ISO 15189 Internal Quality Auditing of Medical Laboratory Quality Management Systems

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.

Delivery Mode

  • Customised

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What's covered?

Please Note: A practical audit within the company forms the basis of day 2. Audit areas within the company must be organised prior to the training so that effective preparation can commence on day 1.  For this reason the numbers on this course are restricted to max 12 (4 audit groups of 3) to ensure all delegates get the attention needed to ensure they become effective Auditors.


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

Delegates must attend both days to receive a Certificate of Attendance.

Who should participate?

All medical laboratory professionals.

What will I learn?

Participants achieve the following learning outcomes from the programme;

  • 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

Who are the tutors?

Kevina O’Donoghue

Kevina O’Donoghue is a PhD graduate of the National University of Ireland, Galway with 10+ years experience working as a Microbiologist and 7+ years as a trainer, auditor and consultant, she has the expertise to deal effectively with both Cleanroom and Quality related issues. She is experienced in problem solving, reviewing and critically analysing documentation, investigating non-conformances, writing reports, meeting deadlines and working with various teams. She is skilled in dealing with human related issues and has an admirable way of interacting and engaging at an interpersonal level with people at all levels of the business. With the wealth of experience Kevina has accumulated to date working with many different life science companies both nationally and internationally, she can appreciate and identify many similar situations thus allowing her to link examples and communicate clearly and effectively, to ensure understanding.

Kevina is knowledgeable in many different quality and regulatory standards within the medical device, pharmaceutical, laboratory, & healthcare industries, is a strong and experienced auditor consistently challenging systems for compliance in a fair and consistent manner. Her main focus is on improvements rather than non-conformances, giving businesses a clear, objective insight into their current conformance status and constructive feedback on how to improve and ensure business goals are achieved successfully. Her interpersonal skills, allied with her excellent communication skills make her a very effective trainer. Kevina’s outstanding attribute is her ability to motivate learners and enable their learning through sharing her knowledge and work-based experiences, in a simple and easy to understand way.

Kevina is engaging, enthusiastic and very passionate about her work. Confidentiality and professional impartiality are strong values and principles that she works to at all times.

How do we train and support you?

In-House Courses
For In-House courses, the Tutor will contact the Course Organiser in advance to discuss the programme in more detail in order to tailor it specifically to the organisation.

Course Manual
Delegates will receive a very comprehensive course manual.

Kevina O’Donoghue


Kevina O’Donoghue


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