How to design a process-oriented and efficient Quality Management System (QMS) in accordance with ISO 13485!
This practical course is designed for quality managers, regulatory affairs specialists, executives, and particularly for Quality Management Representatives (QMRs). You will learn how to implement and maintain an effective QMS compliant with ISO 13485 to meet regulatory requirements successfully.
As a QMR, you will discover how to fulfill your central role in supporting top management, ensuring continuous compliance with applicable requirements, and fostering an effective quality culture within your organization.
- Content
- Definition and fundamentals of quality management
- Quality Management Systems according to EN ISO 9000
- Regulatory framework
- Differences between the MDR and EN ISO 13485
- General Safety and Performance Requirements (GSPRs) and their relationship to ISO 13485
- Changes compared to the previous version (EN ISO 13485:2012)
- Comparison between EN ISO 9001 and EN ISO 13485
- Requirements of DIN EN ISO 13485
- Chapters 0–2: General information and scope of application
- Chapter 3: Terms and definitions
- Chapter 4: Quality management system — quality agreements (QSV) and documentation requirements
- Chapter 5: Management responsibility — commitment, customer focus, quality policy, and planning
- Chapter 6: Resource management — provision of resources, personnel competence, infrastructure, and work environment
- Chapter 7: Product realization — planning, customer-related processes, design and development, purchasing, production and service provision, and control of monitoring and measuring equipment
- Chapter 8: Measurement, analysis, and improvement — monitoring, control of nonconforming products, data analysis, and continual improvement
- Your Benefits
- Learn how to build, maintain, and optimize a process-oriented QMS efficiently in accordance with ISO 13485.
- Implement regulatory requirements effectively and enhance your company’s compliance and performance.
- Benefit from practical examples showing how to streamline processes without compromising quality.
- As a QMR, gain valuable insights to strengthen your interface role between management, staff, and regulatory authorities.
- Methods
Instructor-led sessions, group exercises, facilitated case studies, practical exercises, individual work, real-world case studies, discussions, live coaching, storytelling.
- Target Audience
- Manufacturers of medical devices
- Suppliers, subcontractors, and service providers
- Personnel from Quality Assurance (QA) and Quality Management (QM)
- Top management
- (Future) Quality Management Representatives (QMRs)
- Auditors
- Regulatory or authority personnel
