New changes to ISO 13485, published this spring as EN ISO 13485:2016, mean U.S. medical device companies that sell in Europe will need to integrate risk-based approaches throughout their quality management systems. The emphasis on risk management is the biggest of several changes in the third version of ISO 13485.
RISK IS GIVEN A FRONT-AND-CENTER PRESENCE IN SECTION 6 OF THE STANDARD.
October 2, 2015
Years in the making, the ISO 9001:2015 revision has been published. Prior to the release date, auditors, inspectors, quality managers, and many others studied the initial drafts in an attempt to understand the changes.
Now On Demand! In this webinar, we will look into the concept of risk-based thinking, what it means and how you can apply risk to your Quality Management System. We will specifically look at some of the core tenets of Risk Management, discuss how the standard looks at risk, and look into some of the details around automating risk.