ISO 13485:2016 Internal Auditor Training Course

An ineffective audit can mean severe consequences; resulting in process failure, patient dissatisfaction and regulatory noncompliance. Optimize your auditing skills with the internationally recognized ISO I3485:2016 and boost your internal audit capabilities. Gain confidence in planning and performing an effective audit, as well as reporting and taking corrective action where necessary.

This course is intended for medical device quality professionals wishing to build on their current knowledge of ISO 13485:2016 and evaluate the effectiveness of their QMS. It teaches the principles and practices of effective audits in accordance with ISO 13485:2016 and ISO 19011:2011.


Who should attend?

Medical device quality professionals with knowledge of quality management systems and ISO 13485:2016, as well as individuals interested in conducting first-party or second-party audits, management representatives, internal auditors and consultants.

Prerequisites:
You should have a good knowledge of ISO 13485:2016 and the key principles of a QMS. If not, we strongly recommend you attend our ISO 13485:2016 Introduction or Clause by Clause course.

What will I learn?

On completion, you should gain the knowledge and skills to:

  • Explain the structure and scope of ISO 13485:2016 and how it applies to the organization seeking regulatory compliance
  • Identify the key principles of auditing and auditor responsibilities
  • Plan an internal audit
  • Conduct an effective audit based on process identification, sampling and questioning
  • Determine if corrective action has been effectively implemented

How will I benefit?

This course will help you:

  • Maintain compliance with ISO 13485:2016
  • Improve a global benchmark in quality standards 
  • Be confident that your organization can rely on competent auditors
  • Motivate colleagues through CPD and ensure rigorous regulatory internal processes
  • Write factual audit reports and suggest corrective actions

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.

What is included?

This training course is HRDF approved under the SBL scheme.

On completion, you will be awarded an internationally recognized BSI Training Academy certificate.


Available as an In-House Course

Call us and speak with our training advisors on running an in-house training.

  • Suitable for large groups
  • Flexible & convenient
  • Tailored for your needs

Request a in-house training proposal