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

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ISO 13485:2016 Lead Auditor Course

Our IRCA-registered MD-QMS ISO 13485:2016 Auditor/Lead Auditor Course will give you the very latest training in how to audit medical device quality management systems, from planning and improving systems to leading a full audit team.

This 5-day interactive course is delivered by expert auditors with wide experience of the medical device industry and will provide you with the skills required to perform internal, supplier, or notified body audits. Upon completion, you will have the same qualification as your notified body assessor.

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

Course Cost
Early Bird Price £1,995 + VAT
Available as In house course

Upcoming Courses

  • Skills to ensure you get maximum benefits from quality system audits
  • The purpose of a Medical Device Quality Management Systems
  • Steps to become a value-added quality auditor
  • Steps you should follow to plan, prepare, perform & lead effective QMS audits
  • How to perform effective quality audits by knowing the right questions to ask
  • To become a process-based auditor & why this is important for ISO 13485 systems
  • How to plan for and make sampling plans
  • How to write a nonconformity to deliver effective corrective action every time
  • How to ‘calibrate’ your audit technique and nonconformities with your approved body
  • The skills required to lead an audit team
  • Key system elements such as: links to ISO 9001, risk management, validation, & post-market surveillance

This course is for anyone who wishes to conduct or lead medical device quality management system audits. Specifically, this course is for anyone who:

  • Is involved in the auditing or implementation of QMS for medical devices
  • Would like to better understand medical device QMS design & implementation.

To attend, please see IRCA Pre Course Knowledge Requirements. If you need more pre-training, our ISO 13485 Foundation Course will give you a good one day introduction in preparation for this Lead Audit Course.

This lead auditor training 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 (MD-QMS) as a basis for improvement of regulatory compliance and system effectiveness.

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 are proud to be an IRCA approved training partner and this course is CQI and IRCA certified (2473). 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