Quality Management

Run daily quality processes and policies, qualify personnel and stay compliant with M-Files QMS

M-Files QMS is an easy-to-use quality management solution for SOP management, quality document control, audits, CAPAs, risk management, training and employee qualification.

Organisations use M-Files QMS to support compliance with ISO 9001, ISO/IEC 27001, ISO 13485, ISO 27002, FDA 21 CFR Part 11, EU GMP Annex 11, and many others.

M-Files QMS is a practical and easy-to-use solution that helps manufacturing organisations and related businesses fulfill the documentation and data requirements associated with quality standards such as ISO 9001, CE marking or labeling, compliance with FDA 21 CFR Part 11 and EU GMP Annex 11, and audits associated with all of these activities. M-Files QMS is ideally suited for businesses in regulated industries such as pharmaceutical and life sciences, petrochemicals and other highly process-related manufacturing sectors, food production, transportation (including aviation, automotive, etc.), mining and others.

Features & Benefits of M-Files QMS

Document control

  • Organize and manage all quality documents, such as Standard Operating Procedures (SOPs), policies and work instructions with complete major/minor version history, automatic permissions, built-in annotation and redlining, eSigning, configurable workflows, several publishing options and unprecedented ease of use.
  • Manage a single key document in several languages simultaneously, with dedicated workflows for both document creation and translation. Great for global policies, user guides, patient material etc.
  • Provide controlled printing with printout copy stamping and tracking of controlled printouts.
  • Ensure that quality documents are actually learned by the correct personnel.


Training and learning

M-Files QMS provides a truly unique, real life problem solving training solution that tracks not just all the training records you have, but also the ones you should have.

  • Elevate any content, such as quality documents and courses, into mandatory learning material for selected staff. Define the learners via any HR property, role or group membership.
  • Automate: System automatically calculates and constantly updates a personal training to-do list for every person, including a full induction training list for the new employee.
  • Extend training requirements to personnel without login access to M-Files QMS system, such as factory workers, temporary staff and subcontractors.
  • Build up-to-date reports on training performance or pending and overdue training requirements.


Quality assurance, audits and deviations

  • Manage audits and inspections, and efficiently record and process deviations, audit findings and risks.
  • Easily store all audit records, files and email correspondence.
  • Ensure corrective actions are actually completed in due time – and not forgotten in memos, spreadsheets or emails.



  • Assign role-based access rights and track experience and skills for employees and subcontractors.
  • Extend learning and qualification requirements to any personnel, including external persons with no login access to the M-Files QMS system.


Periodic task automation

Automate recurring tasks and processes and capture auditable evidence of all task completion with comprehensive task handling capabilities.


Inventory, lists and registries

Build and manage company-specific inventories and lists, including software and hardware inventories, with full version history.


Signature management

M-Files Quality Management Software provides a rich set of approval and signing options from single-click workflow approval all the way to Part 11 compliant eSigning or legally binding digital signatures.


Other features

  • PDF overlay processing, watermarking and content protection with certificates.
  • Calendar view with integrated scheduling and follow-up reminders.
  • Ensure sensitive documents exclusively remain in the M-Files QMS system with the Print and Download Prevention feature.

M-Files QMS – On Demand Demo

Is your business in a highly regulated industry? M-Files QMS is ideal for:

  • Pharmaceutical and life sciences, including medical devices, biotechnology, health tech, diagnostics and CROs
  • Petrochemicals and any process-related manufacturing
  • Food and beverage
  • Transportation, aviation, automotive and off-shore
  • Energy, mining and more