ISO 13485:2016 Auditor/Lead Auditor Medical Device - QCS International

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ISO 13485:2016 Auditor/Lead Auditor

(Incorporating ISO 13485:2016 Requirements) (CQI and IRCA Certified 18229)

This IRCA registered course will give you the very latest training in how to audit medical device quality quality systems in addition to giving you an internationally recognised qualification that your notified body and your customers will recognise.

This five-day course is recognised by regulatory agencies as the qualification for auditors and quality managers and gives you the same qualification as your notified body assessor. This course is delivered by expert auditors with wide experience of the medical device industry and will give you the skills required to perform internal, supplier or notified body audits.

Course Cost
Early Bird Price £1,625 + VAT
Two for less Price £3,050 + VAT
Available as In house course

Upcoming Courses

  • Developing skills to ensure you get maximum benefits from quality system audits
  • A practical guide to the purpose of a Medical Device Quality Management Systems
  • Steps to become a value-added quality auditor; the key steps you should follow to plan, prepare, perform and lead effective quality management system audits
  • How you can effectively perform quality audits by knowing the right questions to ask
  • The secrets of becoming a ‘process based’ auditor and why this is important for ISO 9001 systems
  • How to plan for and make sampling plans
  • How you can write a non‐conformity that will deliver an effective corrective action every time
  • How to ‘calibrate’ your audit technique and your nonconformities with your notiifed body
  • The skills required to lead an audit team
  • Key system elements such as links to ISO 9001, risk management, validation and post-market surveillance
  • Registration with CQI/IRCA

This course is for anyone who wishes to conduct, and potentially lead, medical device quality audits. The course is also useful for someone who would like to have a wider understanding of medical device quality management system design and implementation. This will include senior managers, operations managers, quality managers and anyone else who needs to use and audit ISO 13485 quality management system.

To attend, please see IRCA Pre Course Knowledge Requirements. If you need for background consider our Introduction to ISO 13485 Training Course – available for the discounted cost of only £295, this will give you a good one day introduction in preparation for this Lead Audit Course.

This course will give you a good understanding of how to perform quality audits in your organisation and at your suppliers. The course also gives you the same level of training as your ISO 13485 and ISO 9001 certification body assessor. This will help you and your organisation to identify gaps in your quality management system as a basis for improvement of regulatory compliance and system effectiveness.

Learning becomes easier and more effective if you, as a delegate feel involved and participate. We not only lead the training we also encourage thought and analysis by delegates who subsequently gain greater insight and ability. We know you will then be more effective auditors.

As an IRCA approved training partner, this course, our company and our trainers undergo an intensive inspection and assessment every year with the International Register of Certificated Auditors to give you the peace of mind that your qualification is valid and will be recognised by your customers and certification body.


To speak with one of our training experts, you can call us on...01236 734447

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