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Take the complexity out of quality management with M-Files.
M-Files QMS is quality management system software that manages current quality documents, quality records, approvals and audit evidence in one connected structure.
Quality problems stem from disconnected information, not missing documents.
Separate folders, email approvals and tracking spreadsheets break one process into disconnected pieces. M-Files manages quality information together with its relationships, so teams have the context they need to make the right decision.
Risk of outdated versions
Documents circulating in shared folders and email attachments can leave employees working from invalid instructions.
With M-Files: Only the approved version in force is released for use.
Disconnected action tracking
When non-conformities, root causes, corrective actions and outcomes are kept in different tools, it is hard to see the process as a whole.
With M-Files: Related records, owners and due dates come together in a single view.
The pre-audit scramble
Gathering evidence by hand raises the risk of missing records and inconsistent histories, and eats into the quality team’s time.
With M-Files: Version, approval, access and activity history are always to hand in the system.
Let process changes flow into daily work automatically.
Don’t wait for updated procedures to reach the people concerned. M-Files links revised documents to the right roles, departments and locations.
From finding information to tracking actions, every quality-related step runs within the workflows your people already use.
- 01Automatic notifications to the people concerned after each revision
- 02Document-linked reading acknowledgements and training tasks
- 03Consistent practice across departments and sites
The critical processes of your quality management system on one platform.
Thanks to the metadata-based architecture, every quality record is linked to the right product, process, site, supplier, customer or clause of a standard.
Controlled document management
Manage policies, procedures, instructions, forms and records with their owner, effective date, revision and distribution details, and archive old versions in a controlled way.
Change and impact management
See which training, equipment, products and owners a change affects, and automate assessment and approval steps.
Non-conformance and CAPA
Follow the whole process – from logging a non-conformance and root-cause analysis to corrective and preventive action and effectiveness checks – by owner and due date.
Training and competency tracking
Link new or revised documents to training plans and manage reading, briefing, test and sign-off records centrally.
Audit management
Link internal and external audit plans, findings, evidence and actions to processes, and track open items in real time.
Supplier quality management
Bring supplier assessments, certificates, non-conformities and improvement actions together in one profile and make supply risk visible.
Full control, from first draft to audit evidence.
Quality documents are not simply stored: they are drafted, approved, published, delivered to employees and revised when needed. M-Files makes this cycle visible and manageable.
Authoring and collaboration
The document owner prepares the content, and contributing teams work on the same controlled document.
Review and approval
The right approval workflow starts automatically based on document type, department or risk level.
Publishing and training
The approved version is shared with the relevant users, and reading and training tasks are created.
Review and revision
Periodic review dates are tracked, and the reason for each change and the full version history are preserved.
Focus on the information itself, not the folder.
M-Files describes quality documents with metadata, so the same information can be found and managed in the context of a process, site, product, supplier, customer, project or clause of a standard.
- Faster access: find the right document through its content and relationships instead of searching folders.
- Fewer errors: reduce the risks of outdated versions, missing approvals and manual data transfer.
- Greater control: track owners, pending tasks and delays in real time.
- Audit-ready: the audit trail builds itself automatically as the process moves forward.
- Metadata-driven search, automatic versioning and dynamic role-based permissions
- Integration with ERP, CRM, Microsoft 365 and email; cloud, on-premises or hybrid deployment
- Your existing quality documents are moved into a metadata structure through a migration planned with the MechSoft team
Different quality standards, one shared digital foundation.
Your organisation’s own processes and sector requirements are configured with M-Files workflows, building a solid foundation for record integrity and traceability.
ISO 9001
Quality management, documented information and continual improvement
ISO 14001
Environmental records, obligations, risks and action tracking
ISO 45001
Occupational health and safety documents, incident records and improvement activities
IATF 16949
Automotive quality processes, supplier records and change traceability
Quality management system: common questions.
What is a quality management system (QMS)?
A quality management system (QMS) is the structure through which an organisation defines and monitors the policies, procedures, records and processes that assure the quality of its products and services. Standards such as ISO 9001 set its requirements, and QMS software makes them digital and auditable.
What is a quality document management system (QDMS)?
A quality document management system (QDMS) manages policies, procedures, instructions, forms and quality records with revision, approval, distribution and read tracking. M-Files QMS combines this document control with CAPA, audits, training and supplier quality on one platform.
How does QMS software deliver ISO 9001 document control?
Policies, procedures, instructions and forms are managed with owner, effective date, revision and distribution details. The right approval flow starts automatically by document type, the approved version is distributed with read tasks, and old versions are withdrawn.
What is a controlled copy?
A controlled copy is an official copy of a document whose distribution is recorded and which is updated or withdrawn when the document is revised. In M-Files QMS users always reach the single approved version; distribution and read confirmations are tracked and old versions are withdrawn automatically.
Can corrective and preventive actions (CAPA) be managed?
Yes. From non-conformance to root-cause analysis, corrective and preventive action and effectiveness checks, the whole process is tracked by owner and due date and linked to the related documents and audit findings.
Which standards does it support?
The documentation, record and action requirements of standards such as ISO 9001, ISO 14001, ISO 45001 and IATF 16949 are managed on the same digital foundation.
How does it make audit preparation easier?
The audit trail builds automatically as work happens. Findings, evidence and actions stay linked to processes, so there is no record-gathering before an audit and open items are tracked in real time.
Where is quality data stored, and is anything transferred abroad under KVKK?
In MechSoft’s M-Files QMS projects the system is installed on-premises: quality documents and records stay on your own servers, so no personal data is transferred abroad under KVKK, Turkey’s data protection law.
Organisations turning information into measurable results with M-Files.
Let’s review your quality processes together.
Let’s look at your document structure, approval workflows, and non-conformance and audit processes together, and build the M-Files solution architecture that fits your organisation.