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.
Training from LRQA
With LRQA, you can access a wide range of courses to help you further your career and bring improvements to the management systems in your organisation. With many learning styles to choose from, our training courses can help you develop and reach your next level. Find out more about our Training Courses from LRQA.
In-house
If you are looking for a course for four or more people, you may find our in-house option more cost-effective. Contact the team for a quote.
Customised
Work with our training experts to develop a training course or programme specific to your exact requirements.