This three days course has been designed to provide an insight into the use of ISO 13485 as the basis for a quality management system implemented by medical device manufacturers also to provide participants with the knowledge and process steps to enable them to effectively implement a quality management system in line with the requirements for ISO 13485:2016. The course introduces the concepts needed to understand, develop, and implement a quality management system.
Time will be spent during the course reviewing requirements of ISO 13485 and making comparisons to ISO 9001 and the FDA’s Quality System Regulation. In addition to this, participants will also gain an awareness of the relationship between ISO 13485 and ISO 14971, Application of Risk Management to Medical Devices.
How will I benefit?
- Take the first steps towards ISO 13485 certification
- Understand how you can better meet customer and regulatory requirements
- Find ways to increase efficiency and cost savings through quality management
- Monitor supply chains to achieve continuous improvement
- Develop safe and effective medical devices
- Motivate employees through CPD
- Take the first steps towards ISO 13485 certification
- Understand how you can better meet customer and regulatory requirements
- Find ways to increase efficiency and cost savings through quality management
- Monitor supply chains to achieve continuous improvement
Who should attend?
- Senior Management
- Quality Managers
- Regulatory Affairs Managers
- Internal and external Auditors
- Anyone involved with the implementation of the standard
What will I learn?
On completion of this training, participants will be able to:
- Compare the requirements between ISO 13485 and ISO 9001
- Interpret the clauses of ISO 13485 using ISO 14969
- Recognize the role and responsibilities of management in ISO 13485
- Recognize the relationship between ISO 13485 and ISO 14971
- Compare the requirements between ISO 13485 and FDA’s Quality System Regulation
- Appreciate the use of ISO 13485 as the basis of Medical Device Regulations worldwide.
- Describe the fundamentals of quality management systems
- Explain the purpose, structure and requirements of ISO 13485
- Apply a process of implementing a quality management system that meets the requirements of ISO 13485
- Prepare for ISO 13485 certification
What's included?
- You will gain 8 CPD points on completing the course
- Training course notes
- Lunch
- Refreshments
Course resources
Auditor Qualification
Discover our ISO 13485 Qualifications - Our ISO 13485 auditor qualifications will give you a BSI Mark of Trust, reassuring your customers and suppliers that your skills have been validated. You can achieve Practitioner or Professional status by successfully completing courses, exams and demonstrating practical application. Find out more
