qmsWrapper Blog - Take Back Compliance - The Art of Managing Through Quality
Understanding Roles & Processes in ISO 13485:2016
In ISO 13485:2016 there are many new terms, definitions and requirements compared with the 2003 edition so here is a help to make things a more understandable.
Email is a Team Killer
Email was long the go-to app for business communications. Write your message, add a file, send - wait for the reply! And for teams therein lies the problem...
ISO 13485:2016 - New terms to take note of
In the new edition of ISO 13485:2016 16 new terms are added with longer definitions. Let's see what are the differences and similarities between the editions.
ISO 13485:2016 – Creating a Glass Ceiling for Startups
ISO13485:2016 puts a glass ceiling on medical start-ups with a daunting new array certification requirements that will disproportionally impact them.