Training course designed and delivered by our expert dedicated to the Transition to the new ISO 13485:2016 Standard
With over one million certified companies over the world, the international quality management systems standard ISO 13485 is among the most commonly used today.
Since the first publication in 1993, 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.
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 13485:2016
- Comprehend the new regulatory requirements and purpose for ISO 13485:2016
- Cross referencing between the old and new versions for a smooth transition
ISO 13485:2016 – Medical Devices - Quality Management Standard
- 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
- Workshop session
- Transition planning