ISO 13485 QMS build: a system that fits how you work, not a set of downloaded procedures.
Processes, procedures, records and management tools, built and run in My Audit Corner, all the way to certification readiness.
Initial scoping is free, with no commitment. Small company, single site. Certification body fees not included.
What you get
- Processes and procedures
- Records and management tools
- QMS operated in the platform
- Certification readiness
Good to know
- Small company, one site
- Certification body fees not included
Ideal if: you are starting from scratch or from an incomplete system and aiming for ISO 13485 certification without hiring a quality team.
Why off-the-shelf QMS packages fail
Complete ISO 13485-compliant document sets are sold for a few hundred euros. They rarely get through certification, and never through the second year.
The reason is simple: a quality system is not a set of documents, it is a description of how a company actually works. An auditor does not check that the procedure exists, they check that it is applied. The gap between the generic document and real practice shows up in the first interview with an operator.
So the valuable work is not the writing. It is deciding how you want to work, putting it in your own words, and sticking to it.
Build just what you need
The other trap is the opposite one: the oversized system. A small organisation that adopts a large group's documentation structure ends up with processes nobody has time to follow, and therefore with systemic non-conformities from the very first surveillance audit.
ISO 13485 requires the system to be proportionate to the organisation and to the risk of the devices. A company of eight people does not need the same level of formality as a company of three hundred.
We build for the team size and product class you actually have, on the principle that the system must hold up without us.
A QMS that lives in the platform
The difference from a traditional consulting engagement shows at the end, not along the way.
A consultant who builds a QMS hands over a set of documents, then leaves. Maintenance falls entirely on a team that has neither the time nor the tools, and the system deteriorates until the next audit.
Here, the QMS is built and run in My Audit Corner. When a document changes, the platform updates your compliance level and flags anything that becomes inconsistent. You keep shared access throughout the engagement, and the subscription remains available afterwards so you can carry on independently.
The goal is not just to obtain the certificate, it is to keep it without tying up a full-time person.
Frequently asked questions
For a small organisation starting from scratch, allow several months between the start of the build and the initial audit, with the actual timeframe depending mainly on your teams' availability. The timeline is set during scoping, with the dependencies between steps.
No. We build the system and prepare you for the audit, but the certification body's fees remain your responsibility and are contracted directly by you. We can help you choose the body and prepare the application.
Yes, and it is common. In that case we usually start with a gap analysis, which establishes what can be reused and what needs reworking. Rebuilding what already works would be a waste.
Not to build the system, but someone has to own it afterwards. If nobody on the team can take on that role, the outsourced PRRC covers part of the regulatory obligations, without replacing the day-to-day management of the quality system.
The QMS continues to run in the platform and the subscription takes over from the service. Your teams work in the tool, which tracks compliance continuously. Many clients add the annual internal audit, which has to be carried out by an independent auditor in any case.
Aiming for certification without hiring a quality team?
Tell us about your product, its class and the size of your team. Scoping is free.