When companies begin their quest for an ISO 9001 or ISO 13485 certification, they often wonder how many procedures do they need to satisfy certification requirements? It seems that there is a perception that if the number is too big, then the quality system will be too burdensome. If the number is too small, then […]
Month: May 2022
MDD (Medical Device Directive) and Medical Device Regulation (MDR) Transitional Provisions
If you have CE marked products in Europe, you may already be aware of the change from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR). Currently, the MDD is no longer but if you have products that are CE marked under the MDD, Article 120 of the MDR may allow you to […]
Quality System Process Changes
Continuing with the Quality Management discussion that I started in my last blog, let’s talk about how changes may occur within a predefined process. Perhaps your company has a software development process that it has been using for some time. Someone at your company thinks that the process is too burdensome and would like “streamline” […]
Quality System Processes
A Quality Management System (QMS) is a system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. ISO 9001:2015 defined approach to QMS is the most commonly used. However, not all processes defined by ISO 9001:2015 may be pertinent to your organization. So, the question is: What are the processes needed for […]