Cognicert ISO 13485 Medical Devices Quality Management Lead Auditor

• 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

• Build a clear working understanding of ISO 13485 Medical Devices Quality Management Lead Auditor.
• Apply relevant principles, requirements and good practice in realistic organisational contexts.
• Prepare participants to contribute confidently to implementation, assurance or professional practice.

By the end of the programme, participants should be able to explain the core concepts, identify practical requirements, evaluate evidence and plan appropriate improvement actions.

The programme is structured around ISO 13485 and the supporting guidance relevant to the course scope. Cognicert advisers can confirm the edition used for your selected cohort.

Suitable for managers, practitioners, auditors, implementers, consultants and other professionals whose responsibilities relate to ISO 13485 Medical Devices Quality Management Lead Auditor.

• Stronger practical capability and professional confidence
• A structured approach that can be transferred to the workplace
• Assessment and a verifiable Cognicert certificate where the course requirements are met

The programme covers essential concepts, requirements, implementation considerations, evidence-based evaluation, common challenges and practical improvement planning.

Learning combines tutor explanation, guided discussion, examples, exercises and scenario-based application. Delivery may be live online, self-study or arranged for an organisation.