Preparing for ISO 13485:2016.

You want to learn about the latest ISO 13485 standard and have responsibility for managing the transition to your quality management system.

• 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.

Ideally you will have an appreciation of ISO 13485:2003 and / or EN ISO 13485:2012.