Definition of Terms
ISO standards rely on some foundational terms. Here are some that get confused easily.
Creating, Updating, Simplifying Documentation
Writing the QMS documentation is often the most dreaded part of preparing for certification. Here are some concepts we hope will help you!
Does Your Data Add Value?
A presentation hosted by Mike Black, from PaigeBlack Marketing, got us wondering: Does your data add value at all levels of the company?
Adding Depth to Process Audits
Can we strengthen audits to validate processes, resulting in defect-free outputs?
The Impact of EU Medical Device Regulation Deadlines
In May of 2017 the EU passed its revised Medical Device Regulations (MDR) and InVitro Device Regulations (IVDR).
Loving Your Data Security Systems
Even small and midsize manufacturing firms can be targets of organized hacking businesses.
Visualizing 5 Whys
Pioneered in the modern age by Sakichi Toyoda, the 5-Whys method is a way to find the causes of a problem in order to target its solutions.
Why Dread Audits?
Create a system that doesn’t need last minute “cleanup for the auditor.”
