Internal Auditor ISO 13485:2016 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 19011:2018.

Delegates 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.

Connected Learning Live
Do you prefer the convenience of online training? Register here for this training course or read more about Connected Learning Live.

Who should attend?

  • Medical device quality professionals with knowledge of quality management systems and ISO 13485:2016
  • Individuals interested in conducting first-party or second-party audits
  • Management representatives
  • Internal auditors
  • 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 training 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

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:

Learning path

In addition to this introduction training, the following training courses are part of the ISO 13485 course:

1. Introduction ISO 13485:2016 - € 690,-

2. Implementation ISO 13485:2016 - € 1.375,-

4. Lead Auditor ISO 13485:2016 - € 3.250,-

When you choose a combination of training courses, you benefit from a price advantage:

Training courses Price Discount
Combination training courses 1 + 2  € 1.965 € 100
Combination training courses 1 + 3 € 1.965 € 100
Combination training courses 1 + 4 € 3.765 € 175
Combination training courses 1 + 2 + 3 € 3.215 € 225
Combination training courses 1 + 2 + 3 + 4 € 6.290 € 400

In-house training course
For more information about this course and/or the possibilities of an in-house training for your organization, please contact our Training Advisors on 0031 (0)20 346 07 80 or send an email to training.se@bsigroup.com.

Practical Information

  • It's a 2-day course
  • The training and materials will be provided in English
  • Lunch and drinks are included
  • 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.se@bsigroup.com or 0031-(0)20-346 07 80.