ISO 13485:2016 Internal Auditor EN - Training / Workshop von BSI Group Deutschland GmbH

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.   Course Outcomes   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