How technology is modernising quality management
Quality management priorities differ from business to business. Highly regulated organisations must remain compliant at all times, while less regulated businesses often want to manage quality as cost-efficiently as possible, with limited human resources.
But despite new technologies creating more opportunities to modernise, many companies remain cautious about changing their quality management processes. Often, this leaves them reliant on outdated ways of working that slow decision making, increase manual effort and heighten the risk of errors. With a modern quality management system, businesses can reduce time-consuming admin, create more structured ways of working and give teams access to the same data, making quality easier to manage consistently across the organisation.
In this Q&A, Mika Salonoja, Senior Compliance Architect, and Jimmy Graveley, Solution Architect at Columbus Sweden, discuss the challenges of legacy quality management systems, where AI can add value and why QMS is more than a compliance investment.
Can you give us some background on QMS today, and how it differs between highly regulated and less regulated industries?
Mika: Industries like life sciences, pharmaceuticals, and civil aviation live and breathe quality and compliance. Because the regulations are so strict, many businesses remain cautious about changing established processes and ways of working. This means quality management in a lot of organisations is still highly manual and relies on paper-based processes.
These industries can also be surprise-audited at any time, and a single product failure can have serious consequences. Take Philips for example. The medical imaging equipment manufacturer had to close down its US plant in Cleveland after the Food and Drug Administration (FDA) found issues at the facility. This impacted the business not only financially, but reputationally too.
The challenges are different in less regulated industries such as food and beverage, energy and shipping. Quality is still important, but these businesses also need to be highly efficient. That means they need a QMS that can reduce administrative work and make sure product or safety issues on the factory floor are not only recorded but properly followed up and fixed.
One high-consequence example of where this didn’t happen is the prototyping of the McDonnell Douglas DC-10 aircraft. During test flights, a cargo bay door issue was identified but not properly fixed before the aircraft went into production. Years later, a passenger aircraft experienced the same issue, resulting in a fatal accident. It’s a tragic example, but it shows what can happen when a manual quality system records a problem without making sure the right corrective action is completed.
What are the common frustrations businesses face with legacy QMS and document control processes?
Mika: One of the biggest frustrations is that the processes are very time-consuming. I’ve seen businesses where it could take weeks to capture signatures for one document, and then months to distribute it across manufacturing sites and start training. This means the system quickly becomes inefficient and expensive.
Training is another big frustration. Whether a business uses written quality documents, process maps or flow charts, it still needs to prove people have taken the right training and understood the content. Without formal evidence, it becomes a business risk. If the quality management system lacks automation or intelligence, it becomes slow, expensive and dependent on the one person who knows where all key documents and records are stored. If that person leaves, the business can find itself in trouble very quickly.
How have businesses traditionally viewed quality management?
Jimmy: Many companies have viewed quality management from a cost perspective first. Some still see it as an extra burden that has to be managed. But they should see it as a business driver, because it can improve the organisation, support better ways of working and strengthen how the business delivers to end customers.
Mika: I would add that quality management can also create value by helping businesses present themselves as quality-focused organisations. For example, certifications such as ISO 9001 can put a business in a stronger position in customer conversations. They show the market that the business is committed to professional standards and quality.
How are compliance expectations changing for quality management?
Mika: Regulations are often still behind how modern IT systems work. In many cases, they don’t fully recognise cloud, AI or mobile devices. They still refer to requirements such as qualifying hardware, when a lot of businesses now use cloud-based systems. That creates a challenge for quality management because businesses need to use modern technology, but they must also provide formal proof that the system works as intended.
Jimmy: I would say that the way businesses validate systems is changing. Classical CSV work practices are moving towards a more flexible approach to system validation, especially as more quality-impacting systems become cloud-based. Before, the company had full responsibility for managing the system. With cloud systems, businesses often work through a shared responsibility model, where suppliers like us also have responsibility for operating parts of the system. So, expectations are changing in how companies and suppliers work together, and how responsibility is shared.
Why should businesses view a quality management system as more than a compliance investment?
