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 considered as a process. Often the output from one process directly forms the input to the next process. Like well designed software, a well designed quality management system is:
- properly decoupled (each process/system has its role and function within the overall QMS)
- clear and fully defined inputs to each process/system
- data scope is appropriate and outputs from each process/system are measurable and actionable
- risk to product quality is analyzed such that each process/system has specific controls to mitigate risks
Perhaps your QMS started out that way, but many years of quick-fix CAPA has bloated the systems and created inefficiencies. Or off-the-shelf templates were used that do not fit your products, your people, or your specific processes. Or both.
As you prepare for the US regulatory switchover to QMSR, now is a great time to level up to ISO 13485 Quality Management Systems. For example, do you feel that your company is using the internal audit process to ensure compliance with ISO 13485 and ensure metrics based improvements are occurring? Are you seeing the continuing improvement and field quality that you would expect when the quality management system is working well?
We can help in a variety of ways. First, we can provide training to your team to become better internal auditors. Second, we can assist with the internal audit to give a 3rd party view. Third, we can do deep dives to identify more than non-compliance … we can identify process bottlenecks, inefficiencies, and waste (bloat) with our combination audit and assessment.
Contact us today if you would like to discuss. By email: office@softwarecpr.com
By phone: 781-721-2921
