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ISO 13485:2003 Implementation Training Course
Course Category: Medical Devices Quality Management Systems (QMS)
Course Title: Implementing a QMS based on ISO 13485:2003
This two day course introduces the concepts needed to understand, develop, and implement a management system. This course covers the ISO 13485 family of standards. Experienced instructors with real life experience explain how to build a successful management system and integrate it into the current business framework, prepare for, and achieve ISO 13485:2003 registration. Exercises prepare delegates to identify key requirements, create winning documentation, develop project plans, and prepare a scope map, gain top management and employee buy-in, and all at minimum time, effort and cost.
Course Certification
Kelmac Group Certified Course
This course has been designed by leading experts to provide high quality training to professionals seeking to effectively implement a Medical Devices Quality Management System based on ISO 13485:2003.
Who should attend?Benefits to Your Business
- Quality Managers
- Quality Control Professionals
- Healthcare Consultants
- Medical Device Consultants
- Enforcement Officers
- Regulatory Personnel
- Certification Bodies/Registrars
- Implementation Team Members
- Professionals in the Medical Device Industry & Supply Chain
- Do you want to design and implementing a Management System with minimal external assistance and at the lowest cost?
- Do you want to achieve registration at the first attempt?
- Do you want free access to winning documentation templates?
- Do you want to gain top management and employee buy-in?
- Do you want to want to select quality Certification Bodies/Registrars?
- Do you want to keep maintenance costs to a minimum?
Course Pre-requisitesLearning Objectives
- This is an introductory course designed for individuals with little or no previous knowledge of implementing a quality management system. Basic knowledge of medical devices, ISO 9001, or ISO 13485 would be beneficial.
- Understand quality management definitions, concepts, and guidelines
- Understand the purpose of the ISO 13485:2003 series
- Understand the requirements of the ISO 13485:2003 standard
- Build an efficient and effective Quality Management System
- Establishing best practice processes to implement each clause of ISO 13485:2003
- Learn tips for winning employee and top management support
- Establishing controls/risk management
- Monitoring and measurement for Improvement
- Plan for registration
Course Structure
This course is a 16 hour/2 day course.
Course Start: 08:45a.m & Course Finish: 17:30p.m
A detailed course breakdown is as follows:
- Quality Management definitions, concepts, and guidelines
- Purpose of the ISO 13485:2003 series
- Requirements of the ISO 13485:2003 standard
- Conducting the Gap Analysis
- Getting Top Management buy-in
- Managing Human Resources/Change Management
- Gathering Preliminary Data
- Establishing the Controls Measures
- Verification and Validation
- Operational Controls
- Risk Management
- The Audit Registration process
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. It's a total system of enhancing and speeding up both the design and learning process. What makes accelerated learning so effective is that it's 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
- Delivery by Expert (s) with real life experience
- Additional Handouts
- Digital Training Certificate of Attainment and/or Successful Completion
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
