines, tailored specifically to benefit operational efficiency in a business setting, are also designed to benefit the global environment by utilizing quality management practices.

Examples in the EPA’s studies in preparing these guidelines showcased areas where small companies could reduce environmental waste, while simultaneously reducing cost, in numerous areas. These added to substantial reductions and savings, such as a 15 percent waste water reduction which saved a small metal finishing company $15,000 per year.

Similarly, a 2020 study by McKinsey & Company identified ways that optimizing operations could dramatically aid a company’s sustainability with only small outlays of capital, thereby making environmental benefit a by-product of improved profitability.

Employee retention, and more broadly the satisfaction of employees, is another major consideration of QMS. Defined simply, retention is not only the maintenance of a stable workforce without turnover, but the improvement of that workforce with time as they gain skill, confidence, and ability for continued self and organizational improvement. We may be in the post-Industrial Revolution, but thanks to the ideas of QMS, some of the concept of the craftsperson has returned to modern thinking; the individual, once more, has great value.

Quality management systems aid employee retention by allowing the people of an organization to have a direct hand in its improvement. In a study published in 2023 by the journal Quality Innovation Prosperity, 40 percent of organizations which implemented ISO 9001 guidance for the creation of a QMS reported that the process yielded greater employee retention.

A crucial success factor for employee satisfaction is how empowered the employee feels to apply judgment. According to a 2014 study by the Harvard Business Review, companies which set clear guidelines, protect and celebrate employee proposals for quality improvement, and clearly communicate the organization’s quality message while allowing the employees to help shape and implement it, have by far the highest engagement and retention rates. The greatest successes come from cultures where peer-driven approaches increase employee engagement, thereby eliminating preventable employee mistakes. Yet the same study also pointed out that nearly half of all employees feel their company’s leadership lacks a clear emphasis on quality, and only 10 percent felt their company’s existing quality statements were truthful and viable.

Then as now, the need to establish a clear quality culture, to manage and nurture that culture, and to empower the participants is critical to earning the trust of the employee participants and thereby retaining workers who in time can become the invaluable craftspeople of today.

Finally, there is the reduction of waste. Waste can be defined in many ways: waste of time, waste of money, waste of resources. The unifying factor in all definitions is the loss of something valuable, and irretrievable. All inevitably also lead to the increase of another kind of waste: pollution and discarded detritus which steadily ruin our shared planet.

Reducing waste with quality management can take many forms, but ultimately, all center on the realization of strategies which use only what is truly needed. This can mean both operational efficiencies and employee quality, as noted above. The Harvard Business Review survey identified that in 2014, the average large company (having 26,000 employees or more) loses a staggering $350 million each year due to preventable employee errors, many of which could be reduced, mitigated, or eliminated entirely with better implementation of quality management.

This is waste on an almost unimaginable financial scale. Waste eliminated through practices which emphasize efficiency and sustainability, as noted in the McKinsey & Company study, can also yield tremendous savings. In one example, a company which purchased asphalt and previously prioritized only the per-ton price found that, when examining the logistical costs of transporting the asphalt from distant suppliers, they were actually paying more than if they purchased it locally. The quality management analysis they performed yielded them a cost savings, and eliminated 40 percent of the carbon emissions associated with the asphalt’s procurement. In this case, not only was wasteful spending eliminated, but literal waste (pollution) was prevented.

In taking these steps, companies can meaningfully improve their bottom lines, while at the same time doing something worthwhile and beneficial for the planet. That, in turn, helps burnish their reputations. A remarkable plurality of consumers, 88 percent of Americans surveyed in a 2017 study to be exact, said they would be more loyal to a company that supports social or environmental issues.

It is therefore clear that any steps a company can take which save money, improve worker satisfaction, and yield increased positivity in the marketplace are well worth pursuing.

What is the Future of QMS?

Until the 2000s, quality management systems were just that: systems of desirable practices, outlined by individuals and implemented individually. That was the age of the gurus: the visionaries who outlined the systems. But what that age lacked was a practical and easy means for companies, sometimes located far away from direct guidance by the gurus, to implement their teachings.

In the intervening years, technology has radically changed that dynamic. Today, QMS software fills the marketplace, allowing businesses small and large to design and guide their quality management plans. But even these software solutions have not yet solved the last great challenge: personalized assistance in putting standards into practice.

