In October 2023, the International Organization for Standardization (ISO) published ISO 7101, Healthcare organization management: Management systems for quality in healthcare organizations.[1] ISO 7101 is the latest in a series of management systems standards, which includes ISO 37301 on compliance management systems and 37001 on anti-bribery management systems. ISO standards are utilized extensively in Europe and by many multinational companies, including U.S. companies.
Many ISO standards have counterparts in the U.S. system. For example, ISO 37301 shares many of the same concepts as the U.S. Federal Sentencing Guidelines and guidance published by the U.S. Department of Health and Human Services (HHS) Office of Inspector General and the U.S. Department of Justice.
“ISO 7101 is the first international consensus standard for healthcare quality management. It prescribes requirements for a systematic approach to sustainable, high quality health systems, enabling organizations of any scale, structure, or region to:
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“create a culture of quality starting with strong top management;
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“embrace a healthcare system based on people-centred care, respect, compassion, co-production, equity and dignity.
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“identify and address risks;
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“ensure patient and workforce safety and wellbeing;
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“control service delivery through documented processes and documented information;
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“monitor and evaluate clinical and non-clinical performance;
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“continually improve its processes and results.”
Since ISO 7101 goes beyond the traditional boundaries of a broad compliance framework and addresses healthcare quality specifically, its logical U.S. counterparts can also be found in HHS guidance. And much like with ISO 37301, if your organization is meeting the expectations of HHS in terms of quality of care, it is likely also meeting the expectations of ISO 7101.
Nonetheless, the standards represent a benchmark by which healthcare organizations can evaluate their systems—even if there is no direct expectation of compliance with them. In fact, ISO 7101 describes a model for continuous improvement that organizations may find useful.
ISO 7101’s Plan-Do-Study-Act (PDSA) model provides a process that can be used to achieve continual improvement through cycles of ongoing performance measurement and assessment of changes, as follows:[2]
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Plan – establish healthcare quality objectives and processes necessary to deliver results in accordance with the organization’s healthcare quality policy.
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Do – implement the processes as planned.
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Study – monitor, measure, and assess processes against the organization’s policies, including its commitments, objectives, and operating criteria, and report the results.
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Act – take actions to continually improve.
In looking at the PDSA model, it has similarities to the framework we apply to our compliance programs, which isn’t a bad idea at all.