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A New Era of Healthcare: Inside ISO 7101, the First International Standard for Healthcare Quality Management


Standard Enhances Quality of Healthcare Delivered Globally

As new technologies like AI and robotics advance healthcare practices, clinicians and caregivers need guidance and clarity to help them deliver effective, efficient, timely, and risk-minimized safe care. A newly published standard, relevant to all healthcare organizations regardless of size, structure, or location, does just that: ISO 7101:2023, Healthcare organization management—Management systems for quality in healthcare organizations, is the first international standard for healthcare quality management.

The standard was developed under U.S. leadership of the International Organization for Standardization’s (ISO) Technical Committee (TC) 304, Healthcare organization management, with 30 nations contributing. As the U.S. member body to ISO, the American National Standards Institute (ANSI) holds the secretariat of ISO TC 304, with responsibilities delegated to InGenesis. InGenesis also administers the ANSI-accredited U.S. Technical Advisory Group (TAG) administrator to the TC.

Here, ANSI takes a closer look at the current pulse of the healthcare industry, and how standard 7101 can support a new era of improved healthcare.

Enhancing the Quality of Healthcare Delivered Globally: ISO 7101:2023

A look at the current state of the healthcare industry around the world reveals a number of challenges and demanding conditions, including workforce shortages, inflation amid decreasing financial resources, and a general uptick in the number of people needing healthcare services, especially with aging populations on the rise. The worldwide COVID-19 pandemic underscored the importance of technological healthcare systems and the need for structured management systems to deliver quality care to patients.

ISO TC 304 launched its standardization efforts in 2016 to address these challenges and improve care outcomes for patients. Using systematic, evidence-based methods, ISO 7101 helps organizations to deliver high-quality healthcare. The standard was designed for multiple types of users, including ministries of health, public and private healthcare systems, hospitals, clinics, non-governmental organizations and agencies that provide healthcare services—among others.

“More than 20 years have passed since the Institute of Medicine’s seminal studies, ‘To Err is Human’ and ‘Crossing the Quality Chasm,’ highlighted failures in the U.S. healthcare system related to the provision of quality care,” said Dr. Veronica Muzquiz Edwards, chair, ISO/TC 304. “Despite the international attention and focus these reports generated on improving the quality of care, progress in realizing this goal has been variable at best. What has been missing in this effort is a systematic evidence-based solution that can be applied across a variety of healthcare settings. The development and application of an international standardized quality management paradigm is key to the identification and mitigation of risks to ensure quality of care in a rapidly evolving environment.”

When implemented, the standard can help guide organizations to focus on timely, safe, and people-centered care, while highlighting the urgency of adaptation due to the surge of virtual healthcare and technological advances. ISO 7101 prescribes requirements to:

  • create a culture of quality starting with strong top management; 
  • embrace a healthcare system based on people-centered care, respect, compassion, co-production, equity, and dignity; 
  • identify and address risks; 
  • assure patient and workforce safety and wellbeing; 
  • control service delivery through documented processes and documented information; 
  • monitor and evaluate clinical and non-clinical performance; and
  • continually improve its processes and results. 

Ultimately, this standard, which does not override legal responsibilities, serves to improve patient safety, reduce costs, improve efficiency, and boost reputation and market share.

“Clearly, this standard is intended to improve patient safety, reduce costs, and improve efficiency,” said Dr. Muzquiz Edwards. “It is my hope that the ISO 7101 standard is adopted across the continuum of healthcare to foster a just culture focused on quality and patient-centered care. I believe the standard will also promote the development and sustainment of high reliability healthcare organizations that are agile in identifying and addressing the inherent risks associated with the unprecedented pace of change in the delivery of healthcare.”

Access more information about ISO 7101:2023 on ISO’s webpage.

About ISO TC 304

Formed in 2016, ISO TC 304 focuses on standardization in the field of healthcare organization management comprising terminology, nomenclature, recommendations, and requirements for healthcare-specific management practices and metrics (e.g., patient-centered staffing, quality, facility-level infection control, pandemic management, hand hygiene) that comprise the non-clinical operations in healthcare entities.

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Jana Zabinski

Senior Director, Communications & Public Relations


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Beth Goodbaum

Journalist/Communications Specialist


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