Internal Quality Auditing of Medical Laboratory Quality Management Systems

Course details

Internal auditing is fundamental to any quality improvement initiative. Many hospital laboratories have adopted the ISO 15189 Quality Management System standard. A fundamental element of all Quality Management System standards is the measurement of system & process performance using a process based approach. The method for determining this is to conduct internal audits. Trained auditors must carry out these audits.

This two day course focuses on auditing for real quality improvement as well as compliance. The course provides detailed training in developing the skills necessary to be an effective internal auditor using many fun exercises including preparing for, performing and reporting of a real audit.

Attending delegates should have a good working knowledge of ISO 15189.

Learning Outcomes

On successful completion of this training course, delegates should be able to:

• Understand the importance of internal auditing within a quality management system
• Understand the responsibilities of Internal Auditors
• Conduct an effective internal audit e.g. plan and organise an internal audit against the organisation’s documented procedures & compliance standards
• Collect and analyse evidence objectively
• Evaluate and report the results of an internal audit

Course Programme

Day 1:

• Introduction to Quality Systems (ISO 15189)
• Purpose of Internal Audits
• The Audit Process
• Selecting the Audit Team & Audit Behaviour
• Auditor Behaviours: Assumptions, Effective Listening, Dealing with Conflict
• Tools Available to Auditors
• Audit Preparation

Day 2:

• Audit Preparation
• Practical onsite audit
• Evaluating & Reporting the Audit