EN 15224:2016 Healthcare Quality Management System Certification for Companies and Institutions

EN 15224:2016 Healthcare Quality Management System Certification – Strengthen Your Clinical Excellence

Who Can Apply for EN 15224:2016 Certification?

The EN 15224:2016 certification is intended for healthcare organizations and providers, including hospitals, clinics, laboratories, outpatient centers, dental and medical practices, rehabilitation and elderly care facilities, diagnostic and imaging centers, telehealth providers, and healthcare support services. Applications must be submitted by authorized representatives or business owners. Both public and private institutions are eligible to apply.

What is EN 15224:2016?

EN 15224:2016 is the European quality management standard tailored specifically for healthcare services. Built on the ISO 9001 framework, it integrates clinical risk management, patient safety, evidence-based care, and continuity of care into a comprehensive quality management system. The standard guides healthcare providers to design and control processes that directly impact patient outcomes while ensuring transparency, traceability, and effective communication across multidisciplinary teams.

With EN 15224:2016, organizations define and monitor healthcare-specific quality characteristics such as clinical effectiveness, patient-centeredness, accessibility, timeliness, safety, and efficiency. The result is a structured approach that reduces adverse events, improves coordination of care, and enhances trust among patients, clinicians, and stakeholders.

When Was the Latest Version of EN 15224 Released?

The core version of the healthcare quality standard is EN 15224:2016, which is the widely referenced baseline in Europe.
All certificates issued by our system fully comply with EN 15224:2016 and are internationally valid for healthcare quality management.

Benefits of EN 15224:2016 Certification

• Measurable improvements in patient safety and outcomes
• Embedded clinical risk management across all care processes
• Stronger compliance with regulatory and accreditation requirements
• Enhanced interdisciplinary communication and documentation
• Higher patient satisfaction and trust in care delivery
• Competitive advantage in contracts, tenders, and partnerships

Who Is Eligible for EN 15224 Certification?

• Hospitals and integrated healthcare systems
• Private clinics and polyclinics
• Medical and dental practices
• Laboratories and diagnostic centers
• Rehabilitation, elderly care, and home-care services
• Telemedicine and digital health providers

How the EN 15224 Certification Process Works

• Click the “Apply Now” button on this page
• Register through our application panel
• Complete the form with your organization’s details
• Upload your documents and proceed with payment
• Your certificate will be delivered via email as a PDF within 7 business days

Remote Audit and Digital Review

Your healthcare processes and supporting documents will be reviewed digitally by the International Accreditation Board. No on-site inspection is required. Once approved, your certificate will be issued in PDF format with digital verification elements.

Why You Should Get EN 15224 Certified

• Reduce clinical risks and adverse events
• Standardize care pathways and handovers
• Demonstrate compliance and accountability to regulators and payers
• Improve patient experience and clinical effectiveness
• Build a culture of continuous improvement and evidence-based practice
• Strengthen your reputation with patients, partners, and insurers

Key Considerations

• All certificates are issued with international accreditation and are globally recognized.
• Every certificate includes a QR code and a secure verification link for instant online validation.
• Each document is digitally signed and officially stamped for authenticity.
• The entire application and review process is conducted remotely — no physical inspection required.
• We offer clear and competitive pricing with no hidden fees.
• In case your application is not approved, we provide a 100% money-back guarantee.

Business Advantages of EN 15224 Certification

EN 15224 certification evidences clinical quality and patient safety, helping you meet commissioning criteria, enhance insurer and regulator confidence, and differentiate your services in competitive healthcare markets and public procurements.

Validity & Renewal of Your EN 15224 Certificate

Your certificate will be valid for 1 year, in line with global ISO accreditation practices.
Annual renewal is available via our website.

Why Our EN 15224 Certification Is More Affordable

Our process is entirely online, eliminating on-site inspections, travel, and auditor costs. We pass these savings on to you through a customer-friendly pricing model, without compromising legitimacy or quality.

100% Money-Back Guarantee

If your application is not approved by the International Accreditation Board, you will receive a full refund. We stand behind our process with complete transparency and satisfaction assurance.

Frequently Asked Questions (FAQ)

How long does it take to receive the certificate?
Your digital certificate will be delivered via email within 7 business days.

Is EN 15224 different from ISO 9001?
Yes. EN 15224 is built on ISO 9001 but adds healthcare-specific requirements such as clinical risk management, patient safety, and outcome measurement.

Can small clinics get certified?
Absolutely. EN 15224 is scalable for organizations of all sizes, from solo practices to large hospital networks.

How can I verify my certificate?
Every certificate includes a QR code and a direct verification link for secure online validation.