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

Accredited CPD 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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Our public courses run at training venues across the UK.

We offer a ‘BOOK-NOW-PAY-LATER’ policy which allows you to secure a place on the course whilst seeking approval from within your company (t&c’s apply).

Can’t see a date that works for you? Call our training team on 0333 700 9001 to get notified as soon as new dates are added.

Winter SaleIf you are considering training then now is the time; we have discounts on this course during December.

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All prices exclude VAT

Don’t take our word for it

The contact persons at Batalas were very helpful in answering our queries and in the pre-course preparation. The trainer was very engaging and the teaching method was very effective.
Jose Magbanua, Sphere Medical, ISO 13485 Lead Auditor, August 2019
Tutor was brilliant in how he worked the room. Thoroughly enjoyed the course. It was very intense but I was starting at complete novice level. I feel I improved massively by the end of the course.
Anonymous, ISO 13485 Lead Auditor, August 2019
We had an excellent trainer, animated, focus and his delivery methods were perfect. I loved the way he made the training so varied, with lots of opportunities to interact. Second to none. Highly recommendable.
Kirsti Parker, Product Quality Manager, Summit Medical Ltd, ISO 13485 Lead Auditor, March 2019
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
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.
On successful completion of a CPD accredited training course, Batalas will send you a copy of your CPD Certificate; this can be used for inclusion in a formal CPD record. For more information on CPD, please click here

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