The FDA anticipates publishing a proposed rule early in 2019 on aligning the two. The FDA was instrumental in the revision of ISO 13485, most of the Part 820 regulation requirements are covered in ISO 13485. However, there are some requirements that might not be included explicitly in ISO 13485, for example Device History Record (FDA Part 820.184). But, the ISO 13485 standard’s Control of Records (Clause 4.2.5), Planning of Product Realization (Clause 7.1), and Identification (Clause 7.5.8) implicitly relate to the requirements of Device History Record. It has been noted that any changes to the existing regulation to help create closer alignment between the two standards would not simply replace QSR standards.

Because the two are so similar, my only concerns with hard wiring the ISO standard in to the QSR standard is ensuring that there are not gaps created with the integration and that QSR will be at the mercy of ISO if they make a future revision.