The Food and Drug Administration (FDA) recently presented a webcast to the industry regarding the proposed FDA Quality Management Systems Requirements (QMSR). The FDA QMSR is intended to replace the current US FDA Quality Systems Requirements (QSR – 21 CFR 820) with the Internationally recognized standard ISO 13485:2016: Medical devices – Quality management systems – Requirements for regulatory purposes.
For manufacturers who are already in ISO 13485:2016 compliance and are seeking FDA QSR compliance, this may be viewed as a gift. By adding some additional requirements (in the areas of Labeling, Record keeping and documentation), they can be FDA ready. FDA has already been accepting ISO 13485:2016 certificates in lieu of conducting on-site audits for some time.
However, for manufacturers who already have FDA QSR compliance and who need ISO 13485:2016 compliance, the task may not be as straightforward. ISO 13485:2016 includes requirements for assuring customer satisfaction that go beyond the requirements for maintaining customer complaints as per 21 CFR 820. Gathering customer feedback and other customer related processes may not be in place and may be challenging to implement.