Quality in clinical processes

UNI EN 15224 certification

The UNI EN 15224 standard extends the requirements of ISO 9001 to healthcare, specifying quality management systems in clinical processes and integrating clinical risk management in the planning, management, and control of processes.
The standard compliance certification attests to the centrality of the patient in managing all aspects of clinical risk analysis, the appropriateness, accessibility and continuity of care, as well as fairness and safety during treatments.
Certified healthcare facilities can thus be modelled to implement the quality management system in hospitals, nursing homes, outpatient clinics and other healthcare facilities.

Certification Procedure

  • Compilation of the information questionnaire
  • submission of the technical/economic offer which, once accepted, constitutes a service contract
  • audit at the company and related reporting
  • in the event of a successful outcome of the previous phases, certification is assessed by a technical committee
  • in case of successful completion of the previous phases, the certificate is delivered to the company
  • annual audit to maintain the certificate.

The UNI EN 15224 standard can be applied individually or in combination with UNI EN ISO 9001.

Why RINA?

RINA is accredited by ACCREDIA and ANAB for ISO 9001:2008 in the sector 38 - Health and Social Services. Our team issues numerous certifications, both in Italy and abroad, to hospital units, clinics and nursing homes, laboratories, rehabilitation services and social care.

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