TSE ISO/IEC TS 17021-15

TSE ISO/IEC TS 17021-15 addresses the competence requirements for personnel involved in bodies that audit and certify management systems for quality in healthcare organizations. It provides a technical framework for the knowledge, skills, and sector understanding needed by people who participate in certification activities for healthcare-related management systems.

Healthcare quality management systems are closely linked to patient safety, continuity of care, consistency of clinical and administrative processes, risk-based thinking, and compliance with legal or institutional requirements. In this context, audit competence is not limited to general management system knowledge; it also depends on understanding how healthcare organizations operate, how their processes interact, and how certification decisions are supported by evidence. This TS complements ISO/IEC 17021-1, meaning it strengthens the personnel competence dimension for the healthcare field rather than replacing the general certification standard.

What sector-specific auditing competence means in practice

In general technical terms, competence in management system certification is the ability to understand the standard, apply it to an organization’s processes, evaluate objective evidence, and reach sound audit conclusions. In healthcare organizations, this is especially important because performance is shaped by interconnected areas such as multidisciplinary teams, patient-centered processes, records management, supply arrangements, and clinical governance. The focus of this document is the competence of personnel who need to work effectively within that healthcare-specific certification context.

• Competence framework for personnel in certification bodies
• Audit and certification of healthcare quality management systems
• A sector-specific competence layer added to ISO/IEC 17021-1
• Assessment of both clinical and administrative processes in certification work