ISO7101:2023

Management of healthcare organizations

Quality management systems in health organizations

What is ISO 7101?

ISO 7101 is the first international standard for quality management of healthcare organizations. It prescribes the requirements for a systematic approach to sustainable and high-quality health systems that enables organizations of any scale, structure or region to:

  1. Creating a culture of quality starting with strong management;
  2. Adopting a health care system based on people-centered care, respect, co-production, equality and dignity;
  3. identify and address risks;
  4. Ensuring patient and workforce safety and well-being;
  5. control of service delivery through documented processes and documented information;
  6. Monitoring and evaluation of clinical and non-clinical performance;
  7. Continually improve your processes and results.

Why is ISO 7101 important?

Healthcare organizations around the world have been facing important threats for several years, such as decreasing financial resources, shortage of manpower, increasing number of people needing care as a result of aging population, increasing rates of chronic diseases, lack of information for decision making. Manufacturing, lack or inadequacy of medical equipment and drugs and lack of clear governance of the healthcare system are other threats to healthcare organizations that must be controlled and followed up.

Benefits of implementing and obtaining ISO7101 certification
  • Quality assurance provided to health care.
  • Improved patient safety.
  • Cost efficiency.
  • Increase operational effectiveness
  • Strengthen reputation and increase market access