Structural alignment and thematic complementarity between ISO 7101:2023 and Türkiye's hospital quality standards: a...

ISO 7101:2023, adopted in Türkiye as TS ISO 7101:2023, is an international management system standard for healthcare quality management published by the International Organization for Standardization (ISO) in October 2023 and structured according to ISO's harmonised high-level architecture. SKS Hastane Sürüm 6.1 (Sağlıkta Kalite Standartları Hastane Sürüm 6.1) is Türkiye's national hospital quality standards framework, comprising 5 dimensions, 46 sections, 523 standards, and 1,599 assessment criteria calibrated to hospital practice. Both documents coexisted within the Turkish health system at the time of this analysis: TS ISO 7101:2023 was adopted by the Turkish Standards Institution (TSE) in November 2023, while SKS Hastane Sürüm 6.1 has been in use since its publication in 2021. Despite the potential relevance of both frameworks to hospital quality governance, to the author's knowledge, no published study has systematically compared the structural and thematic alignment of ISO 7101:2023 and SKS Hastane Sürüm 6.1. This study aimed to examine the degree and nature of correspondence between ISO 7101:2023 and SKS Hastane Sürüm 6.1 across a comprehensive set of hospital quality management domains.

A qualitative document analysis with structured comparative mapping was conducted using the primary texts of ISO 7101:2023 (accessed as TS ISO 7101:2023) and SKS Hastane Sürüm 6.1. Fourteen analytical dimensions were specified a priori, covering organisational context, leadership and governance, quality planning, patient/person-centred care, patient safety and risk management, workforce competence, clinical and service delivery processes, information management, resource and infrastructure management, external provider management, performance measurement, incident reporting and learning, continuous improvement, and accessibility and equity. A seven-category coding scheme was applied to each dimension: Full Convergence (FC), Partial Convergence (PC), ISO-Dominant Management System Emphasis (ISO-D), SKS-Dominant Operational Specificity (SKS-D), Complementarity (COMP), Limited Explicit Correspondence (LEC), and No Direct Correspondence (NDC). Coding categories are analytical, not evaluative. Standard-level verification extending to confirmed standard codes and assessment-criteria-level content was conducted for five dimensions (D2, D3, D5, D8, D11). ISO 7101:2023 text is paraphrased with clause references; the document is copyrighted and is not extensively quoted.

Thirteen of the fourteen analytical dimensions were classified as Partial Convergence (PC). Dimension 7 (Clinical and Service Delivery Processes) was classified as Complementarity (COMP). No dimension was classified as Full Convergence or No Direct Correspondence. The Partial Convergence pattern reflects shared quality management intent across all domains, accompanied by systematic differences in documentary logic, prescriptive specificity, and regulatory mechanism. ISO 7101:2023 addresses quality domains through normative "shall" obligations within a harmonised management system architecture, leaving implementation methods to the organisation. SKS Hastane Sürüm 6.1 addresses the same domains through prescriptive, surveyable hospital standards and assessment criteria. Standard-level verification confirmed operationally specific requirements in SKS across governance committee structures (KKY06-10), risk management (KRY01-05), patient safety (KKY07), information system security and backup (DBY05, DBY10, DBY13), indicator management (GGİ01-07), and national performance reporting. Several ISO constructs - including formal change management planning (Cl. 6.3), risk awareness culture monitoring (Cl. 6.1.2), structured internal audit with independence criteria (Cl. 9.2), and eleven-input management review (Cl. 9.3) - were not confirmed as single equivalent standards in the verified SKS sections.

ISO 7101:2023 and SKS Hastane Sürüm 6.1 show broad thematic overlap across hospital quality domains. SKS Hastane Sürüm 6.1 provides an operationally specific, nationally calibrated quality infrastructure for hospitals in Türkiye. ISO 7101:2023 provides a complementary management-system architecture that may supplement SKS's operational standards with structural constructs for leadership accountability, quality objective documentation, change management planning, and cyclical system evaluation. The two frameworks are better characterised as potentially complementary than as competing. These findings are based on document-level analysis and cannot be interpreted as evidence of implementation effectiveness. Empirical research is needed to assess how the frameworks interact in hospital practice and to determine what benefits, if any, alignment may offer for hospital quality governance in Türkiye.