In every industry, there are two standards: the floor and the ceiling.
The floor is set by regulators. In healthcare, CMS establishes that floor and accrediting
bodies like The Joint Commission and Det Norske Veritas (DNV) enforce it. These standards matter. They protect patients. They ensure a basic level of safety.
But floors do not create excellence. They prevent failure. Across more than 150 industries worldwide, the ceiling is ISO 9001.
ISO 9001 is not a checklist. It is a management system certified through DNV for reliable performance and continuous improvement. It requires organizations to define what matters, design processes to deliver it, execute reliably, measure performance at every level and improve continuously.
In simple terms: It ensures we say what we do, do what we say, measure it and improve it.
Despite the evidence that good management and accountability are largely lacking in
healthcare, very few health systems have adopted ISO 9001 at scale.
That absence may explain one of healthcare’s most persistent paradoxes: despite decades of effort, safety improvement has plateaued, costs continue to rise and mergers have increased prices without delivering meaningful gains in quality.
In part this is because while hospitals have merged financially, they have not integrated how they manage quality or accountability.
Research from economist Nick Bloom shows that good management is rare in healthcare — and accountability is often absent. Without a disciplined management system, variation persists, learning is slow and performance depends on individual heroics rather than system design.
At University Hospitals, we chose a different path. We became the first health system in the country to achieve ISO 9001 certification for our corporate headquarters and the first health system in Ohio to achieve ISO 9001 certification across all our hospitals and the headquarters.
This required us to standardize processes, build transparent scorecards from the system to the bedside, and create shared accountability for results. It was not easy. But it was necessary.
And it worked not just for one measure but 100s of measures; costs, quality, complications, turnover, engagement, operating margin, revenue, patient experience and patient visits.
Those results were not a fluke or driven by isolated initiatives. They were the function of a system designed to perform.
That transformation was accelerated by our model of Living and Leading with Love — because systems alone do not change organizations. People do.
ISO provided the discipline and accountability. Love provided the energy.
Together, they allowed us to align 14 hospitals and our headquarters into one quality management system that learns, improves and delivers reliably at scale.
If we are serious about improving healthcare, we must move beyond the floor. CMS should consider incentivizing system-level ISO 9001 certification — not as another regulatory requirement, but as a pathway to better outcomes, lower costs and restored trust.
We do not have a knowledge problem in healthcare. We have a management system problem. The future will not be determined by who is largest — but by who can learn
fastest, improve continuously, and deliver reliably at scale.
Because the goal is not to clear the minimum bar.
It is to build a system worthy of the people it serves.
Peter Pronovost, MD, PhD, Chief Quality & Clinical Transformation Officer, University Hospitals
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