Jimmy: A quality management system is a key part of how a business works. It helps organisations create a structured and controlled way of working to make sure issues aren’t missed. That could be errors, defective products, unclear processes, or people working outside the standard process. This consistency helps reduce the cost of mistakes and makes it easier for people to understand how work should be done. If the system is easy to understand and easy to use, quality management and business development go hand in hand.
Mika: The value also comes from better efficiency and transparency. In highly regulated industries, businesses invest a lot in quality because they have to. But in less regulated industries, businesses still need to avoid product recalls, safety issues and reputational damage, without having to build a large team to manage quality manually.
That’s where an intelligent QMS can create value. With the right technology, supported by AI in the right areas, a quality management system can make sure issues are visible and take care of the tedious administrative work.
Where can AI create the most value inside a QMS?
Mika: We can use AI to help create these solutions, for example by generating training material, training videos and supporting parts of the technical build. For businesses, the clearest value is better search. Instead of only searching for keywords, AI can help find information across large volumes of documents and database content. It can also help businesses search for trends and patterns. Regulated industries are naturally cautious about exposing business content to public large language models. That’s why AI needs to operate within the business’s own secure environment.
Jimmy: The easiest step towards more intelligent services is around documentation, such as procedures and work instructions. If AI can use that material, it becomes easier for people to find the right information. In simple terms, people can chat with their QMS. Agentic AI is the big topic at the moment, and we’re still understanding how that will apply, but there could also be ways to use AI to support areas such as issue management in the future.
Can you share a real-life example of how intelligent document management has improved QMS processes?
Mika: One example is a large international medical device and health tech manufacturer with 10,000 employees and 24 factories across three continents. The company had grown through mergers and acquisitions, leaving different countries with local quality procedures, work practices and legacy IT systems. Managing quality manually had become resource-heavy and dependent on a small number of key people. Even distributing an approved quality document to each site could take around two weeks and involved a lot of manual email work.
Using Columbus QMS, we helped them create one validated platform for global and local quality documentation, production and business records, and IT system validation. The solution also allowed each site to adapt global procedures for local requirements, such as legislation, IT setup or language, while maintaining document control and approvals. This gave the business a more consistent, transparent and efficient way to manage quality across sites.
What should organisations consider when moving from static quality processes to a more intelligent QMS?
Jimmy: We would recommend starting with the specific problem the business is trying to solve. For low and mid-regulated businesses, it’s often about organising controlled documents, such as policies, guidelines, and work instructions. But they usually also need a clear framework for managing training records and showing that training is complete, valid and up to date.
For highly regulated businesses, the requirements are broader. They need to make sure issues are followed up properly, which often means having automation, guidance and clear action lists in place. That’s where an intelligent quality management system can help by giving businesses a structured way to manage documents, training, issues and follow-up actions in one controlled process.
Mika: Our quality management solution is designed to support several use cases such as quality document control, process maps, risk management and validation. It’s also configurable, meaning businesses can start with the use cases most relevant to them and bring in other areas later if needed. That makes the system more future-proof and able to support different levels of regulation.
But alongside the technology, we also advise businesses on how to choose and shape the right quality management system for their needs. There’s no true out-of-the-box QMS, because every business has its own processes, regulatory requirements and ways of working. The value is in controlled configurability.
Without that configurability, businesses risk issues like processes not matching day-to-day operations, teams creating workarounds, regulatory or organisational changes becoming harder to manage, and unclear ownership, approvals and audit trails across teams and systems. When we guide a business through this process, the goal isn’t to make heavy customisations. It’s about configuring the system within a controlled framework to make sure it fits the business while still supporting compliance, consistency and long-term use.
Achieve excellence with an intelligent QMS
With the right quality management system, organisations can make quality processes easier to control, follow and prove. At Columbus, we combine our QMS, ERP and business-critical systems expertise to help organisations connect quality processes with the systems and workflows that support daily operations. To discuss your business needs in more detail, reach out to us using the contact details below.
