Quality in healthcare: the contribution of UNI ISO 7101

In recent years, health systems around the world are facing increasingly complex challenges , which directly impact the quality, efficiency and sustainability of health care.
According to the World Health Organization, there will be a shortage of approximately 18 million health workers, including doctors, nurses, midwives, and other roles, by 2030 .

At the same time, universal health coverage remains a distant goal for many countries, and the progressive aging of the population —with the share of people over 65 estimated by ISTAT to reach 34.6% in Italy by 2050— is accentuating the demand for care and the organizational complexity of health services.

The framework: laws and regulations

In a context of increasing pressure on healthcare systems , therefore, it becomes essential to adopt management tools that guarantee quality, safety and sustainability.

In Italy, the Presidential Decree of 14 January 1997 and Legislative Decree 229/1999 defined institutional accreditation , based on structural, technological and organizational requirements for the authorization and exercise of healthcare activities.

In continuity with this path, Accredia has started voluntary accreditation , according to the standard ISO/IEC 17021-1, of the bodies that certify quality management systems in healthcare organizations according to UNI ISO 7101:2024.

Culture of quality and growth of trust

The UNI ISO 7101:2024 certification “Management of healthcare organizations – Quality management systems in healthcare organizations – Requirements” certifies the ability of healthcare organizations to:

• promote a culture of quality,
• offer person-centered care
• effectively manage risks to patients and staff.

Through continuous improvement and performance monitoring , this certification process helps organizations generate a more efficient use of resources and strengthens the trust of institutions, professionals and citizens in an increasingly safe, equitable and sustainable healthcare system.

ISO 9001 and ISO 7101

Compared to ISO 9001 , which is applicable to any type of organization regardless of sector, ISO 7101 places emphasis on aspects specific to the healthcare sector , such as:

• Access to care.
• Development of risk culture.
• Effective clinical communication.
• Use and protection of health information.
• Emergency management and system resilience plans.
• People-centered care, promoting inclusivity and diversity.
• Health literacy of users.
• Well-being of healthcare workers, including adequate training in managing ethical issues.

Therefore, while ISO 9001 provides general requirements for quality management systems, ISO 7101 offers specific guidance for healthcare organizations , addressing the unique challenges of the sector and promoting high-quality, safe and efficient healthcare.