ISO 15189:2022 Medical Laboratories Lead Auditor

Introduction to ISO 15189:2022 and Medical Laboratory Accreditation Scope, principles, and role of medical laboratory management systems.

ISO 15189:2022 Requirements and Clauses Structural, resource, process, and management system clauses.

Competence of Medical Laboratory Personnel Qualifications, training, and competence evaluation.

Impartiality, Confidentiality, and Integrity in Medical Laboratories Ensuring independence, objectivity, and confidentiality in audits.

Audit Principles and ISO 19011 Guidelines Audit types, principles, and auditor responsibilities.

Audit Planning and Preparation Developing audit programs, checklists, and resource allocation.

Conducting On‑Site Medical Laboratory Audits Opening meetings, evidence collection, interviews, and operational observations.

Audit Reporting and Documentation Writing audit reports, recording non‑conformities, and corrective actions.

Continual Improvement in Medical Laboratory Management Systems Corrective/preventive actions, monitoring, and embedding improvement culture.

Certification Process and Lead Auditor Role Preparing laboratories for ISO 15189 certification, managing audit teams, and leadership responsibilities.