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ISO 7101:2023

Healthcare organization management — Management systems for quality in healthcare organizations — Requirements

Standard Details

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:

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

General Information

Status : Published
Standard Type: Main
Document No: ISO 7101:2023
Document Year: 2023
Pages: 35
Edition: 1
  • Section Volume:
  • ISO/TC 304. Healthcare organization management
  • ICS:
  • 03.100.70 Management systems *Standards included in this sub-group shall also be included in other groups and/or sub-groups according to their subject *Including environmental management systems (EMS), road traffic management systems, energy management systems, hea
  • 11.020.01 Quality and environmental management in health care *Including quality and environmental management in health care technology *Health care management systems, see 03.100.70 *IT applications in health care technology, see 35.240.80

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ISO 7101:2023
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