From Crisis to Culture: The History of Quality Management Systems

A Quality Management System, or QMS, is often now viewed as a necessary cornerstone of regulated industries such as life sciences or pharmaceuticals. But quality wasn’t always as structured or essential as it is today. The evolution of the quality management system is one shaped by public health crises, regulatory reform, and technological innovation. Here's how we got here.

1960s: Tragedy Sparks Reform

The modern concept of QMS took root in the 1960s, catalyzed by the thalidomide disaster and the passage of the Kefauver-Harris Amendments in the U.S. These events underscored the need for formal oversight and quality control in drug development. During this decade, the FDA issued its first GMP (Good Manufacturing Practice) guidelines, and the World Health Organization followed with its own standards in 1969. The idea of a Quality Control Unit was also born—a dedicated team responsible for maintaining compliance and product integrity.

1970s: Formalizing the Framework

The 1970s saw a focus on formalizing GMP regulations for both drugs and devices. QMS expectations began to move from suggestions to legal requirements. Manufacturers began to be legally obligated to document and validate their processes, laying the foundation for modern compliance.

1980s: Enter Global Standards

As the industry became more global, so did the push for standardized quality. The first ISO 9001 quality standard launched in 1987, setting the stage for international harmonization. Europe expanded GMP and Quality Assurance guidelines, and the Declaration of Helsinki laid the groundwork for ethical clinical trial conduct, feeding into the development of Good Clinical Practice (GCP).

1990s: Improving the Global Baseline

The 1990s saw the instituation of the International Council for Harmonisation (ICH) and the publication of the E6 GCP Guideline, a global standard for the ethical quality standard in clinical trials. Meanwhile, the FDA restructured device GMP into the Quality System Regulation (QSR), and ISO 13485 was introduced specifically for medical devices. Electronic systems also entered the spotlight with the FDA’s 21 CFR Part 11, establishing standards for computerized system validation.

2000s: Risk Management and Continued Improvements

The of the century brought a mindset shift—from documentation and control to risk management and quality by design. Initiatives like ICH Q9 (Risk Management) and ICH Q10 (Pharmaceutical Quality System) further emphasized the proactive approach to quality. Regulators began to expect continuous improvement and management engagement in addition to adherence to procedures.

2010s: Lifecycle Thinking and Quality Maturity

In the 2010s, the focus on quality expanded to the entire lifecycle of quality systems. The updated ICH guidelines put an emphasis oversight, vendor management, and the use of electronic systems. Regulators began to synchronize expectations across borders, and terms like "quality culture" and "maturity models" started to dominate the conversation.

Today and Beyond: AI, Automation, and Culture

These days, a QMS on paper is no longer enough. Regulatory expectations span the entire product lifecycle, and there’s a growing emphasis on quality culture—the idea that quality should be embedded in an organization’s DNA.

Technology now plays an increasingly important role. AI and automation are now being explored to help with policy drafting, training, CAPA management, and even audit readiness. Tools that once supported manual, disconnected tasks are evolving into fully integrated quality ecosystems.

Why It Matters

Since inception, quality management systems have been shifting from regulatory checkbox to a strategic enabler of compliance, efficiency, and trust. Whether it's preventing trial delays, safeguarding data integrity, or protecting patient safety, a well-designed QMS is more than infrastructure—it’s insurance.

As Jay Smith, Trial Interactive’s Head of Product put it during a recent webinar:

“A strong QMS isn’t just reactive—it’s the net that catches issues before they hit the ground. It’s how you build resilience into the DNA of your organization.”