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ISO 13485:2003 Internal QMS Auditor Training Course
Course Category: Medical Devices Quality Management Systems (QMS)
Course Title: Internal QMS Auditor with emphasis on ISO 13485:2003
Kelmac Group's Internal QMS Auditor with emphasis on ISO 13485:2003 course, designed for those with knowledge of medical device manufacturing, starts with one full day of review of ISO 13485. Delegates gain a broad understanding of the ISO 13485 quality management system requirements. 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. Delegates also learn how to apply the guidance of ISO 19011:2002, "Guidelines for Quality and/or Environmental Management Systems Auditing," to implement effective internal audit programs for medical device manufacturing organizations.
Course Certification
Kelmac Group Certified Course
This course has been designed by leading experts to provide high quality training to professionals seeking to effectively audit a Medical Devices Quality Management System based on ISO 13485:2003.
Who should attend?Benefits to Your Business
- Quality managers
- RA managers
- Auditors of medical device manufacturing firms (internal and external)
- Cross functional team members implementing the standard
- The knowledge and skills to effectively internally audit your management system
- To conduct a risk assessment of the effectiveness and maturity of your management system
Course Pre-requisitesLearning Objectives
- There are no formal pre-requisites for this course.
- Understand quality management definitions, concepts, and guidelines
- Understand the quality management principles
- Interpret all clauses of ISO 13485
- Apply principles of PD CEN ISO/TR 14969 and ISO 14971
- Apply principles of ISO 19011:2002 to the auditing process
- Plan, conduct, and report effective internal audits to ISO 13485
- Understand the registration process
Course Structure
This course is a 24 hour/3 day 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
- Audit Roles & Responsibilities
- Audit Planning
- Developing the Audit Plan/Scope
- Developing Audit Protocols/Checklists
- Opening Meeting
- Collecting and Verifying Information
Day 3
- Interviewing Skills
- Auditing Top Management
- Audit Reporting - Non-Conformity Reports
- Audit Finding Reporting (NCR/OI)
- Completing the Audit/Audit Follow Up
- Closing/Exit Meeting
- Course Summary/Continuous Assessment Report
- 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.
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
