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).
Why Dread Audits?
Create a system that doesn’t need last minute “cleanup for the auditor.”
Mind The Gaps
In our COVID-19 alternate reality, most businesses are running at some level. As a certifying body, we at PQA have a unique insight on...
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 I need Internal Auditors as part of my Quality Management System staff?
Part of any quality management system (QMS) is checking to see if you are really doing what you claim.
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.