Use case · Quality system
Has your QMS piled up over the years? See its real state, then slim it down without breaking compliance.
Procedures written by successive consultants, records in Excel, months without a quality manager: you inherit a system nobody fully masters. My Audit Corner assesses it requirement by requirement, spots what contradicts itself and tells you what to fix first.
No migration: MAC reads your documents where they are, Word, Excel or PDF.
An inherited QMS is a QMS nobody sees as a whole
Each layer was added for a good reason. Together they make a system that is heavy, inconsistent and hard to defend in an audit.
Successive layers
Every consultant and every tool left its own structure, templates and duplicates. Excel and Word share what a single document should say.
Lost memory
Months without a quality manager, and nobody knows why a given procedure exists, or whether it is still followed.
An unmanageable annual review
Without an overall view, the management review becomes a compilation of spreadsheets rather than a decision on the real state of the system.
Taking over the QMS, without and with My Audit Corner
| Step | Without the tool | With My Audit Corner |
|---|---|---|
| 1. See the real state | Re-read every procedure and record, without knowing where to start | A score requirement by requirement, against ISO 13485, the MDR or IVDR and the other standards that apply to you. Non-applicable requirements are flagged with their justification, in plain language |
| Spot contradictions | Find them by chance, or through the auditor | Document consistency analysis detects inconsistencies between your documents |
| 2. Prioritise | An unordered list of gaps, with duplicates from one audit to the next | An automatically generated action plan, deduplicated tasks, a Kanban board: you know what to fix first |
| 3. Make it last | A sampling-based internal audit, an annual review compiled by hand | An assisted internal audit, built on the facts MAC has found, and a weekly email summary. The annual review becomes manageable again |
1. See the real state
Without the tool
Re-read every procedure and record, without knowing where to start
With My Audit Corner
A score requirement by requirement, against ISO 13485, the MDR or IVDR and the other standards that apply to you. Non-applicable requirements are flagged with their justification, in plain language
Spot contradictions
Without the tool
Find them by chance, or through the auditor
With My Audit Corner
Document consistency analysis detects inconsistencies between your documents
2. Prioritise
Without the tool
An unordered list of gaps, with duplicates from one audit to the next
With My Audit Corner
An automatically generated action plan, deduplicated tasks, a Kanban board: you know what to fix first
3. Make it last
Without the tool
A sampling-based internal audit, an annual review compiled by hand
With My Audit Corner
An assisted internal audit, built on the facts MAC has found, and a weekly email summary. The annual review becomes manageable again
MAC does not delete or rewrite anything for you. It gives you the facts to decide what to simplify, and checks that compliance holds after each change.
Why now
Just taken over the system? This is the best time.
Until the baseline is done, every audit exposes you to gaps you did not create. With an objective assessment in your first weeks, you know what you have inherited and you can show it to management.
- A full baseline, without re-reading hundreds of documents by hand
- A factual basis to set priorities with management
- Gaps known and handled before the surveillance audit, not discovered during it
Two ways to move forward
With the tool, by your team
Connect MAC to your documents: assessment, document consistency, action plan and assisted internal audit are included in every plan.
With our experts
Our experts carry out the baseline or your internal audit, with the platform as their engine. You come away with findings and priorities.
Frequently asked questions
Yes. My Audit Corner reads your documents in their own format and where they are (SharePoint, Google Drive, OneDrive…). There is nothing to migrate or re-key.
ISO 13485 and, depending on your devices, the MDR or IVDR, along with the other standards that apply to your business. Each requirement gets a score, and non-applicable requirements are flagged with their justification.
No. MAC shows you what contradicts itself, what is missing and what to fix first. You decide what to simplify, and MAC reassesses the system after each change to check that compliance holds.
Tasks are generated automatically from the gaps, deduplicated when several findings lead to the same action, and tracked on a Kanban board.
The state of the system is tracked continuously and you receive a summary by email every week. The annual review starts from these facts instead of a compilation of spreadsheets.
You did not write this QMS. You can still own it.
Connect MAC to your documents: you see the real state of the system, what contradicts itself and where to start.