Definition of Terms
ISO standards rely on some foundational terms. Here are some that get confused easily.
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.
Medical Device Acronyms - DHF, DMR, DHR
Three of the most connected and confused are DHF, DHR, and DMR. Let’s unpack them together.
Why have a Documented Quality Management System?
A QMS is a set of frequently-updated controlled documents that define what you do and how you do it in your business.
Why do root cause analysis?
Root cause analysis will help you make lasting corrective actions which will prevent recurrences.
What’s the difference between being ISO compliant and ISO certified?
Being compliant, but not certified, is like going through college but never taking the exams to prove you learned anything.
What is ISO 14001 & why do I need it?
ISO 14001 is a standard companies use to certify their businesses have made a commitment to reducing the company's impact on the environment
What is ISO 13485 & why do I need it?
ISO 13485 takes the core quality management concepts of ISO 9001:2008 and adapts them to the medical device industry.
What is ISO 9001 & why do I need it?
The concept of ISO 9001 certification can seem overwhelming. But the truth is, ISO 9001 is really just good business practices written down.
We Don’t DO Design. Can we exclude it from our ISO certification?
What do you think of when asked if you do design--engineers? Original concept development? What about processes development?