M-Files Quality Management Software (QMS)

Run daily quality processes and policies, qualify personnel and stay compliant with M-Files Quality Management Software (QMS)

Ensure your quality processes, compliance and certifications

M-Files Quality Management Solution (QMS) is an easy-to-use solution for Standard Operating Procedure (SOP) management, quality document control, quality audits, Corrective and Preventative Actions (CAPAs), risk management, training and employee qualification.

Organizations use M-Files quality management software 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.

Top 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 – The Best Agile eQMS Software of 2020

Use content management software that’s simpler, faster, and more efficient than ever!

Technology has completely changed the way we do business, communicate with others, and achieve our goals. So – why do so many businesses seem stuck in the Stone Age when it comes to their document management systems? Let us help you evolve into a streamlined, well-managed, and efficient business by using M-Files. Start our 30-day trial and be blown away by the amazing results.

Let M-Files help you focus your valuable resources, capitalise on your investments, and empower your business to reach its full potential. Take a look at our engaging video to learn more!

Don't just believe our words


Happy M-Files users


Organizations use M-Files


Growth in past 3 years


The 2020 Gartner Magic Quadrant Most Visionary

M-Files received this recognition thanks to its prowess as a professional Content Services Platform. This award was bestowed based on M-Files’ innovative solutions, unstoppable growth, and seamless execution of state-of-the-art information management systems and solutions.


The Leader for 2020 Nucleus Research Technology Value Matrix

The fact that M-Files was recognized as a Leader in the 2020 Nucleus Research Technology Value Matrix for ECM is exceptional. The fact that they’ve consistently received this recognition for the past 7 years is almost unbelievable! Download the report to compare the top 17 Content Management vendors


The Top-Rated Enterprise Content Management (ECM) Software

End-Users on Trust Radius rated M-Files as one of the top providers of intelligent content management software at the enterprise level.  M-Files received some of the highest scores that vendors could receive based on their product scalability and incredible performance.

What People Are Saying

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Theresa Reeves

Extra Space

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Ada Leonard

Monarch Inc

They Manage their documents intelligently

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