The purpose of our quality system is to Design, Develop, Manufacture and Market products ranging from consumer products, to tooling, to medical devices and components.
What is a quality management system (QMS)?
A QMS is a form of Business Management System (BMS)
A QMS reduces business risk
A QMS is the “ticket to play” for medical products
It is tied to laws and regulations
In other words, if we want to manufacture medical devices, we MUST have –Â and follow – a QMS
A single QMS can meet worldwide requirements for medical product marketing
We don’t have to have a different QMS to sell a product in China vs. the US
Quality Concepts and General Principles
Quality cannot be inspected into a product
It must be designed into the product from the beginning
It must be manufactured into the product
The entire process must be controlled in order to ensure quality
High level quality concepts
Say what you are going to do (i.e. write procedures)
Do what you said you were going to do (i.e. implement and follow the procedures)
Prove that you did what you said you were going to do (i.e. keep records)
Check on the results (i.e. Perform regular audits of the activities actually done vs what the procedures said would be done)
Act on the difference by changing procedures to reflect how things are actually done, or changing how things are done so that procedures are followed.