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.
Early Bird Price £395 + VAT
Two for less £700 + VAT
Available as In house course
- 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.
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Read what our delegates say:
I found the course very helpful to understanding more about ISO 13485 and how to carry out internal audits. Alistair was very helpful on any questions I had and very good at explaining different areas....
Found this course to be very helpful & it gives you a better understanding on how to audit properly & what you are looking for...
Good course which I can relate to my place of work..
Great experience, great trainer, I enjoyed the course very much and I would use QCS again in the future....
Great course very well presented. Active learning through practical exercises is a great way to deliver the course...
The training was very excellent, well informed and tutor knowledge of auditing was tremendous. It will really help me to conduct future audits....