The SOP changed. The training didn't.
A new revision is approved; the training matrix still points at the old one.
M-Files for Quality · QMS for South African manufacturers
Audit-ready on an ordinary Tuesday. The QMS that builds your evidence as you work.
M-Files for Quality connects controlled documents, training, CAPA, nonconformances, audits and supplier quality in one governed system — inside the Microsoft 365 your team already uses.
I'm audited against:
Official M-Files partner in South AfricaGartner® Magic Quadrant™ Leader, Document Management 2026
Evidence packReady
SOP-042 rev 6Current, approved, at point of use
Training14 of 14 signed off on rev 6
CAPA-0231Linked to NCR-0187 · Verified closed
Supplier certificateValid to Mar 2027
- HL Technology · 80% faster change-request handling
- HL Technology · 98% process compliance
- TTI · 66% less QA processing time
- Gartner® Magic Quadrant™ Leader 2026
The disconnect
Quality work isn't broken. It's disconnected.
The CAPA has lost its origin.
No one can trace the corrective action back to the nonconformance that raised it.
The evidence lives somewhere else.
Audit evidence sits apart from the work that produced it.
The certificate expired in an inbox.
Supplier certificates and audit reports are scattered across email.
Your team already does every one of these things. Nothing connects them — so audit week connects them by hand.
The auditor's questions
Five questions every auditor asks. How long do yours take?
TodaySomeone walks to the line to check the printout matches the server.
With M-Files for QualityOnly the current approved version is visible; old ones are withdrawn automatically, and one click shows the approval trail.
ISO 9001 reference · 7.5.3FSSC 22000 (ISO 22000) · 7.5.3IATF 16949 · 7.5.3ISO 9001 · 7.5.3ISO 13485 · 4.2.4
TodayA training matrix in a spreadsheet, last updated before the change.
With M-Files for QualityChanging the document triggers the training tasks; completion is recorded as evidence.
ISO 9001 reference · 7.2FSSC 22000 (ISO 22000) · 7.2IATF 16949 · 7.2ISO 9001 · 7.2ISO 13485 · 6.2
TodayThe NCR is in one folder, the CAPA in a spreadsheet, the root cause in an email.
With M-Files for QualityCAPA and NCR workflows with owners, stages and links — one record shows the whole chain.
ISO 9001 reference · 10.2FSSC 22000 (ISO 22000) · 10.1IATF 16949 · 10.2.3ISO 9001 · 10.2ISO 13485 · 8.5.2
TodayPlans in Word, findings in Excel, close-out by email.
With M-Files for QualityAudit plans, findings, evidence and corrective actions in one place.
ISO 9001 reference · 9.2FSSC 22000 (ISO 22000) · 9.2IATF 16949 · 9.2.2ISO 9001 · 9.2ISO 13485 · 8.2.4
TodayCertificates and supplier audits scattered across inboxes.
With M-Files for QualitySupplier records, documents, audits and corrective actions alongside your internal processes.
ISO 9001 reference · 8.4FSSC 22000 (ISO 22000) · 7.1.6IATF 16949 · 8.4ISO 9001 · 8.4ISO 13485 · 7.4
How many could you answer in five minutes? Book a QMS walkthrough
The QMS
One connected QMS, inside Microsoft 365
Controlled documents, always up to date
Version control, review and approval routing, audit trails and role-based access. People only see the current, approved version.
Training linked to real change
When a controlled document changes, training tasks go to the people affected, and completion is recorded as evidence.
CAPA and NCR that drive action
Defined stages, named owners, due dates and full traceability. No spreadsheets, no email chains.
Audits, internal and supplier
Plans, findings, evidence and corrective actions together, so most evidence exists before the audit starts.
Supplier quality
Supplier records, certificates, audits and corrective actions in the same system as everything else.
“Quality doesn't live in a separate tool your teams have to remember to use.”— M-Files
It runs in Teams, SharePoint and Outlook, starting from preconfigured quality workflows, not a blank system.
Quality Agent
An assistant that won't let a record move on half-finished.
M-Files' Quality Agent fills in nonconformance reports, CAPA action plans and audit responses using the documents and records around them — and flags missing details before a record moves forward. Half-completed quality records are audit findings waiting to happen. It works because the documents underneath are governed.
By standard
What your standard asks for, and where M-Files holds the evidence
FSSC 22000
- The requirement
- Controlled documented information (ISO 22000 7.5); at least one unannounced audit in every certification cycle.
- What auditors look for
- Current HACCP and PRP documents at the point of use, retained records, evidence available without notice.
- Where it lives in M-Files
- Controlled documents, record retention, CAPA and supplier records — ready on any day.
