Course Content:

· Introduce the purpose and benefits of a Medical Device Management System, MDMS and evolution of the ISO 9000 series of standards on which ISO 13485 is based, the continuing development process of these standards and key concepts and terminology. 

· The 8 Quality Management Principles, their applications and potential benefits. 

· Explain the structures, purpose, content and interrelationship of ISO 16485, ISO 14971:2012 and ISO 19011:2002 and the difference between auditable standards and guidance documents.

· Discuss and explain the requirements of the ISO 13485:2012, use ISO/TR 14969:2009 and the 8 Quality Management Principles, where appropriate, for illustration and to enhance understanding.

· Explain the benefits and approaches of documentation, circumstances of exclusion of the ISO 13485:2016 requirements and the Process-based Quality Management system model.

·Describe the certification/registration and accreditation processes, types of audits (1st, 2nd and 3rd party) and the differences between legal compliance and conformance with ISO 17021:2006. 

·  How to plan and prepare MDMS audits based on the "Process Approach" including the ability to develop and use Checklists and Process-based Audit Plans, using appropriate information gathered during the document review and/or stage-1 audit.

· How to Conduct, Report and Follow-up MDMS audits based on the "Process Approach" including various Audit Methodology, Questioning Techniques, Roles and Responsibility in order to collect and analyse evidence, exercise objectivity and make decisions on the significance of observation made in accordance to relevant audit criteria.