Internal Auditor – Medical Device / ISO 13485 - QCS International

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ISO 13485:2016 Internal Auditor Course

Our ISO 13485:2016 Internal Auditor Course will give you the very latest training on how to audit medical device quality management systems.

This is an interactive  2-day course which will enable you to plan, prepare, and conduct an effective internal audit of medical devices quality management system and present your findings in a clear and coherent way.

You can view our upcoming course dates below, or get in touch to learn more.

Course Cost
Early Bird Price £975 + VAT
Available as In house course

Upcoming Courses

  • How to get maximum benefits from your internal audits.
  • Basic understanding of a process-based quality/medical device management system.
  • Steps to ensuring you become a value-added internal auditor.
  • Key steps you should follow to plan, prepare and perform an effective audit.
  • How to effectively perform the audit by knowing the right questions to ask.
  • How to write a nonconformity to deliver effective corrective action every time.
  • Relationship between quality management, production service conformity, regulatory requirements, and customer satisfaction.

This course is for anyone who wishes to conduct effective internal audits on their medical device quality management system. Specifically, this course is aimed at:

  • Anyone new to internal auditing
  • Anyone involved in the process of auditing or auditing systems
  • Anyone wanting to improve their existing audits or medical device management system.
  • Those who have completed our ISO 13485 Foundation Course.

If you are not sure if you have the required pre-course knowledge, please see IRCA Pre Course Knowledge Requirements. Our ISO 13485 Foundation Course will give you a good one day introduction in preparation for this audit training course.

This ISO 13485 training course will give you a thorough understanding of how to perform value added internal audits of your organisation’s processes. This will help you and your organisation to identify gaps in your medical device quality management system as a basis for improvement of regulatory compliance and system effectiveness. 

Completing this training also allows you to demonstrate to your certificate body that your internal auditors have been trained to a recognised standard.

Our Approach to Training Courses

We believe that learning becomes easier and more effective if you, as a delegate, feel more involved and participate. As we lead the engaging training experience, we actively encourage thought, analysis, and involvement from participants to ensure you gain greater insight and understanding.

IRCA Approved Training Partner

We were the first training organisation in the UK/Europe to hold IRCA approval for our internal and lead auditor courses within the medical device sector and we continue to be the leader in preparing IRCA-registered auditor courses.

This course is both CQI and IRCA certified (18203). Our company and our trainers undergo intensive inspection and assessment every year with the International Register of Certificated Auditors (IRCA). This means that the qualifications obtained from completion of this course are valid and will be recognised by your customers and certification body.

If you would like further information on this training course, you can speak to our experts by calling

01236 734447

or by using our enquiry form below.

Early bird discounts are obtained by reserving a place and paying the discounted fee at the time of booking or invoice date. Two for less discounts are available for two or more people from the same organisation attending the same course, making the reservation at the same time and paying the discounted fee by the invoice date. For all discounts no cancellation refunds are available but transfer may be possible with at least 15 days notice.

Why use QCS for training... • CQI/IRCA Approved Training Partner for all auditor courses • Ongoing investment in ALL courses • Interactive Courses... involving you in the learning experience • Highly trained and qualified industry experts • Access at highest level in all sectors • Competitive prices • 100% guarantee