ISO 13485:2016 Internal Auditor Training Course

An ineffective audit can mean severe consequences; resulting in process failure, patient dissatisfaction and regulatory noncompliance. Optimize your auditing skills with the internationally recognized ISO I3485:2016 and boost your internal audit capabilities. Gain confidence in planning and performing an effective audit, as well as reporting and taking corrective action where necessary.

This course is intended for medical device quality professionals wishing to build on their current knowledge of ISO 13485:2016 and evaluate the effectiveness of their QMS. It teaches the principles and practices of effective audits in accordance with ISO 13485:2016 and ISO 19011:2011.

Learn how to audit the processes of an ISO 13485:2016 Quality Management System (QMS). This course provides guidance and practical experience in planning, executing, reporting and audit follow-up of an internal audit when monitoring the effectiveness and conformity of a ISO 13485:2016 compliant QMS.


Who should attend?

Medical device quality professionals with knowledge of quality management systems and ISO 13485:2016, as well as individuals interested in conducting first-party or second-party audits, management representatives, internal auditors and consultants.

Prerequisites

You should have a good knowledge of ISO 13485:2016 and the key principles of a QMS. If not, we strongly recommend you attend our ISO 13485:2016 Introduction or Clause by Clause course.

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

  • Explain the structure and scope of ISO 13485:2016 and how it applies to the organization seeking regulatory compliance
  • Identify the key principles of auditing and auditor responsibilities
  • Plan an internal audit
  • Conduct an effective audit based on process identification, sampling and questioning
  • Determine if corrective action has been effectively implemented

 

Practical Information

  • It's a 2-day course
  • The training and materials will be provided in English
  • Lunch and drinks are included.

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 Internal Auditor learning path is modular. You can follow the training in all combinations. We recommend the following order:

Leergang

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

1. Introduction

2. Implementation

4. Lead Auditor

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

No.

Training

Price

 

1

ISO 13485:2016 Introduction

 €          675

 

2

ISO 13485:2016 Implementation

 €       1.325

 

3

ISO 13485:2016 Internal auditor 

 €       1.325

 

4

ISO 13485:2016 Lead auditor 

 €       3.150

 

 

Total

 €       6.475

 

 

 

 

 

 

 

Investment

Discount

 

 Combination training 1 + 2 

 €       1.850

 €         150

 

 Combination training 1 + 3

 €       1.850

 €         150

 

 Combination training 1 + 4

 €       3.825

 €         200

 

 Combination training 1 + 2 + 3

 €       3.025

 €         300

 

 Combination training 1 + 2 + 3 + 4 

 €       5.975

 €         500

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


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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