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Results

Quality management systems and auditing according to ISO 13485 for medical devices

This training course will prepare you for designing and controlling a QMS for the medical device industry in accordance with the ISO 13485 standard, and for auditing a quality management system as per ISO 13485. On completing the training, you will be able to:

- design and control a QMS for the medical device industry in accordance with the ISO 13485 standard,
- audit quality management systems in accordance with ISO 13485.

 

Advantages of this training

  • Participation-based teaching: knowledge test, hands-on exercises, case studies
  • Feedback, situation examples

Who is concerned?

Who is concerned?

  • Medical device manufacturers: Quality assurance managers/Regulatory affairs managers, etc.
  • Users: Site directors/Quality managers/Maintenance managers/Engineers/Technicians, etc.

Prerequisites

There are no prerequisites for this training course.

Training sequence and content

Defining the scope of the quality management system

Understanding the context of ISO 13485 and the regulations

  • Medical device sector issues
  • Structure linking European directives, guides and standards

Familiarization with the ISO 13485 standard specific to medical devices

Understanding and analyzing the ISO 13485 standard

  • Application areas: conditions and justifications for exclusions and non-applications
  • Significant modifications justifying the absence of equivalence to compliance with ISO 9001
  • General requirements and requirements specific to certain medical devices

Implementing the quality system in accordance with the ISO 13485 standard

  • Methods necessary to control the system
  • Continual improvement

Acquiring the quality audit methodology in accordance with the ISO 13485 standard

  • Key points in the audit process
  • Audit process basics
  • Deciphering the ISO 19011 standard and its essential steps

Audit methodology applied to medical devices

  • Audit preparation
  • Performance (kick-off meeting, deviations, etc.)
  • Conclusion of the audit (report, closing meeting, etc.)

 

Monitoring and measuring the system and process performances

 

Putting improvements in place
•    Improvement tools
•    Enhancing customer satisfaction

 

Using the vocabulary judiciously
•    Vocabulary associated with each stage of the training

 

Understanding the stages in the certification project
•    Coordination of the certification project
•    Positioning certification amongst the company’s issues

Why choose AFNOR Group?

We are committed to support you in the success of your training.

40 years of experience in trainings

12 training centers worldwide

A large range of e-learning training courses

10 000 students per year

Certified training courses (ICA, IRCA, …)

40 offices worldwide

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