ISO 7101:2023

Why ISO 7101 Certification is a Game-Changer in Healthcare

ISO 7101:2023 is the first global standard specifically designed for quality management and leadership in healthcare organizations. Developed to complement existing healthcare regulations and accreditation systems, it sets a new benchmark for excellence, accountability, and patient-centered care.

Unlike generic management system standards, ISO 7101 is tailored to the unique challenges and responsibilities of healthcare delivery. It focuses on aligning clinical quality, governance, and strategic leadership to drive measurable improvements in patient outcomes and organizational performance.

Key features of ISO 7101 include:

  • Integration of clinical quality and organizational governance
  • Emphasis on patient safety, equity, and access
  • Alignment with the principles of sustainable, resilient healthcare systems
  • Promotion of leadership accountability and a culture of continuous learning

Certification to ISO 7101 demonstrates that your organization not only meets international standards but also embraces a holistic, future-ready approach to healthcare excellence. To be certified, your organization must implement a robust Healthcare Quality Management System (HQMS) that fulfills the requirements of the standard and supports ongoing improvement.

How to become an ISO 7101:2023 certified healthcare organisation?

  1. Application for certification
  2. Initial Audit (Stage 1)
  3. Initial Audit (Stage 2)
  4. Certification Award
  5. Periodical audits
  6. Re-certification audits
  7. Suspension and withdrawal
  8. Transfer from another Certification Body
  9. Use of certification marks and logos
  10. Changes that affect the certificate

Achieving compliance with Quality Management Standards is a significant accomplishment, formally recognized by the awarding of AACI’s Medal of Certification.

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