Where does your quality system actually stand?
Start with the standards themselves — every clause, free and complete, with nothing behind a login.
Then check your own documents against them. The structural scan is free, runs on the documents you choose, and needs no sales call.
- Design and development planning
- Risk management plan
- Complaint handling
- Internal audit
Compliance knowledge is not a product. It's a public good.
Understanding regulations shouldn't be hard, and neither should identifying the gaps in your QMS. So we publish the foundational references and guides free — and a free structural scan maps your own QMS against the standards: what you have, and what's missing. When you need it, the full report evaluates each document — where it meets each clause and where the gaps are.
Eight standards and regulations, in plain English
Practical requirements for each standard — what it demands, what evidence to produce, how it maps across frameworks.
Browse all guides →185 requirements, one searchable map
Every clause mapped against the others across seven frameworks — overlaps, additions, and the gaps in your QMS.
Open the crosswalk →Software speed with consultant depth.
Not a keyword scan. The free scan checks your document set against what each requirement expects — what's there, what's missing, what's out of date. The clause-by-clause evaluation of what each document actually says — whether the intent is addressed, with enough specificity and evidence to hold up to an audit — is on the way.
Your Risk Management Plan names risk control measures but does not document the option analysis the clause requires — why each control was chosen over alternatives.
What's missing: a documented rationale comparing control options for each identified hazard.
The scan is free — run it, act on the gaps, and scan again.
A free structural scan you run again as you close gaps: each pass shows what's missing or out of date in your QMS, so you get closer to complete every time. No sales call, no credit card to start.
Reviewed before publication. Audited on a cadence.
- Every guide carries a reviewed-by byline and a last-reviewed date.
- Every requirement we check against is grounded in the published standard, traced to its clause — in the guides today, and in scan findings once the evaluation ships.
- Each requirement is cross-checked against the normative source standard.
Real people stand behind the methodology, the guides, and every review.
Kelsey Quality is built by people who have spent years working in highly regulated industries. We don't compromise quality or accuracy for speed. Experienced life-science quality professionals advise the methodology and review the guides.
Read more about who we are and how we approach our workThree ways to start.
Read the guides, browse the crosswalks, or run a free structural scan on your own documents.