EN 15224 Healthcare Services Quality Certification

What is EN 15224? It is a quality management system standard for healthcare. The standard is designed for all organisations that provide health and medical services.

Differences between EN 15224 and ISO 9001. EN 15224 covers all of the requirements in ISO 9001 but adds clauses designed specifically for healthcare organisations. The key differences are the Risk Management and Patient Safety clauses.

Characteristics. The standard focuses on quality, customer focus, and cost benefit. Healthcare quality cannot be reduced to money or other simple units. It is not a service area you can measure with a phone-based customer-satisfaction survey alone. Many other factors must be taken into account.

EN 15224 Healthcare Quality Standard Clauses

1. Appropriate care: Treatment based on a clinician's assessment of the patient's minor complication grade.
2. Accessibility: Healthcare services that are reachable and accessible.
3. Continuity of care: Monitoring and follow-up after care and treatment.
4. Effectiveness: Treatment delivered to the patient in the shortest possible time.
5. Efficiency: Achieving the best result for the patient with the fewest resources.
6. Equity: The same service for every patient.
7. Evidence: Care based on documentation and evidence.
8. Physical and psychological support: Providing physical and psychological support with the patient's consent.
9. Patient information: Keeping the patient informed at every stage of treatment.
10. Patient safety: Identifying every risk tied to clinical operations.
11. Timely access: Healthcare delivered without unreasonable waiting times.

Certification Process. EN 15224 is voluntary, not a mandatory certificate or standard. Certification is open via impartial surveillance and audit. The process runs as follows:

• Briefing on the standard
• Internal observation and findings are reported
• Consultancy
• Certification audit
• Nonconformity management (if needed)
• Certificate issuance

What Are the Benefits?

• A quality marker for service provision in the community
• Higher profitability through continuously improving processes
• Cost savings
• Improved patient satisfaction

For any questions on the EN 15224 standard, reach out to Eurocert specialists.