ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.
COURSE OBJECTIVES
The “ISO 13485:2016 Lead Auditor” course provides comprehensive training for participants to be able to:
- 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
WHO NEEDS THIS COURSE?
- Persons responsible for lead certification audits according to ISO 13485:2016 requirements
- Persons involved in the ISO 13485:2016 certification audits processes.
COURSE CONTENT
Day 1
- 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
Day 2
- Document Management
- Inspection Operations managements
- Resource Management
- Subcontracting
- Process Improvement
- Monitoring and Evaluation
Day 3
- Fundamentals of Auditing
- Auditing according to ISO 17011
- Managing Audit Program
- Audit Evidences
- Audit Process
- Audit Planning Preparation
Day 4
- Leading an audit
- Conducting Onsite Audit
- Conducting Audit Follow-Up
- The Root Cause Analysis Process
- Certification Audit processes and criteria
Day 5
- Revision and
- Examination
Duration: 5 days
Training Methodologies
- Case Study
- Individual Exercises
- Role Play
- Group Exercises
- Group Presentation
- Examination
