Course Structure

The pre-course assignment and online test is expected to require between 8 and 15 hours to complete, based upon student's prior knowledge/experience.

The on-site class is a 40-hour (/5-day) course. Evening study will be required of every delegate (student). It is expected the supervised evening study may be between 6 and 8 hours. The Kelmac Group® recommends that all students attending treat the course as residential (you could lose a valuable hour or more in commuting).

The post on-site class will culminate in a written QMS Auditor examination. The written examination is planned to take two hours to complete

Course Start: 08:30am / Course Finish: 17:30pm

A detailed course breakdown is as follows:

Day 1

• Introduction and Welcome
• Accreditation and Certification/Registration
• 8 Principles of Quality Management
• Process Management and the PDCA Cycle
• Introduction to the ISO 9000 Standard Series including guidance and reference standards
• International Quality Management System Standard ISO 13485:2003
• Day 1 Learning Cycle Review

Evening:

Process and techniques for the assessment of QMS

Day 2

• Day 1 Recap
• Document Management Systems
• Processes and techniques used for the assessment of Quality Management Systems
• Medical Devices Statutory and Regulatory Framework and Requirements
• Introduction to Auditing
• Auditor Competence, Roles and Responsibilities and Performance
• Sample Examination Review

Evening:

Audit Plan/Scope and Audit Protocols/Checklist

Day 3

• Day 2 Recap
• Initiating the Audit and Preparing for the on-site activities
• Developing an Audit Plan/Scope
• Developing Audit Protocols/Checklists
• Conducting on-site audit activities
• Opening Meeting
• Collecting and verifying information
• Evidence and verifying information
• Day 3 Learning Cycle Review

Evening:

Audit Finding/Audit Reporting

Day 4

• Day 3 Recap
• Review of Case Study
• QMS Simulated audit Interviews based upon QMS case study
• Writing Audit Findings including classification
• Audit Reporting
• Writing the Audit Report
• Day 4 Learning Cycle Review

Evening:

Audit Finding/Audit Reporting

Day 5

• Day 4 Recap
• Completing the Audit
• Evaluating Corrective and Preventive Actions including audit finding closure
• Audit Follow-Up Strategies
• Analysing the audit Findings
• Final Audit Team Meeting
• Closing/Exit Meeting
• Course Summary/Continuous Assessment Report
• Examination Instructions
• Course Close

Student Assessment

The student is assessed prior to the start of the on-site class, during the on-site class 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.

Post the on-site class. There is a two-hour written auditor examination at the end of the on-site class. The written auditor examination is based on QMS, or ISO 13485. The written examination is closed book; however, the student is required to have a hard-copy version of the relevant management system standard (ISO 13485) for class use. The minimum pass rate for each written auditor examination is 70%.

Training Methodology

"Accelerated Learning"

(AL) is the most advanced teaching and learning method available today – it is a total system of speeding up and enhancing the design and learning process. What makes Accelerated Learning so effective is that itʼs based on the way we naturally learn. It actively involves 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

• FREE online access to relevant reference material via the Kelmac Group® for the training
• FREE online access to all primary and relevant standards from course registration until completion of the course program
• FREE online study guide to assist in the completion of the pre-course assignment tests, on-site delegate assessment and post assessment, written examinations
• FREE online assessments prior to commencing the on-site class via the Kelmac Group® Learning Management System
• Access to a two hour study preparation session led the Kelmac Group® Instructor on the evening prior to completing the IRCA FSMS written examination
• Comprehensive quality delegate manual that can be used as a reference manual by students following the on-site course
• During delivery of the on-site class, students may have access to a variety of Instructors who are experts in their respective fields
• The Kelmac Group® is an IRCA-Approved TORS. Kelmac Group® Instructors will be delighted to assist any student wishing to become an IRCA Registered Auditor, complete the IRCA Auditor application, and/or review the student's support documentation for conformity with the relevant IRCA's Auditor scheme.
• The Kelmac Group® will also be delighted to process the student's completed application with IRCA. Students who meet IRCA's Auditor scheme requirements and who process their application via the Kelmac Group® qualify for a 25% reduction in the IRCA auditor application fee. Each student is responsible for and liable for online payment of the relevant fees with IRCA.