ISO 13485:2016 Clause by Clause

Level Understanding Duration 2 days

Available to book: Public classroom PHP16000 See all dates and book

Available to quote: In-house Request a quote

To address the requirements of Medical Device Directives, manufacturers must demonstrate their commitment to the safety and quality of their medical devices. This course enables a clause by clause understanding of ISO 13485:2016, which provides an effective solution to meet the comprehensive requirements of an effective QMS. Learn to apply your knowledge to the development of an ISO 13485:2016 compliant QMS and maintain the on-going certification of your organization.

How will I benefit?

This course will help you:

Describe the requirements and structure of ISO 13485:2016
Interpret and apply requirements relevant to your organization
Appreciate how a QMS can be applied as a framework to produce safer medical devices
Evaluate how requirements can be effectively implemented to meet and maintain regulatory compliance

Our high impact accelerated learning approach increases learning by improving knowledge retention and skill application. This course is activity-based, resulting in a deeper understanding of the material and a greater impact on job performance.

On completion, you should gain the knowledge and skills to:
- 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
Senior management, quality managers, regulatory affairs managers, internal and external auditors, consultants and anyone involved with the implementation of the standard.
On completion, you will be awarded an internationally recognized BSI Training Academy certificate.
Auditor Qualifications

This course forms part of our auditor qualification programme. Our ISO 13485 auditor qualifications will give you a BSI Mark of Trust, reassuring your customers and suppliers that your skills have been validated. You can achieve Practitioner or Professional status by successfully completing courses and exam.

Medical Devices Regulation (MDR) Qualifications

This course forms part of our MDR Practitioner Qualification. This qualification will give you a BSI Mark of Trust, reassuring your customers and suppliers that your skills have been validated. You can achieve Practitioner status by successfully completing courses, exams and demonstrating practical application.

I'm interested, please send me more information about the course.
There are no formal prerequisites, however it will be useful for delegates to read the standard before attending the course.

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