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.
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.
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
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 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
What is included?
On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.
