What is a ISO 13485:2016 Transition Workshop?

A highly interactive 1 day ISO 13485:2016 transition workshop that is designed to give delegates a detailed understanding of the changes to the ISO 13485:2016 medical devices standard

Who should attend?

  • All existing internal and external auditors that wish to be able to audit ISO 13485:2016
  • Quality managers, process owners and anyone that needs to understand the ISO 13485:2016 audit process
  • Anyone involved in the implementation or transition of ISO ISO 13485:2016

ISO 13485 specifically requires that staff are trained and competent, this course satisfies this requirement

What will you learn?

A detailed understanding of:

    • Quality management fundamentals and principles
    • Medical device and quality terminology
    • The differences in the clauses of ISO 13485:2003/2012 and ISO ISO 13485:2016
    • Implications for the auditor and the organisation
    • Timeline for changes

£415 + vat

1 Day Classroom Workshop

From 08:45 to 17:30

Includes full delegate manual, lunch, refreshments & certificate

In-house courses from £150 per person

Prior Knowledge

VERY IMPORTANT – as this is a transition workshop it is assumed that anyone attending this course has a prior working knowledge of the previous revision of ISO 13485:2003/12

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97% Pass Rate

Average 99% Pass Rate

Money Back Guarantee

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98% of our delegates would recommend us

Course Dates and Venues

Date Venue Price Accommodation Availability
There are currently no dates available for public courses

If you have more than 3 people in your organisation this course can be delivered at your offices

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All prices exclude VAT

Don’t take our word for it

The Batalas Trainer was extremely knowledgeable and professional. The course was well structured and delivery method was appropriate and facilitated learning and reflection. I would recommend this course to my colleagues.
Steve Fitzjohn, Defence Diving School Portsmouth, QMS Lead Auditor, May 2015
Dennis was extremely knowledgeable and was happy to apply the theory to real life situations which is always a great help. The course itself is ‘very’ intense with many hours out of class spent working on the material. Dennis was great he kept me fully engaged throughout.
Louise Ellison BA (Hons), GKN Aerospace Services, QMS Lead Auditor, May 2015
The personal experiences and first hand examples given by the tutor brought the course to life.
Lorraine Bell, Sage, QMS Lead Auditor, March 2015

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Some recent clients

Tutor led sessions interspersed with individual and team based exercises (approx 25% theory and 75% practical). Extensive use of a case study to enable skills to be developed.
A Batalas certificate for those who successfully complete all elements of the course, including written and practical skills assessment.
Includes full delegate manual
Lunch and refreshments
Each delegate must attend 100% of the course. You will be assessed on your individual and group participation and general performance during the course, including the interactive exercises, case studies, role-play and any other activities covered on the course.

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