Professional Training
4.6 (5 Reviews)

CQI IRCA ISO 13485:2016 Lead Auditor Training Course

Batalas Ltd, Online (+2 locations)
5 days
5 days
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Course description

CQI IRCA Certified ISO 13485:2016 Lead Auditor Training Course - Quality Assurance and Auditing - Open Course

Over the course of  five days on this ISO 13485 Lead Auditor course, delegates will gain the skills and knowledge to plan, lead and report audits within their own company, their suppliers and with third party organisations. Versatile, this course prepares delegates to conduct effective audits in any auditing situation.

The format of the ISO 13485 Lead Auditor course utilises accelerated learning techniques and is therefore highly interactive, with tutor-led sessions interspersed with individual and group exercises. A realistic case study and role-play activities provide an excellent opportunity to practice ISO 13485 auditing skills.

You will 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

As part of our continued support in helping you get the best from our training course, all delegates will receive access to the Batalas Toolkit. This toolkit includes pre-course exercises and a series of e-learning/video tutorials that have been designed to support you in your preparation of this training course.

We also offer a 'no-pass no-fee' guarantee and 'book now pay later' policy with this course (t&c’s apply).

If you have a team of 4 or more auditors then this course can also be taught on an in-house basis, tailored to your organisation's needs as a cost-effective alternative – please enquire for a quote.

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Suitability - 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.

Outcome / Qualification etc.

Upon successful completion of this course, delegates will be awarded:

  • a CQI IRCA certificate
  • a CPD certificate (Continuing Professional Development)



Average rating 4.6

Based on 5 reviews.
Reviews are published according to our review policy.
Write a review!
Nat. Bates, GAMA Healthcare Ltd.
01 Oct 2017

Thoroughly informative and appropriately intimate sessions, overall a very enjoyable experience.

Russell Malone ThermoFisher Scientific
03 Nov 2015
Expert knowledge

Very good delivery and pace of course, with the person delivering it having expert knowledge of the subject and real life application. Brilliant.

Mark Brightwell ThermoFisher Scientific
03 Nov 2015

Steve was excellent


The fee for this course is £1645 + VAT.

This fee is inclusive of full delegate manual, lunch, refreshments & certificate.

Special offers may be available for this course, please enquire for details.

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