REF. MQ03 – INTRA / INTER
QUALITY SYSTEM
COURSE DESCRIPTION
CE-marking requires the implementation of a Quality organization. European standard EN ISO 13485 sets out the requirements for the Quality Management System to enable an entity to demonstrate its ability to regularly supply Medical Devices that comply with customer requirements and applicable regulations.
DURATION
1 day / 7 hours
IN-PERSON
VIRTUAL CLASSROOM
OBJECTIVES
- Become familiar with the terms and vocabulary
- Analyze and understand EN ISO 13485 requirements
- Identify the ties between the regulations and EN ISO 13485
TARGET TRAINEES
- Medical Device manufacturers
- Operators in an ISO 13485 environment
- Quality Managers
- Quality Engineers
PREREQUISITES
- Familiarity with basic Quality Management principles
- Familiarity with the Medical Device sector
TRAINING RESOURCES
- PowerPoint presentation handed out at the end of training
- Examples tailored to the company’s products
- Quizzes
COURSE CONTENT
Participants welcomed and presented/Course objectives/Presentation of the course content.
- Introduction
- A brief history
- Normative and regulatory framework
- Scope
- Exclusion – non-applicability
- A few definitions
- Quality Management principles and concepts
- What is a process approach?
- What is continuous improvement?
- Quality Management principles
- Analysis of ISO 13485:2016 requirements
- Chapter 4: Quality Management System
- Chapter 5: Management responsibility
- Chapter 6: Resource management
- Chapter 7: Product realization
- Chapter 8: Measurement, analysis and improvement
- Summary/Q&A
- Course evaluation and conclusion
EVALUATION METHODS
- Course evaluation quiz
- Satisfaction survey
- Attendance certificate
This training is assessed based on an evaluation of each individual’s acquisition of knowledge via quizzes during and at the end of the program (success criteria >= 75%).