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.