Internal Auditor ISO 13485 Training Course - International

Niveau Auditeur interne Durée 2 journées de formation

Disponible pour réserver: Salle de classe virtuelle 2050€ + TVA Book your place

Designed by your partner in learning as an intensive course for medical device quality professionals, this ISO 13485 internal auditor training builds knowledge for an effective quality management system.

The two-day training is delivered either in person or live online in a classroom environment. Guided by experienced instructors, you will learn how to explain the structure and scope of the standard and identify an auditor’s key responsibilities. You’ll also discuss every stage of the internal audit process through role-play, workshops and tutorials, plan and conduct an audit and assess if it was done effectively.

Although some prior understanding of ISO 13485:2016 is useful, you’ll leave the course with all the knowledge you need. You’ll be able to maintain compliance and internal processes and motivate colleagues to do the same.

Please note that this training will be held in English!

Prerequisites

There are no formal prerequisites for this course.

Pedagogical objectives

Able to fully grasp and comply with ISO 13485:2016
Confidence that your organization is using competent auditors
Maintain rigorous internal processes
Write factual audit reports and suggest corrective actions

- 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
On completion of this training, participants 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
- Questionnaire to assess the knowledge at the end of the training
- Customer survey
Course materials including:
- Introduction to the training, detailed program and security assignments
- Course presentation, theory and activities/roles plays
- Answers to the activities
- Videos
- Additional documents, distributed during the sessions, to use for the activities
- Attendance sheet to be signed
- Course materials, providedelectronically
- Letter of attestation
- Official certificate
This guide will give you all the necessary information.
Download our training guide: ISO 13485 Internal Auditor - International
* These training modules are eligible to the subsidizing by the public institutions in France (OPCO).

**Each delegate receives a training convention after enrollment.

***Please note that for the public sessions, you have until 48h before the start of the course to confirm your enrollment. For the in-house sessions, the deadline would be of two weeks prior to the start of the course.

****Should you be in a disabled situation, please contact us and indicate what details should be taken into account.

You can contact us on training.france@bsigroup.com or 01 89 79 00 40.

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