Software for quality management

Secure documents, instructions and procedures

Quality management software from M-Files makes it easy for companies to improve their quality management and easily comply with certification requirements. Thanks to years of experience with stringent quality and compliance needs, M-Files possesses all the common document and process management capabilities that are important in quality management.

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Easily meet quality certification requirements

With M-Files QMS, you easily comply with quality standards and norms. Quickly comply with ISO 9001:2015, ISO 13485 and CE certification, among others.

Out of the box support

Do away with paper and automate your quality management processes. M-Files QMS supports most common processes as standard, allowing you to get started right away.

Comply with all laws and regulations

M-Files QMS is designed to comply with applicable laws and regulations in aviation & automotive, pharmaceutical, healthcare, petrochemical and (food) manufacturing.

A complete solution for daily quality management

Not a standard quality manual or a simple system to publish SOPs with, but a very complete QMS suite that secures all your quality documents, processes and communication. So you have one version of all your quality documents and it is always the right one. All processes and communications are logged in M-Files and are extremely easy to search.

Saving time with Document Control

Document Control is designed to manage essential business documents such as SOPs (standard operating procedures), instructions, guidelines, training materials, key production documents and official company templates. Different signing options, major and minor versions, automatic predefined document permissions and document requests are just a few functionalities that will save your quality management a lot of time.

Quality management tuned thanks to modules

With the modules staff, QMS training, stocks, quality assurance, repetitive quality tasks and subcontractors & suppliers you make gains in all areas of quality management.

Quality management functionalities

Training

Manage course lists and materials. Maintain and report on training courses.

Inventory, lists and registers

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

Staff

Assign role-based access rights and track experience and skills progression for employees and subcontractors.

Signature management

When documents need to be approved or authorised, M-Files QMS supports three signing options: built-in digital signature, external digital signature and handwritten signatures. These are compliant with 21 CFR Part 11.

Quality assurance, audits and deviations

Manage audits and inspections, and efficiently record and process discrepancies and corrective actions.

Document control

Organise and manage all quality-related documents, such as Standard Operating Procedures (SOPs) and Corrective and Preventative Actions (CAPAs), with full version history, security, workflow and publication.

Task automation

Automate and document repetitive tasks and processes with extensive workflow capabilities and reminders.

Other functions

PDF conversion, watermarking and content protection with certificates.
Calendar view with integrated scheduling and follow-up reminders.

Achieve ISO 9001:2015 certification with a customised ECM

Does your organisation comply with ISO 9001:2015? A customised Enterprise Content Management solution helps organisations comply with this ISO standard.

In this white paper, you will discover how ECM systems can help automate and simplify the information and process management required for ISO certification.