Description

This course aims to equip participants with the knowledge and skills required to conduct internal audits of Quality Management Systems in medical laboratories in accordance with the guidelines of ISO 19011:2018, while ensuring compliance with the accreditation requirements specified in ISO 15189:2022.

The course focuses on understanding quality management system requirements and the technical competence of medical laboratories, applying audit principles, managing audit programs, planning and conducting internal audits, and preparing audit reports. It also covers the identification of nonconformities and opportunities for improvement, contributing to enhanced laboratory readiness for accreditation and improved quality and reliability of laboratory services and test results.

The course includes practical exercises and case studies that enable participants to effectively link the requirements of ISO 15189:2022 with the auditing methodology outlined in ISO 19011:2018, empowering them to perform the role of an internal auditor with professionalism and confidence.

Outline

1. Introduction to Medical Laboratory Accreditation

Overview of medical laboratory accreditation

Purpose and scope of ISO 15189:2022

Relationship between ISO 15189 and ISO/IEC 17025

Benefits of accreditation for medical laboratories

2. Overview of ISO 15189:2022 Requirements

Structure and key changes in ISO 15189:2022

General requirements

Structural and governance requirements

Resource requirements

Process requirements

Management system requirements

3. Quality Management System in Medical Laboratories

Quality policy and objectives

Documented information and records control

Risk-based thinking and opportunities for improvement

Management review and continual improvement

4. Fundamentals of Auditing (ISO 19011:2018)

Principles of auditing

Types of audits (internal, external, combined)

Auditor competence and responsibilities

Managing an audit program

5. Planning and Preparing for Internal Audits

Defining audit scope, criteria, and objectives

Developing audit plans and checklists

Sampling techniques in laboratory audits

Audit evidence and documentation

6. Conducting Internal Audits

Opening meeting

Audit techniques and interviewing skills

On-site audit activities in medical laboratories

Identifying conformity and nonconformity

7. Audit Findings and Reporting

Classification of audit findings

Writing clear and objective nonconformity statements

Preparing audit reports

Closing meeting and communication of results

8. Corrective Actions and Follow-up

Root cause analysis

Corrective action planning

Verification of effectiveness

Audit follow-up and closure

9. Practical Applications and Case Studies

Practical audit scenarios related to ISO 15189:2022

Case studies and group exercises

Role-play for internal audit simulations

10. Final Assessment and Course Wrap-up

Knowledge assessment

Review of key learning points

Feedback and course conclusion

Audience

Technical and management staff  in medical laboratories