iso13484-2016

Just Released – ISO 13485: 2016 Training Course

ByPharmOut Updated on

Be the first in the know.  Join our devices expert Seamus Orr in Melbourne and Sydney for ISO 13485 : 2016 Training Course

Seamus Orr an expert in ISO 13485

Some regulatory and standard version updates are anticlimactic – years of review and then the key changes are semantics that leave manufactures still pondering intent.

This is not the case for ISO 13485:2106. After four years of industry and other expert review, the updated version was published on 1st March 2016 and brings the previous revision (2003) up to date with the more agile European and other international regulatory standards.

The changes are clear (and here)

Helpfully, Annex A in the new release clearly outlines key changes including:

  • Harmonising of global regulatory requirements
  • Adding increased feedback mechanisms and expectations for post-production monitoring
  • Increasing transparency of the complete life cycle of the product (from design to distribution to support)
  • Changes to infrastructure requirements i.e. ISO 14644 and ISO 14698
  • Embedding risk management and risk based decision making throughout the quality management system


Because of the significant additional focus on risk management in ISO13485, Seamus will follow the ISO13485 course with a half day ISO 14971 on Quality Risk Management.

Download ISO 13485 templates

Gap analysis template