Cognicert ISO 13485 Medical Devices Quality Management Lead Auditor

Plan and conduct audits of medical device quality management, evaluate evidence and follow up findings on documented processes, risk controls and medical-device quality evidence.

Work through documented processes, risk controls and medical-device quality evidence and connect them to the responsibilities of your audit or assessment role. The detailed programme explains the methods and activities covered.

• Understand how to audit each and every ISO 13485:2016   requirements
• Learn fundamental auditing skills;
• Implement methods to comply with the ISO 13485:2016
• Audit process and techniques
• Improve Auditor’s skills and techniques
• Examine the requirements of ISO 13485 from an Auditor Perspective
• Write Audit reports process and follow up corrective actions
• Plan, Lead, Conduct and report an ISO 13485 audit;
• Effectively verify root cause analysis as part of the ISO 13485 Management procedure on corrective action

• Persons responsible for lead certification audits according to ISO 13485:2016 requirements
• Persons involved in the ISO 13485:2016 certification audits processes.

• Background and Development of ISO 13485:2016
• Interpreting the Requirements of the ISO 13485:2016  Standard
• The Process Management Approach
• Roles and responsibilities
• Management System Planning

• Document Management
• Inspection Operations managements
• Resource Management
• Subcontracting
• Process Improvement
• Monitoring and Evaluation

• Fundamentals of Auditing
• Auditing according to ISO 17011
• Managing Audit Program
• Audit Evidences
• Audit Process
• Audit Planning Preparation

• Leading an audit
• Conducting Onsite Audit
• Conducting Audit Follow-Up
• The Root Cause Analysis Process
• Certification Audit processes and criteria

• Revision and
• Examination

• Case Study
• Individual Exercises
• Role Play
• Group Exercises
• Group Presentation
• Examination