Case study: Designing a ISO 13485-Compliant Quality Management System
Michael Wienholt
Michael Wienholt

Kestrel BioSciences, LLC


The client performs contract design, development and manufacturing of immunoassays for manufacturers of in vitro diagnostic medical devices. In order to satisfy existing customer requests, attract more clients and grow the business, the client decided to pursue certification to the international standard for quality systems for medical devices (ISO 13485:2003). This is an expensive, lengthy and complex endeavor that typically takes a year or more and requires an investment in the tens of thousands of dollars.


I started the project at the end of March 2014 with a project plan and outline of the documentation requirements. I solicited bids from the various registrars (e.g., TUV, BSi) and established a budget. Over the next 4 months, I partnered with the senior operations manager to draft the entire quality system documentation in preparation for a pre-assessment audit conducted in July 2014. The Stage 1 assessment audit was conducted in August; the Stage 2 assessment audit was conducted in September. Minor nonconformances were addressed through a corrective action plan submitted to the registrar for approval.


The client received its certificate of registration to the standard from BSi on October 16, 2014 - only 6 months after we started the project.