Transition to the new ISO 13485:2016 - QCS International

part of the phsc group

ISO 13485:2016 Auditor Transition Workshop

Organisations seeking to update their Quality Management System for Medical Device Manufacture require to ensure their own auditors are prepared for the changes associated with the new ISO 13485:2016 Standard. Competent internal auditors ensure that your organisation is fulfilling all new requirements to give you a level of assurance that you are fit to host a visit from your Certification Body.

The QCS one-day auditor transition workshop is designed to give auditors the required knowledge of the new standard, together with an understanding of the additional evidence they now have to seek in order to check conformance.

Course Cost

Early Bird Price £395 + VAT
Two for less £700 + VAT
Available as In house course

Upcoming Courses

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  • Introduction to the 2016 standard and its new requirements
  • Review of auditing new requirements such as:
    • Risk management
    • Validation processes
    • New documents and records
    • New product realisation requirements
  • What is required to update audit programmes
  • Identification of nonconforming situations relevant to the new standard
  • Case studies to enhance all learning objectives

This course is for delegates who are already experienced medical device auditors and need updated training to the new standard. The course is suitable for both internal and lead auditors.

The course is designed to give you a good, practical basis of the implications of auditing to the new Standard ISO 13485:2016

All QCS trainers have extensive experience in the management of quality management systems for medical device manufacture and are experts in their field, which ensures they bring a wealth of knowledge to bring the course to life. QCS takes a practical approach to ensure that you learn through discussion, analysis and participation; this makes for a more beneficial learning experience.

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.


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