One Size Does Not Fit All
A start-up, 5-person medical device company started to build its Quality System on processes that were designed for
a device company with more than 180 people. Prior to finalizing its Quality System documentation suite, management asked us to confirm that
the proposed Quality System meets both the 21 CFR part 820 regulations and ISO 13485 standards.
We quickly found that the proposed Quality System was too complicated for a 5-person company, especially given that
many of the activities were performed by the client's external vendors.
To determine what our client must have in place in order to comply with 21 CFR part 820 regulations and ISO 13485
standards and, yet, be able to operate given its size, we created a roadmap as a starting point to help our client to address each component of the Quality System
regulation as it applies to its environment. This document illustrated what activities were being performed by the client,
what activities were being performed by the respective vendors, and identified required policies and procedures that our client and its
vendors must have.
We also envisioned that such a roadmap, after all policies and procedure references were included in it, 1) could serve as an introduction to our
client's Quality System (a "read-me-first" document) and 2) would ensure clarity for those who are unfamiliar with the client’s operations.
Creation of the roadmap allowed us to effectively "downsize" the proposed Quality System to fit the 5-person company and
helped to identify what documents exist but need to be modified, what documents should be eliminated and what documents need to be developed. Subsequently, in less than 2 weeks, our client had a new and greatly
simplified Quality System that met the requirements of both 21 CFR part 820 and ISO 13485.