Internal Quality Auditing Course for Manufacturers of Medical Devices

Skills based competence for confident, robust and effective auditing

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Internal auditing is a core requirement of the standards and regulations governing the medical device sector. It plays a critical role in demonstrating compliance internally as well as meeting the expectations of notified bodies and regulatory authorities.

This course is designed to build the practical, handson competencies essential for conducting comprehensive and effective internal audits in the medical device sector.

Over two days, participants adopt an auditor’s perspective, giving them deeper insight into compliance expectations, evidence gathering and audit evaluation, through an entirely new lens.

Having well trained, confident internal auditors is fundamental to maintaining a robust and effective quality management system.

This intensive, hands-on two-day programme focuses on applied learning and real-world skills.

Day 1 covers audit principles and the role of internal audits within a QMS, guiding participants through the audit process from preparation to reporting, with interactive exercises on communication and conflict management. Learners then work in teams to prepare for a Day 2 audit, integrating relevant standards and regulatory clauses.

Day 2 consists of three team-based stages: refining preparation, conducting the audit and completing the audit report.

Programme Topics

Day 1

Understanding the role audits play in maintaining compliance, driving improvement, and supporting organisational performance.
A clear breakdown of each stage of the audit process: Setting Up, Preparing, Performing & Reporting.
How to communicate effectively, manage challenging situations, and handle conflict with professionalism and confidence.
Practical guidance on how to plan and prepare for an audit.

Day 2
A real onsite practical audit takes place on this day

Audit preparation (building on day 1) - Finalising plans and aligning on the audit approach before commencing the audit.
Practical on-site audit - Conducting a real, live audit onsite, applying the techniques, behaviours, and processes covered on Day 1.
Evaluating and reporting the audit - preparing a clear, accurate, and professional audit report.

Class sizes are limited to 12 participants (max 3 audit groups) to support effective supervision during all the practical elements, with tailored training to meet specific organisational needs.

This course is suitable for anyone working in the medical device industry who wishes to develop new auditing skills or strengthen their existing internal auditing capabilities, regardless of their role or department. This course supports learners at all levels.

A good standard of written and spoken English is important to engage effectively with this course.

By completing this programme, the learner will be able to:

Set up, plan, conduct and report internal audits in a structured and professional manner
Develop confidence in interpreting and applying relevant standards and regulatory requirements
Strengthen professional conflict management skills, recognising that auditing involves both people as well as processes
Enhance day-to-day performance through understanding the auditor’s mindset and evidence evaluation approach
Build valuable competencies, including critical thinking, objective evidence gathering and awareness of regulatory expectations
Build capability, competence, confidence and tangible organisational value
Drive meaningful quality improvement and compliance beyond procedural box-ticking

These outcomes ensure learners return with practical skills and knowledge necessary to contribute effectively to compliant and value-driven internal audits.

This programme is delivered by experienced tutors with extensive industry knowledge in quality systems and auditing for medical device manufacturers. Each tutor brings a wealth of industry experience, sector-specific insights and a passion for practical training. Their focus is on building learner confidence through engaging, hands-on exercises and personalised support.

Anne Marie Newell

Anne Marie is an established Quality professional with over 20 ...

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Kevina O’Donoghue

Kevina takes great pride in the training she delivers. She unde...

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This is an instructor-led highly practical programme, delivered over two days and is offered live virtually or as an in-company programme. The course is busy, interactive, and hands-on, but learners leave with genuine confidence in their ability to carry out internal audits and a much deeper understanding of auditor expectations.

Pre-training consultation with a highly experienced Tutor to tailor content to organisational needs
Hands-on experience is provided through conducting real audits within the company environment
Pre-course work is included to maximise engagement and learning during the training
The programme goes beyond teaching auditing by influencing how participants think, act and contribute to quality

Class sizes are generally limited to 12 participants to support personalised learning and individual support.

Learners who complete this programme can progress to further training in auditing, quality management and regulatory compliance to deepen their expertise.

Potential next steps include:

ISO 13485
ISO 13485:2016 & The Medical Devices Regulation (CE Marking Process)
Understanding QMSR: Key Updates & Compliance Changes
MDSAP Internal Quality Auditor

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Snapshot

Online Learning FAQ >

Course Code

LS019

Duration

2 training days

Delivery Mode

Available for In-House and delivered through virtual classroom training.

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