ISO 13485:2016 Lead Auditor Training Course

This course teaches the key principles and practices of effective quality management system audits in accordance with ISO 13485:2016 and ISO 19011, “Guidelines for auditing management systems”. Experienced instructors guide students through the entire audit process, from managing an audit programme to reporting on audit results. Participants will gain the knowledge and skills to plan, conduct, report and follow up a QMS audit that establishes conformity and enhances overall organizational performance. 

Who should attend?

  • Medical device quality professionals interested in conducting first-party, second-party, and/or third-party audits
  • Management representatives
  • Quality directors, managers, and engineers
  • Consultants

Do you already have a good knowledge of ISO 13485:2016?

If not, we highly recommend you take our ISO 13485:2016 Clause by Clause training course first as there are particular requirements you need to understand before you can be an auditor.

By the end of the course delegates will be able to:

  • Gain the skills to plan, conduct, report and follow up an audit in accordance with ISO 19011
  • Identify the purpose and benefits of an ISO 13485:2016 QMS
  • Explain the role of an auditor in planning, conducting, reporting and following up an audit in accordance with ISO 19011 (and ISO 17021 where appropriate).

 

Practical information

  • It's a 5-day course.
  • The training and materials will be provided in English
  • Lunch and drinks are included
  • The residential option also includes 4 nights accommodation and evening meals from the first day of the course
  • On completion, you'll be awarded an internationally recognized BSI Training Academy certificate.

For further information regarding reduced rates at the hotel where the training is being conducted please contact training.nl@bsigroup.com or 0031-(0)20-3460780.

ISO 13485:2016 learning path and combination discount

The ISO 13485:2016 Lead auditor learning path is modular. You can follow the training in all combinations. We recommend the following order:

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Besides this lead auditor course, are the following training courses also part of the ISO 13485:2016 learning path:

1. Introduction

2. Implementation

3. Internal Auditor

Attending several training courses of a learning path is associated with special discounts.

No.

Training

Price

 

1

 Introduction ISO 13485:2016

    € 675

 

2

 Implementation ISO 13485:2016

    € 1.350

 

3

 Internal Auditor ISO 13485:2016

    € 1.350

 

4

 Lead Auditor ISO 13485:2016

    € 3.200

 

 

 Total

    € 6.575

 

 

 

 

 

 

 

 Investment

 Discount

 

 Combination training 1 + 2 

€ 1.925

€ 100

 

 Combination training 1 + 3

€ 1.925

€ 100

 

 Combination training 1 + 4

€ 3.700

€ 175

 

 Combination training 1 + 2 + 3

€ 3.150

€ 225

 

 Combination training 1 + 2 + 3 + 4

€ 6.175

€ 400

If more employees need to understand, implement, audit, your management system, training can be delivered at your location. Based on your learning needs we could provide a customized in-house training course for your team.  

For more information about the learning path or in-house training courses, please contact Mark Leenaers via +31 20 346 07 83 or send an email to mark.leenaers@bsigroup.com.

In-company

We can deliver this training course to your team in-house. Training in-company allows you to save on each individual delegate and also cut out travel and accommodation expenses, which can be significant.With our in-company training, not only can you meet your business needs, but you can also:

  • Refresh your team’s skills and boost their confidence
  • Give your team an overview of your management system(s)
  • Train a group of auditors to the same level, using the same consistent techniques

For more information about the in-company training or to request a quote, please contact Mark Leenaers via +31 (0)20 346 07 83 or send an email to mark.leenaers@bsigroup.com.