ISO 13485:2016 Clause by Clause - International

Niveau Spécialiste Durée 2 journées de formation

Disponible pour réserver:: Salle de classe virtuelle 1630€ View dates and book now

This two-day course provides an in-depth understanding of ISO 13485:2016. It’s designed specifically for those who are looking to further their knowledge of the management system.

Training will be delivered either live and online or in-person in a classroom setting. You will learn how to explain the scope and structure of ISO 13485:2016 and interpret what’s required for your own organization.

You will finish this stage of your learning journey with deeper knowledge and confidence and have a clear pathway for putting ISO 13485:2016 certification into place for any organization.

Prerequisites

There are no formal prerequisites for this course

Pedagogical objectives

Full understanding of ISO 13485:2016 requirements
Able to explain and interpret requirements, relevant to your organization
Learn how a quality management system provides a framework for safer medical devices
Comprehensive training notes and 14 CPD points on completion

- Regulatory, quality, research, design, development, and manufacturing personnel who will be involved in working with ISO 13485:2016 and need to have a greater understanding of the management system
- Organizations preparing to put ISO 13485:2016 in place
- Personnel who have joined an organization who have ISO 13485:2016 and require in depth knowledge
- Delegates attending the Lead Auditor to ISO 13485:2016 course who do not already have a good knowledge of the standard
Explain the scope and the structure of ISO 13485:2016

Describe the requirements of ISO 13485:2016

Explain how to interpret the requirements of the standard within your organization

Develop your knowledge of how the requirements of ISO 13485:2016 are
established and maintained in an organization

Identify the systems that are required to implement an ISO 13485:2016 QMS in order to gain or maintain certification to ISO 13485:2016
- Course materials, provided electronically
- Letter of attestation
- Official certificate
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
More information

Course guide - eng (PDF)
- Questionnaire to assess the knowledge at the end of the training
- Customer survey

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