Medical Laboratory Quality Management Programs

ISO 15189 2022 requires laboratories to conduct a self-evaluation of their activities. This forms the basis of internal Quality Audits. The audits are required to ensure that laboratory activities; conform to the requirements of the Quality Management System (QMS), are conducted in a manner that meets the needs of users, are implemented, effective, and maintained. This course equips the participants with practical skills and knowledge on audit techniques to identify gaps in the QMS and initiate continuous improvement cycle.

• Pre-examination, examination, and post-examination processes.

By the end of this course, participants will:

• Learn how to use audits to measure the effectiveness of the QMS
• Apply their knowledge and understanding of auditing principles to a wide variety of situations to allow the design, planning, justification, and delivery of internal audits
• Learn  how  to  use  internal  audit  outcomes  to  create  public  trust  in the laboratory's reputation
• Understand how risk & opportunity inform internal  audits  and  non- conformities
• Categorize   non-conformity   cause, impact, and   action   to   address underlying issues
• Undertake a structured preparation for the internal audit process, including feedback to relevant stakeholders
• Learn how to use the internal audit to gain the agreement audits employee commitment

• Personnel specifically designated as auditors
• Laboratory management staff
• Laboratory technical staff
• Those who maintain and support the quality management systems of the services delivered
• Those who manage, coordinate, and/or deliver internal audits within the organizations

• Principles of auditing
• Internal Audit program
• Audit planning, execution and follow-up
• Auditors attributes
• Audit methods/techniques
• Raising audit findings
• Evaluation of audit program