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​UNI EN 15224 extends the requirements of ISO 9001 to the health sphere: it specifies the quality management system, as well as the relative risk management, in clinical processes concerning the various areas of the health sector, where the products mainly comprise services and where the customers are the patients.

Certification of conformity to this standard certifies the centrality of the patient in the management of all aspects of analysis of the clinical risk, appropriateness, accessibility and continuity of treatment, equity and safety.


  • Harmonise UNI 15224 with ISO 9001 and all system standards
  • integrate clinical risk management in the sphere of process planning, management and control
  • act as a model for the implementation of quality management systems in hospitals, nursing homes, surgeries and other health structures.


The offer of certification services by RINA SERVICES has added value thanks to our professionalism, competence and operating efficiency, as confirmed by numerous accreditations and the extensive experience of our inspectors.

In particular, in the Health and Services sector we have obtained:

  • dual ACCREDIA and ANAB accreditation for the ISO 9001:2008 scheme in sector 38 - Health and Social Services
  • numerous certifications, both in Italy and abroad, at hospitals, clinics and nursing homes, laboratories, rehabilitation facilities and social services
  • qualification of audit teams.



The certification procedure involves:

  • compilation and dispatch of the questionnaire
  • definition of the offer and stipulation of the contract
  • optional pre-audit
  • initial certification audit and documents review
  • issue of certificate
  • annual surveillance audits
  • recertification audits (every 36 months).

UNI EN 15224 can be applied on its own or integrated with UNI EN ISO 9001.


What structures does certification apply to?
It can be applied to all health organisations, such as hospitals, mental hospitals, dental surgeries, physiotherapy, occupational health services and social services.
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