Evolution of Quality Management in Italian Healthcare (2016-2024) Beyond Mandatory Accreditation Through the International Organization for Standardization (ISO), Joint Commission International (JCI), and the New ISO 7101 Standard: A Scoping Review.

Abstract

In the Italian National Health Service (Servizio Sanitario Nazionale, SSN), healthcare quality governance operates through a dual-track system: mandatory institutional accreditation regulated at the regional level under Legislative Decree 502/1992, and voluntary third-party certifications such as International Organization for Standardization (ISO) 9001:2015 and Joint Commission International (JCI). The enactment of Law 24/2017 ("Gelli-Bianco") mandated clinical risk management (CRM), while ISO 7101:2023 introduces a paradigm shift toward people-centered quality management. This scoping review maps the adoption and integration of these quality frameworks in Italian healthcare. The review was conducted following the updated JBI methodology and reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews (PRISMA-ScR) checklist. The protocol was prospectively registered on the Open Science Framework (OSF). A systematic search was performed in PubMed/MEDLINE and Scopus from January 2016 to December 2024, complemented by a targeted grey literature search. The Population, Concept, Context (PCC) framework guided the research question. Data were extracted into a predefined charting table and synthesized narratively. Twenty-six sources were included. The Italian accreditation system shows persistent regional heterogeneity, with no peer-reviewed studies evaluating accreditation effectiveness during the review period. Law 24/2017 remains incompletely implemented, with 72% of clinical risk managers (CRMs) lacking regular interaction with regional centers. ISO 9001:2015 is the most widely studied voluntary standard, with 73.3% of respondents reporting continuous improvement. JCI accreditation remains concentrated in approximately 28 highly specialized centers. The first empirical study on ISO 7101:2023 demonstrated significant improvements in patient health literacy (66.35 to 76.29, p<0.001). The Agenzia Nazionale per i Servizi Sanitari Regionali (AGENAS) Programma Nazionale Esiti (PNE) documents a persistent North-South quality divide. The Italian healthcare quality landscape is evolving from a compliance-driven model toward an integrated, multi-framework ecosystem. ISO 7101:2023 represents a strategic inflection point as a potential unifying paradigm. Future research should prioritize the empirical evaluation of ISO 7101 adoption in Italian settings and the investigation of the Southern quality governance gap.