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.
Learning Objectives:
By the end of this course you will be able to:
Explain the structure and scope of ISO 13485:2016 and how it applies to the organization seeking regulatory compliance
Determine if corrective action has been effectively implemented
Identify the key principles of auditing and auditor responsibilities
Plan an internal audit
Conduct an effective audit based on process identification, sampling and questioning
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.
Medical device quality professionals with knowledge of quality management systems and ISO 13485:2016
Consultants
Management representatives
Individuals interested in conducting first-party or second-party audits
Internal auditors
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.