That is why the latest innovations, particularly in artificial intelligence, have the potential to upend the equation. Already, major companies have started to use artificial intelligence in connection with QMS datasets managed by software, utilizing the programs for statistical analysis, suggested improvements, and even prediction of potential faults before they occur.

These are immensely valuable opportunities, hence why huge players such as Honeywell are spending billions of dollars to bring innovative AI technology companies into their platforms to refine existing QMS systems.

But while AI has already begun to significantly affect the biggest players, small and mid-sized companies remain eager, but not yet able, to take full advantage. It is thus the next great revolution for a new evolution of QMS, one which will bring these emerging technologies to all companies, regardless of size or scale. The future of QMS, and therefore the future of efficiency in business, rests upon this shift from companies being the recipients of ‘guru knowledge,’ to themselves being the designers of their own quality-minded futures.

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Onega Ulanova is the CEO of QMS2GO, a provider of quality management systems leveraging AI in manufacturing.

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Houston medtech startup clears FDA approval for new surgical tool

precision surgery

Houston-based Prana Surgical will soon bring a new electrosurgical tool to operating rooms around the country. The Prana System officially cleared U.S. Food and Drug Administration (FDA) approval earlier this month.

"Receiving FDA clearance for the Prana System represents a defining milestone for our company," Joanna Nathan, CEO and co-founder of Prana Surgical, said in a news release. "Surgeons today are increasingly focused on achieving precise outcomes while minimizing disruption to healthy tissue. The Prana System was designed to support that shift by integrating targeting and excision into a single, streamlined tool."

Prana Surgical began as Prana Thoracic in 2022. Back then, the company primarily focused on developing screening tools for lung cancer diagnosis. It raised $6 million in series A funding rounds in 2023 and 2024 before transitioning to broader surgical needs in 2025.

The Prana System is a minimally invasive, image-guided, single-use tissue extraction tool designed to retrieve samples without damaging healthy tissue. The tool is still designed with the respiratory system in mind, helping Prana in the fight against lung cancer and other thoracic diseases.

Reducing the impact of tissue extraction via electrosurgery and enhanced image scanning can significantly reduce complications. The Prana System combines localization and tissue-cutting capabilities in one, which keeps surgeons from having to swap out components during a procedure, making for a smoother process. It can core, cut and feel blood vessels on the way toward the intended target, giving surgeons greater control over tissue preservation.

"Electrosurgery is foundational to modern surgery, but there is still opportunity to improve how energy-based tools are applied in minimally invasive settings," Nathan added. "Our goal is to introduce a new class of image-guided surgical tools that enable more precise intervention across a range of procedures."

The company projects sales of $7.5 billion from the Prana System in the United States, estimating that 2.5 million surgical modules will be able to use the new tool. While starting out focused on biopsies, the company plans to evolve the system into other procedures, such as ablation, in the future. It is also planning for a controlled U.S. clinical rollout as it moves toward commercialization

Texas still ranks as No. 1 in U.S. for inbound moves, but growth dips

by the numbers

Texas continues to be the country’s No. 1 magnet for newcomers from other states, giving a boost to the state’s economy. However, Texas’ appeal weakened in 2024 compared with the previous year, due in large part to spiking home prices.

An analysis of U.S. Census Bureau data by self-storage platform StorageCafe shows Texas saw net interstate migration of 76,000 people in 2024. Texas’ net interstate migration dropped nearly 50 percent from 2023, according to the analysis. Net migration refers to the number of incoming residents minus the number of outgoing residents.

California remained the top source of newcomers for Texas, sending nearly 77,000 residents to the Lone Star State in 2024, the analysis says. Florida ranked second, followed by New York, Colorado and Illinois.

“These trends reveal Texas’ continued pull from both high-cost coastal markets and other large Sun Belt states, resulting in a mix of affordability-driven and job-driven relocation,” StorageCafe says.

Putting a damper on the influx of new residents: a roughly 124 percent surge in Texas home prices over the past decade, according to StorageCafe.

“While the state remains significantly more affordable than California, its top feeder state, the once-wide pricing gap has narrowed,” says StorageCafe. “For many movers, Texas is still a relative bargain, but no longer an undisputed one.”

Nonetheless, Texas keeps attracting young, highly educated people, which bodes well for the state’s long-term economic outlook, StorageCafe says. More than half of new arrivals to Texas in 2024 held at least a bachelor’s degree, and the age of newcomers averaged 32.

