What is an ISO 13485 Foundation Course?

A highly interactive 1 day ISO 13485 foundation training course that is designed to give delegates a sound knowledge of the requirements of ISO 13485 and the fundamentals of a medical device management system

Who should attend?

  • People new to ISO looking to gain the knowledge of the clauses of ISO 13485
  • Those who already work as an auditor but need a refresher
  • Those looking to attend an auditing course but do not have the necessary prior knowledge

ISO 9001 specifically requires that staff are trained and competent, this course satisfies this requirement.

What will you learn?

A detailed understanding of:

  • Quality/medical management systems
  • Quality principles
  • Management system structures
  • Quality terminology
  • Interpreting the requirements of the ISO 13485: 2016 standard
  • The Process Approach
  • (Continual) Improvement

£415 + vat

1 Day Classroom Training Course

From 08:45 to 17:30

Includes full delegate manual, lunch, refreshments & certificate*

(London £395 + VAT)

In-house courses from £150 per person

FREE Training Toolkit – supporting you through your learning journey

Our classroom courses come with a unique toolkit which helps you prepare for training, including:

- Pre-course exercises
- Series of training videos
- Training manual

Buy Now Pay Later

Book Now Pay Later

97% Pass Rate

Average 99% Pass Rate

Money Back Guarantee

No Pass No Fee Guarantee

98%

98% of our delegates would recommend us

Course Dates and Venues

Date Venue Price Accommodation Availability
18th March 2019 Milton Keynes - Kents Hill Park
www.kentshillpark.com
£415 £119 per night
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Places available
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29th April 2019 Heathrow - Holiday Inn
(M4 Jct 4)
Click here for details
£415 £119 per night
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Places available
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30th September 2019 Milton Keynes - Kents Hill Park
www.kentshillpark.com
£415 £119 per night
Click here for info
Places available
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21st November 2019 Heathrow - Holiday Inn
(M4 Jct 4)
Click here for details
£415 £119 per night
Click here for info
Places available
BOOK

All prices exclude VAT

Don’t take our word for it

I really liked the way the training was delivered, especially the group work and discussions. It was so much easier to stay focused and absorb information.
Geraldine Johnson, Eumar Technology Limited, ISO 13485 Foundation, September 2018
Steve is very knowledgeable and delivered a complicated and somewhat dry topic well. We will consider other training days in the future.
Richard Radford, BPR Medical, ISO 13485 Foundation, March 2017

Stephen Coles talks to us about his experience on our ISO 9001:2008 Foundation Training Course (video above)

Stephen Coles, Retail Motor Industry Federation (RMI), ISO 9001 Foundation, November 2015
The tutor David was fantastic, easy to get on with, easy to speak to, extremely helpful and knowledgeable
Nicola Lumley, Electronic Temperature Instruments Ltd, ISO 9001 Foundation, July 2015
I was very pleased with the course, and really helped with my preparation for the internal auditing course I attended.
Tony Matthews, Reheat International, ISO 9001 Foundation, June 2015
The course was engaging and I would recommend this course to any of my colleagues.
Amrik Fashion, M Lambourne Ltd, ISO 9001 Foundation, June 2015
Fantastic trainer! A great help towards a future career.
Roger Harper, ISO 9001 Foundation, June 2015
Although I appreciate that some employers feel that Foundation courses are not required, this level of course was of great benefit in setting the scene for the courses that follow. I think anyone who is considering training in the ISO standards should attend the foundation level.

The trainer of this course was really good and engaged well with all delegates dealing with any issues, concerns or queries in an appropriate way and keeping all delegates involved throughout the day

Rosalind Davis, Vector AeroSpace, ISO 9001 Foundation, July 2015

Read more client testimonials here >

Some recent clients

Have you seen our fantastic Course Bundles?

Enjoy a discounted price when you book any of the below course bundles. This offer applies to public courses on ANY date** at ANY venue listed on the website.

Our course bundles also include the following benefits:

• ‘Book now pay later’ guarantee*
• ‘No pass no fee’ guarantee*

Batalas Special Offer

Batalas Special Offer

Please email training@batalas.com or call 0333 700 9001 to book your Course Bundle!

**Course dates must be consecutive. **t&c’s apply

ISO Standard Courses Bundle Price
ISO 9001:2015 1 day Foundation and 2 day Internal Auditor plus FREE Training Toolkit £995 + VAT
ISO 9001:2015 1 day Foundation and 5 day Lead Auditor plus FREE Training Toolkit £1500 + VAT
ISO 13485:2016 1 day Foundation and 2 day Internal Auditor plus FREE Training Toolkit £1125 + VAT
ISO 13485:2016 1 day Foundation and 5 day Lead Auditor plus FREE Training Toolkit £1845 + VAT
AS9100:2016 Rev D 1 day Foundation and 2 day Internal Auditor plus FREE Training Toolkit £1125 + VAT
AS9100:2016 Rev D 1 day Foundation and 5 day Lead Auditor plus FREE Training Toolkit £1845 + VAT
Data Protection 1 day Introduction to GDPR and 1 day ISO 27001 Foundation plus FREE Training Toolkit £600 + VAT
Data Protection 1 day Introduction to GDPR and 5 day ISO 27001 Lead Auditor plus FREE Training Toolkit £1425 + VAT
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.
An Batalas approved certificate* for those who successfully complete all elements of the course, including written and practical skills assessment.
Includes full delegate manual
Lunch and refreshments
Certificate*
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.

Related training courses

ISO 13485:2016 Transition Workshop

1 day £415
More info

ISO 13485 Internal Auditor Training Course

2 days
£875
More info

ISO 13485 Lead Auditor Training Course

5 days
£1595
More info

*IRCA course approval pending

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