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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.

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  • Customised
    In-Company
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Course Code
L003

Duration
2 training days

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 takes great pride in the training she delivers. She understands that supporting you effectively means meeting challenges and deadlines, understanding your specific needs, communicating effectively with you and providing accurate and honest advice, with integrity and confidentiality.

Kevina is a PhD graduate from the National University of Ireland, Galway. Since graduating she has worked in the life science industry for 20 years, both nationally and internationally. Beginning in the diagnostics sector, working for Cambridge Diagnostics she then moved to the medical device sector working for Abbott Vascular, Galway. Here she worked as a Microbiologist and was closely involved in the setting up, validation and monitoring of cleanroom environments and evolved into the Quality and Regulatory areas of the Life Science Industry.

Kevina delivers training programmes on many different topics related to Auditing, CE Marking, Quality Standards, Cleanroom Controls and Behaviours, GMP, as well as developing bespoke training programmes to meet specific client’s needs. 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 thus allowing the learners to achieve their learning goals successfully.

In addition to providing expert training, Kevina routinely works as a consultant and auditor. Kevina has the expertise to deal effectively with both Cleanroom, Quality and Regulatory related issues. 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. With the wealth of experience Kevina has accumulated to date working with many different companies, she can appreciate and identify many similar situations thus allowing her to link examples and communicate clearly and effectively to ensure understanding.

Kevina provides key support to both start up and multinational companies. She is an accomplished trainer with a Certificate in Training and Continuing Education from NUI, Maynooth and has also successfully completed QMS Auditor / Lead Auditor training.


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

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Kevina O’Donoghue

Duration: 2 days
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