ISO 13485:2003 Understanding Training Course
Course Category: Medical Devices Quality Management Systems (QMS)
Course Title: Understanding ISO 13485:2003
Kelmac Group's Understanding ISO 13485:2003 training course gives delegates a broad understanding of the quality management system requirements outlined in the medical devices standard ISO 13485 requirements. The course includes exercises to provide delegates with the opportunity to practice the information taught in the course. Our instructors also encourage discussion and debate as part of the learning process.
Course Certification
Kelmac Group Certified Course
This course has been designed by leading experts to provide high quality training to professionals seeking to effectively understand a Medical Devices Quality Management System based on ISO 13485:2003.
Who should attend?
- Quality managers
- RA managers
- Auditors of medical device manufacturing firms (internal and external)
- Those individuals working in an ISO 13485 complaint environment or in the Medical Devices Industry
- Cross functional team members implementing the standard
Benefits to Your Business
- The knowledge and skills to effectively understand your management system and legislation applicable.
Course Pre-requisites
- Participants should have a basic knowledge of quality management systems, ISO 9001, or ISO 13485
Learning Objectives
- Interpret all clauses of ISO 13485
- Understand the role of management in ISO 13485 implementation
Course Structure
This course is a 8 hour/1 day course.
Course Start: 08:45a.m & Course Finish: 17:30p.m
A detailed course breakdown is as follows:
- 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
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.
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
Further Information
Kelmac Group offer all of our Training Solutions on an In Company/In House basis. These solutions can be tailored to meet the specific needs and requirements of the client.
Our fees are very competitive and if you would like further information, please contact our office directly on +353 (61) 491224 or email info@kelmacgroup.com
€1,395/Person-
07 March 2012
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07 March 2012
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26 March 2012
