ISO 15189:2022 – Medical Laboratory Quality & Accreditation
Internal Auditing of Medical Laboratories in Accordance with ISO 15189:2022
SPEA Approved Certificate
Overview
Practical approaches to planning and conducting internal audits, assessing conformity, documenting findings, and following up corrective actions to enhance medical laboratory quality and accreditation readiness.
- This training course develops medical laboratory professionals’ knowledge and practical skills in planning, conducting, and reporting internal audits in accordance with ISO 15189:2022. It supports the evaluation of management system effectiveness, technical competence, continual improvement, and accreditation readiness.
- The course covers internal auditing principles, audit scope and criteria, audit planning, checklist preparation, objective evidence collection and evaluation, identification and documentation of nonconformities, audit reporting, and corrective action follow-up.
- Through practical exercises and case studies, participants learn to review laboratory documents and records, conduct audit interviews, evaluate objective evidence, and formulate clear, verifiable audit findings while maintaining impartiality, objectivity, and professional competence.
- The course focuses on practical internal auditing skills in medical laboratories without covering the full implementation of quality management systems or advanced technical applications addressed in other specialist programs within the training package.
- This professional development course does not grant formal laboratory accreditation or certified auditor status.
Who Should Attend
- Medical laboratory managers and supervisors.
- Laboratory quality and accreditation managers and officers.
- Internal auditors and laboratory audit team members.
- Medical laboratory scientists and technicians assigned quality responsibilities.
- Compliance and continual improvement personnel.
- Members of accreditation preparation and conformity assessment teams in laboratories and hospitals
Learning Outcomes
- By the end of the course, participants will be able to: Explain ISO 15189:2022 internal auditing requirements and fundamental auditing principles.
- Define audit scope and criteria and develop an appropriate medical laboratory audit plan.
- Prepare audit checklists covering management system, technical competence, and laboratory process requirements.
- Collect and evaluate objective audit evidence through interviews, observation, and record review.
- Document audit findings and nonconformities and prepare clear, evidence-based audit reports.
- Follow up corrective actions and verify their effectiveness to support continual improvement.
Course Outline
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Module 1: Internal Auditing Fundamentals and ISO 15189:2022 Requirements
• Internal audit objectives and their role in laboratory quality. • Relevant standard requirements, impartiality, and objectivity. • Auditor responsibilities and competence requirements.
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Module 2: Audit Planning and Checklist Development
• Defining audit scope, criteria, and objectives. • Preparing audit plans and assigning responsibilities. • Developing checklists for medical laboratory requirements.
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Module 3: Audit Execution and Reporting
• Collecting evidence through interviews, observation, and record review. • Assessing conformity and documenting nonconformities. • Formulating audit findings and preparing the final report.
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Module 4: Practical Applications and Corrective Action Follow-Up
• Simulating an internal audit in a medical laboratory. • Analyzing nonconformities and reviewing corrective actions. • Verifying action effectiveness and closing audit findings.
Assessment
• Short knowledge checks on internal auditing principles and requirements. • Practical exercise on audit planning and checklist preparation. • Case study involving evidence evaluation and nonconformity reporting. • Simulated internal audit and preparation of a concise audit report. • Final assessment of the intended learning outcomes.