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 define the:

On completion, you should gain the knowledge and skills 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

This two day training course includes lunch and drinks. The training and the materials will be provided in English. 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.

Modular training course

The course ISO 13485:2016 Internal Auditor Training Course is modular. This means you can follow the training in all combinations. We recomment the following order:

Leergang

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

No.

Training

Price 2017

 

1

ISO 13485:2016 Introduction Training course

 €          675

 

2

ISO 13485:2016 Implementation Training Course

 €         1325

 

3

ISO 13485:2016 Internal Auditor Training Course

 €         1325

 

4 ISO 13485:2016 Lead Auditor Training Course  €        3.150  

 

Total

 €        6.475

 

 

 

 

 

 

 

Investment

Discount

 

 Combination training 1 + 2 

 €       1.850

 €         150

 

 Combination training 1 + 3

 €       1.850

 €         150

 

 Combination training 1 + 2 + 3

 €       3.025

 €         300

   Combination training 1 + 2 + 3 + 4   €       5.975  €         500

When there are more employees who need to understand, implement or audit your management system, a training could be delivered at your location as well. Based on your learning needs we could deliver 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