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FORMATION
ISO 13485: 2016 – Deviations from ISO – #32
790.00 € HT
Context
- You wish to prepare for an upcoming certification according to the ISO 13485 medical device standard.
- 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.
- You are looking for a correct interpretation and understanding of the deviations from ISO 9001 for a relevant application to your company context.
Objectives
- Understand the requirements of ISO 13585.
- Identify the impact of the additional requirements of ISO 13485 compared to ISO 9001.
- Know how to implement the requirements of ISO 13485 and build your action plan.
Recommanded for
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Quality / QHSE managers, engineers and technicians.
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Project managers.
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Process managers.
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Internal auditors.
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ISO 13485 certification project managers with knowledge of the ISO9001 standard.
Prerequisites
Knowledge of ISO 9001:2015
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
Training :
Consulting services : EURO-SYMBIOSE can assist you in the concrete implementation in your company. Contact us to know more about it.
Session 1
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 2
Analysis of the standard § 4 to 6 :
- Study in sub-groups of the specific requirements of the ISO 13485 standard.
- Restitution and reinforcement by the facilitator with highlighting of the specific requirements of ISO 13485.
- Transposition to the company: identification of the impacts on the processes concerned by these chapters, self-evaluation and determination of the action plan.
Session 3
Analysis of the standard § 7 :
- Study in sub-groups of the specific 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 own company: each trainee’s self-assessment and action plan is completed.
Session 4
Analysis of the requirements of the standard § 8 :
- Work in sub-groups to identify the risks covered by the specific requirements of ISO 13485.
- Presentation by each sub-group of the understanding of the requirements and reinforcement by the facilitator.
- Transposition to one’s own company: each trainee’s self-assessment and action plan is completed.
Session 5
Consolidation of the personal action plan.
Sylvain LIBAUD - LACROIX ELECTRONICS
“Good timing, well presented, the trainer knows the standard very well.”
About Instructor
Valérie LE COUËDIC
Speciality: EURO-SYMBIOSE consultant since 2001, Valérie masters both automotive and aeronautical standards. Technical contact for the VDA-QMC.