ISO 13485:2016 Clause by Clause - International

Dauer 2 Tage

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This two day course has been designed to provide an in depth understanding of ISO 13485:2016.

On completion of this training, participants will be able to apply their knowledge to the development of a ISO 13485:2016 compliant quality management system and help maintain on going certification of their organization.

How will I benefit?

Describe the requirements and structure of ISO 13485:2016
Interpret and apply requirements relevant to your organization
Appreciate how a QMS can be applied as a framework to produce safer medical devices
Evaluate how requirements can be effectively implemented to meet and maintain regulatory compliance

- 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
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
"Our international reach is unrivalled with operations in 147 countries"
- You will gain:
  
  14 CPD points on completing the course
  
  Training course notes
  
  Lunch
  
  Refreshments.
Dieser Kurs findet auch auf Deutsch statt. Erhalten Sie hier eine Übersicht der Termine und Verfügbarkeit.

More information

Course guide - eng (PDF)

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