QMS Consulting — ISO 13485 & ISO 9001
A quality management system should be the operating system of your company — not a binder that comes out when the auditor arrives. Confiquora designs and implements QMS frameworks under ISO 13485 and ISO 9001 that are certification-ready and, just as importantly, practical for your team to run every day.
Whether you are building a QMS from scratch ahead of your first certification, remediating findings from a notified body audit, or consolidating systems after growth, we work inside your organization: mapping real processes, writing SOPs your people will actually follow, and setting up CAPA loops that close.
What you get
- Certification-ready QMS
- Practical SOPs teams actually follow
- CAPA system that closes loops
- Audit findings reduced release-over-release
Standards & frameworks we work in
How an engagement runs
Discovery → Gap Assessment → Strategy → Implementation → Certification → Ongoing Support. Every engagement follows the same spine — scoped in the first call, priced before we start, and handed over with your team trained to run what we build.
Frequently asked questions
How long does ISO 13485 implementation take?
For most small to mid-size manufacturers, a certification-ready QMS takes 4–8 months depending on starting maturity, product complexity, and team availability. A structured gap assessment in the first two weeks gives you a realistic, dated roadmap.
Do you support both ISO 13485 and ISO 9001?
Yes — including integrated systems that satisfy both, plus GMP and MDSAP overlays where your markets require them. One system, multiple certificates.
Do you stay involved after certification?
If you want us to. Many clients keep us for internal audits, management reviews, and change control support — the parts of a QMS that quietly decay without attention.
Talk it through with us
Free 30-minute consultation. No obligation — just a clear read on where you stand and what it takes.
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