Digitalization is no longer just a buzzword, but a reality in practice – especially in quality management. Anyone who still believes today that they can remain competitive with analog processes and rigid inspections will be quickly left behind by more complex products, growing volumes of data, and increasingly demanding customer and regulatory requirements. Digitalization in production is fundamentally changing not only manufacturing processes but also the understanding of the role of quality managers.
This change is not an end in itself. It is an opportunity to sustainably improve internal and cross-organizational processes. Products increasingly consist of countless individual parts, and companies are closely interconnected with customers, suppliers, and other interested parties. This is precisely why the proper handling of quality data is becoming a decisive factor for success. A purely cause-and-effect approach is no longer sufficient – what is needed is systemic thinking, as essentially required by ISO 9001 with its emphasis on the “context of the organization.”
From this perspective, nine key areas of action for digitalization in quality management can be identified, which are organized into three perspectives:
Depending on the industry, company size, and objectives, individual areas can be weighted differently. One thing is clear, however: a digital quality management system that keeps all nine areas in view gives companies a genuine competitive advantage. In the following, we present all nine areas of action in detail.
The starting point is the so-called (Automotive) Core Tools – six established methods defined by the VDA that, among other things, support the requirements of IATF 16949:
These tools have been an integral part of the automotive industry and its supply chains for years. Implemented with software support, they form a continuous quality control loop that has long surpassed many of the discussions surrounding “Industry 4.0” in practice. For quality managers, these core tools will therefore remain one of the most important areas of focus in the future – precisely because customers are increasingly looking for a consistent “common thread” across all methods during audits.
Customer-specific requirements, standards such as ISO 9001 or IATF 16949, as well as legal regulations, shape the day-to-day work in quality management like hardly any other topic. The challenge lies in reconciling often ambitious external requirements with one’s own, sometimes conflicting organizational structures – a task made more difficult by smaller batch sizes and increasing product customization.
With the introduction of a uniform chapter structure in the management system standards (Harmonized Structure), additional effort is also to be expected in the short term. It is not uncommon for quality management to be accused of building an “ivory tower” of bureaucracy with ever-new, barely comprehensible requirements. Yet it is precisely this criticism that also presents an opportunity: Quality managers should not only focus on mere compliance with standards but should actively contribute their expertise to the design of business processes. Only when quality work is truly embedded in the company’s structures can requirements be met sustainably.
A decidedly uncomfortable but important area of action: Does quality management enjoy grandfathering protection against the change that other departments have long been subject to? Or is it even included in discussions about new business models and necessary changes?
The fine line lies between actively shaping the future within the company and reacting to external customer requirements. Those who participate early on in internal discussions about future topics are better prepared when customers set new expectations for quality work. At the same time, it’s clear that growing demands and limited personnel resources are making it increasingly impossible for individuals to handle all their tasks. The role of the quality manager must therefore be redefined – moving away from purely operational responses toward strategic involvement in business processes, employee training, and sustainable value creation for customers and other stakeholders.
While products are becoming easier for end customers to use, their actual manufacturing is becoming increasingly complex. A modern LED headlight consists of around 200 individual parts, while a complex medical device comprises up to 3,000 components. Instead of a traditional supply chain, experts today more accurately refer to complex supply networks.
At the same time, the increasing digitization of data is opening up new possibilities: An inexpensive RFID chip, costing just a few euros per year, already provides additional information on location, temperature, or humidity. Clinging to old, cherished testing methods is no longer an option here – anything that can be automated, both technically and economically, will be automated in the future. Quality managers play a crucial translator role between what is technically feasible and the needs of the business units. However, one thing remains important: End-to-end, software-supported data availability throughout the entire production cycle, as well as close, collaborative cooperation within the supply network, are fundamental prerequisites for consistently high quality.
Hardly any other field collects as much data as quality management – for example, through statistical process control (SPC), which draws on decades of experience in working with algorithms. But data alone does not create added value. What matters is deriving concrete actions from it, rather than merely collecting it.
It is helpful here to distinguish between “datafication” and “digital transformation”: If analog information is merely converted into digital data (such as an 8D report that is processed digitally instead of on paper), this is datafication. If, in addition, this report is shared with suppliers on a common platform and thereby changes existing processes, this is referred to as true digital transformation. Especially in digital quality management, there is enormous, often untapped potential here – provided that the human factor is taken into account and the benefits of new software solutions are actively communicated.
According to the VDI, the Digital Factory describes a comprehensive network of digital models, methods, and tools – from simulation to 3D visualization – that are interconnected through end-to-end data management. The goal is the holistic planning and continuous improvement of all structures, processes, and resources of a real factory in its digital representation.
For quality management, this means that changed customer specifications, lot size 1, and product-specific inspection plans are becoming part of everyday operations. Those who rely on rigid organizational structures will not be able to meet the demands of a networked, automated production environment. When implemented correctly, however, companies benefit from significantly greater data transparency, a more realistic zero-defect production, and faster adjustments to manufacturing parameters. Digitalization at any cost is not the goal here – every company must find the cost-benefit ratio that works for it. One thing is clear, however: without a methodical shift in thinking regarding quality management, the digital factory will remain a patchwork.
ISO 9001 requires companies to address their own purpose, mission, and the expectations of interested parties – all of which feed into the quality policy. Crucially, however, this policy must not merely be displayed on the company’s website for promotional purposes; it must actually be put into practice in day-to-day operations.
Closely linked to this is the question of ethics and sustainability. Good product quality that relies on child labor, environmental destruction, or questionable tax practices is not only ethically questionable but also uneconomical in the long run. Not least due to the Supply Chain Act, companies are increasingly taking responsibility – including for their suppliers’ processes. Digital quality management software, such as that used for key performance indicator (KPI) management and risk minimization, can help companies efficiently implement these requirements.
Quality management always operates within the classic triangle of tension between quality, time, and costs. Digitalization offers new opportunities to optimize processes, work faster, and use data in a targeted manner – the challenge lies in achieving good quality without sacrificing efficiency, and vice versa.
Those who focus solely on short-term cost reduction – for example, through offshoring or aggressive pricing strategies – risk compromising customer satisfaction and competitiveness in the long run. Sustainable success arises when quality is understood as a leadership responsibility – embedded in an integrated management system (IMS) that takes the interests of all stakeholders into account. The artificial separation of quality management and pure quality assurance, as well as an obsession with certifications, should be a thing of the past.
Often positioned in middle management, quality managers frequently refrain from actively engaging in major change processes – out of concern that their voices will not be heard sufficiently against powerful functional departments. Yet it is precisely here that enormous potential lies: The revision of ISO 9001 explicitly calls for a systemic approach that is not oriented toward departmental boundaries.
Quality managers possess precisely the systems knowledge required for successful organizational development – from modeling cross-functional processes to sustainable supplier development. To make this knowledge visible, quality managers must take the initiative themselves, reach out to colleagues, and position themselves as co-creators of digital transformation – rather than waiting for an invitation to the “big push.”
The nine areas of action demonstrate that digitalization in quality management is far more than just the introduction of new software. It requires a new understanding of one’s role – from merely complying with standards to actively shaping corporate strategy. Those who have a firm grasp of regulatory fundamentals, can handle complex products and growing volumes of data, and at the same time play a strategic role in shaping the company’s future can turn digitalization in production into a genuine competitive advantage.
With a well-thought-out, software-supported strategy for digital quality management, all nine areas of action can be successfully addressed – from automotive core tools to the digital factory and a quality policy that is put into practice. The key success factor here remains: quality managers who actively engage themselves and inspire others within the company.
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