ISO 13485:2016 Awareness and Internal Auditor

Level Internal auditor Duration 3 days

Available to book: Public classroom View all dates and book

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This three-day course is intended for medical device quality professionals with the aim of building a system based on the current knowledge of ISO 13485 and evaluating the effectiveness of the quality management system in the organization.

This course provides the ISO 9001:2015 standard requirement that incorporates the development of the skills needed to assess and report on conformity and implement processes based on dedicated ISO 9001:2015 for medical device manufacturing. You will learn how to initiate assessments, prepare and conduct audit activities, draft and distribute audit reports, and complete follow-up activities.

How will I benefit title?

This course will help you:

Understanding the requirements of ISO 13485:2016
Continue to better comply with ISO 13485:2016
Maintain and improve global benchmarks of quality standards
Acquire skills to assess an organization's ability to manage QMS
Write a factual assessment report and recommend corrective actions.

Our high-impact accelerated learning approach increases learning by improving knowledge retention and skill application. This course is based on experiential activity, which serves as a basis for enhancing a deeper understanding of the material and a greater impact on work performance.

Which qualification will I achieve title?

The training certificate is issued by BSI and is widely recognised internationally.

Upon completion of this course, students will be able to:
- Organize retraining on standard requirements for the organization's staff
- Explain the structure and scope of the ISO 13485 management system standard and how to apply it to a global regulatory compliance organization
- Define the audit principles and responsibilities of the auditor.
- Internal audit planning
- Carry out cross-notification and non-notification cross-assessment activities
- Perform assessments based on the process of identification, sampling, and questioning
- Provide feedback by word of mouth or in written form
- Brief documentation of non-conformities
- Report on Audits Effectively
- Track corrective activities.
This course is suitable for:
- Medical device quality experts want to supplement and improve their knowledge with ISO 13485
- Individuals who have the goal of developing a career in first- or second-party auditing.
- Representing the management of production and service activities of the enterprise
- Internal Auditor
- Administer
- Professional consultants.
- Training materials
- Notebook
- Lunch
- Snacks (tea, coffee, cakes, candies, fruits, and soft drinks)
- Certification of training.
If you have any questions, let us know how we can help you.

Call: +84 (28) 3820 0066
Email us: info.vietnam@bsigroup.com

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