Course Structure

This course is a 40 hour/5 day course.

There is a 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: 08:30a.m & Course Finish: 17:30p.m

Evening study will 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

• ISO in Brief
• Accreditation and Certification/Registration
• Overview of the ISO 13485:2003 standard series
• Eight Principles of Management
• Process Approach
• ISO 13485:2003 Structure and Requirements
• ISO 13485:2003 Application
• Day 1 Learning Cycle Review
• 
  

Day 2

• Statutory and Regulatory infrastructure and relationship with ISO Accreditation and Certification/Registration Bodies
• Overview of primary Statutory and Regulatory Requirements
• Keeping up to-date with statutory and regulatory requirements and different sources
• Checking for compliance
• Documentation requirements and benefits, hierarchy and document types, systems
• Document review process
• Terminology, Principles, Types of conformity audits and other audits
• Roles and responsibilities, auditor qualities and role of psychometric assessment tools
• Auditor life cycle
• Audit Roles & Responsibilities
• ISO/IEC 17021:2006 Two Stage Audit Approach
• QMS Document Review
• Day 2 Learning Cycle Review

Day 3

• Initiating the Audit and Preparing for the on-site activities
• ISO 13485 Scope, Audit Scope, QMS Scope
• Developing the Audit Plan
• Auditee Information and Data - Case Study
• Developing the Audit Protocols/Checklists
• Opening Meeting
• Evidence, Methods and Procedure for Gathering Evidence
• Interviewing Techniques
• Audit Reporting Instruction
• Interviewing Instructions and Interviews
• Audit Scenarios
• Day 3 Learning Cycle Review

Day 4

• Interviewing Interviews and Audit Scenarios continued
• Audit Team Performance and Communications
• Handling Difficult Situations
• Audit Findings and Summary Audit Report
• Writing Audit Findings
• Writing Summary Audit Report
• Examination Preparation and Study
• Day 4 Learning Cycle Review

Day 5

• Audit Follow-Up Strategies
• Evaluating Corrective and Action including root cause analysis and audit finding closure
• Audit Follow-Up
• Closing/Exit Meeting
• Course Summary/Continuous Assessment Report
• Examination Instructions and 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