Overview
ISO/IEC TS 17021-15:2023 specifies competence requirements for personnel involved in the audit and certification of management systems for quality in healthcare organizations. Designed to complement ISO/IEC 17021-1, this Technical Specification clarifies the knowledge and attributes expected of auditors, audit teams, technical experts, report reviewers and certification decision-makers when assessing conformity to healthcare quality management systems (notably those using ISO 7101). It emphasises collective team competence, sector-specific knowledge and safe, people-centred auditing practices.
Key Topics and Requirements
-
Scope and relationship to ISO/IEC 17021-1: Complements generic competence requirements by specifying healthcare-specific knowledge and skills.
-
Generic competence definition (Clause 4): Certification bodies must define competence for each certification function, taking into account ISO/IEC 17021-1 and this TS.
-
Audit team composition (Clause 5.1): Teams must collectively possess the competence to achieve audit objectives; not every member must have identical skills.
-
Healthcare delivery knowledge (Clause 5.2): Auditors need familiarity with healthcare terminology, people‑centred care themes (service user experience, compassionate care, inclusivity, health literacy, co‑production), PDSA cycle, risk‑based thinking and quality tools/methods.
-
Context of the organization (Clause 5.3): Understanding of internal/external issues, stakeholder needs, scope boundaries, confidentiality and patient safety processes is required - including local/geographical sector knowledge.
-
Client outcomes and processes (Clause 5.4): Competence in sector-specific terminology, statutory/regulatory requirements, infrastructure and environment for safe care, outsourced services and healthcare performance indicators.
-
Other certification personnel (Clause 6): Report reviewers and certification decision-makers must possess similar healthcare-specific knowledge (risk-based thinking, leadership impacts, PDSA, people‑centred care).
-
Annex A: Informative summary table of required knowledge mapped to certification functions.
Applications and Who Uses It
This Technical Specification is primarily intended for:
- Certification bodies designing competence frameworks for healthcare audits.
- Lead auditors, audit team members and technical experts who perform audits of healthcare quality management systems.
- Personnel reviewing audit reports and certification decision-makers responsible for impartial certification outcomes.
- Healthcare organizations preparing for certification to ISO 7101 or improving internal audit competence.
- Regulators and accreditation bodies assessing the suitability of certification schemes in healthcare.
Practical benefits include improved audit quality, enhanced patient safety focus, clearer expectations for auditor selection and stronger alignment between certification activities and healthcare sector risks and outcomes.
Related Standards
- ISO/IEC 17021-1:2015 - Generic requirements for bodies providing audit and certification of management systems.
- ISO 7101 - Management systems for quality in healthcare organizations - Requirements.
- ISO 19011 - Guidance on auditing management systems (informative background).
Keywords: ISO/IEC TS 17021-15:2023, competence requirements, auditing and certification, management systems for quality in healthcare, ISO 7101, certification bodies, people-centred care, risk-based thinking, PDSA.