ISO 13485:2016 Clause by Clause

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. 

How will you benefit?

• 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

What will you learn?

• 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

Who should attend?

• 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

Why choose BSI?

We are:

• A full scope Notified Body

• A full scope UK Approved Body

• A national Standards Body

• An accredited ISO 13485 Certification Body

• A recognized Auditing Organization under the Medical Device Single Audit Program

• A globally recognized Certification Body

What's included?

You will gain:

• 14 CPD points on completing the course

• Training course notes