ISO 13485:2016 Lead Auditor Training Course

Gain the confidence to effectively audit a QMS in accordance with internationally recognized best practice techniques. Demonstrate your commitment to the quality of medical devices by transforming existing auditor skills to ISO 13485:2016. Consolidate your expertise with the latest developments and contribute to the continuous improvement of the business.

You’ll grasp the key principles and practices of effective QMS audits in line with ISO 13485:2016 and ISO 19011 “Guidelines for auditing management systems”. Using a step-by-step approach, you’ll be guided through the entire audit process from initiation to follow-up. Over 5 days, you’ll gain the knowledge and skills required to undertake and lead a successful management systems audit. Learn to describe the purpose of an ISO 13485:2016 QMS audit and satisfy third-party certification. Acquire the skills to plan, conduct, report and follow up a QMS audit that establishes conformity and enhances overall organizational performance.

Develop the knowledge and skill required to conduct a full audit of an organization’s Quality Management System (QMS) to ISO 13485:2016.


Who should attend?

Anyone with the need to audit an organization’s ISO 13485:2016 QMS.

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 course.

By the end of this 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 to plan, conduct, report and follow up an audit in accordance with ISO 19011 (and ISO 17021 where appropriate)

Practical Information

This five-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 Lead Auditor Training course is modular. This means you can follow the training in all combinations. We recomment the following order:

Leerroute

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

No.

Training

Price 2017

 

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 + 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