8 Mandatory Elements of a QMS System

8 Mandatory Elements of a QMS System

In the current landscape of tightly regulated industries, a Quality Management System (QMS) is a critical set of processes that ensure compliance with FDA, ISO, and global GxP regulatory requirements. The ultimate goal: delivering safer, top-notch products while boosting productivity. No matter your industry – be it manufacturing, medical devices, aerospace, pharmaceuticals, or nutraceuticals – a successful QMS must be adaptable to meet your specific business needs.

So, what should you look for in a top-notch QMS?

A comprehensive QMS framework goes beyond just data analytics; it empowers users to make informed decisions, enhancing productivity across your organization. Here are eight robust QMS applications you should have:

  1. Managing Nonconformance (NCM):

    A vital part of any continual improvement plan, Intellect’s QMS Platform allows you to capture, track, and maintain accurate, auditable nonconformance records via a centralized database. Transparency for departments, sites, or locations ensures you surpass audit and corrective/preventive action requirements, including ISO 9001, ISO 14001, and OHSAS 18001.

  2. Complaints Management:

    Customer retention, regulatory compliance, and protection against product liability lawsuits are essential. Intellect QMS comes with change management, automation, version control, and workflows, enabling seamless communication, acknowledgment, and implementation of requirements.

  3. Change Management:

    Crucial for closed-loop quality, change management demands automation, version control, and efficient workflows. Intellect QMS seamlessly integrates with your enterprise systems, offering complete transparency throughout the change process.

  4. CAPA (Corrective and Preventive Action):

    Implementing corrective and preventive actions is a must to comply with industry regulations, such as GMP, ISO 9001, and 14001, TSCA, and REACH. Intellect QMS’s CAPA process workflows ensure a controlled environment, reducing the risk of recurring issues.

  5. Document Control Management:

    Centralize your documents with approval workflows and audit trails. Say goodbye to document redundancy and outdated SOPs, and welcome efficiency in organizing your critical documents.

  6. Supplier Quality Management:

    Effectively qualify, select, and monitor suppliers and supply chain partners. Intellect QMS’s flexibility allows you to define, track, manage, and report supplier actions, ensuring top-notch quality across your operations.

  7. Audit Software:

    Reduce risk and ensure harmonized processes with Intellect’s secure centralized system. Comply with government regulations and industry standards while providing management with essential data for evaluating audit effectiveness.

  8. Employee Training:

    Maximize your employees’ skills with a single interface for developing and managing training initiatives. Intellect QMS’s comprehensive employee life-cycle management system keeps certifications up-to-date.

Discover the Intellect QMS Advantage:

As an industry leader in highly configurable QMS and no-code platform software, Intellect offers a faster implementation time, robust out-of-the-box capabilities, and the flexibility to meet your unique process requirements. Easily adapt to changing business needs and regulations by building and modifying new business apps to address your diverse requirements.


1- Can Intellect’s QMS Platform cater to my specific industry requirements?

Absolutely. Whether you’re operating in manufacturing, medical devices, aerospace, pharmaceuticals, or nutraceuticals, Intellect’s QMS Platform is designed to be versatile and adaptable. Our solutions can be tailored to align perfectly with the unique regulatory and operational demands of your industry. By customizing workflows, data capture, and reporting, we ensure that your QMS is finely tuned to meet your needs.

2- How does Intellect QMS ensure compliance with a range of regulations?

Intellect QMS is purpose-built to streamline compliance with a multitude of regulations and standards, including ISO 9001, ISO 14001, GMP, and more. Our platform incorporates advanced features like audit trails, document control, risk management, and CAPA workflows, ensuring your processes adhere to regulatory requirements. By centralizing data, automating workflows, and providing real-time reporting, Intellect QMS makes achieving and maintaining compliance effortless.

3- Can Intellect QMS adapt as regulations and business needs evolve?

Absolutely. One of the standout benefits of Intellect QMS is its configurability. As regulations change and your business requirements evolve, our platform empowers you to make necessary adjustments without the need for complex coding. Whether it’s modifying existing processes or creating new business apps, you can effortlessly ensure that your QMS remains aligned with the latest industry standards and the changing goals of your organization.