ISO 13485 Lead Auditor Training Course

Course Category: Medical Devices Quality Management Systems (QMS)  

Kelmac Group's QMS Auditor/Lead auditor based on ISO 9001:2008 and ISO 13485:2003 Training Course begins with a review of ISO 13485 and continues to teach the principles of process auditing in accordance with quality management system standards and ISO 19011:2002, "Guidelines for Quality and/or Environmental Management Systems Auditing."  In addition, the concepts of ISO 14971, "Application of Risk Management to Medical Devices," are introduced.  Through small group activities, audit role-plays, lively discussions, and instructor-led lectures, delegates gain a thorough understanding of the principles of auditing and how to apply the guidance of ISO 19011:2002 to implement effective audit programs for medical device manufacturing organizations.

Course Structure

This course is a 40 hour/5 day course.

There is a 16 hour pre course assignment that must be completed by all delegates in advance of attending. Completed assignments are to be handed to the tutor on day 1 of the training course.

Course Start: 08:45a.m & Course Finish: 17:30p.m

Evening study may be required as part of this course. It is recommended that all delegates attending treat the course as residential.

A detailed course breakdown is as follows:

Day 1

• Accelerated Learning - 8 Principles of Quality Management 
• Auditor Certification and ISO/IEC 17021:2003
• Introduction to the ISO 9001:2000 Standard Series and ISO 13485:2003 QMS Framework and Process Management
• Eight Principles of Quality Management
• ISO 13485:2003 Requirements
• Permissable Exclusions
• 
  

Day 2

• ISO 9001:2000/ISO 13485:2003 Process Model
• Medical Devices Directives/FDA QS Regulations and guidance documents
• Documentation Requirements
• Customer Satisfaction Identification and Measurement
• Accreditation and Registration
• Two stage approach to initial registration
• Audit Roles & Responsibilities
• Audit Planning
• Initiating the Audit
• Preparing for the on-site activities
• Developing the Audit Plan/Scope
• Examination Revision

Day 3

• Conducting the Document Review
• Developing Audit Protocols/Checklists
• Conducting the on-site audit activities
• Opening Meeting
• Collecting and Verifying Information
• Auditing Top Management
• Handling Difficult Situations
• Examination Revision

Day 4

• Conducting on-site audit activities
• Opening Meeting
• Collecting and Verifying Evidence
• Interviewing Skills
• Auditing Top Management
• Audit Reporting - Non-Conformity Reports
• Audit Finding Reporting (NCR/OI)
• Examination Techniques/Revision

Day 5

• Preparing, Approving and Distributing the Audit Report 
• Generating the Summary Audit Report
• Completing the Audit/Audit Follow Up
• Closing/Exit Meeting
• Course Summary/Continuous Assessment Report
• Course Examination
• Course Evaluation/Feedback 

Course Assessment

The delegate is assessed based on participation and performance throughout the duration of the course. This includes all exercises, role plays, case studies and all other activities during the course. Please note, full attendance is required during the training course.

There is a 2 hour written examination at the end of the course. The exam is open book in that a delegate is entitled to use their own notes taken while on the course, the use of the delegate manual and any other supplementary material provided including their copy of the International Standard (s) in question. The minimum pass rate for the examination is 70%.

Training Methodology

Accelerated learning is the most advanced teaching and learning method available today. Itʼs a total system of enhancing and speeding up both the design and learning process. What makes accelerated learning so effective is that itʼs based on the way we naturally learn. It does this by actively involving the whole person, using physical activity, creativity, collaboration among learners, variety that appeals to all learning styles, contextual learning with real-world immersion, the creation of a positive physical, emotional, and social environment and other methods designed to get people deeply involved in their own learning.

What's Included on the course

• Comprehensive Course Manual
• Expertise and Wisdom of Tutor (s)
• Additional Handouts