Implementation ISO 13485 training course - International

Niveau Mise en œuvre Durée 2 journées de formation

Disponible pour réserver: Salle de classe virtuelle 1770€ + TVA Book now

This two-day course gives you the knowledge and steps to implement a quality management system (QMS) in line with ISO 13485:2016. It’s suitable for managers or members of an implementation team.

Choose to take this stage of your learning journey in-person or live online in a classroom environment. You’ll learn how to plan, organize and schedule everything needed to define an ISO 13485: 2016 QMS, as well as how to implement it. You’ll also carry out a baseline review, specific to your own organization.

On completing the course you’ll gain a certificate and 16 CPD points. The training helps you to generate your own comprehensive course notes and will leave you with a thorough understanding of how to implement the ISO 13485:2016 standard.

Prerequisites

There are no formal prerequisites for this course.

Pedagogical objectives

Understand and plan ISO 13485:2016 implementation
Find ways to increase efficiency, add value and monitor supply chains effectively
Take the first steps towards ISO 13485:2016 certification

- Anyone involved in defining, planning, or implementing an ISO 13485:2016 based quality management system
- Management representatives
- Implementation team members
On completion of this training, participants will be able to:
- Define an ISO 13485:2016 QMS
- Identify the steps for defining, planning, organizing and scheduling
  necessary activities
- Implement an effective quality management system
- Conduct a base line review of an organization’s current position with regard to ISO 13485:2016
- Course materials, providedelectronically
- Letter of attestation
- Official certificate
Assessment specifics
- 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/ role plays
- Answers to the activities
- Videos
- Additional documents, distributed during the sessions, to use for the activities
- Attendance sheet to be signed
This guide will give you all the necessary information.
Download our training guide: ISO 13485 Implementation
* 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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