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2 days training course designed and delivered by our expert dedicated to the Transition to the new ISO 9001:2015 and ISO 13485:2016 standards


training course medical device With over one million certified companies over the world, the international quality management systems standards ISO 9001 and ISO 13485 are among the most commonly used today.

Since their first publication (1987 for ISO 9001 and 1993 for ISO 13485), several revisions have taken place aligning those standards to the evolution of the market needs. The latest edition of ISO 13485 standard for the medical device industry was officially published February 25th, 2016 and ISO 9001 was made available on September 2015. Manufactures have yet to understand the changes involved to undertake a smooth transition of their QMS and maintain compliance. 

 

Objectives of the training 

• Understand the new concepts and definitions introduced by ISO 9001:2015 and ISO 13485:2016

• Identify the new revised High Level Structure (HLS) for ISO 9001:2015

• Comprehend the new regulatory requirements and purpose for ISO 9001:2015 and ISO 13485:2016

Cross referencing between the old and new versions for a smooth transition

 


PROGRAM

Day 1 – ISO 9001:2015 Quality Management Standard

8:30 am to 05:00 pm

  • What’s new? Definitions & Terminology
  • The new ISO Management Systems High Level Structure (HLS)
  • The changes and the new requirements impacting:
    • Clause 4: Context of the Organization
    • Clause 5: Leadership and commitment
    • Clause 6: Planning
    • Clause 7: Support
    • Clause 8: Operations
    • Clause 9: Performance & Evaluation
    • Clause 10: Improvement processes
  • Workshop session
  • Transition planning

Day 2 - ISO 13485:2016 – Medical Devices - Quality Management Standard

8:30 am to 05:00 pm

  • The regulatory context surrounding the revision of ISO 13485
  • The areas of increased emphasis
  • Additions, key requirements and evolutions:
  • Introduction, scope and role,
    • Clause 3: Definitions
    • Clause 4: General requirements introduced by the 2016 version
    • Clause 5: Management Responsibility
    • Clause 6: Resource Management
    • Clause 7: Product Realization
    • Clause 8: Measurement, Analysis and Improvement
  • Case of dual QMS certification ISO 9001:2015 and ISO 13485:2016
  • Workshop session
  • Transition planning

 


What's included?

  • lne gmed notified body certification titleTraining presentation and case studies.
  • Certificate of attendance from LNE/G-MED.
  • Breakfast, Lunch and Refreshments.

 


WEST COASTEAST COAST
April 28, 29
Soka University of America
1 University Cir,
Aliso Viejo, CA 92656
USA
May 16, 17
The Silver Spring Civic Building
One Veterans Place
Silver Spring, MD 20910
USA

Click here to Register

Click here to Register

 

About the trainer
Florianne Torset Bonfillou LNE Gmed

Florianne Torset-Bonfillou
Director of Regulatory, Education and Quality – Lead Auditor at LNE/G-MED North America, Inc.
Florianne Torset-Bonfillou is the Director of Regulatory , Education and Quality at LNE/G-MED North America. She received her Bachelor’s Degree in Biology from the University of Burgundy and her Master’s Degree in Chemistry from University of Paris 12. She holds a professional certificate in Quality, Safety and Environmental Management. Prior to joining LNE/G-MED, Florianne worked in the Pharmaceutical and Medical Device industry as a Quality Assurance Project Manager.  At LNE/G-MED, Florianne is a Senior Design Dossier Reviewer and Lead auditor. She is also a trainer on the European Regulation, Quality Management, Risk Management, and other regulatory and quality topics.

MDSAP Prepare the transition, worldwide market access

Questions?

We serve your passion for progress in the Medical Device (MD) and In Vitro Diagnostics (IVD) industry from the United States

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