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 gaps and changes involved to maintain compliance. In order to help you comprehend these changes, LNE/G-MED will be exploring during this webinar the following points.
The structure of those new management system standards
The main changes and evolutions introduced by the new versions for both ISO 9001 and 13485:
- Scope and Definitions
- Quality Management System Requirements
- Resources Management
- Product Realization, including Risk Management, Design Process, Purchasing…
- Measurement, Analysis and Improvement
Can a QMS be compliant with both ISO 9001:2015 and ISO 13485:2016 standards?