ISO 13485:2016 Medical Devices Auditor/ Lead Auditor Training Course

Please see the ISO 13485:2016 Medical Devices Auditor/ Lead Auditor Training Course Synopsis for a more comprehensive overview of this course and to review any pre-course requirements that might apply.

The aim of this course is to provide students with the knowledge and skills required to perform first, second (including supplier) and third party audits of quality management systems against ISO 13485:2016, in accordance with ISO 19011.

Upon completion of this course, learners will be able to:

• Explain the purpose of a management system, third party certification and the business benefits of a quality management system for medical devices. 
• Understand the importance of meeting applicable regulatory requirements
• Explain the role and responsibilities of an auditor to plan, conduct, report and follow-up on a QMS audit in accordance with 19011. 
• Plan, conduct an report on a QMS audit to establish conformity with ISO 13485 and applicable regulations

Before starting this course, students are expected to have the following prior knowledge:

MANAGEMENT SYSTEMS:

• The core elements of a management system and the interrelationship between top management responsibility, policy, objectives, planning, implementation, measurement, review, and continual improvement.

QUALITY MANAGEMENT:

• The fundamental concepts and the seven quality management principles (see ISO 9000):

• Customer focus
• Leadership
• Engagement of people
• Process approach
• Improvement
• Evidence-based decision making
• Relationship management

ISO 13485:2016 STANDARD:

• Knowledge of the requirements of ISO 13485, and the focus on meeting applicable regulatory requirements, using a risk based approach. 
• Preferable experience in performing internal audits against ISO 13485

Learners will need to demonstrate acceptable performance and be fully involved in the interactive workshops in order to complete the course successfully.