You may have experienced the concept of diffusion of responsibility – when members of a group feel less personal obligation to perform an activity or task, assuming “someone else will handle it,” leading to inaction, delays, or reduced accountability. This can occur when the quality management system either poorly defines responsibility or defines responsibility to...Read More

We understand the tension. You get it … we all want to be process focused. Create and maintain a good process, and good outputs will come forth. But you may be the one that faces the auditor or faces the inspector. They ask for evidence that the process was performed. You think, “life would be...Read More

The international standard, ISO 13485:2016, Medical devices — Quality management systems — Requirements for regulatory purposes, provides the framework of the set of interrelated processes that work to ensure product quality.  This international standard is based on a process approach to quality management. Any activity that receives input and converts it to output can be...Read More