Booking options
£720 - £800
£720 - £800
Delivered Online or In-Person
Advanced level
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