Audit-ready by design not by last-minute firefighting.

In the easy13485 Makerspace, audit support is not a standalone service. It is the natural continuation of a living QMS that your team understands, owns, and can defend with confidence..

You walk into audits prepared, calm, and in control — regardless of the standard.

Audit Readiness is built
Not Rushed

Audits are not won in the audit week. They are the logical outcome of a QMS that works every day.
In the easy13485 Makerspace, audit support is embedded in daily operations — so you run audit-safe by default.

In the easy13485 Makerspace, audit support is not a rescue mission or a document clean-up exercise. It is the continuation of a living QMS that your team understands, uses, and can defend with confidence.

Instead of preparing for audits, we prepare you to operate in a way that creates clean evidence, credible CAPAs, and consistent processes — month after month.

What this creates

  • Working processes — familiar, not theoretical
  • Clean evidence — structured, complete, traceable
  • Credible CAPAs — understandable and defensible
  • Confident teams — clear ownership and roles

What makes Makerspace audit support different?

We don’t “take over” your audit. We make sure your organization is able to stand behind its QMS — calmly, clearly, and credibly.

  • Enablement instead of dependency
  • Operational training instead of theory
  • Evidence-first thinking instead of document polishing
  • Clear accountability stays with the startup

Ipp

Provides structure, guidance, challenge, and validation — and turns findings into clear, workable actions.

Tools & Academy

Create consistency and speed: training, evidence logic, and standardized workflows across the QMS.

Your Team

Owns the QMS, operates it daily, and speaks with confidence in audits — with IPP as your quality gate.

Audit Support As a Journey

Audit readiness fails when it’s treated as a separate project. In the Makerspace, we connect operations, evidence, CAPA, and audit execution into one coherent storyline.
Continuous readiness Evidence-first thinking End-to-end CAPA Clear ownership

From daily operations to confident audits

This is how audit readiness unfolds in the Makerspace — structured, repeatable, and aligned with how your QMS should run in real life.

1. Audit-safe routines

Make quality work operational: records, reviews, and responsibilities that stick.

2. Clean evidence

Traceable proof across processes — easy to find, easy to present, hard to challenge.

3. CAPA effectiveness

From issue → root cause → action → verification — with defensible outcomes.

4.Internal Audit & Closure

Independent check, prioritized findings, and guided CAPA closure to “done”.

5. External Audit support

Briefing, Q&A tracking, evidence mapping — and fast, clean follow-up after.

The result: you don’t “explain” your QMS — you show how it works, backed by consistent evidence and accountable ownership.

Supported Standards

ISO 13485
MDR
ISO/IEC 27001
AI Act

The Makerspace promise

We don’t replace your responsibility in an audit. We make sure your team can carry it — with structure, training, and expert validation as your quality gate. Confidence over dependency.

Discover - The Makerspace

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QMS-Service

Easy13485 combines the speed of an out-of-the-box solution with the flexibility to reflect each team’s specific setup.

🎓
Academy

Designed to develop high potentials—like top consulting firms—the Academy turns training into a strategic growth tool.

📄

Tech-Doc.

Consultants are used strategically, not permanently.

💻

Certificator.AI

Answers in seconds, so teams stay in flow and budgets stay lean.

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Audit Support

Confidence on audit day—fewer findings, fewer costly loops.

OR

Contact us
You Decide

Start smart. Choose how you want to begin.

For startups, we offer a simple entry into professional compliance and quality management.

E-Learning & free Consulting call

Build the right foundation and get rewarded.

  • “16 Obligations of a Manufacturer” course
  • Certificate after completion
  • First consulting call included – free

Direct Consulting

Start immediately with tailored expert support.

  • First consulting hour: €162
  • No prerequisites
  • Startup-focused, practical guidance
Contact
Office hours
Monday to Friday
8:00 am - 2:00 pm