CQI and IRCA Certified ISO 13485: 2016 Lead Auditor Training

Benefits of completing iso 13485 medical devices qms lead auditor course
successful completion of this irca certified training course by passing the relevant irca examination and skills assessment, will demonstrate knowledge and basic skills to undertake and lead a management system audit. 

From managing an audit programme to reporting on results, this lead auditor training course teaches you everything needed to conduct a quality management system (QMS) audit. 

Led by experienced instructors over five days, the training is suited to quality managers, directors, engineers or consultants. It will help you fully identify the benefits of a QMS and explain the role of the auditor.

On completing this stage of your learning journey, you will be able to apply risk-based thinking, leadership and process management and understand the arrangements for BSI certification. 

How will I benefit?

• Identify the aims and benefits of an ISO 13485:2016 audit
• Plan, conduct and follow up on auditing activities
• Build stakeholder confidence by understanding the latest requirements

Who should attend?

• Medical Device professionals interested in conducting first-party, second-party, and/or third-party audits
• Management Representatives
• Quality Directors
• Consultants  

Prerequisites
Before attending this course, delegates are expected to have:Knowledge of the following quality management principles and concepts:

• The Plan, Do, Check, Act (PDCA) cycle
• The relationship between quality management and customer satisfaction
• Commonly used quality management terms and definitions and the 8 Quality Principles as given in ISO 9000
• The process approach used in quality management
• The Model of a Process Based Quality Management System, the structure and content of ISO 13485
• Knowledge of the requirements of ISO 13485

What will I learn?
On completion of this training, participants will be able to:

• Interpret the requirements of ISO 13485:2016 in the context of an audit
• Describe the purpose of a quality management system and explain the 8 principles of quality management
• Explain the role of an auditor to plan, conduct, report and follow up a quality management system audit in accordance with ISO 19011
• Plan, conduct, report and follow-up on a QMS audit in accordance with ISO 19011 and by interpreting ISO 13485:2016
• Manage the duties of a lead auditor in their organization or for a third-party

What is included?

• You will sit a 2 hour exam to test your knowledge and understanding. Detailed course notes and lunch provided. IRCA course reference number: A18190.
• On completion, you will be awarded an internationally recognized BSI Training Academy certificate.