Looking for a Quality Management Standard Designed Specifically for Healthcare?
You aim to manage your processes effectively and implement a robust quality management system—but feel that ISO 9001 doesn’t fully meet the specific needs of your healthcare organization?
EN 15224, often referred to as the “ISO 9001 for Healthcare,” is a dedicated quality management standard tailored for healthcare providers across all disciplines. It is a stand-alone document that builds on the foundation of ISO 9001, incorporating additional interpretations and requirements specifically relevant to the healthcare sector.
Key features of EN 15224 include:
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Full integration of ISO 9001 principles, adapted for healthcare environments
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A strong focus on clinical risk management throughout the planning, execution, and control of healthcare processes
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Applicability across the entire continuum of care—from diagnosis and treatment to prevention, physiotherapy, and long-term care
As cross-border healthcare grows in significance within Europe, EN 15224 plays an essential role in ensuring quality and consistency across healthcare systems. It is widely used for multidisciplinary certification and is fully aligned with European conformity assessment procedures.
Whether your organization is already certified to ISO 9001 or is considering transitioning to or pursuing certification under EN 15224, AACI is here to guide you through every step. We’ll help you understand the evolving structure and requirements and support you in aligning your systems with the latest standards in healthcare quality management.
How to become an ISO 15224 certified healthcare organisation?
- Application for certification
- Initial Audit (Stage 1)
- Initial Audit (Stage 2)
- Certification Award
- Periodical audits
- Re-certification audits
- Suspension and withdrawal
- Transfer from another Certification Body
- Use of certification marks and logos
- Changes that affect the certificate
Certification Mark
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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