What is a ISO 13485 Lead Auditor?

The Batalas ISO 13485 Lead Auditor training course is suitable for those wishing to conduct internal and external audits to ISO 13485.

This 5-day ISO 13485 Lead Auditor training course enables delegates to plan, lead and report audits within their own organisation, their suppliers and with third party organisations. Our ISO 13485 lead auditor training course will enable you to conduct effective audits in any auditing situation.

The format of the ISO 13485 lead auditing training course is highly interactive, with tutor-led sessions interspersed with individual and group exercises. An case study is used to practice auditing skills.

Who should attend?

This course is vital for any professional that is involved in implementing and/or auditing quality management systems for medical devices, or those leading a supplier quality assurance program.

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

What will you learn?

A detailed understanding of:

  • Types of audit
  • Audit objectives
  • Audit scope and criteria
  • Audit responsibilities
  • Interviewing skills
  • Team leader skills
  • The audit process
    • Preparation and planning
    • The opening meeting
    • Checklist development
    • Document review
    • Conducting and leading on-site audit activities
    • The closing meeting
    • Reporting audit findings

Book this course and get our ISO 13485 e-Learning course free of charge (normally £49). It gives you an overview of ISO 13485:2016 and is designed and authored by our industry experts and includes interactive exercises, videos and additional learning

CQI-IRCA-Certified-Course

£1595 + vat

5 Day Classroom Training Course

Monday to Thursday 08:45 to 18:45, Friday 08:45 to 13:00

Includes full delegate manual, lunch, refreshments & certificate

In-house courses from £600 per person

IRCA course ref 1746

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Course Dates and Venues

Date Venue Price Accommodation Availability
25th - 29th March 2019 Milton Keynes - Kents Hill Park
www.kentshillpark.com
£1595 £119 per night
Click here for info
Places available
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20th - 24th May 2019 Heathrow - Holiday Inn
(M4 Jct 4)
Click here for details
£1595 £119 per night
Click here for info
Places available
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28th October - 1st November 2019 Milton Keynes - Kents Hill Park
www.kentshillpark.com
£1595 £119 per night
Click here for info
Places available
BOOK
9th - 13th December 2019 Heathrow - Holiday Inn
(M4 Jct 4)
Click here for details
£1595 £119 per night
Click here for info
Places available
BOOK

All prices exclude VAT

Don’t take our word for it

Thoroughly informative and appropriately intimate sessions, overall a very enjoyable experience
Nat. Bates, GAMA Healthcare Ltd, ISO 13485 Lead Auditor, October 2017

Richard Lloyd

Richard Lloyd tells us about this experience on the ISO 13485:2016 Lead Auditor Course (video above)

Richard Lloyd, Tecan Switzerland, ISO 13485 Lead Auditor, May 2017

Read written client testimonials here >

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
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 Internal Auditor Training Course

2 days
£875
More info

ISO 13485 Foundation Training Course

1 day
£415
More info

ISO 13485:2016 Transition Workshop

1 day £415
More info

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