ISO 13485:2016 Medical Devices Quality Management Internal Auditor Training Course
Course Aim: Learn how to audit the processes of an ISO 13485:2016 Quality Management System (QMS). This course provides guidance and practical experience in planning, executing, reporting and audit follow-up of an internal audit when monitoring the effectiveness and conformity of a ISO 13485:2016 compliant QMS.
Course Description: 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 19011:2018.
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.
What will you 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 you 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
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.
- Refreshments & Lunch
- Delegate Training Course Folder, Pen & Notepad
- Case Studies
- On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.
- Loan copy of the standard (to be returned after the course)
- Suitable for small groups
- Suitable for single person
- Learn from other organizations
- Suitable for large groups
- Flexible & convenient
- Tailored for your needs