ISO 13485:2016 Clause by Clause

Level Understanding Duration 2 days

Available to book: Instructor led training £1530 + VAT Akamai View dates and book now

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

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
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
You will gain:
- 14 CPD points on completing the course
- Training course notes

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