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FORMATION
ISO 13485 : 2016 – QMS for Medical Devices – Understanding the requirements of the standard – #320
1,390.00 € HT
Context
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You wish to prepare for an upcoming certification according to the ISO 13485 medical device standard.
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You wish to know the requirements of this standard in order to develop your activity in the medical devices sector or following a new function in this sector.
Objectives
- Understand the issues and requirements of ISO 13585.
- Discover in a concrete way how to implement the requirements of ISO 9001: 2015.
- Build your compliance action plan.
Recommanded for
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Quality / QHSE managers, engineers and technicians.
- Project managers.
- Process managers.
- Internal auditors.
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ISO 13485 certification project managers with knowledge of the ISO9001 standard.
Prerequisites
No prerequisites.
Specific operating conditions for remote sessions
- Have a PC equipped with a microphone, webcam and, if possible, a headset for greater comfort. Note: To blur or hide the view from behind, background screens are available in Zoom or Teams.
- A good Internet connection, tested before the session.
- Locate in a quiet, isolated area; switch to « not available » status in Teams; close your email access and mute your phone to avoid distraction during the session.
- To avoid off-topic discussions during the session, participants from the same organisation should not be grouped together in the same room, but rather at their own desks. Virtual sub-groups will be set up specifically for the exercises, which will also allow for mixed groups to be created.
- The webcam and microphone must be open during remote qualification/certification exams. It may also be necessary for us to check that you are the only one in the room.
- We ask that you connect at least 5 minutes before the beginning of the session.
Pedagogy
- The requirements of the standard are studied in an active way, and in the form of teamwork based on the description of your processes:
Systematic reinforcement by the facilitator through the illustration of concrete examples.
Individual reflection to allow each participant to project themselves into the concrete context of their company.
- Development of action plans for their company.
- Consolidation by the trainer during an individual debriefing.
- Complementary group debriefing.
Evaluation mode
- Knowledge test (MCQ).
Course materials
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Participant file containing the presentations delivered during the training and the exercise materials.
To go further
Trainings :
Consulting services : EURO-SYMBIOSE can assist you in the concrete implementation in your company. Contact us to know more about it.
Session 1
- The ISO 13485 standard: objectives, field of application, history of its evolution.
Session 2
- The structure of ISO 13485, common to management system standards.
Session 3
Analysis of the standard § 0 to 3 :
- Study in sub-groups of the specificities of application, and definitions specific to the medical devices sector.
- Reinforcement by the facilitator to better understand the context of the sector.
Session 4
Analysis of the standard § 4 to 6 :
- Study in sub-groups of the requirements of the ISO 13485 standard.
- Restitution and reinforcement by the facilitator with highlighting of the specific requirements of ISO 13485.
- Transposition to one’s company: identification of the impacts on the processes concerned by these chapters, self-evaluation and determination of the action plan.
Session 5
Analysis of the standard § 7 :
- Study in sub-groups of the requirements of the ISO13485 standard.
- Presentation by each sub-group of their understanding of the requirements and reinforcement by the facilitator.
- Transposition to one’s company: the self-assessment and action plan of each trainee is completed.
Session 6
Analysis of the requirements of the standard § 8 :
- Work in sub-groups to identify the risks covered by the requirements of ISO 13485.
- Presentation by each sub-group of the understanding of the requirements and reinforcement by the facilitator.
- Transposition to one’s company: the self-assessment and action plan of each trainee is completed.
Session 7
Consolidation of the personal action plan.
About Instructor
Valérie LE COUËDIC
Speciality: EURO-SYMBIOSE consultant since 2001, Valérie masters both automotive and aeronautical standards. Technical contact for the VDA-QMC.