A quality management system, or QMS, is a formalized framework that defines, documents and manages an organization’s processes, procedures and responsibilities to achieve consistent quality in products or services, thereby meeting customer and regulatory requirements. It centralizes document management, ensuring easy access to up-to-date records and facilitating better communication and collaboration between teams.
The exact size of the market is difficult to ascertain for several reasons. All the vendors are privately held, packages vary in size and complexity, and they include ancillary software, such as databases, as well as consulting costs.
Grand View Research estimates the QMS market at $11 billion, while Gartner suggests it could be as high as $25 billion, according to Sam New, director and analyst – supply chain at Gartner.
“It’s hard to estimate, because it’s hard to define exactly what a QMS product is, as some of them are contained within broader software applications. Also, a lot of vendors don’t disclose their QMS product line revenue,” New said.
What makes for a strong QMS?
A strong quality management system package is a combination of functionality, effective process integration, and compliance with recognized standards such as ISO 9001 or FDA regulations.
A quality QMS package has both core components and ancillary features and functions. Core components include quality assurance (QA), quality control (QC), document control, audit trails, supplier risk management, change management and compliance management. Additional features include cloud and mobile support, analytics and integration with other systems.
Emir Sabljakovic, director of conversation analysis at QC consultancy Authenticx, says the hallmark of a good QMS system is one that is customer experience-oriented. “We continue to assess how the customer or the patient interacts with your organization, and each of those touch points, how well we’re performing, and then being able to assess that performance at scale,” he said.
Renee Glendenning, owner of the Quality Control Collective, a provider of quality control training and education, says that document control is the number one element when it comes to quality control, whether it’s used in manufacturing or construction.
“The slogan at my company is that quality control is what remains after the dust settles. So, when everyone walks away from a project, quality control is what remains, and that’s what makes or breaks companies, whether they’re small or big,” Glendenning said.
Benefits to the enterprise
There are numerous benefits of using QMS software. QMS software automates many manual tasks, helping to reduce error rates and streamline workflows across departments, thereby increasing overall efficiency and productivity. This emphasizes and enforces compliance and efficiency, while also facilitating ongoing improvement and customer satisfaction across the organization, all of which contribute to a stronger reputation and improved financial performance.
Whether a company is in software or heavy manufacturing, quality control is essential. Beyond being nearly mandatory, a QMS provides several key benefits for organizations:
- Regulates quality control processes, which drives efficiency and adherence to industry compliance.
- Supports compliance with industry regulations and standards.
- Streamlines operational workflows and reduces redundancies.
- Enhances customer satisfaction through consistent product and service quality.
- Provides data-driven insights for better decision-making.
Glendenning says that the number one benefit she sees repeatedly is that it gives a centralized location for all the data. “Good software standardizes the way that the quality programs run across multiple projects, and it also gives it a unified location for all the documents, which is very important,” she said.
Challenges CIOs face and how to overcome them
As with any software package, QMS faces challenges to adoption. They range from integration with legacy systems to siloed data to good old resistance and reluctance to change.
New says siloed data is one of the biggest challenges for enterprises. “Sometimes it’s easy to function or operate in silos and become disconnected from enterprise-level strategy or from what is ultimately best for the overall enterprise architecture. Not enough organizations consider or do that,” he said.
New said other challenges include data migration from disparate, far-flung legacy systems, change management and user adoption, and finally, cutting through the hype and hysteria surrounding emerging tech and AI.
“The average organization isn’t really in a space or maturity level to use AI in a meaningful way right now,” he said. “Vendors are struggling with offering end-user communities pragmatic features and workflows with AI embedded that can be used in a meaningful way. So, it’s still in the early stages.”
Selection and implementation of best practices
It is challenging to compile a comprehensive list of best practices, as requirements vary from one industry to the next and between companies. However, there are some core practices that apply to everyone, such as phased rollouts and pilot programs.
Glendenning says best practices really are company-specific based on what they’re doing and what they are trying to accomplish. “It really goes back to making sure that the programs that you use are fit for your company, and they’re fit for the data that you want to pull out at an ownership level,” she said.
Sabljakovic says an enterprise should assess a potential platform based on its desired outcome, including what it wants out of the QMS, ways to support agents, the friction points in the journey and what it needs to do to enable the insights needed to reach its goals.
In creating a checklist for choosing a vendor, Glendenning says to look for their reputation, past reviews and how they set up their customer support for help. “There is no time to wait 24, 48, 72 hours. You can’t wait a long time for an answer. You want to know that there’s someone you can reach out and talk to,” she said.
Sabljakovic says that whatever tool a company chooses ultimately needs to solve the problem, whether that’s scaling or adapting to changing volumes over time while maintaining cost. He also strongly advocates the use of vertical over general-purpose products.
“Vertical healthcare, for example, is a space that is very complicated, with a lot of nuances, a lot of different regulations and compliance, things to consider. So, when picking a tool, you also want to make sure that it can meet those demands as well,” he said.
Measuring impact
Sabljakovic says the focus should be on ROI, since it can be tough to measure it in a QMS system. Success in manufacturing means the product functions properly and doesn’t malfunction or fail.
ROI on quality control and quality assurance is difficult to quantify. But Sabljakovic says it should be the focus when choosing a package, and not just products or staffing. “Generally, the focus really needs to be on that ROI, making sure that whatever vendor or tool we choose will ultimately add value back to you,” he said.
New believes that one of the simplest ways to measure ROI is by tracking cost reductions — specifically, decreases in the cost of quality and the financial impact of poor quality. If the CRM is connected to the QMS, companies can also measure the potential decrease in customer complaints.
Next steps for IT executives
So, what’s next for QMS in the enterprise? Sabljakovic says that IT needs to understand the manufacturing side to fully understand what he’s trying to do with QMS.
“It’d be really nice if the IT guys who are tailoring those kinds of systems understood the process and its construction,” he said. “It really helps when the IT guys and the programmer spend some time in the dirt, and they understand the process.”
Glendenning said IT departments need to embrace AI, cautiously. “It’s fascinating, but it’s not yet cost-effective for smaller companies. But I really believe we’re going to see AI taking over a lot of the site plans and a lot of the submittal reviews and even RFI writing,” she said.
New said there needs to be a push for alignment of quality strategy with business and IT strategy. “That’s huge. It’s something that I advise all the time, literally every single day. Too few organizations are doing that and are making some of these decisions in isolation with overly influential end user communities,” he said.
Andy Patrizio is a technology journalist with almost 30 years’ experience covering Silicon Valley who has worked for a variety of publications on staff or as a freelancer, including Network World, InfoWorld, Business Insider, Ars Technica and InformationWeek.
