UNI ISO 7101, CSQA is the first accredited body in Italy

CSQA is the first certification body in Italy to have obtained accreditation from Accredia for certification according to UNI ISO 7101 , the first international standard specifically dedicated to quality management systems in healthcare organizations.

This recognition certifies CSQA's expertise, independence, and impartiality in evaluating the systems adopted by healthcare organizations and guarantees that audits are conducted according to transparent, rigorous, and internationally recognized criteria.

This result confirms the role of CSQA, a publicly controlled certification body, in developing new tools capable of accompanying market evolution and responding to the needs of organizations, institutions, and citizens.

A management system built for healthcare

UNI ISO 7101 was created to bring the principles of quality management even closer to clinical and healthcare processes, the safety of care, and the outcomes for the person being cared for.

All organizations providing healthcare services, regardless of size, organizational structure, legal status, or management model, that assume direct responsibility for caring for the patient and that intend to systematically improve the quality, safety, effectiveness, and outcomes of healthcare can be certified according to this standard.

Key aspects include:

• clinical governance and the integration of quality, safety, ethics and clinical outcomes;
• the active involvement of patients, families and other stakeholders in decision-making and improvement processes;
• equity of care , with particular attention to reducing inequalities and barriers to access to services;
• management of care pathways and multidisciplinary and multiprofessional coordination;
• the culture of quality and safety , promoted at all levels of the organization;
• the management of health information and data , including confidentiality, availability and use for improving care;
• the sustainability of the healthcare organization, from an economic, social and environmental perspective;
• organizational resilience and the ability to adapt effectively to changes, crises, and unforeseen situations, ensuring the continuity and reliability of health services;
• innovation, digitalization , and the appropriate use of health technologies to support the effectiveness and safety of care.

Accredited certification therefore allows healthcare organizations to demonstrate, through independent assessment, their ability to systematically manage the quality of care and improve the safety, effectiveness, and efficiency of services.

From ISO 9001 to UNI ISO 7101

For healthcare organizations already certified according to ISO 9001, UNI ISO 7101 represents a natural evolution of the path undertaken.

ISO 9001 provides a solid, cross-cutting basis for quality management .

UNI ISO 7101 allows for further development of the system through requirements specifically developed for the healthcare sector and the complexity of its clinical, care, and organizational processes.

The integration between the two systems allows for the enhancement of what has already been achieved, identifying the requirements already covered and the aspects requiring evolution or strengthening.

An award that strengthens CSQA's commitment to healthcare

Accreditation represents a particularly significant step for CSQA and enhances the experience gained in the healthcare and social healthcare sector, in the evaluation of management systems, clinical-care processes, and organizational models.

"Trust isn't declared, it's demonstrated. In healthcare, this principle is perhaps more important than in any other sector. The UNI ISO 7101 standard offers organizations an internationally recognized tool to demonstrate their ability to manage quality, safety, and continuous improvement. For CSQA, being the first accredited body in Italy for this certification represents the result of a forward-thinking decision: investing early in a standard destined to become a benchmark for the sector. It means providing the healthcare system with expertise, independence, and tools capable of supporting its evolution toward increasingly reliable, transparent, and outcome-oriented models," states Maria Chiara Ferrarese, General Manager and CEO of CSQA.

Choosing to undertake a journey towards UNI ISO 7101 means investing in governance, safety, and continuous improvement of care, while strengthening transparency and trust among patients, professionals, institutions, and citizens.

CSQA provides healthcare organizations with specialized expertise to evaluate the path to certification and, for organizations already certified to ISO 9001, identify the most effective level of integration with the existing system.