This two-day course gives you the knowledge and steps to implement a quality management system (QMS) in line with ISO 13485:2016. It’s suitable for managers or members of an implementation team.
Choose to take this stage of your learning journey in-person or live online in a classroom environment. You’ll learn how to plan, organize and schedule everything needed to define an ISO 13485: 2016 QMS, as well as how to implement it. You’ll also carry out a baseline review, specific to your own organization.
On completing the course you’ll gain a certificate and 16 CPD points. The training helps you to generate your own comprehensive course notes and will leave you with a thorough understanding of how to implement the ISO 13485:2016 standard.
Prerequisites
There are no formal prerequisites for this course.
Pedagogical objectives
- Understand and plan ISO 13485:2016 implementation
- Find ways to increase efficiency, add value and monitor supply chains effectively
- Take the first steps towards ISO 13485:2016 certification
Skills to be acquired
On completion of this training, participants will be able to:
- Define an ISO 13485:2016 QMS
- Identify the steps for defining, planning, organizing and scheduling
necessary activities - Implement an effective quality management system
- Conduct a base line review of an organization’s current position with regard to ISO 13485:2016
Targeted audience
- Anyone involved in defining, planning, or implementing an ISO 13485:2016 based quality management system
- Management representatives
- Implementation team members
Pedagogical, technical and framing means
Course materials including:
- Introduction to the training, detailed program and security assignments
- Course presentation, theory and activities/ role plays
- Answers to the activities
- Videos
- Additional documents, distributed during the sessions, to use for the activities
- Attendance sheet to be signed
Assessment specifics
- Questionnaire to assess theknowledge at the end of the training
- Customer survey
What is included?
- Course materials, providedelectronically
- Letter of attestation
- Official certificate
Do you need more information?
If you have any concerns, please do not hesitate to contact our service department on the following numbers:
Telephone: 01 89 79 00 40
Email: training.france@bsigroup.com Or via the webchat service on our website: bsigroup.com
You will be put in touch with our team if necessary.
