You need this course if...
You want to learn about the latest ISO 13485 standard and have responsibility for managing the transition to your quality management system.
You will learn...
- The structure of ISO 13485:2016 and how it interrelates with the Plan Do Check Act cycle
- The differences between EN ISO 13485:2012 and ISO 13485:2016
- How the principal changes defined in the new standard may be accommodated by an organisation that already has ISO 13485 certification and the transition timelines that apply
- The role of the Medical Devices Single Audit Program
- The interrelationships between ISO 13485:2016 and the associated European Directives / Regulations
- How ISO 13485:2016 aligns with the quality management system requirements defined in ISO 9001:2015, which is based on Annex SL
- The significance of the new and enhanced requirements in ISO 13485:2016 in terms of your own organisation’s QMS and initiate preparations for a smooth transition.
You will need...
Ideally you will have an appreciation of ISO 13485:2003 and / or EN ISO 13485:2012.