IATF 16949
- The requirement
- Everything in ISO 9001, plus customer engineering specifications reviewed and implemented to the customer's timeline (7.5.3.2.2) and structured problem solving (10.2.3).
- What auditors look for
- A log of customer specification changes, linked problem-solving records, training on changed documents.
- Where it lives in M-Files
- Controlled documents, linked CAPA, training triggered by change.
ISO 9001
- The requirement
- Controlled documented information (7.5), competence (7.2), internal audit (9.2), nonconformity and corrective action (10.2).
- What auditors look for
- Current versions, training evidence, an audit programme, closed CAPAs.
- Where it lives in M-Files
- All four in one connected system.
ISO 13485
- The requirement
- Control of documents (4.2.4) and records including retention (4.2.5), training (6.2), corrective action (8.5.2).
- What auditors look for
- Strict versioning, record retention, electronic signatures, traceable CAPA.
- Where it lives in M-Files
- Controlled documents, e-signatures, retention and linked CAPA.
Regulated device teams — ask us about system validation.
ISO 14001 / 45001
The same documented-information principles apply (7.5), so one platform can hold your environmental and health & safety documentation alongside quality.
No software makes you compliant. M-Files holds the controlled documents, records and evidence your certification depends on — and makes them easy to show.
Proof
Quality teams that connected the dots
HL Technology
Swiss manufacturer- 80% less time handling change and modification requests
- 98% process compliance
- Nonconformity reports sent in seconds instead of one to two days
TTI Europe
- 66% less QA processing time
- Complaints and customs penalties all but eliminated
Blue Bell
- Supplier approval documents centralised
- Audits streamlined
- Training management supported
Gartner® Magic Quadrant™ Leader, Document Management 2026
Who it's for
Built for the person who carries the audit
You run the QMS
Quality Manager · Head of Quality · QA · Document Controller · SHEQ
Stop being the archivist. Spend audit week on improvement.
You sign off the budget
MD · COO · FD
Fewer findings, faster CAPA close-out, one system instead of five spreadsheets.
You run the systems
CIO · IT
Native to Microsoft 365, role-based access, on a platform with ISO/IEC 27001 and SOC 2 certification.
Food & beverageAutomotivePharmaceuticalMedical devicesChemicalsPackagingIndustrial
Engineering changes and supplier drawings too?
M-Files for Manufacturing governs engineering change control and supplier transmittals on the same platform.
Why TDW
Your M-Files partner in South Africa
TDW Digital is an official M-Files partner and part of The Document Warehouse group. We map your existing QMS — procedures, forms and registers — into M-Files, migrate your controlled documents, set up training and CAPA workflows, and support you through your next audit.
If M-Files is more than you need, we'll tell you — and show you a simpler option.
“The best audit is the one nobody has to prepare for. When the evidence builds itself as people work, audit week becomes just another week.”Harrie Terblanche, Chief Executive Officer, TDW Digital
FAQ
Questions quality managers ask
No software can — certification depends on how you run your QMS. M-Files holds the controlled documents, records and evidence, and makes the trail easy to show.
No. We migrate your controlled documents and registers and map your procedures into M-Files workflows. Preconfigured workflows mean you start from a working QMS.
Yes. When a controlled document changes, training tasks are created for the people affected, and completion is recorded as evidence.
Supplier records, certificates, audits and corrective actions sit in the same system as your internal processes. We'll show you the supplier workflow in the walkthrough.
M-Files supports electronic signatures and full audit trails. We'll take you through validation for your environment in the walkthrough.
M-Files for Quality is designed to work inside Microsoft 365 — Teams, SharePoint and Outlook. [confirm requirement and deployment options]
An AI assistant that fills in NCRs, CAPA plans and audit responses, and flags missing details before a record moves on.
You start from preconfigured quality workflows, not a blank system. We'll give you a realistic timeline before your next audit date.
M-Files holds ISO/IEC 27001 and SOC 2 certifications, and TDW works within POPIA.
It depends on users, sites and scope. You'll get a clear quote after the walkthrough.
Book a QMS walkthrough
Bring your last audit report. We'll show you M-Files closing it.
30 minutes with a TDW M-Files for Quality specialist. Pick two or three findings from your last audit and we'll show you how each would have been prevented — or closed — in M-Files.
- Your two biggest audit risks, identified
- Document control, training and CAPA working together, live
- A realistic plan before your next audit
No deck. No obligation. Your audit report is only used to prepare the call.
Rather talk now? Call +27 11 478 5443.
Thanks. A TDW Digital specialist will be in touch.
