Built by Someone Who’s Actually Done This
18 years in medical device quality engineering, running FMEAs, closing CAPAs, sitting across the table from notified body auditors and FDA reviewers. Every system on this site started as something I needed for my own work, not a template built to look good in a store listing.
Quality Doc Hub exists because good QMS documentation is hard to find and even harder to build from scratch under deadline pressure. These are the same Excel systems and templates I’ve used to pass real audits, adapted so any quality professional can put them to work immediately.
Who is this for
Quality engineers and RA professionals who need a working system today, not a blank spreadsheet and a deadline. Independent consultants building out a client’s QMS from scratch. Startups getting their first ISO 13485 certification and don’t have years to figure out what “good” looks like.
Practical Systems, Not Theory
Excel-based QMS systems and templates built from real audits and real deadlines, not standards documents rewritten as templates.
Practical FMEA & CAPA
Risk registers and corrective action tracking built the way an auditor actually expects to see them, not a generic framework borrowed from a textbook.
Internal Audits & Supplier Quality
Audit planning and supplier tracking that holds up under scrutiny, built from running these processes for real, not simplified for a sales page.
Seamless Change Control
Change request and impact assessment tools that keep your documentation defensible when engineering updates roll in.