Where are most of these young, highly educated newcomers settling?

Lloyd Potter, former Texas state demographer, tells StorageCafe that population growth in Texas is happening most rapidly in suburban “ring counties” at the expense of slowing growth in urban cores. Ring counties are on the outskirts of major metro areas.

“Many people are moving from urban cores to suburban rings seeking lower costs, newer housing, better schools, and more space,” Potter says. “Typically, a move to a suburban county will be within commuting or hybrid‑commuting distance of major metro economies.”

Artemis II makes historic call to space station with help from Houston Mission Control

History in the making

Still aglow from their triumphant lunar flyby, the Artemis II astronauts made more history Tuesday, April 7: calling their friends aboard the International Space Station hundreds of thousands of miles away as they headed home from the moon.

It was the first moonship-to-spaceship radio linkup ever. NASA's Apollo crews had no off-the-planet company back in the 1960s and 1970s, the last time humanity set sail for deep space.

"We have been waiting for this like you can’t imagine,” Artemis II commander Reid Wiseman called out.

For Christina Koch on Artemis II and Jessica Meir aboard the space station, it marked a joyous space reunion despite being 230,000 miles (370,000 kilometers) apart. The two teamed up for the world's first all-female spacewalk in 2019 outside the orbiting lab.

Koch told her “astro-sister” that she'd hoped to meet up with her again in space “but I never thought it would be like this — it's amazing.”

“I'm so happy that we are back in space together,” Meir replied, “even if we are a few miles apart.”

Houston's Mission Control arranged the cosmic chitchat between the four lunar travelers and the space station's three NASA and one French residents.

Koch described being awe-struck by not just the beauty of Earth, “but how much blackness there was around it.”

“It just made it even more special. It truly emphasized how alike we are, how the same thing keeps every single person on planet Earth alive,” she told the space station crew. “The specialness and preciousness of that really is emphasized” when viewing the home planet from the moon.

By late Tuesday afternoon, the Artemis II astronauts had beamed back more than 50 gigabytes' worth of pictures and other data from the previous day's lunar rendezvous, which set a new distance record for humanity. The highlight: an Earthset photo reminiscent of Apollo 8's Earthrise shot from 1968.

"While they are inspirational and, I think, allow all of us to really feel a little bit of what they were feeling, there's also a lot of science hidden inside of those images," said Mission Control's lead lunar scientist Kelsey Young. “The conversations and the science lessons learned are just beginning."

During a debriefing with Young, the astronauts recounted how they spotted a cascade of pinpricks of light on the lunar surface from impacting cosmic debris. The flashes lasted mere milliseconds and coincided by chance with Monday evening's total solar eclipse.

Young said it was too soon to know whether the crew witnessed an actual meteor shower or more random, run-of-the-mill micrometeoroid hits. Either way, there were “audible screams of delight” in the science operations center, she said.

Koch described being awe-struck by not just the beauty of Earth, “but how much blackness there was around it.”

“It just made it even more special. It truly emphasized how alike we are, how the same thing keeps every single person on planet Earth alive,” she told the space station crew. “The specialness and preciousness of that really is emphasized” when viewing the home planet from the moon.

The first lunar explorers since Apollo 17 in 1972, Wiseman and his crew are aiming for a splashdown off the San Diego coast on Friday to wrap up the nearly 10-day test flight. The recovery ship USS John P. Murtha left port Tuesday for the target zone.

It sets the stage for next year's Artemis III, a lunar lander docking demo in orbit around Earth. Artemis IV will follow in 2028 with two astronauts attempting to land near the lunar south pole.

As for the Orion capsule’s pesky potty, Mission Control assured the astronauts that no maintenance was required Tuesday. The toilet has been on-and-off limits to the crew ever since last week’s launch, prompting them to rely on a backup bag-and-funnel system for urinating.

NASA Administrator Jared Isaacman told the crew following the lunar flyby Monday night: “We definitely have to fix some of the plumbing” ahead of the next Artemis mission. Engineers suspect a clogged filter in the overboard flushing system.

Aside from the toilet and other relatively minor matters, the mission has gone well, Isaacman noted at a news conference Tuesday, “but I'll breathe easier when we get through reentry and everybody's under chutes and in the water.”